Mi presentación en las jornadas "MINIMALLY INVASIVE PROSTATE SURGERY" en Oporto del 24 y 25 de enero del 2014 - "Gestión de las complicaciones después de la prostatectomía radical laparoscópica (PRL): Cómo mejorar la incontinencia temprana y gestionar la disfunción eréctil".

1. MANAGEMENT OF COMPLICATIONS AFTER LRP:
HOW TO IMPROVE EARLY CONTINENCE
AND MANAGE ERECTILE DYSFUNCTION
Eduard García Cruz
Urología y Salud del Hombre
Servicio de Urología
Hospital Clínic de Barcelona
ecruz@clinic.ub.es
@drgarciacruz
www.reisho.com
Conflict of interest: I received funding for investigation from BAYER, Lilly, Pfizer, Auxilium and Janssen, and I have fomred part of comittees for Bayer, Lilly,
Gebro, Almirall, Janssen, Italpharmaco abd Menarini. I am speaker for Lilly, Pierre Fabre and Bayer. CEO at DocFitSolution.

2. STEP 1. BEFORE
STEP 2. DURING
STEP 3. AFTER

6. DO WE GIVE REALISTIC AND COMPREHENSIVE INFO TO OUR PATIENTS?
DO WE PREOP STRESS THE IMPORTANCE OF EARLY FUNCTIONAL REHAB?
DO WE HAVE RELIABLE PREDICTING TOOLS?
DO WE USE VALIDATED QUESTIONAIRES?

10. STEP 1. BEFORE
Neurovascular preservation indication.
Use Validated Questionaires.
Assess Risk.
Realistic information about options and timing.
STEP 2. DURING
STEP 3. AFTER

11. STEP 1. BEFORE
Use Validated Questionaires
Assess Risk.
Neurovascular preservation indication.
Realistic information about options and timing.
STEP 2. DURING
STEP 3. AFTER

22. AGE, URETHRAL LENGTH, ROBOT (NS), NERVE SPARING (NS)
AGE, ROBOT, TESTOSTERONE, D´AMICO RISK GROUPS (NS)

23. STEP 1. BEFORE
Use Validated Questionaires
Assess Risk.
Neurovascular preservation indication.
Realistic information about options and timing.
STEP 2. DURING
Best possible surgery.
STEP 3. AFTER

24. STEP 1. BEFORE
Use Validated Questionaires
Assess Risk.
Neurovascular preservation indication.
Realistic information about options and timing.
STEP 2. DURING
Best possible surgery.
STEP 3. AFTER

