Stress Urinary Incontinence 女士尿失禁

1. Female Urinary
Incontinence
In #NoMesh Era
Dr. Ka Lun Chui, FRCSEd(Uro), FHKAM (Surgery)

2. 吊床理論

6. In 2014 the Scottish government put in place
a suspension in the use of mesh for stress
urinary incontinence.

7. The Australian government has issued a
national apology to women affected by a
vaginal mesh scandal, acknowledging
decades of "agony and pain".
The Royal Australian and New Zealand college
of obstetricians and gynaecologists admit that
‘there is very little information on the efficacy
and long term safety of polypropylene mesh’.
Australia bans
transvaginal mesh
products on Dec 2017 as
'too risky'

8. The FDA has stated that “it is not clear that transvaginal
POP repair with mesh is more effective” than non-mesh
repair, and “may expose patients to greater risk.”
On April 16, 2019, the FDA ordered all manufacturers of surgical mesh
intended for transvaginal repair of anterior compartment prolapse (cystocele)
to stop selling and distributing their products immediately.

9. Plaintiff wins $120m in latest pelvic mesh trial
against Johnson & Johnson unit

11. UK Government halts vaginal
mesh surgery in NHS hospitals
July 2018

12. “The ban on mesh for stress
urinary incontinence reflects the
inadequate evidence base that let
risky mesh devices on to the
market, the lack of long-term
evidence to inform their use and
the inadequate response of
health professionals to emerging
harms.”

13. The National Institute for Health and Care Excellence
(Nice) clinical guidelines for urinary incontinence and
pelvic organ prolapse continue to include surgical use of
mesh as one option for women with particular conditions.
However, the guidelines say surgery should only be offered
to women for whom non-surgical approaches have failed or
been rejected.
They also stress that women must be counselled about the
possible complications and that both short- and long-term
outcomes must be recorded in a national registry.
April 2019
Health and social minister Jackie Doyle-Price has urged
women who were injured by vaginal mesh to take legal
action against medics as well as manufacturers

14. No more referals are allowed to mesh removal expert,
surgeon Suzy Elneil of UCLH, owing to a huge backlog of
work. The announcement shows a widespread lack of care
and treatment options, says MP Owen Smith, who
recognises the distress the news will cause for women.

17. Pelvic Floor Exercise
Retropubic Suspensions
Laparoscopic Sacrocolpopexy
TVT/TOT

18. Pelvic Floor Exercise
Retropubic Suspensions
Sacrocolpopexy
EMsella
Vaginal Laser
Urethral Laser

19. BTL EMSELLA™
POWERED BY HIFEM™ TECHNOLOGY
BTL EMSELLA works on the principle
of patented High Intensity Focused
Electromagnetic Technology (HIFEM).
This is an extremely powerful focused
electromagnetic field. Its high intensity
enables to reach supramaximal muscle
contractions, while the patient comfortably
sits on the Emsella applicator.
*This product, the methods of its manufacture and the use are covered by one
or more US and foreign patents or pending patent applications.

20. BTL EMSELLA™ MECHANISM OF ACTION
*
▶ BTL EMSELLA uses High Intensity Focused
Electromagnetic Technology (HIFEM) to cause deep
pelvic floor muscles stimulation
▶ Key effectiveness is based on focused electromagnetic
energy, in-depth penetration, and stimulation of the entire
pelvic floor area
▶ A single session brings thousands of supramaximal
pelvic floor muscle contractions, which are extremely
important in muscle re-education of incontinent patients

21. BTL EMSELLA™ MECHANISM OF ACTION

22. EMsella arrived HONG HONG
in Dec 2017

23. EMSELLA EXPERIENCE IN HONG
KONG
▶ In Prince of Wales Hospital
▶ SUI/OAB patient pool from PWH
▶ One finished pilot study:
▶ 1-hour Pad test on 20 SUI patients while 9 have complete data
▶ One recruiting study:
▶ Evaluation of Emsella Efficacy and safety on Urinary Incontinence on
Male and Female – 60 patients

24. ▶ The patient should sit
at the centre of the
chair with spine
straight
▶ Set the chair height
so that the patient’s
feet are on the ground

25. EFFICACY OF EMSELLA – PILOT
STUDY
▶ 9 patients (8 female and 1 male) with Stress UI
▶ Age 49-86 (Average: 63)
▶ 6 Tx, Twice per week
▶ 2 – 4 weeks follow up after the 6th Tx
▶ Intensity of 100%
▶ Assessments:
a) 1- hour Pad test Pre and Post
b) I-PSS (International Prostate Symptom Score)
c) IIQ7 (Incontinence Impact Questionnaire)
d) UDI6 (Urgenital Distress Inventory)
e) OABSS (OverActive Bladder Symptom Scores)

