The field of Urogynaecology has expanded dramatically over the past decade with the advent of a number of new medical and surgical treatment modalities. The evidence base on pelvic floor dysfunction has also grown extensively. This multi-contributor textbook will prove invaluable to gynaecology, urology and surgery registrars and specialists. Physiotherapists and nurses working in the field of Urogynaecology will also find it extremely useful.
Editors: Stephen Jeffery, Peter De Jong
Institution: University of Cape Town
This resource is part of the African Health Open Educational Resources Network: http://www.oerafrica.org/healthoer. The original resource is also available from the authoring institution at http://opencontent.uct.ac.za/.
Creative Commons license: Attribution-Noncommercial-Share Alike 3.0
4. Developed by the
Department of Obstetrics and Gynaecology
University of Cape Town
Edited by Stephen Jeffery and Peter de Jong
Creative Commons Attributive Licence 2010
This publication is part of the CREATIVE COMMONS
You are free:
to Share – to copy, distribute and transmit the work
to Remix – to adapt the work
Under the following conditions:
Attribution. You must attribute the work in the manner specified by the author
or licensor (but not in any way that suggests that they endorse you or your
use of the work)
Non-commercial. You may not use this work for commercial purposes.
Share Alike. If you alter, transform, or build upon this work, you may
distribute the resulting work but only under the same or similar license to
this one.
For any reuse or distribution, you must make clear to others the license terms of
this work. One way to do this is with a link to the license web page:
http://creativecommons.org/licenses/by-nc-sa/2.5/za/
Any of the above conditions can be waived if you get permission from the
copyright holder.
Nothing in this license impairs or restricts the authors’ moral rights.
Nothing in this license impairs or restricts the rights of authors whose work is
referenced in this document
Cited works used in this document must be cited following usual academic
conventions
Citation of this work must follow normal academic conventions
http://za.creativecommons.org
5. Contents
List of contributors 1
Foreword 2
The Urogynaecological History 3
Lower Urinary Tract Symptoms and Urinary incontinence:
Definitions and overview. 8
Examination and the POP-Q 17
Essential Urodynamics 23
Medical Management of the Overactive Bladder 26
Intractable OAB: Advanced Management Strategies 40
The Treatment of Stress Incontinence 45
Management of Voiding Disorders 55
Sexual Function in women with Incontinence 64
Urinary Tract Infections (UTIs) in Women 71
Neurogenic Bladder 76
Interstitial Cystitis 95
Introduction to Pelvic Organ Prolapse 97
Pathoaetiolgy of Prolapse 108
Conservative Management of Pelvic Organ Prolapse 119
Surgical Management of Urogenital Prolapse 126
Sacrocolpopexy 133
Pelvic Floor Muscle Rehabilitaion 137
Management of Faecal Incontinence 149
6. Use of Mesh, Grafts and Kits in POP surgery 154
Management of Third and Fourth degree tears 181
Management of Urogenital Fistulae 186
Role of the laparoscope in Urogynaecology 198
Suture Options in Pelvic Surgery 201
Thromboprophylaxis in Urogynaecological Surgery 213
7. Contributors
Corina Avni Suren Ramphal
Women’s Health Physiotherapist Department of Obstetrics and
Lavender House Gynaecology
Kingsbury Hospital University of Natal
Claremont
Cape Town Peter Roos
Department of Urogynaecology
Dick Barnes University of Cape Town
Department of Urology
University of Cape Town Trudie Smith
Department of Obstetrics and
Hennie Cronje Gynaecology
Department of Obstetrics and University of the Witwatersrand
Gynaecology
University of the Free State Douglas Stupart
Department of Colorectal Surgery
Peter de Jong University of Cape Town
Department of Urogynaecology
University of Cape Town Paul Swart
Department of Obstetrics and
Etienne Henn Gynaecology
Department of Obstetrics and University of Pretoria
Gynaecology
University of the Free State Kobus van Rensburg
Department of Obstetrics and
Barry Jacobson Gynaecology
Department of Haematology University of Stellenbosch
University of Witwatersrand
Frans van Wijk
Stephen Jeffery Pretoria Urology Hospital
Department of Urogynaecology Pretoria
University of Cape Town
1
8. Foreword
First Edition of Textbook of Urogynaecology
Urogynaecology is an exciting and dynamic subspecialty. The last decade
has seen a rapid advance in the management options available to the
gynaecologist in treating women with pelvic floor dysfunction. Stress
incontinence surgery was revolutionised by the development of the TVT
and exciting long term data has confirmed this device as a gold standard
in the management of SUI. Overactive bladder has seen the launch of
a number of new anticholinergic drugs with better side-effect profiles
and dosing schedules. We also now have some alternatives to the drugs
including Botulinum Toxin A and neuromodulation. We are developing
a greater understanding of the role of childbirth and pregnancy in pelvic
floor dysfunction. The last three years has seen the launch of intriguing
pelvic floor replacement systems and although we are some way off from
achieving long term data on these devices, this is no doubt an important
step in the evolution of pelvic floor surgery.
This book has been written by a number of authors from different parts
of South Africa. The field of urogynaecology is still in its infancy and we
therefore have many unanswered questions. In this volume, the reader
will therefore encounter varying opinions. There is a significant amount
of overlap and difference of opinion and we hope this will stimulate the
reader to read widely and formulate his or her own opinion.
The electronic format of this text has made it possible to offer it to the
reader at an affordable price. We trust that this book will contribute to
a better understanding and management of South African women with
pelvic floor dysfunction. We dedicate it to the women of South Africa.
A special thanks to Robertha and Anthea Abrahams for secretarial work,
and Dr Julie van den Berg for assistance with proof reading.
The Editors
2
9. Chapter 1
The Urogynaecological History
Stephen Jeffery
Pelvic floor dysfunction is the doctor have been shown to be
associated with multiple fraught with subjective influences.
symptoms including bladder, A number of questionnaires are
bowel and sexual complaints. In now available which are able to
addition, women may present elicit symptoms in a standardised
with neurological symptoms, form and quantify them. This is
psychological issues and particularly useful in a research
relationship dysfunction. It is setting but these instruments
therefore imperative that the are now increasingly being
history and examination are used in day-to-day practice.
performed in a comprehensive Similarly, the examination of the
fashion. urogynaeological patient has
become more scientific with the
Urogynaecological symptoms advent of more detailed and
are never life-threatening but scientific prolapse scoring systems.
they can have a profound impact
on the women’s quality of life.
Clinical assessment therefore
aims to determine the extent of
History
the impairment on quality of life
Urinary Symptoms
and thereby institute the most
appropriate route of investigation
Frequency
and management.
This is defined as the number of
voids during waking hours. Normal
Clinicians use the traditional
frequency is considered to be
approach of history and
between four and seven voids a
examination. Symptoms as elicited
day.
by the traditional interview by
3
10. Nocturia comfortably deferred by the
This is the number of times a woman.
woman has to awake from sleep to
pass urine. This varies with the age Urgency Incontinence
of the woman, with an increase Here, the women describes the
reported in woman above the age symptoms of urgency and she is
of 70 years where normal would unable to get to the toilet in time
be considered to be twice at night, and develops incontinence as a
three times for women over 80 result.
and four times for women over 90
years of age. Determining the severity of
Incontinence
Incontinence It is important to make a clinical
Symptoms of Urinary Incontinence attempt to determine the severity
are notoriously difficult to of the incontinence symptoms. The
evaluate. The International woman could be asked to quantify
Continence Society defines the symptoms on a scale of 0 to
this as the “involuntary loss I0. When this is done using a chart
of urine which is a social or it is called a visual analogue scale
hygienic problem and objectively (VAS). Many women present with
demonstrable”. mixed symptoms of both stress and
urge incontinence and by asking
Stress Incontinence them to quantify each symptom
This is the involuntary loss of urine using the visual analogue score,
with a rise in intra-abdominal we are able to determine which is
pressure. Factors that commonly more severe.
elicit stress incontinence include
running, laughing, coughing, The patient should also be asked
sneezing and standing up from a about the use of continence aids
seated position. such as pads and how often she
changes her underwear. The
Urinary urgency number of incontinence episodes
This is the compelling desire to per day can also be indicative of
void which is difficult to defer. the severity of the condition.
It must be differentiated from
urinary urge which is a normal Symptoms of voiding
desire to void which can be dysfunction
4
11. These symptoms are not as
common in women as in men Prolapse symptoms
but if present, should prompt Women with prolapse have a
the appropriate investigation of broad range of symptoms. Studies
urinary residual and flow rate. have shown that the symptoms
These symptoms include: increase significantly with stage 2
Hesitancy prolapse or greater. Most women
Straining to void will complain of a bulge or a lump,
Incomplete Emptying whilst others will describe either
Post- Micturition dribbling discomfort or a burning sensation.