25. of Erecti l e Functi on, and al so answ ered ‘yes’ to
the questi on, ‘Over the past 4 w eeks, have your
erecti ons been good enough for sati sfactory sexual
acti vi ty?’
Secondary measures w ere changes from basel i ne
i n the si x-i tem Erecti l e Functi on domai n of the
Internati onal Index of Erecti l e Functi on and, for
the pl ethysmography subgroup, the durati on of
penile tumescence and rigidity. The Erectile Functi on
domai n has a score range of 1–30, w i th ED graded as
severe (1–10), moderate (11–16), mi l d to moderate
(17–21), mi l d (22–25) and none (26–30).12
Statistics
On the basi s of anal yses of Q3 and Q4 of the
Internati onal Index of Erecti l e Functi on i n previ ous
studi es, a conservati ve standard devi ati on of 2.00
w as assumed. If the mean si l denafi l versus pl acebo
di fference for at l east one of the si l denafi l groups
w as 1.5 poi nts for both vari abl es, then a sampl e si ze
of 44 pati ents per treatment group w oul d provi de
90% pow er to detect a si gni fi cant di fference
betw een vari abl es si ngl y and 80% pow er to detect
si gni fi cant di fferences for both vari abl es joi ntl y,
based on tw o-si ded anal ysi s of vari ance tests
conducted at the 0.05 si gni fi cance l evel w i th
Dunnett’s adjustment. Assuming that 80% of randomized patients would contribute to the i ntent-to-treat
anal yses, a sampl e si ze of 55 pati ents per treatment
group w as requi red. How ever, enrol l ment ceased
after 125 because an i nteri m bl i nded revi ew of data
from the 35 compl eted pati ents show ed a response
rate of onl y 25% (9 of 35), w hi ch w as not w hat w as
pl anni ng possi bl e future studi es.
A l l stati sti cal anal yses w ere performed usi ng
Stati sti cal A nal ysi s System softw are versi on 6.12
for effi cacy anal yses and versi on 8.2 for demographi c and safety anal yses. Pri mary and secondary
effi cacy vari abl es w ere anal yzed i n pati ents w ho
compl eted the 36-w eek doubl e-bl i nd treatment
peri od and the 8-w eek drug-free eval uati on peri od.
In the ori gi nal stati sti cal anal ysi s pl an, the pri mary
effi cacy measure (percentage of responders) w as
to be anal yzed usi ng the pai r-w i se Cochran–
M antel –Haenszel (CM H) test. How ever, because
the M antel –Fl ei ss cri teri on w as not sati sfi ed, the
CM H test w as determi ned to be i nappropri ate for
anal ysi s purposes. Therefore, Fi sher’s exact test
(tw o-tai l ed) w as used as an al ternati ve (and appropri ate for the exi sti ng number of pati ents) approach,
w i th the Bonferroni adjustment to account for
mul ti pl e compari sons w i th pl acebo. Secondary
effi cacy measures w ere anal yzed usi ng the nonparametri c Wi l coxon rank-sum test. Safety w as assessed
i n pati ents w ho took at l east one dose of study
medi cati on.
Resul ts
Of 238 pati ents screened, 125 w ere randomi zed to
treatment and 123 recei ved at l east one dose of study
drug. In total , 94% (117 of 125) of the randomi zed
pati ents w ere enrol l ed at fi ve North A meri can si tes.
Pati ents w ere l argel y si mi l ar among treatment
groups w i th respect to demographi cs (Tabl e 1).
A cross the groups, a si mi l ar number of pati ents
Tabl e 1 Demographi cs of the pati ents w ho took study medi cati on and of the anal yzed popul ati on
Took study medication (n ¼ 123)/anal yzed (n ¼76)
Placebo
Number of pati ents (n)
M ean age, year (s.d.)
(range)
Race (% )
Whi te
Bl ack
Other
M ean w ei ght, kg (s.d.)
(range)
Sildenafil (50 mg)
Sildenafil (100 mg)
42/25a
57 (7)/56 (6)
(42–70)/(42–67)
40/23a
55 (6)/55 (6)
(42–67)/(42–63)
41/28
55 (6)/55 (6)
(38–68)/(38–65)
88/92
12/8
0/0
80/83
17/13
3/4
90/89
7/11
3/0
88 (12)/88 (14)
(68–123)/(68–123)
89 (11)/90 (12)
(68–110)/(71–110)
84 (15)/85 (14)
(66–113)/(66–113)
a
One addi ti onal pati ent w as randomi zed to thi s group, but di sconti nued before recei vi ng study drug.
International Journal of Impotence Research

34. Figure 2: The flow of patients throughout the study
Mikkel Fode, MD 1, Michael Borre, MD, PhD, DSc (Med) 2, Dana A. Ohl, MD 3, Jonas
Lichtbach 4 , Jens Sønksen, MD, PhD, DSc (Med) 1
1. Department of Urology, Herlev University Hospital, Herlev, Denmark
The device was set to an amplitude of 2 mm and a vibration frequency of 100 Hz. Patients
through a reusable but disposable black plastic disc as seen on the right end of the picture.
Figure 1: The FERTI CARE® vibrator. The vibratory stimulation of the device is delivered
Accepted Article
2. Department of Urology, Aarhus University Hospital, Aarhus, Denmark
3. Department of Urology, University of Michigan, Ann Arbor, USA
Running title:
PVS after Radical Prostatectomy
Authors:
seconds of stimulation every day).
seconds of stimulation followed by a 10 second pause repeated 10 times (for a total of 100
were instructed in stimulating the frenulum once daily with a sequence consisting of 10
pted Article
Title:
Penile vibratory stimulation in the recovery of urinary continence and erectile function after
nerve sparing radical prostatectomy: A randomized, controlled trial1
This is an open access article under the terms of the Creative Commons
Attribution-NonCommercial-NoDerivs License, which permits use and
distribution in any medium, provided the original work is properly cited, the
use is non-commercial and no modifications or adaptations are made.
This article is protected by copyright. All rights reserved.
22
ted Article
Title page