26. PROTOCOL FOR 1 HOUR PAD TEST
1. Empty the urinary bladder
2. Record the weight of a new pad and let patient wear it
3. Drink 500ml water within 15 mins
4. Walk for 30 minutes (Includes going up and down one flight of stairs,
voiding is not allowed durng the procedure)
5. Bladder Scan
6. 15 mins exercises as follow:
a) Stand up and sit down 10 times
b) Place running 1 minute
c) Hard coughing 10 times (Standing with legs apart)
d) Pick up small objects from the floor 5 times
e) Wash hands 1 min
7. Weigh the same pad again after finishing the above steps

27. RESULTS – 1-HOUR PAD TEST
▶ For the 1-hour Pad Test, an increase of 1 to 10 g represents mild
incontinence, 11 to 50 g represents moderate incontinence and > 50 g
represents severe incontinence*
*Krhut J, et al. Neurourol Urodyn. 2014;33(5):507–510.
Pre (g) Post (g) Reduced
by (g)
Reduced
by %
21.4 4 -17.4 81.31%
4.5 0.5 -4 88.89%
8.5 5.5 -3 35.29%
1.6 1.4 -0.2 12.50%
5.1 1.6 -3.5 68.63%
17.5 12.8 -4.7 26.86%
8.2 2.4 -5.8 70.73%
3.6 1.8 -1.8 50.00%
10.9 0.4 -10.5 96.33%
Average: -5.66 59%
Colored indicates
Moderate Incontinence
Colored indicates
Mild Incontinence
Colored indicates
No Incontinence

28. RESULTS- 1 HOUR PAD TEST
*1 tail t-test p-value = 0.01
P <0.05*

29. RESULTS – INTERNATIONAL
PROSTATE SYMPTOM SCORE
P <0.05*
Mild (symptom score less than of equal to 7)
Moderate (symptom score range 8-19)
Severe (symptom score range 20-35)
*1 tail t-test p-value = 0.009

30. RESULTS – OVERACTIVE BLADDER
SCORE
P <0.05*
OABSS: A total score ranging from 0-15
*1 tail t-test p-value = 0.008

31. RESULTS- UROGENITAL DISTRESS
INVENTORY
P <0.05*
UDI6: A total score ranging from 0-100 *1 tail t-test p-value = 0.02

32. RESULTS- INCONTINENCE IMPACT
QUESTIONNAIRE
P <0.05*
IIQ7: A total score ranging from 0-100 *1 tail t-test p-value = 0.04

33. CASE REPORT IN HK
▶ Ms Choi; Age: 65; 2 Childs
▶ Diagnosis of Mixed Incontinence for > 3 years
▶ Pelvic floor training recommended, but not much improvement.
▶ Urine Leakage whenever cough, jump, laugh, or play with kids
▶ Pre-treatment:
▶ > 3 pads per day
▶ 1-hour Pad test: 21.4g
▶ Post-treatment:
▶ 1 pad per day
▶ 1-hour Pad test: 4g
▶ “Before I couldn’t even sense my pelvic floor muscle, so I don’t
know how to contract it, so Kegel was not so effective to me.
But now, I could feel the muscle! I tried jump after the 1st
treatment but nothing leaks out!”

34. CASE REPORT IN HK
▶ Mr Lee; Age:83
▶ Prostatectomy on 2017 March
▶ SUI post-prostatectomy
▶ Pre-treatment:
▶ Nocturia > 3 times daily
▶ 6 pads per day
▶ Sudden urge resulting urine leakage > 5 times daily
▶ After Emsella 6 Tx,
▶ Nocturia =1 time daily
▶ 2 pads per day
▶ Sudden urge resulting urine leakage = 1 time daily