Poor Stream Still others will describe associated
Double Voiding voiding or defaecatory difficulty,
needing to reduce the prolapse to
Bladder pain void or completely evacuate their
Women with bladder pain should bowels.
be questioned in detail regarding
the nature and occurrence Bowel symptoms
of the symptoms. Pain that is Evaluation and questioning
relieved with passing urine may regarding bowel symptoms is an
be associated with Interstitial essential part of the evaluation of
Cystitis/ Painful Bladder Syndrome. the pelvic floor.
Women with pain as a significant
symptom should be evaluated Anal Incontinence
with cystoscopy and biopsy since This is the involuntary passage of
pain may also be associated with flatus.
tumours and stones.
Faecal Incontinence
Urethral Pain This is defined as the involuntary
This may be associated with passage of liquid or solid stool.
infections or urethritis. This should be quantified by asking
the women about the frequency,
Haematuria severity, use of continence aids
Women with urinary symptoms and impact on quality of life.
should always be questioned
regarding the presence or Faecal urgency and urge
absence of blood in the urine and incontinence
investigated appropriately. This is an important symptom
5
12. which is often underreported and be recorded.
seldom elicited by the clinician. Medications
A note should be made of
Defaecatory dysfunction medications that may be
Women should be asked about worsening the symptoms, including
any difficulty in completing diuretics and alpha –blockers.
defaecation including digitation,
splinting or manual evacuation. Medical History
Diabetes Mellitis and Insipidus are
Constipation usually associated with polyuria.
A record should be made of Cardiac failure can present
frequency of stools and any with nocturia as a result of the
symptom of constipation. redistribution of fluid when the
patient is lying down.
Sexual History
A detailed history of sexual Fluid Intake
function is vital to a thorough The amount and type of fluid
assessment of pelvic floor consumed on a daily basis should
disorders. Women should be be recorded. Caffeine and alcohol
asked if they are sexually active. can exacerbate symptoms of
Any problems should be noted overactive bladder significantly
including dyspareunia, vaginal and these products in particular
slackness, vaginal tightness, should be enquired about.
anorgasmia, coital faecal or urinary
incontinence during intercourse. Obstetric History
The number and type of deliveries
are important as well as any history
Other relevant parts of perineal or anal sphincter injury.
of the history Surgical History
Previous pelvic surgery, including
Neurological history
prolapse and incontinence surgery,
Women should be questioned
should be noted.
regarding symptoms of limb
weakness and sensory fallout.
Any history of multiple sclerosis,
parkinsonism, spinal cord injury,
stroke or spina bifida should also
6
13. Causes of Incontinence
I. Stress Incontinence
Sphincter Dysfunction
Abnormal Bladder neck support
2. Detrusor Overactivity
Idiopathic
Neurogenic
3. Mixed incontinence
4. Overflow Incontinence
5. Functional Incontinence
Confusion
Dementia
6. Pharmacologic
7. True incontinence
Fistulae
8. Transient Incontinence
UTI
Restricted Mobility
Constipation
Atrophic Urethritis
9. Congenital Abnormalities
I0. Excessive urine production
Diabetes Mellitis and Insipidus
Diuretics
Cardiac failure
Adapted from Textbook of Female
Urology and Urogynaecology Eds
Cardozo and Staskin.
7
14. Chapter 2
Lower urinary tract symptoms
and urinary incontinence: an
overview
Peter de Jong
Definitions of Symptoms symptoms cannot be used to make
Lower urinary tract symptoms, a definitive diagnosis. However
(LUTS) are equally bothersome LUTS can also indicate pathologies
to men and women, and greatly other than lower urinary tract
affect the quality of life (QOL). dysfunction, such as urinary
infection. The clinician will make
The term “Lower urinary tract his/her best efforts to exclude
symptoms” is used to describe other causes of LUTS.
a patient’s urinary complaints
without implying a cause. Lower Lower urinary tract symptoms are
urinary tract symptoms were categorized as storage, voiding
defined by the standardization sub and post micturition symptoms.
– committee of the International (Table 1)
Continence Society.
Storage Symptoms are experienced
LUTS are the subjective indicators during the storage phase of the
of a disease or change in bladder, and include daytime
conditions as perceived by the frequency and nocturia.
patients, carer or partners and may
lead her to seek help from health Increased daytime frequency is
care professionals. Symptoms may the complaint by the patient who
either be volunteered or described considers that he/she voids too
during the patient interview. They often by day. The average person
are usually qualitative. voids 6 times a day.
In general, lower urinary tract Nocturia is the complaint that the
8
15. individual has to wake at night Stress urinary incontinence is the
one or more times to void. complaint of involuntary leakage
on effort or exertion, or on
Urgency is the complaint of a sneezing or coughing.
sudden compelling desire to pass
urine, which is difficult to defer. Urgency urinary incontinence is the
complaint of involuntary leakage
Urinary incontinence is the accompanied by or immediately
complaint of any involuntary preceded by urgency.
leakage of urine.
In each specific circumstance, Mixed urinary incontinence is the
Table 1 LUTS
FILLING / STORAGE EMPTYING / VOIDING POST VOIDING SYMPTOMS
Frequency Hesitancy Post – micturition dribbling
Urgency Straining to void Feeling of incomplete
emptying
Nocturia Poor stream
Urgency Incontinence Intermittency
Stress Incontinence Dysuria
Nocturnal Incontinence Terminal dribbling
Bladder / Urethral Pain
Absent or Impaired Sensation
urinary incontinence should be complaint of involuntary leakage
further described by specifying associated with urgency and also
relevant factors such as type, with exertion, effort, sneezing or
frequency, severity, precipitating coughing.
factors, social impact, effect
on hygiene and quality of life, Enuresis means any involuntary
measures used to contain the loss of urine. If it is used to denote
leakage, and whether or not the incontinence during sleep, it
individual seeks or desires help should always be qualified with
because of urinary incontinence. the adjective “nocturnal”.
9
16. Nocturnal enuresis is the complaint or in comparison to others.
of loss of urine occurring during
sleep. Intermittent stream or Double
voiding (Intermittency) is the term
Continuous urinary incontinence used when the individual describes
is the complaint of continuous urine flow which stops and starts,
leakage and may denote urinary on one or more occasions, during
fistula. micturition.
Bladder sensation can be defined, Hesitancy is the term used when
during history taking, into four an individual describes difficulty
categories. in initiating micturition resulting
in delay in the onset of voiding
Normal: the individual is aware after the individual is ready to pass
of bladder filling and increasing urine.
sensation up to a strong desire to
void. Straining to void describes the
muscular effort used to initiate,
Increased: the individual feels an maintain or improve the urinary
early first sensation of filling and stream.
then a persistent desire to void.
Terminal dribble is the term used
Reduced: the individual is aware when an individual describes a
of bladder filling but does not feel prolonged final part of micturition,
a definite desire to void. when flow has slowed to a trickle
or dribble.
Absent: the individual reports
no sensation of bladder filling or Post micturition symptoms are
desire to void. experienced immediately after
micturition.
