The Influence of Typology and Posology of Exercise for the Preoperative Strengthening Training of Pelvic Floor in Urinary Incontinence Post RALP
Phase: NA
Conditions: Urinary Incontinence
Sponsor: Istituto Clinico Humanitas

 
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The influence of typology and posology of exercise for the 
preoperative strengthening training of pelvic floor in 
urinary incontinence post RALP 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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PROTOCOL NAME: The influence of typology and posology of exercise for the 
preoperative strengthening training of pelvic floor in urinary incontinence post RALP 
 
 
PROTOCOL IDENTIFYING NUMBER: CLF19/02 
 
 
PROTOCOL VERSION DATE 29/01/2019 
 
 
 
 
 
 
Contact addresses :                                                  roberto.gatti@hunimed.eu 
 
 
 
 
 
 
 
Coordinator of the study: 
Roberto Gatti 
+390282245610  
 

 
 
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Signatures Page 
 
 
 
 
 
 
 
 
STUDY COORDINATOR SIGNATURE (where applicable) 
 
ROBERTO GATTI 
Printed name 
 
Physiotherapy service manager and educational 
coordinator of Physiotherapy degree course  
Role & Department 
 
 
 
 
29/01/2019 
Signature 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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CENTRE SIGNATURE – PRINCIPAL INVESTIGATOR 
 
I read this protocol entitled “The influence of typology and posology of exercise for the 
preoperative strengthening training of pelvic floor in urinary incontinence post RALP” and I agree 
to conduct this study, as detailed here, and according to the guidelines of the Good Clinical 
Practice, by applying the regulations envisaged. 
I will provide all the information supplied by the sponsor to the personnel involved in the study, 
overseen by me, and I will inform them about their responsibilities and obligations. 
 
 
ROBERTO GATTI 
Printed name 
 
Physiotherapy service manager and educational 
coordinator of Physiotherapy degree course 
Role & Department 
 
 
Via Manzoni 56 Rozzano (Mi) 20089 
Address 
 
 
 
 
29/01/2019 
Signature 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Glossary of abbreviations 
 
 
RALP: Robotic-assisted laparoscopic prostatectomy 
PF: Pelvic Floor 
UI: Urinary Incontinence 
RP: Radical Prostatectomy 
PFME: Pelvic Floor Muscle Exercise 
PFMT: Pelvic Floor Muscle Training 
STS: Sit To Stand 
ICH: Istituto Clinico Humanitas 
 
 
 
 
 
 
 
  
 

 
 
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INDEX 
 
1 
SYNOPSIS ................................................................................................................ 8 
2 
BACKGROUND AND INTRODUCTION ................................................................. 10 
3 
RATIONAL OF THE STUDY .................................................................................. 10 
4  
GENERAL OBJECTIVES ................................................................................................. 10 
4.1 
End-points ............................................................................................................................. 11 
4.1.1 
Primary endpoint ................................................................................................................ 11 
4.1.2 Secondary endpoint ............................................................................................................ 11 
5 
SELECTION CRITERIA OF PATIENTS ................................................................. 11 
5.1 
Inclusion criteria .................................................................................................................. 11 
5.2 
Exclusion criteria ................................................................................................................. 11 
6 
STUDY DESIGN ..................................................................................................... 11 
6.1 
General design ...................................................................................................................... 11 
7 
STATISTICAL CONSIDERATIONS ....................................................................... 13 
7.1 
Sample size ....................................................................... Errore. Il segnalibro non è definito. 
7.2 
Analysis ................................................................................................................................. 13 
8 
ABANDONMENT OF THE STUDY ........................................................................ 13 
9 
MODULES AND PROCEDURES FOR DATA COLLECTION AND  
MANAGEMENT  ................................................................................................................ 13 
10 
ETHICAL CONSIDERATIONS ............................................................................... 14 
10.1 
Patient’s protection .............................................................................................................. 14 
10.2 
Entity Identifier – Protection of personal data ................................................................. 14 
10.3 
Informed consent.................................................................................................................. 14 
11 
CONFLICT OF INTEREST ..................................................................................... 14 

 
 
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12 
OWNERSHIP OF THE DATA ................................................................................. 14 
13 
PUBLICATION POLICY ................. ERRORE. IL SEGNALIBRO NON È DEFINITO. 
14 
BIBLIOGRAPHY ..................................................................................................... 15 
 
 

 
 
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1 Synopsis  
 
Title 
The influence of typology and posology of exercise for the 
preoperative strengthening training of pelvic floor in urinary 
incontinence post RALP 
 