35. ONGOING STUDY – EVALUATION OF
EMSELLA EFFICACY AND SAFETY ON
URINARY INCONTINENCE IN MALE AND
FEMALE
- Prince of Wales Hospital Initiated
- 60 patients (male and female) with SUI
- For male patients, they should had undergone prostatectomy for at
least 1 year
- ICIQ-UI-SF > 6 points
- Primary objective: 50% reduction from baseline in daily number of
SUI episodes
- Primary Endpoint of Safety is the incidence of treatment-related
serious adverse events (SAEs)
- Secondary objective: % of patients successfully maintaining the
primary effectiveness at 12 month
Wagner TH, Patrick DL, Bavendam TG, et al. Quality of life with urinary incontinence: development of a new measure. Urology 1996; 47(1):
62-72
Uebersax JS, Wyman JF, Shumaker SA, McClish DK, et al. Short forms to assess life quality and symptom distress for urinary incontinence in
women: The incontinence impact questionnaire and the urogenital distress inventory. Neurology and Urodynamics 1995; 14: 131-139
Sandvik H, Hundskaar S, et al. Validation of a severity index in female urinary incontinence and its implementation in an epidemiological
survey. J Epidemiol Community Health 1993; 47:497-499. AND Sandvik H, Selm A, et al. A severity index index for epidemiological surveys of

36. ONGOING STUDY – EVALUATION OF
EMSELLA EFFICACY AND SAFETY ON
URINARY INCONTINENCE IN MALE AND
FEMALE
- Emsella treatment – 6Tx, Twice a week
- Follow up at 3 months after last treatment
- Assessments:
- 1 hour Pad test
- Incontinence Quality of Life (IQOL)
- Incontinence Impact Questionnaire (IIQ7)
- Urogenital Distress Inventory (UDI6)
- Global Quality of Life Assessment (GQOL)
Ueversax JS, Wyman JF, Shumaker SA, McClish DK, et al. Short forms to assess life quality and symptom distress for urinary incontinence in women:
The incontinence impact questionnaire and the urogenital distress inventory. Neurology and Urodynamics 1995; 14: 131-139.
This question is taken from the International Prostate Symptom Score (IPSS) Assessment. The IPSS assessment includes the same seven questions as
the American Urological Association (AUA) Symptom index plus an additional quality of life (QOL) question. The question referred to here as the GQOL
is the QOL question from the IPSS Assessment Ref: AUA Practice Guidelines, Committee (2003). :AUA guideline on management of benign prostatic
hyperplasia. Chapter 1: Diagnosis and treatment recommendations”. J. Urol. 170 (2 Pt 1): 530-47.

37. 95% SATISFACTION
OF INCONTINENT PATIENTS
85% IMPROVEMENT IN OVERALL
INTIMATE SATISFACTION

39. Joseph Berenholz, MD, Michigan, USA
Tracey Sims, MD; George Botros, MD, Liverpool, UK
• 30 patients; all types of urinary incontinence
• 6 therapies; scheduled 2x a week
• Standardized King´s Health Questionnaire, Number of used
hygienic pads
Results:
• 95% of treated patients improved quality of life
• 67% of treated patients totally eliminated or decreased
the use of hygienic pads
• The results were maintained during 6-month follow-up
HIFEM Technology Can Improve Quality of Life of Incontinent
Patients

40. Red Alinsod, MD, Laguna Beach, California
Vasil Vasilev, MD, Sofia, Bulgaria
38th ASLMS Annual Conference on
“Energy-based Medicine and Science”, 2018
• 30 patients; stress urinary incontinence
• 6 therapies; scheduled 2x a week
• Standardized King´s Health Questionnaire
Results:
• 93% of treated patients reported decreased
negative incontinence impact on quality of life
• The results were maintained during 6-month
follow-up
HIFEM Technology – A New Perspective In Treatment
of Stress Urinary Incontinence

41. Julene Samuels, MD, Louisville, KY;
Nathan Guerette, MD, Richmond, VA
38th ASLMS Annual Conference on “Energy-
based Medicine and Science”, 2018
• 20 patients; stress/urge/mixed urinary incontinence
• 6 therapies; scheduled 2x a week
• Standardized King´s Health Questionnaire (KHQ)
Results:
• 60% improvement in both parts of KHQ
• The results were maintained during 6-month
follow-up
HIFEM Technology – The Non-invasive Treatment of Urinary
Incontinence

42. Delgado Cidranes E, MD, Madrid, Spain
Estrada Blanco, MD, Madrid, Spain
Medical and Clinical Research, Vol.3 (2)
• 32 patients; urinary incontinence
• 6 therapies; scheduled 2x a week
• KHQ; ICIQ-SF; MRI; Uroflowmetry; Urethrocystoscopy
Results:
• Significant changes in objective evaluations were
detected in 84% of patients
• Elastographic changes were detected in 94%
of patients
Safety And Preliminary Efficacy of Magnetic Stimulation of
Pelvic Floor with HIFEM Technology in Urinary Incontinence

43. Er:YAG Smooth Mode Controlled Tissue Heating Process
Temp °C
Time
(sec)
35°
40°
45°
50°
55°
60°
Laser
Pulses
0 1 2 3
Pulse Train
Temp °C
Time
(sec)
35°
40°
45°
50°
55°
60°
Laser
Pulses
0 1 2 3
Pulse Train
Applications FAQ
How does it work?