Voiding symptoms are experienced
during the voiding phase. Feeling of incomplete emptying
is a self – explanatory term for
Slow stream is reported by the a feeling experienced by the
individual as the perception individual after passing urine.
of reduced urine flow, usually
compared to previous performance Post micturition dribble is the term
10
17. used when an individual describes incontinence episodes.
the involuntary loss of urine
immediately after passing urine, FVC’s have been shown to be
usually after leaving the toilet. reproducible and more accurate
when compared with the patient’s
Frequency – Volume Chart recall. The optimal length of
(Bladder Diary) a diary varies according to the
Frequency – volume charts (FVC) parameter assessed and precision
have become an important and sensitivity required. In
part of the evaluation of LUTS. addition, if one is trying to assess
Most experts would agree that change, the baseline parameter
these charts provide invaluable (e.g number of voids, incontinence
information about a number episodes) will affect the length
of symptoms including urinary of the diary needed to detect
frequency, urgency, incontinence a certain change. A 7 day diary
episodes, and voided volume. In is a reasonable option for most
fact some symptoms, like nocturia, patients with incontinence. If
cannot be properly evaluated record keeping for 7 days increases
without a chart. Frequency – a patient’s burden the number of
volume charts are critical for the days required to evaluate voiding
distinction between nocturnal symptoms should be reduced.
overactive bladder and nocturnal
polyuria, two common causes The majority of information
of nocturia. Despite this the collected on FVC’s or bladder
structure, content and duration diaries has been used to establish
of chart keeping for evaluation baselines or to study patients with
has not been standardised. There OAB or incontinence.
are a number of parameters
that can be assessed by the FVC, Physical examination
including: total number of voids A general physical examination
per 24 hours, total number of of the patient is mandatory, since
daytime (awake) voids, total many co–morbid conditions are
number of night time voids, likely to impact on the symptoms
total fluid intake, total voided of LUTS (Table 2)
volume, maximum, minimum and
mean voided volume, number of
urgency episodes, and number of
11
18. Table 2 Comorbid conditions and nitrites, although infection
causing LUTS may exist in the absence of pyuria
and, in the elderly population,
Medical disorders pyuria may develop in the absence
›! Hypertension / heart failure of UTI. Microscopic haematuria can
›! Mulitple sclerosis be easily identified by dipsticking
›! Diabetes Mellitus because of the presence of
Reduced mobility haemoglobin. The detection of
Alzheimers haematuria is important because
Medical therapy, i.e diuretics the condition is associated with
Neurological disorders a 4 – 5% risk of diagnosing a
urological disorder or malignancy
A detailed gynaecological within 3 years. Because of the
assessment is important, with high prevalence of urinary tract
particular attention to pelvic infection (UTI) and the increase
floor disorders, and prolapse. A of LUTS in the presence of UTI, all
full neurological examination guidelines on the management
is also required. Digital rectal of patients with LUTS and urinary
examination is useful to evaluate incontinence, endorse the use
the possibility of co – existent anal of urinalysis in primary care
/ faecal incontinence. management.
Special investigations Urodynamic
Investigations
Urinalysis
Urinalysis is not a single test What is meant by the term
- complete urinalysis includes Urodynamic investigations?
physical, chemical, and microscopic In 1970 Bates coined the expression
examinations. Dipstick urinalysis that ‘the bladder often proves to
is certainly convenient but false be an unreliable witness’, meaning
positive and false negative results that the presenting symptoms
may occur. It is considered an of the patient and the eventual
inexpensive diagnostic test able to diagnosis of the problem are often
identify patients with urinary tract at variance. In 1972 Moolgaoker
infection (UTI) as indicated by the stated that ‘urinary symptoms in
presence of leucocyte esterases the female do not form a scientific
12
19. basis for treatment’. Videocystourethrography is used
in advanced centres and is the
Urodynamic tests have been gold standard of the investigation
developed to confirm the of female urinary incontinence.
underlying diagnosis in a patient It involves contrast media and
complaining of symptoms of screening radiology superimposed
urinary incontinence. These upon conventional cystometry to
tests identify the etiology of provide an accurate diagnosis. This
the problem and elucidate its modality is not widely available.
pathophysiological mechanism.
Their use is sometimes debatable, Increasingly, ultrasound imaging is
since grade A evidence supporting also being used to measure both
the general use of urodynamics in bladder neck descent and bladder
the investigation of incontinence, wall thickness. Electromyography
is not available. and cystoscopy are adjuncts to
The most basic form of urodynamic urodynamics in complex patients
testing which is used in present with atypical pathology.
day practice consists of:
The measurement of urethral
1. Uroflowmetry (otherwise resistance pressure has recently
known as a ‘free flow been pioneered. This does have
measurement’ potential as a diagnostic tool of
2. Multichannel urodynamics the future. However, at present
which involve filling and its widespread use as a routine
voiding cystometry (the latter urodynamic tool is questionable
being a so – called ‘pressure – and it should only be used in
flow’ study). research studies aimed at clarifying
its value.
Depending on the sophistication of
the apparatus used, either a leak Basic tests which should be
– point pressure measurement, or performed on patients prior to
urethral pressure profilometry may urodynamic testing include a
be performed additionally as a test urine microscopy and culture,
of urethral function. Urodynamic and a measurement of residual
testing can either be static or urine volume, either by catheter
ambulatory. or ultrasound. A bladder diary
(frequency / volume chart) is
13
20. also a necessary aid to diagnosis. of these conditions may mimic
The latter has been shown to the symptoms associated with
provide valuable information on stress incontinence and destrusor
the patient’s voiding pattern and overactivity.
functional bladder capacity, as well
as giving an indication of leakage A cough – induced bladder
episodes. contraction causing leakage
may be confused with stress
It can be said that most incontinence (so called ‘stress –
urodynamic tests are expensive, induced instability’).
time consuming and invasive
(involving catheterization of There may be serious sequelae if
the patient). They also require a patient suffering from urinary
considerable expertise and access incontinence is not adequately
to sophisticated equipment. evaluated and an incorrect
There should therefore be sound diagnosis is made. The most serious
motivation for their use as a of these is inappropriate surgery.
diagnostic tool. Failure to recognize concomitant
detrusor overactivity and / or
Clinical Indications for voiding dysfunction may also
Urodynamics Investigations affect the outcome of appropriate
There are many etiological factors surgery.
leading to urinary incontinence
in women. Certainly the most Table 1 lists the most important
common problems are urodynamic indications for urodynamic studies.
stress incontinence due to
urethral sphincter weakness or Table 1: Indications for
bladder neck hypermobility, and urodynamic studies
detrusor overactivity leading to
incontinence (in most cases ‘urge 1. Prior to surgery
incontinence’). Other causes of
2. Failed medical or surgical treatment
incontinence include fistulae,
3. Complex symptomatology
urethral diverticulae, urethral
instability, the urethral syndrome 4. Neurological dysfunction
and also the contributory effect 5. Voiding dysfunstion
of urinary tract infection. It
6. Medico – legal cases
must be emphasized that many
14
21. Clinical Diagnosis versus History, clinical examination
urodynamic diagnosis and basic tests
Over the past 35 years there have In the ongoing search for an
been ongoing discussions in the uncomplicated and cost – effective
literature on how best to evaluate approach to the pre – operative
patients with incontinence. The evaluation of a patient for
accurate identification of patients stress incontinence surgery,
with SUI has received considerable several authors looked at other
attention parameters which could prove
useful.
The accuracy of history alone
Most of the early papers looked In summary the addition of other
at the discriminatory value of clinical parameters and simple
a pure history of either stress office tests do enhance the
incontinence or detrusor instability. sensitivity of a history. However,
Symptoms alone were used to the various authors still found
make a diagnosis before patients the combination inadequate for
were subjected to confirmatory a reliable diagnosis and most
cystometry. Most of the earlier felt that additional research was
studies had relatively low numbers warranted.
of patients. In summary, it is clear
from the majority of studies that In South Africa, Urogynaecology as
a history of incontinence alone is a subspeciality is still in its infancy.
not enough to enable a clinician Treatment decisions in female
to make an accurate diagnosis urinary incontinence management
for a decision on whether or not are mostly made on clinical
to embark on stress incontinence judgment. There are very few
surgery. The symptom of stress management protocols in place
incontinence may be very sensitive, and this is an area which urgently
but is so nonspecific as to render it requires development, particularly
of little diagnostic value. at specialist level.
History is best used as a guide to Medical practice is increasingly
the subsequent evaluation process becoming dogged by litigation and
and to serve as a measure of practitioners have to be able to
disease severity. show that they have their patient’s
best interest at heart by backing
15
22. up clinical diagnosis with special
investigations.
In the larger centres in SA
there are facilities available for
performing urodynamic studies
but these are mostly underutilised.
They are often also run by staff
who are not properly trained to
provide good quality results and
interpretation.
There is an increasing number of
practitioners in SA who have a
special interest in Urogynaecology
and who manage female patients
with urinary incontinence. It is
these practitioners who should
be at the forefront of attempts
to develop mechanisms which are
aimed a providing the best possible
service for their patients. “Best
practice’ therefore also means
a move away from ‘preference
– based’ to ‘evidence – based’
medicine.