 
Coordinator of the study  
Roberto Gatti 
Protocol number  
CLF19/02 
Date of the protocol 
29/01/2019 
Background e rational 
 
The male urinary incontinence is one of the possible 
complications following radical prostatectomy surgery. 
In patients undergoing this type of surgery, it represents one of 
the main problems to be solved, since it has a great impact on 
quality of life, on physical activity and on social well being of 
the individual. 
The recent literature defines strengthening exercises for the 
pelvic floor as the most effective conservative approach for the 
postoperative continence recovery, while the effect of a 
preoperative exercises training is still controversial. 
At present, studies evaluating the influence of a preoperative 
rehabilitation program in postoperative urinary incontinence to 
varying of exercises posology (number of daily repetitions) and 
of the exercises typology (isometric exercises VS functional 
exercises) have still not been published. 
The aim of this clinical study is to investigate possible chances 
concerning the urinary incontinence in subjects undergoing a 
robotic-assisted laparoscopic prostatectomy, to varying of 
posology and typology of preoperative exercises. 
Population 
and 
inclusion 
criteria  
 
120 subjects undergoing a RALP (Robotic-assisted laparoscopic 
prostatectomy) will be recruited.  
The inclusion criteria will be: RALP surgery planned after 
approximately 30-40 days from the preoperative session, 
objectivity of Pelvic Floor Muscle recruitment and contraction at 
manual perineal testing during preoperative session. 
Subjects with urinary incontinence before surgery, patients 
receiving radiotherapy treatment before surgery or patients who 
have had previous urogenital surgery shall be excluded from the 
study. 
Moreover, subjects with cognitive and/or psychiatric deficits and 
subjects with concurrent neurological conditions, internal 
conditions or disorders of the musculoskeletal system, which 

 
 
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may affect the functional or motor recovery, will be excluded 
from the study.  
Study design and duration  
 
 
The study is a randomized controlled clinical trial.  
It will begin in March 2019 and the recruitment is expected up to 
November 2019. Then, data processing, analysis and the writing 
of a scientific work will be executed. 
 
Objectives  
The aim of the study is to investigate how posology and 
typology of preoperative strengthening training of Pelvic Floor 
Muscle before RALP surgery can affect the postoperative 
urinary incontinence. 
The recruited patient will be randomized and stratified by age in 
4 groups according to exercise posology and typology. 
The primary outcome is to quantify the amount of the urinary 
leakage for 48h after 45-55 days post-surgery (Pad Test 48h). 
The secondary outcome is to evaluate urinary symptoms (IPSS 
and ICIQ-SF) and their impact on quality of life (index of quality 
of life 0-6), through self-assessment questionnaires compiled 
during preoperative session (about 30-40 days before surgery) 
and after 45-55- days (follow-up). 
 
Statistical methods and data 
analysis  
At the end of the data collection, a verification of normality and 
homogeneity of demographic variables and of outcome measures 
will be proceeded. Any differences between groups will be 
investigated through ANOVA test for mixed models with 
possible post-hoc analysis. 
Ethical consideration 
 
The aim of the study is to conduct an investigation in subjects 
who will undergo a RALP surgery. Participants will receive a 
treatment similar to treatment already described in literature and 
free from any adverse events for health. 
 
 
 
 
 
 
 

 
 
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2 Background and introduction 
Prostate cancer is a common male cancer and a major cause of cancer-related death in men (Lin 
YH et al., 2011).  
At present, radical prostatectomy (RP) appears to be the most used therapeutic option for solving 
this issue (MacDonald R et al., 2007). Despite improvements in surgical techniques, which allow a 
detailed dissection and a watertight vesical–urethral anastomosis, urinary incontinence (UI) remains 
a significant problem in several men undergoing radical prostatectomy (Kjellby-Wendt G et al., 
2001).  
The reported prevalence of patients with post-prostatectomy UI varies between different studies and 
it is found in more than 80% of patients one month after surgery and in 30% of patients UI is still 
present after one year (Chang JI et al., 2016; Zhang AY et al., 2015).  
UI may dramatically worsen the quality of life (QoL) of a patient who has been successfully cured 
of prostate cancer (D.F. Penson et al., 2005). Many therapeutic strategies have been adopted for 
treating UI, ranging from behavioral interventions to pharmacotherapy and surgical therapy (Bauer 
RM et al., 2009).  
Pelvic floor muscle exercise (PFME) is the most common conservative management for UI and it 
can improve the strength and endurance of striated muscles of the pelvic floor by repeated 
contractions, partially compensating for the urethral sphincter insufficiency (Anderson CA et al., 
2015). PFME is thought to be an economical and safe therapy for patients (Huebner M et al., 
2011).  
Studies have shown that post-operatory PFME guided by a physiotherapist has favored a rapid 
recovery of urinary incontinence after RP (Tienforti D et al., 2012; Manassero F et al., 2007;  
Filocamo MT et al., 2005). 
Some studies, nevertheless, support that preoperative PFME can aid patients to recover urinary 
incontinence early post-surgery. Other studies, however, showed that preoperative PFME had 
limited benefits in patients after RP (Aydın Sayılan A et al., 2018; Bales GT et al., 2000; 
Centemero A et al., 2010). 
 