44. Using the proper dosage of Smooth Mode
the temperature in mucosa reaches
60°C to 63°C
This is the optimal temperature for the
process of shortening the collagen fibers
and neocollagenesis [1]
1) Dams SD, de Liefde-van Beest M, Nuijs AM, Oomens CW, Baaijens FP : Pulsed heat shocks enhance procollagen type I
and procollagen type III expression in human dermal fibroblasts, Skin Res Technol. 2010 Aug;16(3):354-64
How does it work?
Applications FAQ

45. SMOOTH mode controlled Tissue Heating Process
Example of the calculated
depth of the thermally
affected mucous tissue
during STEP 2 of the
procedure:
Irradiation with four Er:YAG
SMOOTH mode pulses with
a full beam fluence of 3
J/cm2.
4th SMOOTH pulse
1st
2nd
3rd
67 0C
How deep is the heat going ?

46. 1. Photo-Thermal Interaction
2. Thermo-Mechanical Interaction
3. Growth of New Collagen Fibers
Mechanism of action consists of three components:
Mechanism of Action

47. Vaginal wall structure
Before
Shrinked and thicker wall
after neo-collagenesis
After
Photo-thermal effect
Laser Irradiation
Mechanism of Action
Thermal shrinkage of top
layers and mechanical
pull of deeper structures
CourtesyofJunaClinic
CourtesyofJunaClinic
M. Rivera measured an average shrinking of
vaginal canal of 12 mm (or 17%)
A.A. Bezmenko measured an average
thickening of vaginal wall of 1.5 mm (or 56%)

48. 48
Thermally processed vaginal wall
Laser beam is applied along the vaginal canal
until full tissue coverage is achieved
Non-ablative Er:YAG for Controlled Tissue Heating

49. 49
Dr. Adrian Gaspar
Poster on FIGO2015
Vancouver, Canada
Er:YAG laser treatment for SUI

50. FotonaSmooth
New handpiece for Intra-Urethral treatments

51. Gynecology with FotonaSmooth
IncontiLase Intra
UUI MUI SUI
ISD
* Lukban J C, Aguirre O A, Van Hegewald W, Davila G W: THE PREVALENCE OF INTRINSIC SPHINCTER DEFICIENCY IN
PATIENTS WITH STRESS URINARY INCONTINENCE AND URETHRAL HYPERMOBILITY,
http://www.ics.org/Abstracts/Publish/42/000318.pdf
Prevalence of ISD
could be more
than 20% of SUI
patients*

53. Non-ablative, thermal only treatment of urethra

54. Non-ablative, thermal only treatment of urethra

55. FotonaSmooth
Obstetrics & Gynecology
International Journal,
July 2015
Dr. Mohamed M Khalafalla et al.

56. FotonaSmooth
Obstetrics & Gynecology
International Journal,
July 2015
Dr. Mohamed M Khalafalla et al.

57. FotonaSmooth
Obstetrics & Gynecology
International Journal,
July 2015
Dr. Mohamed M Khalafalla et al.

58. 58
Er:YAG laser treatment for SUI
Accepted for publication in
IUJO
Dr. Yi-Wen Tien
Dr. Sheng-Muo Hsiao
Dr. Chien-Nan Lee
Dr. Ho-Hsiung Lin
National Taiwan University
Hospital IRB study

59. 59
Er:YAG laser treatment for SUI
Presented at Annual
Meeting of Taiwan
Association of Obstetrics
and Gynecology in 2016
Dr. Yi-Hao Lin
Chang Gung Memorial Hospital study
Urodynamics, 1h pad test, perineometry, sexual and UI questionnaires

60. 60
Er:YAG laser treatment for SUI
Chang Gung Memorial Hospital study (2016)
Urodynamics, 1h pad test, perineometry, sexual and UI questionnaires

61. 61
Er:YAG laser treatment for SUI
Chang Gung Memorial Hospital study (2016)
Urodynamics, 1h pad test, perineometry, sexual and UI questionnaires

62. FotonaSmooth
Dr. Jack Pardo
Clınica Sara Moncada,
Santiago Chile
2016

63. Gynecology with FotonaSmooth
Dr. Jack Pardo
Clınica Sara Moncada,
Santiago Chile
2016
80% of patients significantly improved after
IncontiLase