16
23. Chapter 3
Physical Examination and the
POP-Q
Peter de Jong, Stephen Jeffery
All women presenting with lower limbs. The anal sphincter
pelvic floor dysfunction should tone should be tested.
be thoroughly examined in
the supine, left lateral and
standing positions. Where a Gynaecological
surgical intervention is planned,
the responsible surgeon should
Examination
determine exactly what may
It is impossible to perform an
be required at operation – so
adequate urogynaecological
that the appropriate consent
examination without using a
can be obtained and the correct
Sims speculum and in some
intervention planned.
circumstances two Sim’s speculae
are required. The examination
begins with the woman in the
General dorsal position. The vulva and
vagina are inspected for any
The women’s mobility and general lesions, atrophy or excoriation.
condition should be noted. The woman is then asked to
cough or valsalva while the
clinician observes for any stress
Neurological incontinence. She is then asked
examination to turn onto her left side and the
Sims speculum is used to inspect
The spinal segments S2,3.4 should the anterior and posterior vaginal
be assessed by testing the tone, walls for prolapse. It is imperative
strength and sensation in the that the middle compartment is
17
24. also adequately assessed for any Grade I: Descent halfway to the
uterine or vaginal vault descent. introitis
This can be difficult, but if one Grade 2: Descent down to the
uses two Sims speculae placed vaginal introitis
anteriorly and posteriorly, while Grade 3: Descent beyond the
the women strains down, it introitis but not maximal
is relatively easy to assess this Grade 4: Maximal descent
compartment. The prolapse should
be graded using either the Baden- This grading system is useful in day
Walker or POP-Q systems (see to day clinical practice but it has a
below). If the women’s symptoms number of shortcomings. It does
are not adequately explained by not give a quantitative impression
the findings at examination, it may of the severity of the prolapse.
be useful to perform an additional It does not address the vaginal
assessment with her standing. This length, perineal body size or the
is accomplished by asking her to length of the urogenital hiatus.
stand with her legs apart while The POP-Q (Pelvic Organ Prolapse
the examiner bends in front of Quantification System) was
the patient and gently palpates developed by the International
the anterior, middle and posterior Continence Society to address
compartments. She is then asked these issues and it supercedes the
to cough again in the standing previous systems used to describe
position. POP. The new objective assessment
allows a clear and unambiguous
description of prolapse, facilitating
Classification and better objective assessment,
management and surgical
grading of prolapse comparison. Precise staging made
gynaecological oncology an
Grading and classification of pelvic
objective progressive disciple, and
organ prolapse enables clinicians
it is hoped that introduction of
to communicate with each other
POP – Q will allow similar advances
and is also useful in a research
in the management of prolapse.
setting. The most commonly used
Terms used in the past such as for
grading system is the Baden-
example small, medium or large,
Walker halfway system which
cystocoele or rectcoele, are no
grades prolapse as follows:
longer applicable. At first glance,
18
25. the system appears complicated the following table.
and difficult to master but
once it is understood, it can be All measurements are made to the
performed in less than 30 seconds nearest 0.5cm
while performing a routine
gynaecological examination. It Consensus and validation of the
is based on measurements that new system has been extensive.
are taken using the introitis as The clinical examination is
reference. Any measurement performed and the measurements
above this is negative and recorded on the “POPQ grid”.
anything below this is positive. (Table 2)
The measurements are taken using
a marked Pap smear spatula. Six
specific vaginal sites (points Aa, Ba,
C, D, Bp and Ap) and the vaginal
length (tvl) are assessed using
centimeters of measurement from
the introitus. The length of the
genital hiatus (gh) and perineal
body (pb) are measured.
The points are defined as follows,
with the ranges as suggested in
TABLE 1: POP - Q DEFINITION AND RANGES
Point Measurement Range
Aa Anterior vaginal wall 3cm proximal to the hymen -3 to +3
Ba Leading – most point of anterior vaginal wall prolapse -3 to +tvl
C Most distal edge of cervix or vaginal cuff (if cervix is absent) -/+ tvl
D Most distal portion of the posterior fornix -/+ tvl
Ap Posterior vaginal wall 3cm proximal to the hymen -3 to +3
Bp Leading – most point of posterior vaginal wall prolapse -3 to +tvl
gh Perpendicular distance from mid – urethral meatus to posterior hymen No limit
pb Perpendicular distance from mid – anal opening to posterior hymen No limit
tvl Posterior fornix or vaginal cuff (if cervix is absent) to the hymen No limit
19
26. TABLE 2: The POPQ Grid – Used Both the patient’s position during
to Record Examination Results. the examination (lithotomy,
anterior anterior anterior birthing chair, or standing) and the
wall wall wall state of her bladder and rectum
Aa Ba C (full or empty) should be noted
genital perineal total vaginal
hiatus body length Staging of the grade of pelvic
support is objectively done on a
gh pb tvl
five – stage system. (Table 4)
posterior posterior posterior
wall wall fornix
Table 4: The five stages of
Ap Bp D* Pelvic Organ Support
Stage 0: No descent of any compartments
*Measurement D is not taken in
Stage 1: Descent of the most prolapsed
the absence of a cervix compartment between perfect
support and – 1cm, or 1cm
proximal to the hymen
The measurement of prolapse
Stage 2: Descent of the most prolapsed
is performed in accordance
compartment between -1cm and
with certain measurement +1cm.
fundamentals. (Table 3) Stage 3: Descent of the most prolapsed
compartment between +1cm
and (tvl -2cm)
Table 3: POPQ Measurement
Fundamentals Stage 4: Descent of the most prolapsed
compartment from (tvl -2cm) to
All measurements are made to the nearest complete prolapse
0.5cm
All measurements are made relative to the
hymen
Points proximal to the hymen are negative Explanation of
(inside the body)
individual points
Points distal to the hymen are positive (out-
side the body)
Points Aa, Ab, Pa and Pb are the
The hymen is assigned a value zero
most difficult to understand. They
gh, pb, and tvl measurements will always represent the extent of prolapse,
have a positive value
be it above the introitis ( ie
All measurements, except for tvl, are made negative) or below the introitis ( ie
while patient is bearing down
positive)
20
27. Point Aa Point Bp
If an imaginary small man walked Again, this point describes more
from the introitis up the anterior extensive prolapse beyond the
vaginal wall and made a mark once 3 cm mark of Ap similar to Ba.
he had covered 3 cm this would be Again if there is no prolapse, by
point Aa. The distance this point convention it is -3.
descends on the vertical plane can
therefore be either -3, -2, -1 if it Point C
is above the introitis, 0 at the This describes the prolapse of the
introitis and +1,+ 2 or +3 below the cervix or vaginal vault. If the cervix,
introitis. This point is therefore for example, is 7cm above the
never more than 3 and represents introitis, this point is then -7, if it is
the bottom 3cm of the vagina. 4 cm below C is +4.
Point Ba Point D
This point describes additional This describes the descent of the
prolapse of the anterior vaginal posterior fornix again similar to
wall that goes beyond the first the cervix.
3 cm. It is the most distal part of
the prolapse. It can therefore be Total vaginal Length
greater than the +3 described for This is the measurement of
point Aa. For the milder prolapse, the length of the vaginal tube
it often equates to that of Aa. from top to bottom. It is usually
Because it essentially defines more measured with the marked spatula
extensive prolapse, when there inserted to its maximum into the
is no prolapse, by convention we vagina.
make it the same as Aa.
Urogenital hiatus
Point Ap The measuring spatula is placed
Again our imaginary man makes anteroposteriorly along the
the 3cm trip up the posterior wall introitis and measures from the
where he marks off point Ap. The urethral meatus to the midline of
distance this point descends can the posterior hymen.
again be therefore either -3, -2, -1
if it is above the introitis, 0 at the Perineal body
introitis and +1,+ 2 or +3 below the Again the perineum is measured
introitis. from the posterior hymen to the
21
29. Chapter 4
Essential Urodynamics
Stephen Jeffery
Urodynamics bladder is has a double lumen, one
to measure the bladder pressure
Whole books have been written (Pves) and the other lumen is used
on Urodynamic practice and to fill the bladder with water via
technique. The diagnosis in women the pump system. Sometimes,
with urinary incontinence based two separate catheters are used
on clinical findings is correct in for filling and pressure recording.
only 65% of cases. There is a large The rectal probe measures the
overlap between symptoms and intra-abdominal pressure (Pabd)
examination and urodynamic and this pressure could therefore
findings. 55% of women with also be obtained by inserting the
stress incontinence will have a line into the vagina or even into
mixed picture. The cystometrogram a colostomy. A Urodynamic report
becomes essential, in a number usually gives 3 pressure tracings:
of women, to enhance diagnostic Pves (bladder pressure), Pabd
accuracy and therefore enable us (abdominal) and Pdet (detrusor
to institute treatment. pressure). The detrusor pressure is
obtained by the following formula
Pdet = Pves-Pabd. Urodynamics is
therefore often called Subtracted
The equipment Cystometry.
The Urodynamics system comprises
two catheters, one placed in the
bladder and another in the rectum, The Procedure
a computer and the urodynamics
software and pressure transducers, The test comprises three
a pump system, and a flowmeter. phases.