 
 
3 Rational of the study 
Several studies in literature analyze the effect of a rehabilitation program after RALP surgery on 
post-operatory urinary incontinence, but there are conflicting results. The most important limitation 
of these studies is the variability of administered treatment due to a lack of standardization in 
typology and posology of suggested exercises. 
 
4 General objectives 
The study aims to investigate possible changes in terms of urinary incontinence in patients 
undergoing RALP, to varying of posology and typology of preoperative exercises.  
 
 
 

 
 
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4.1 End-points  
4.1.1 Primary endpoint  
 
The primary endpoint is to investigate the amount of urinary leakage during 48h after 45-55 post-
operatory days (Pad Test 48h). In order to quantify the amount of leakage the weight of pad used by 
patients during 48h will be measured. 
 
4.1.2 Secondary endpoint  
The secondary endpoint is to evaluate urinary symptoms (IPSS and ICIQ-SF) and their impact on 
quality of life (index of quality of life 0-6), through self-assessment questionnaires compiled by 
patients during the preoperative session (about 30-40 days before the surgery) and after 45-55- 
days, during the follow-up session. 
 
 
5 Selection criteria of patients  
5.1 Inclusion criteria 
Inclusion criteria: 
• On the list for RALP (Robotic-assisted laparoscopic prostatectomy) surgery expected 30-40 
days before preoperative session  
• Objectivity of Pelvic Floor Muscle recruitment and contraction at manual perineal testing 
during pre-operative session   
5.2 Exclusion criteria  
Exclusion criteria:  
• Incontinence before surgery 
• Radiotherapy treatment before surgery 
• Previous urogenital surgery  
• Simultaneous presence of neurological disorders, internal conditions or disorders of the 
musculoskeletal system that may affect the functional or motor recovery. 
Recruited subjects should respect all the mentioned eligibility criteria. 
 
6 Study design  
The study is a RCT and it will be held at Humanitas Research Hospital.  
6.1 General design  
120 subjects on the list for RALP surgery will be recruited. Subjects will be evaluated during the 
preoperative session (T0) and about 45-55 days before the surgery (T1). The initial assessment shall 
provide for the compilation of two self-assessment questionnaires concerning urinary symptoms: 
IPSS (International Prostatic Symptoms Score) and ICIQ-SF (International Consultation on 
Incontinence Questionnaire- Short Form). Furthermore, the impact of quality of life of patient 

 
 