35. Article
ccepted Articl
Table 2: Erectile function outcomes in the two groups after RP. Results reported as median (range) and
proportions respectively.
IIEF-5 at 3
IIEF-5 at 6
IIEF-5 at 12
IIEF-5 ≥ 18
IIEF-5 ≥ 18
IIEF-5 ≥ 18 at
months
months
months
at 3 months
at 6 months
12 months
PVS
5 (0-25)
10.5 (0-25)
18 (0-25)
5/30 (17%)
13/30 (43%)
16/30 (53%)
Control
5 (0-25)
5 (0-25)
7.5 (0-25)
4/38 (11%)
9/38 (24%)
12/38 (32%)
p-value
0.25
0.08
0.09
0.46
0.09
0.07
Table 3: Continence rates and pad use (median and range) after surgery
Continence at 3
Continence at 6
Continence at
Pad use at 3
Pad use at 6
Pad use at 12
months
months
12 months
months
months
months
PVS
65.5%
83.3%
90%
1 (0 - 6)
0 (0 - 3)
0 (0 - 2)
Control
62.9%
91.9%
94.7%
1 (0 - 4)
1/3 (0 - 6)*
0 (0 - 3)
p-value
0.83
0.28
0.46
0.09
0.14
0.56
*One patient reported to use 1/3 of a pad daily. As there was no pre-specified decision on how to deal with
such reporting, it was taken at face-value when analysing the results.

36. ICI, IUA and VED
TIMING OF THE REHAB

42. STEP 1. BEFORE
Use Validated Questionaires
Assess Risk.
Neurovascular preservation indication.
Realistic information about options and timing.
STEP 2. DURING
Best possible surgery.
STEP 3. AFTER
Early onset?
Multimodal?
Optimal strategy unknown.
PFMT and lifestyle changes

44. AFTER CATHETER
REMOVAL
Tadalafil 5/24
MUSE* 3/week
3 MONTHS
STOP REHAB AND ASSESS
BACK TO BASELINE
FUNCTIONAL
ERECTIONS
Observation
Tadalafil 5/24
12 MONTHS
NON-FUNCTIONAL
ERECTIONS
Tad 5/24 + MUSE 3/week
STOP REHAB AND ASSESS
BACK TO BASELINE
FUNCTIONAL
ERECTIONS
Observation
Patient preference
NON-FUNCTIONAL
ERECTIONS
PDEI-5* vs MUSE*
NON-FUNCTIONAL
ERECTIONS
PENILE PROSTHESIS
* Minimum dose to get functional erections

45. AFTER CATHETER
REMOVAL
PFMT
3 MONTHS
ASSESS
DRY
1 PAD
Observation
PFMT
12 MONTHS
>1 PAD
PFMT + DULOXETINE
STOP REHAB AND ASSESS
NOT DRY
RSP + DULOXETINE*
1 PAD
RSP + DULOXETINE
2 PADS
SLING
>2 PADS
SPHINCTER

46. MANAGEMENT OF COMPLICATIONS AFTER LRP:
HOW TO IMPROVE EARLY CONTINENCE
AND MANAGE ERECTILE DYSFUNCTION
Eduard García Cruz
Urología y Salud del Hombre
Servicio de Urología
Hospital Clínic de Barcelona
ecruz@clinic.ub.es
@drgarciacruz
www.reisho.com
Conflict of interest: he recibido fondos para investigación de BAYER, Lilly, Pfizer, Auxilium y Janssen, he formado parte de comités asesores para Bayer, Lilly,
Gebro, Almirall, Janssen, Italpharmaco y Menarini. Soy ponente para Lilly, Pierre Fabre y Bayer. CEO en DocFitSolution.