The catheter that is placed in the
23
30. 1. Free flow phase are measuring appropriately,
The woman is asked to arrive when the women coughs, there
at the investigation with a full should be no deviation of the
bladder. She is then asked to Pdet – only on the vesical line and
void on the flowmeter, which is the abdominal line since these
usually mounted on a commode, in are both under the influence
privacy. It should be noted that this of abdominal pressure. In other
part of the test differs from the words, when there is a rise in
voiding cystometry, which is done abdominal pressure with coughing,
after the filling phase once the the same pressure is transferred
bladder is full and the lines are in to the bladder. The Pdet will
situ to measure the pressures. therefore be zero since Pves minus
Pabd is zero and the detrusor line
Flow Meter Commode will be flat with deviations only in
the Pabd and Pves.
Bladder filling is commenced
once the operator is satisfied that
the tracing is technically correct.
The patient is asked to report
on her first desire as well as the
moment she has a strong desire to
void. Any urgency and associated
incontinence is noted. Provocative
measures through the filling phase
2. Filling phase include asking the woman to heel
The bladder and rectal lines are bounce, wash hands and cough.
inserted with the patient supine This will also hopefully elicit any
and any urinary residual is noted. stress incontinence which is usually
The lines are flushed and the also occasionally recorded on the
system is zeroed. The women trace by a flowmeter but if this
is asked to cough to check that modality is not available on the
the Pdet measurement is correct. filling phase, is usually observed
For example, if the Pabd is not by visual inspection of the vulva.
measuring correctly, the Pdet will When the patient is unable to
not be accurately calculated. If tolerate any more filling, the pump
both the vesical and rectal lines is stopped, this is the maximum
24
31. cystometric capacity. During voiding Cystometery
Pressures are measured during
3. Voiding Cystometry the voiding cystometry phase
This is done by asking the patient and therefore parameters such
to void while the pressures are as PdetQmax, the detrusor
recorded. pressure during maximum flow,
is measured. A pressure greater
than 20cmH2O would suggest an
Possible Diagnoses obstruction.
During Free Flow
Flow rate is abbreviated as Q. A
normal flow curve is bell-shaped.
An obstructive pattern is flat or
with intermittent sections of flow.
The maximum flow is denoted
as Qmax. A normal flow rate is
defined as less than I5ml/s.
During Filling phase
Any contractions of the detrusor
tracing suggest a diagnosis
of detrusor overactivity (DO).
One should always look at the
abdominal tracing and this
should be flat during a detrusor
contraction to diagnose DO. If the
abdominal curve is also elevated,
this would suggest possible poor
subtraction and a diagnosis of
DO should not be made. If the
Detrusor pressure curve rises
slowly during the filling phase, this
would suggest poor compliance. If
one notes both stress incontinence
and DO during filling, a diagnosis
of mixed incontinence is made.
25
32. Chapter 5
The Medical Management
of the Overactive Bladder
Syndrome
Peter de Jong
Introduction 17.5 million women in the USA
who suffer from the condition.
The term “overactive bladder” The prevalence increases with
was proposed as a way of increasing age being 4 percent in
approaching the clinical problem women younger than 25 years and
from a symptomatic rather than 30 percent in those older than 65
a urodynamic perspective. The years. The overall prevalence of
overactive bladder syndrome OAB in individuals aged 40 years
(OAB) has been defined by the and older is 16%. Frequency, the
International Continence Society most common symptom, occurs in
as urinary urgency with or without 85% of respondents, while 54%
urge incontinence usually with complain of urgency and 36% of
frequency and nocturia. It is a urge incontinence.
diagnosis based on lower urinary
tract symptoms alone. While not Initial management of OAB should
life threatening, it can have a take into account the individual’s
considerable adverse impact on lifestyle and any appropriate
the quality of lives of those who interventions that can be
suffer from it, and it is highly employed to minimize symptoms.
prevalent within society. Recent For example, reducing excessive
epidemiological studies have fluid intake (25ml / kg / day is
reported the overall prevalence sufficient) and minimising caffeine
of OAB in women to be 16%, and alcohol consumption may
suggesting that there could be be helpful, as well as reviewing
26
33. any medication that may have prescribed for OAB have an
an impact on lower urinary tract antimuscarinic component, and
function, such as diuretics. this limits compliance with the
treatment because of a lack of
Behavioral therapies and, acceptability to some people.
particular, bladder retraining Recent advances have included
may help a person regain central sustained release preparations of
control of micturition and can be existing compounds, innovative
highly effective in well – motivated routes of administration and
individuals, although there is a newer antimuscarinic preparations.
recognized high relapse rate.
While many people will be
Drug therapy is the mainstay of considerably improved and even
treatment for OAB, and from cured of their symptoms by drug
the number of preparations that therapy, there are always those
have been studied, it is clear who do not respond and for them,
that there is no ideal drug for all it is most important that further
people. In the past, clinical results investigations are undertaken to
of treatment have often been ensure that the correct problem
disappointing due to both to poor is being addressed. Urodynamic
efficacy and unacceptable adverse studies will confirm (or otherwise)
effects. Earlier preparations were a diagnosis of detrusor overactivity
not subjected to the current in which case, further trials
rigorous randomised controlled of different antimuscarinic
trials and, therefore, lack evidence preparations would be desirable,
– based data. Comparison of whereas in the absence of
drug therapies for this condition proven detrusor overactivity,
is difficult due to the placebo an alternative diagnosis should
effect of 30 – 40%, and since the be sought to avoid further
response to any of the available ineffectual treatment and, hence
drugs is only in the region of 60%, disillusionment and a waste of
any differences that are detected resources.
are likely to be small, and thus
require large – scale studies to Definition of OAB
show efficacy.
syndrome
The drugs that are currently
OAB is a clinical diagnosis and
27
34. comprises the symptoms of is in line with current opinion
frequency (>8 micturitions / regarding the importance of
24 hours), urgency and urge urgency as the driving force behind
incontinence, occurring either the other components, frequency,
singly or in combination, which nocturia and incontinence,
cannot be explained by metabolic which are also mentioned in the
(e.g diabetes) or local pathological definition. Urgency is, however,
factors (e.g urinary tract infections, difficult to measure and in many
stones, interstitial cystitis). of the clinical trials assessing the
pharmacological treatment of OAB
In clinical practice, the empirical syndrome, micturition frequency
diagnosis is often used as the has often been used as the primary
basis for initial management endpoint as it is easier to quantify.
after assessing the individual’s
lower urinary tract symptoms,
physical findings and the The OAB – how
results of urinalysis, and other
indicated investigations. Thus, the
common is it?
International Continence Society in
There are at present only a few
its Standardisation of Terminology
population – based studies that
report from 2002 defined the
have assessed the prevalence
OAB syndrome as urgency with or
of OAB. The prevalence of OAB
without urge incontinence, usually
symptoms was estimated in a large
with frequency and noctuira.
European study involving more
These symptom combinations
than 16 000 individuals. Data were
are suggestive of urodynamically
collected using a population –
demonstrable detrusor overactivity,
based survey of men and women
but can be due to other forms of
aged 40 years, selected from
urethro – vesical dysfunction. The
the general population in France,
term “overactive bladder” can be
Germany, Italy, Spain, Sweden and
used if there is no proven infection
the UK using a random, stratified
or other obvious pathology.
approach. The main outcome
measures were prevalence of
In the current International
urinary frequency (>8 micturitions
Continence Society (ICS) definition
/24 hours), urgency and urge
of the OAB syndrome, urgency
incontinence; proportion of
is an obligatory component. This
participants who had sought
28
35. medical advice for OAB symptoms; 18 years and representative of
and current previous therapy the US population by sex, age,
received for these symptoms. and geographical region was
The overall prevalence of OAB assessed. The overall prevalence
symptoms in this population of of OAB was similar between men
men and women aged 40 years (16.0%) and women (16.9%) and
was 16%. About 79% of the was similar to the results reported
respondents with OAB symptoms earlier from Europe. The impact
had experienced symptoms for of OAB symptoms on quality of
at least 1 year and 49% for 3 life was assessed in a subset of the
years. Sixty – seven percent of participants from the NOBLE study.
the women and 65% of the men In individuals who reported OAB
with OAB symptoms reported that symptoms, these symptoms had a
their symptoms had an impact clinically significant negative effect
on daily living. The prevalence on quality of life, quality of sleep,
of OAB symptoms increased with and mental health.
age in both men and women.