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(index of quality of life 0-6) will be evaluated, in order to give a numerical indicator to the patient’s 
perception about its condition. 
The same questionnaires will be given by a physiotherapist during follow-up session (T1) before 
45-55 days post-surgery, when the amount of urinary incontinence through PAD test 48h will be 
evaluated, that provides for the weighing of used pad by patient during 48 hours before the session 
and preserved in a zip lock bag to avoid the evaporation of urine. 
A properly trained physiotherapist, who will use always the same scale, shall undertake weighing. 
Patient shall fill out a diary where he will take his activities carried out and the amount of drinks 
during the test. 
Recruited subjects will be divided randomly into 4 groups: 
1. ISOMETRIC STRENGTHENING once a day (1RI): patients in this group will have to play 
20 tonic contractions of Pelvic Floor Muscle with a duration of 5 seconds each, performed in 
supine position (with bent knees and feet resting on the bed), in sitting position and in erect 
position. Every recruited subject will be adequately educated by a physiotherapist (following 
standardized instructions) during an individual session at pre-hospital (T0), and he will be 
instructed to continue the same exercises at home once a day (only in the morning) from the 
day following the session until the day before surgery. The same exercises in the same way 
will be resumed independently by patient 2 days after the removal of bladder catheter and 
they will be executed until the follow-up session (T1), about 45-55 days after surgery in 
order to verify the compliance with the planned program. Every subject should complete a 
diary where he will take the execution of daily exercises from the pre-hospital session until 
follow-up (excluding days of hospitalization for surgery). 
2. ISOMETRIC STRENGTHENING twice a day (2RI): patients in this group will have to play 
the same typology of exercises in the same way just described (see above), but twice a day 
(in the morning and in the evening). 
3. FUNCTIONAL STRENGTHENING once a day (1RF): patients in this group will have to 
play 10 times the postural passage from supine position to sitting position on a bed and 10 
times the postural passage from sitting position to erect position (STS), maintaining the 
contraction of Pelvic Floor Muscle during the execution of each functional act. In sequence, 
starting from erect position, they will have to play 10 trunk flexion bending their knees (as 
to pick up an object on the ground), maintaining the contraction of Pelvic Floor Muscle 
during the execution of each functional movement. Every recruited subject will be 
adequately educated by a physiotherapist (following standardized instructions) during an 
individual session at pre-hospital (T0), and he will be instructed to continue the same 
exercises at home once a day (only in the morning) from the day following the session until 
the day before surgery. The same exercises in the same way will be resumed independently 
by patient 2 days after the removal of bladder catheter and they will be executed until the 
follow-up session (T1), about 45-55 days after surgery in order to verify the compliance 
with the planned program. Every subject should complete a diary where he will take the 
execution of daily exercises from the pre-hospital session until follow-up (excluding days of 
hospitalization for surgery). 
 

 
 
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4. FUNCTIONAL STRENGTHENING twice a day (2RF): patients in this group will have to 
play the same typology of exercises in the same way just described (see above), but twice a 
day (in the morning and in the evening). 
 
Furthermore, a control session with a physiotherapist will be carried out before the surgery, in order 
to verify the proper execution of exercises learned by recruited subjects. 
 
 
7 Statistical consideration  
7.1 Sample size 
This protocol refers to a pilot study, therefore no normative data are available. There is no study 
investigating the effectiveness of a preoperative Pelvic Floor Muscle Training in subject undergoing 
Radical Robotic-assisted Prostatectomy in literature. 
These studies analyze a sample of about 100 subjects. For this protocol 120 subjects will be 
recruited. They will be enough to obtain an initial estimate of any changes with parameters 
considered.  
 
7.2 Analysis 
The statistical analysis will be made at the end of the data collection through the software SPSS 
20.0. Categorical variables will be described in terms of the proportion, while continuous variables 
will be described in terms of an average and standard deviation or median and interquartile range.  
The verification of assumption of normalcy of demographic variables and of outcome measures 
through Kolmogorov-Smirnov test will be proceeded. Differences between groups in time will be 
evaluated through mixed models ANOVA test with possible post-hoc analyses. Statistical 
significance level will be set at 0.05.    
 
8  Abandonment of the study  
Subjects, who during or at the end of each evaluation included in the study protocol decide to give 
up the study for whatever reason, will be immediately excluded from it.  
Moreover, the possibility of abandoning the study also during the period from the preoperative 
session (T0) to follow-up (T1) will be made explicit to patients, after informing one of the 
experimenters. The uncompleted evaluations of recruited subjects will be excluded from the 
analysis of results.  
 
9 Modules and procedures for data collection and management  
Data from demographic variables and outcome measures will be included in anonymous form into 
Excel worksheet (Annex B). Only two experimenters will collect these data in order to minimize 
possible errors and they will be preserved in electronic format, protected by the appropriate 
password.  

 
 
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10 Ethical considerations 
10.1 Patient’s protection 
The coordinator of the study shall ensure that this study will be conducted according to the 
principles outlined by Helsinki Declaration (Annex C) and according to laws and rules of the 
Country in order to ensure maximum protection of subjects recruited in the study. 
After describing the protocol, the study will be conducted according to the guidelines (ICH) for 
Good Clinical Practice. 
Protocol and its annexes are subjected to review and approval borne by the relevant Independent 
Ethics Committee (ICE)  
 
10.2 Entity Identifier– Protection of personal data  
All data related to the acquisitions, evaluations and all the information related to individuals will be 
treated in strict confidence and to the extent permissible under laws in force. 
Privacy will be protected and no information will be made public. Patient’s name and surname will 
not be asked, subjects will be identified with ID code, as indicated in Annex B. Information 
requested will be therefore date of birth, sex, weight and height. Only and exclusively person 
actively involved in the study will have access to database. 
Each patient will be informed through a proper module related to protection of personal data (Annex 
D) and each one of them will have to sign the informed consent without which the patient cannot be 
involved in the study. 
 