OAB symptoms were relatively
more common in younger women Impact of OAB
compared with men, while the
opposite was found for the older
symptoms on
age groups where symptoms were employment, social
more common in men. However, interactions, and
when comparing the total
emotional wellbeing
population of men and women,
there was little difference in the
Symptoms suggestive of an OAB
overall prevalence reported in
often have a profound negative
women and men.
influence on quality of life. It
is not only episodes of leakage
The prevalence of OAB symptoms
that effect wellbeing but also
has also been assessed in a
urgency and frequency have
large population based survey
considerable detrimental effects
from the USA. The National
on daily activities. Constant worry
Overactive Bladder Evaluation
about when urgency is going to
(NOBLE) was designed to assess
strike results in the development
the prevalence and burden of
of elaborate coping mechanisms
OAB. A sample of 5204 adults
to enable people to manage
29
36. their condition (e.g voiding incontinence and noctuira have
frequently in an effort to avoid been shown to be associated with
leakage episodes, mapping out an increased incidence of falls and
the location of toilets, drinking fractures among elderly.
less, or the use of incontinence
pads). It is not difficult to see how The intensity of urinary urgency
these troublesome symptoms may has a significant association
disrupt people’s daily lives and with other symptoms of OAB.
occupations. Despite the negative Urgency is the ‘driving’ symptom
impact of these symptoms on in OAB, those experiencing OAB
quality of life, many affected frequently experience urgency at
individuals fail to report this inconvenient and unpredictable
condition to their physicians of times and consequently, often
symptoms for many years. This lose control before reaching the
may be due to embarrassment or toilet. This adversely affects their
possibly because of the mistaken physical and psychological state by
opinion that effective treatment is limiting daily activities, intimacy,
not available. compromising sexual function
and worsening self – esteem.
It is no surprise therefore that
The management of improvements in urgency are often
stated by people to be the most
overactive bladder noticeable response to therapy.
Incontinence occurs in
Urgency is a sensory symptom
approximately a third of people
and as such is difficult to define,
presenting clinically with OAB,
to communicate to both patients
and approximately a third of them
and colleagues alike and the
have a mixed picture of combined
measure and quantify. Despite
sphincteric weakness and detrusor
the difficulties, urgency and the
overactivity. The prevalence of
other symptoms of OAB result
OAB is higher among the elderly
in a significant deterioration in
population (age 64 and above); it
HRQL. To date, patient diaries have
is estimated to be approximately
been shown to be a reliable way
30 – 40% among persons older
to collect various OAB symptoms,
that 75 years, and this may have
including urgency episodes, and
additional ramifications as both
diary entry remains the most
urinary urgency, associated
30
37. accurate and sensitive method and healthcare professionals in
for evaluating changes in urgency community based primary care
with pharmacotherapy. Data services play a pivotal role in
obtained on the basis of 3 – or 4 the management of incontinent
– day diaries suggest that short – patients.
duration diaries are just as reliable
as those recorded for 7 days, and Behavioural therapy and
because they impart less patient pharmacotherapy are the
burden, may be an acceptable mainstay of treatment, and there
method of assessing the symptoms is continuing search for more
of OAB. Apart from increases effective and selective drugs
in cystometric capacity, invasive with minimal adverse effects
pressure flow studies have failed to (AEs). About 50% of people
show positive results with existing gain satisfactory benefit from
antimuscarinic therapy. pharmacotherapy. The role of
physiotherapy in the treatment of
Initial assessment must include urge incontinence remains unclear
a thorough history and physical as evidenced by systematic review
examination. A complete of clinical trials.
pelvic and neurological exam
is mandatory, to exclude other Treatment of OAB is multifaceted.
conditions that may mimic OAB Effective treatment modalities
symptoms. Urine analysis, and include lifestyle modifications,
microscopy and culture will exclude medications, bladder retraining,
urinary infections. Further special and exercises to strengthen the
investigations are not required. pelvic floor (Kegel Exercises)
Treatment for all forms of 1. Lifestyle modifications
incontinence should commence The patient should limit
with conservative methods before intake of foods and drinks
progressing to more complex that may irritate the bladder
surgical procedures if these do not or stimulate the production
work. A multidisciplinary approach of urine e.g alcohol, caffeine,
is important in its management. coffee, tea and fizzy drinks,
In addition to urologists and and aspartate sweeteners.
gynaecologists, continence nurse Drink 25ml / kg / day of
specialists, physiotherapists fluids
31
38. Maintain healthy bowel worldwide. It has antimuscarinic
actions. Eat high fibre foods activity acting primarily on the
such as wholewheat bread M1 and M3 receptor over the M2
and pastas. receptor. Two oral formulations
Stop smoking of this drug are now available on
Lose weight (if obese) our market and include immediate
– release (IR) and extended –
2. Bladder retaining release (ER) forms. More recently, a
transdermal formulation has been
The patient should - introduced. Several randomised
Gradually increase the time placebo controlled trials have
between voids shown oybutynin IR to be
Increase the time intervals by effective in producing subjective
15 minutes until she reaches improvement in patients (at least
an optimal time which is 50% improvement in incontinence
comfortable for her. episodes) as well as objective
parameters. Dose begins at 2.5mg
3. Pelvic floor muscle exercises bd, going up to a maximum of
(Kegel Exercises) (See 5mg tds. Adverse effects include
elsewhere) dry mouth, blurred vision,
constipation, urinary retention,
Surgical options (some still gastro – oesophageal reflux,
experimental) have been added dizziness and central nervous
in recent years and these include, system (CNS) effects. The AEs,
neuromodulation and botulinum particularly dry mouth, can lead to
toxin injection therapy, but these a high (up to 80%) dropout rate
interventions are reserved for cases within 6 months of commencing
where medical therapy fails. treatment.
In an attempt to reduce the
Drug therapy incidence of these AEs, a new
formulation, allowing a more
There are a number of controlled release of the drug over
antimusarinic agents in a 24 – hour period (oxybutynin
contemporary use. Oxybutynin ER) was introduced. The sustained
chloride is the most commonly release produces a more sustained
prescribed anticholinergic for OAB plasma concentration when
32
39. compared with the IR preparations oxybutynin metabolites are
and, hence, a much more stable the principal cause of AEs,
steady – state concentration for 24 alternative delivery routes have
hours. Tablet doses between 5 and been sought that would avoid
10 mg are available, and several oral administration and first
randomized controlled studies pass metabolism. Consequently,
have shown that oxybutynin ER a transdermal preparation of
is as effective as IR preparations oxybutynin has been developed.
with the additional benefit At the present time, this agent has
of a reduction in dry mouth. not yet been licensed for use in
Other modes of oxybutynin SA. An initial short – term study of
delivery include intravesical and transdermal verus oral oxybutynin
transdermal administration. IR in adults with urinary urge
Intravesical therapy was developed incontinence reported that both
to increase the balance in treatment options had similar
favour of efficacy over AEs in efficacy, but the transdermal
those patients routinely using route produced significantly less
intermittent self – catheterisation. dry mouth. A double – blinded
Oxybutynin (typically 5mg) is randomised controlled trial (RCT)
mixed with normal saline and of transdermal oxybutynin at 3.9
administered twice a day via a mg administered twice weekly
urethral catheter. Several small versus placebo, reduced the
open – label studies have shown number of weekly incontinence
that intravesical administration of episodes, reduced average daily
oxybutynin can reduce subjective urinary frequency increased
and objective detrusor overactivity. average voided volume and
Clearly, the main limitation of this significantly improved quality of
route of administration, associated life (QOL) compared with placebo.
with the use of intermittent self The incidence of dry mouth
– catheterisation, is the increased was similar in both the groups,
risk of developing cystitis due to an and the main AEs associated
irritant effect of the solution, and with transdermal delivery were
a higher risk of developing urinary erythema and pruritis at the site of
tract infections with subsequent application.
high dropout rates.
Following the hypothesis that
33
40. Different anticholinergics available in RSA
Drug Name Brand Name Licensed dose
Tolterodine tartrate ER Detrusitol XL 4mg o.d
Darifenacin hydrobromide Enablex 7.5 – 15mg tds
Oxybutynin hydrochloride Ditropan 2.5mg b.i.d – 5mg tds
Oxybutynin hydrochloride ER Lyrinel XL 5 – 20mg o.d
Oxybutynin hydrochloride tds Kentera 1 patch twice weekly
Trospium chloride Uricon 20mg b.i.d
Solifenacin succinate Vesicare 5 – 10mg o.d
Propiverine hydrochloride Detrunorm 15mg o.d. – tds
Propiverine hydrochloride ER Dertrunorm XL 30mg o.d.