10.3 Informed consent 
All subjects will receive information about the study, methods of performance and its goal. They 
will also be informed of the strict confidentiality on how their data will be processed. It is submitted 
that participation will be voluntary and that patient can abandon the study at any time. Each subject 
will compile the informed consent and only after the compilation data may be included in the 
collection table (Annex E). 
 
11  Conflict of interest  
All members of the study declare that they have no conflict of interest. 
 
12 Ownership of the data 
In accordance with Guidelines (ICH) of the Good Clinical Practice and considering that the study is 
a single institution study, the owner of the data is the Humanitas Research Hospital. 
 
 
After the completion of the study, the coordinator will prepare a manuscript with the final results on 
the basis of the statistical analysis. This manuscript, following revision, will be sent to proper 

 
 
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scientific journal. The coordinator of the study will revise all publications, abstract, presentations, 
manuscripts and slides, including data of this study. 
 
 
13 Bibliography 
 
• Anderson CA, Omar MI, Campbell SE, Hunter KF, Cody JD, et al. Conservative 
management for postprostatectomy urinary incontinence. Cochrane Database Syst Rev 
2015; 1: CD001843. 
• Aydın Sayılan A, Özbaş A. The effect of pelvic floor muscle training on incontinence 
problems after radical prostatectomy. Am J Mens Health 2018; 12: 1007–15. 
• Bales GT, Gerber GS, Minor TX, Mhoon DA, McFarland JM, et al. Effect of preoperative 
biofeedback/pelvic floor training on continence in men undergoing radical prostatectomy. 
Urology 2000; 56: 627–30. 
• Bauer RM, Bastian PJ, Gozzi C, Stief CG. Postprostatectomy incontinence: all about 
diagnosis and management. Eur Urol 2009; 55: 322–33 
• Centemero A, Rigatti L, Giraudo D, Lazzeri M, Lughezzani G, et al. Preoperative pelvic 
floor muscle exercise for early continence after radical prostatectomy: a randomized 
controlled study. Eur Urol 2010; 57: 1039–43. 
• Chang JI, Lam V, Patel MI. Preoperative pelvic floor muscle exercise and 
postprostatectomy incontinence: a systematic review and meta-analysis. Eur Urol 2016; 69: 
460–7. 
• Filocamo MT, Li Marzi V, Del Popolo G, Cecconi F, Marzocco M, et al. Effectiveness of 
early pelvic floor rehabilitation treatment for post-prostatectomy incontinence. Eur Urol 
2005; 48: 734–8. 
• Huebner M, Riegel K, Hinninghofen H, Wallwiener D, Tunn R, et al. Pelvic floor muscle 
training for stress urinary incontinence: a randomized, controlled trial comparing different 
conservative therapies. Physiother Res Int 2011; 16: 133–40. 
• Lin YH, Yang MS, Lin VC, Yu TJ, Chiang PH. The effectiveness of pelvic floor exercise on 
urinary incontinence in radical prostatectomy patients. Int J Urol Nurs 2011; 5: 115–22. 
• MacDonald R, Fink HA, Huckabay C, Monga M, Wilt TJ. Pelvic floor muscle training to 
improve urinary incontinence after radical prostatectomy a systematic review of 
effectiveness. BJU Int 2007; 100: 76–81. 
• Manassero F, Traversi C, Ales V, Pistolesi D, Panicucci E, et al. Contribution of early 
intensive prolonged pelvic floor exercises on urinary continence recovery after bladder 
neck-sparing radical prostatectomy: results of a prospective controlled randomized trial. 
Neurourol Urodyn 2007; 26: 985–9. 
 
• Tienforti D, Sacco E, Marangi F, D’Addessi A, Racioppi M, et al. Efficacy of an assisted 
low-intensity programme of perioperative pelvic floor muscle training in improving the 
recovery of continence after radical prostatectomy a randomized controlled trial. BJU Int 
2012; 110: 1004–10. 
• Zhang AY, Bodner DR, Fu AZ, Gunzler DD, Klein E, et al. Effects of patient-centered on 
persistent urinary incontinence after prostate cancer treatment: arandomized controlled trial. 
J Urol 2015; 194: 1675–81. 
 

 
 
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List of annexes 
Annex A_ Scheme of study  
Annex B_ Data collection sheet 
Annex C_ Helsinki Declaration 
Annex D_ Informed consent 
Annex E_ Privacy statement 
Annex H_ Curriculum Vitae Roberto Gatti