Key:
o.d. = once daily
b.d. = twice daily
tds = three times daily
Propiverine hydrochloride is a with OAB, propiverine 15 mg
tertiary amine with a half – life three times daily was compared
of approximately 20 hours, with oxybutynin 5 mg twice
showing peak levels in serum daily and placebo. Both drugs
after approximately 2.3 hours produced objective and subjective
after ingestion. Like oxybutynin improvements compared with
it exhibits a mixed action, placebo at 4 weeks compared
exhibiting both anticholinergic with baseline. Propiverine was as
and musculotropic effects (calcium effective as oxybutynin in reducing
channel blocking activity). Doses urgency and urge incontinence,
vary between 15 and 30 mg but was associated with a lower
daily. The clinical trials and data incidence of dry mouth.
with this agent are limited to
a month’s duration or less. In a Tolterodine was launched in
double – blinded randomized 1998 and was the first modern
placebo – controlled trial of people anticholinergic on the market.
34
41. The ER formulation was released voiding diary parameters
as a once – daily preparation (frequency, urgency and urge
aimed at producing a stable serum incontinence) for up to 52 weeks
concentration over 24 hours. ER after trospium 20 mg twice – daily
has peak serum concentration at treatment.
2 – 6 hours post administration.
Therapy with tolterodine ER 4mg Two new anticholinergic agents
appears to be efficacious in both have been released in recent
older and younger people with years, namely solifenacin and
OAB; it is useful for at least up to darifenacin. Solifenacin has a
12 months with improvement in mean time to maximum plasma
voiding diary parameters including concentration of 3 – 8 hours and
urgency, and patient perception of long elimination half – life of >45
their condition with a benefit of – 68 hours. Solifenacin produces
HRQL based on the King’s health a significant reduction in voiding
questionnaire. The ER formulation frequency and a significant
is more effective than placebo in increase in volume voided/void in
different degrees of incontinence people with OAB and urodynamic
severity. It has been shown to be evidence of detrusor overactivity.
effective in treating women with The recommendation is for
mixed urinary incontinence with a an initial 5 mg dose with the
predominance of urge symptoms possibility of dose flexibility by
over stress. increasing the dose to 10 mg as
required. The long term efficacy
Trospium chloride, a quaternary of solifenacin has been reported
amine, is purported to lack in an open – label extension of
CNS effects as it does not cross randomised placebo – controlled
the blood – brain barrier. Its trials. The efficacy seen in the
half – life is between 12 – 18 initial trials was maintained for
hours and reached peak plasma up to 52 weeks. About 85% of
concentrations between 4 and the study population was satisfied
6 hours. The usual dose is 20mg after 24 weeks of flexible dosing,
twice daily. Trospium 20 mg twice and with regard to efficacy, 74% of
daily has shown similar results the population were satisfied after
when compared with oxybutynin 24 weeks of flexible dosing.
5 mg twice daily, with significant
reduction in urodynamic and Darifenacin is a tertiary amine
35
42. derivative and is the most selective to cardiac effects and M3 and
M3 receptor antagonist. It has M5 to visual effects. Certainly, in
been shown to have a higher this population, this would be of
degree of selectivity for the M3 greater significance due to the
over the M2 receptor compared existence of comorbidity and the
with other anticholinergics, with susceptibility to impaired cognitive
marginal selectivity for the M1 function and nervous system
receptor. In healthy volunteers effects. Definitive comment on
after oral administration of this subject will inevitably await
darifenacin, peak plasma adequately powered head – to –
concentrations are reached after head comparative studies. Dose
approximately 7 hours with flexibility has been explored with
multiple dosing, and steady – darifenacin and clearly showed
state plasma concentrations that some people who do not
are achieved by the sixth day respond to a lower dose of drug
of dosing. In a double – blind, (7.5mg) will do so at higher
radomised, crossover study doses (15mg), but will develop
comparing darifenacin with more pronounced AEs inevitably,
oxybutynin in people with however, they may accept this as
proven detrusor overactivity and part of the ‘trade – off’ for the
associated symptoms of OAB, greater efficacy experienced
darifenacin was as effective
as oxybutynin in terms of the It is clear that among the many
ambulatory urodynamic variables drugs tried for the treatment
tested but darifenacin 15 and of OAB, acceptable efficacy,
30 mg controlled release was documented in RCT’s of good
significantly better in salivary flow quality, has only been shown
compared with oxybutynin 5 mg for a limited number. The
three times daily. anitmuscarinics tolterodine,
trospium, solifenacin and
The introduction of darifenacin has darifenacin, the drugs mixed
fuelled debate over the potential actions, oxybutynin and
importance of pharmacological propiverine, and the vasopressin
selectivity as related to the AE analogue, demopressin, were
profile. M1 and M3 receptor have found to fulfill the criteria
been attributed to dry mouth, for level1 evidence according
M1 to cognitive impairment, M2 to the Oxford assessment
36
43. system and were given grade of symptoms caused by significant
A recommendations by the genital atrophy. Oestrogen is
International Consultation on not useful for treating urinary
Incontinence. All antimuscarinics incontinence, but may reduce the
apart from oxybutynin IR were incidence of UTI’s.
found to be well tolerated. Dry
mouth was the most commonly
reported adverse event and no
drug was associated with an
MIXED
increase in any serious adverse INCONTINENCE
event.
Ethipramine
Generally there is little or no good
evidence to choose between the
Tricyclic anti – depressants have
anticholinergics
been used widely for symptoms
of frequency, urgency, urge
incontinence and especially
Oestrogen nocturia for many years. Although
grade 1 evidence justifying their
Whilst the use of oestrogen in the use is lacking, many patients
treatment of women with stress are satisfied with the results.
incontinence is controversial, its Ethipramine is inexpensive and
use in women with the irritative widely available, with a multitude
symptoms of OAB is more of effects – and side effects.
established. Postmenopausal
women with genital atrophy or Its actions are anticholinergic
OAB symptoms may receive oral in nature, with an adrenergic
or topical therapy provided no effect on the bladder neck.
contra – indications exist, but at Theoretically at least, this makes
present, oestrogen therapy for it ideal for mixed incontinence,
stress incontinence is unwise. As but its side – effects are often
we wallow in post “Women’s troublesome. It causes cardiac
Health Initiative” hype, we must conduction defects and this has
remember the negative impact caused the WHO to warn against
of withholding the beneficial its use. Dry mouth and drowsiness
effects of oestrogen on the pelvic are the most bothersome side
floor, and not precipitate a host effects, limiting its use. The drug
37
44. is available in 10mg and 25mg overall benefits of OAB treatment,
tablets, and the usual starting it is critical that RCTs use validated
dose is 10mg in the mornings, instruments to assess HRQL and to
with 25mg or 50mg at night. The relate these changes to changes in
soporific effect of ethipramine may OAB symptoms. The International
be used to advantage, allowing Continence Society advocates the
increased evening dosage. Contra use of HRQL measures in clinical
– indications are as for other anti – research has provided increasing
cholinergics. If clinicians prescribe evidence for the HRQL benefits
ethipramine, they must be aware conferred by effective OAB
of its cardiac effects especially in treatments.
elderly women.
The future emphasis of work in
this field must also incorporate
Imipramine patient – perceived outcomes using
existing tools to assess bother and
The use of imipramine is parallel QOL.
to that of ethipramine – with the
proviso that it remains untested
as a pure anticholinergic for use The future
in incontinence. Imipramine is
primarily, with amytriptyline, an There is an overall trend towards
antidepressant, and its useful development of once daily
anticholinergic effects are purely extended release preparations for
fortuitous. Clinicians must be existing anticholinergics, such as
aware that these agents are of extended release oxybutynin and
limited use as niche agents, and propiverine. Multiple strengths
that ethipramine is perhaps more are now available in certain once
clinically useful. daily agents such as solifenacin,
allowing more flexible therapeutic
Pharmcotherapy remains the options. Urinary urgency does not
mainstay of therapy for the always arise within the bladder,
treatment of OAB, and the and that when investigating OAB
contemporary literature shows that we should consider a variety of
antimuscarinic agents are used pathological causes. With the
as a first line therapy for OAB. To exception of botulinum toxin
gain a better understanding of the and neuromodulation for failed
38
45. medical therapy for OAB, there
have been no new important
surgical innovations. These last
two options have superceded
bladder augmentation by bowel
interposition, since they are far less
invasive, are reversible, and have
fewer side effects.
39
46. Chapter 6
Intractable Overactive Bladder:
Advanced Management
Strategies
Stephen Jeffery
Introduction from the incontinence clinic, only
7% of the cohort reported being
The mainstay of treatment cured, with 65% still suffering
for Overactive Bladder is fluid significant symptoms. Previously,
management, bladder retraining the only therapeutic option for
and anticholinergic drug therapy. these patients was surgery in the
There are, however, a subset of form of bladder augmentation.
women who do not respond to These operations, however,
these standard treatment regimens carry a high morbidity with
and remain incontinent, their most having voiding dysfunction
symptoms having a profound requiring clean intermittent self
impact on their quality of life. catheterization, and troublesome
Studies have shown that only mucus production.
18% of women stay on their A number of newer promising
drug treatment for longer than treatment options have been
6 months. This appears to be as developed, including Botulinum
a result of inadequate efficacy Toxin and nerve stimulation
and not side effects. Morris et al techniques.
performed one of the only trials
on long –term outcomes of women 1. Botulinum Toxin
treated for OAB with a standard Botulinum Toxin, which is
care package of anticholnergics produced by the bacterium,
and bladder retraining. Looking Clostridium Perfringens, is the
at the same subjects a mean of most potent toxin known to man.
eight years following discharge It is a Gram positive, anaerobic
40
47. bacteria which is commonly found using either a flexible or rigid
in the soil and 1g of the toxin can cystoscope using a flexible 26
kill 1 million people. It blocks the gauge needle that is threaded
release of acetylcholine at the through the working channel of
neuromuscular junction in the the scope. The toxin is diluted
detrusor muscle. Amongst those into 20 ml of normal saline and
who have contributed to the injected in 1ml aliquots under
science of Botulinum Toxin, credit local or general anaesthesia.
must be given to Schantz who Most practitioners avoid injecting
purified the toxin and enabled its the bladder trigone because of
mass production. Its first clinical the theoretical risk of reflux.
use was in 1980 when it was Recent work has, however, shown
used to treat strabismus. There that trigonal injections are not
are 7 subtypes, A, B, C, D, E, F , associated with reflux and have
G, however only Toxins A and B equivalent efficacy to the extra-
are available commercially. The trigonal administration. When a
Botulnum A Toxin preparation, flexible cystoscope is used, the
Botox® (Allergan Inc.) is probably Botox can be given using local
the most well known, but there anaesthetic gel but sedation or
is an alternative called Dysport® general anaesthesia is usually
(Ipsen Pharma). Botulinum Toxin necessary when using a rigid scope.
B is marketed by Solstice.
Schurch et al were the first to use
Botox® has been more extensively intradetrusor Botox injections for
evaluated in the literature than the treatment of severe detrusor
Dysport®, but there are now overactivity in spinal cord injured
a number of studies that now patients. Profound improvements
confirm its efficacy. Botox® is were demonstrated, with 17 of 19
three times more potent than patients achieving continence. A
Dysport and most reports use large amount of data has emerged
300u for Neurogenic DO and 200u since then suggesting excellent
for Idiopathic DO. Exact dosages efficacy in Neurogenic DO. Schurch
for Dysport are less clear and et al reported again in 2005 on
ranges from 500u to 1000u are 59 NDO patients. This was double
administered. blind placebo controlled parallel
group study. They gave patients
The toxin is usually administered either placebo, Botox 200u or
41
48. Botox 300u. Up to six months self catheterization or have a
follow-up, they reported a 50 % suprapubic catheter inserted.
reduction in incontinence episodes
with 49% of the cohort reporting The Botulinum Toxin effect on the
being dry. The urodynamic findings detrusor lasts for approximately
compared to placebo were six to nine months and it usually
remarkable with highly significant requires repeat administration
increases in maximum cystometric following this. As the urgency and
capacity at two, six and 24 weeks urge incontinence return, normal
compared to placebo. voiding is also regained in those
women who developed urinary
Following the success in NDO a retention.
number of studies began looking
at the treatment of Idiopathic An important factor to take into
DO. The problem with IDO is the consideration is the cost of the
risk of voiding dysfunction – since Botulinum Toxin product. Botox is
unlike in NDO, most of these sold in vials of 100u and a single
patients have normal voiding course of 300u would have a cost
function. Popat et al published in excess of R6000. Dysport has
the first data on IDO using Botox, only recently been launched in
achieving continence rates of South Africa and would have a
57%. The incidence of de novo comparable price tag. One would
voiding dysfunction was 19%. In need to add to this the costs of
a further randomized controlled administration, including surgeons
trial, Sahai et al report profound fees, theatre time and disposables.
improvements in multiple
outcomes following the injection 2. Sacral Nerve Stimulation
of Botox when compared to (SNS)
placebo. This device works by implanting a
pacemaker-like neurostimulator
The main adverse event following in the lower back that sends mild
Botulinum injections is temporary electrical impulses to electrodes
urinary retention, with a reported that are usually placed adjacent
incidence of between 19% to to the third sacral nerve root.
35%. Women who develop The device received European
this complication are required Union approval in 1994 and USA
to perform clean intermittent FDA approval in 1999 and more
42
49. than 35000 devices having been reduction in leakage episodes.
implanted worldwide to date. In A further systematic review
patients with OAB, SNS restores confirmed these findings with
the balance between inhibitory 67% of patients reporting being
and excitatory control systems dry or having a more than 50%
at various sites in the peripheral improvement in symptoms.
CNS. This involves stimulation of Another trial that followed
somatosensory ascending tracts patients up for a mean of more
projecting from the bladder into than 5 years reported continued
the pontine micturition centre success in 76% of the cohort.
in the brain stem. The electrical
impulses also activate the pelvic Despite these success rates, this
efferent hypogastric sympathetic therapeutic option is not accessible
nerves, which promotes to the majority of women largely
continence. due to the cost of the device and
the expertise required to place and
The device is inserted in two maintain the neurostimulator. It is
phases. The test phase includes the available in South Africa, supplied
temporary insertion of a needle by Medtronic, but retails for
into the sacral foramen under approximately R55000.
local anaesthetic and the electrical
stimulation is derived from an There are also significant adverse
externally placed battery and events associated with this
generator. If the subject reports a equipment including pain and
satisfactory response after three to discomfort, seroma formation,
four weeks, defined as more than disturbed bowel function and
50% improvement in symptoms, wound dehiscence.
a permanent device is sited.
This involves the implantation 3. Posterior Tibial Nerve
of a long-term battery and Stimulation
neurostimulator in the buttock and Because of the technical and
lower back. cost implications of SNS, indirect
neuromodulation of S2,3 and 4
A RCT reported continence via stimulation of the posterior
outcomes of 47% at six month tibial nerve, was developed. The
follow up, with a further 29% technique is performed by passing
reporting more than 50% an electric current between a
43
50. small acupuncture needle 4cm of neuromodulation and Botox
above the medial malleoulus and has provided us with additional
an electrode on the sole of the options prior to resorting to
patient’s foot. The device has surgery. Augmentation procedures
only recently become available also have a high incidence of
and marketed by Manta Surgical urinary retention requiring
under the name of “Urgent PC” in catheterization.
South Africa. There is a significant
disposable component to the 5. Alternative therapy
equipment, including a single use A number of studies have shown
electrode and needle and this acupuncture to be a useful
unfortunately drives up the cost of adjunct to therapy. A study
using this device. The treatment performed in the late 1980’s
regime consists of up to 12 weekly reported a 77% reduction in
sessions of 30 minutes although urgency and frequency in 77% of
it may be efficacious after shorter their patients versus only 20%
treatment periods, it does not last in placebo. These findings have
indefinitely and it needs to be been confirmed by Bergstrom et
repeated after a few months. al who also demonstrated reduced
incontinence episodes. The most
It has been shown to be efficacious interesting data have emerged
in two trials with one reporting from a trial where women were
more than 50% reduction in randomised to acupuncture in
leakage episodes in 70% of bladder specific points versus
their cohort, 46% of the subjects relaxation point acupuncture.
reporting being dry. 71% of the They demonstrated significant
cohort of 53 patients in another improvements in quality of life
trial reported treatment success. and frequency episodes in the
group receiving bladder specific
4. Surgical Therapy acupuncture. Acupuncture is
Clam ileocystoplasty and readily available, is inexpensive
augmentation procedures are and can be performed by many
usually reserved for patients physiotherapists- and hence should
with neurogenic detrusor be kept in mind for those women
overactivity and high pressure who do not want medication.
bladders with the potential of
upper tract damage. The advent
44