The Efficacy of Pre-operative Educational Pelvic Floor Intervention on Urinary Continence

Study Overview
=================
Brief Summary
-----------------
Prostate cancer is the most common type of cancer between male population and urinary incontinence (UI) is the most common of long-term sequelae. Nowadays, robotic prostatectomy became the surgery standard but there is still discrepant results regards the incidence of UI and there is a lack of studies about the use of pelvic floor rehabilitation in this population. Our study aims to assesses the efficacy of preoperative educational method in urinary incontinence after robotic prostatectomy.

Detailed Description
-----------------
Prostate cancer is the most common type of cancer between male population, with 161,300 new cases a year in the USA and an incidence of 10% in Italy. Since many years surgery is the treatment of choice, both at an early stage and in advanced cases, but involves side effects. From the post-operative problem presents in literature, urinary incontinence (UI) is the most common of long-term sequelae and significantly affects the quality of life and the psychological aspect in the post-surgical period. The incidence of UI after prostatectomy surgery varies between 0.8% and 87% in the first 3 and 6 months and between 5% and 44.5% after 1 year. This variability depends on the UI definition and the type of measurement used, which are not homogeneous among the various studies in the literature. Evaluations that are not objective make it difficult to compare the results obtained, thus creating discrepancies. To date, robotic prostatectomy is becoming the gold standard for its recognized greater accuracy when compared with the open surgery and laparoscopic procedure, with a reduced learning curve for operators and giving better post-surgical results. Progress technological aspects, such as the three-dimensional vision of the operative field, the macroscopic magnification and better image resolution, have made the robotic procedure a less invasive surgery with better functional outcomes. Despite these factors, UI is still present and in the majority of cases management is not completely evidence based. Moreover there is not yet a definite consensus regarding the predictive factors (age, disease stage, body weight, prostate volume and other comorbidities) in the incidence of the UI. When patients presents UI diagnoses, the conservative intervention through the pelvic floor rehabilitation is recommended in an attempt to reduce the impact of this complication. Muscle strengthening and pelvic floor awareness after surgery are used for years in clinical practice with results widely documented in the literature, but their effectiveness in the pre-operative period, especially if after robotic surgery, has not yet been sufficiently studied. Currently, there are discrepant results mainly due to the type of rehabilitative methodology applied and the time of beginning the preoperative treatment. Our study tries to evaluate, through an objective and reproducible measurement, the efficacy of a preoperative educational method in urinary incontinence after robotic prostatectomy.

Official Title
-----------------
The Efficacy of Pre-operative Educational Pelvic Floor Intervention on Urinary Continence in Patients Underwent Robotic Prostatectomy. A Randomized Clinical Trial

Conditions
-----------------
Prostatectomy, Pelvic Floor Disorders

Intervention / Treatment
-----------------
* Other: Pre operative exercise
* Other: Control Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent form Age >= 40 <= 70 years old Body mass Index <= 27 Indication of robotic prostate surgery Tumor with clinical stage T1 and T2. Extracapsular Extension Score <= 3, measured with magnetic resonance before surgery. Exclusion Criteria: Pathologic T3 tumor with radiotherapy indication Previous prostate surgery Previous urinary incontinence. Metabolic disorder Central or peripheral neurologic disorders Inability to understand informed consent or to carry out the rehabilitation protocol autonomously.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Superiority trial with 1:1 allocation ratio, randomized with two-arm parallel group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre operative exercise<br>The educational pelvic floor intervention group will receive one months before surgery a physiotherapy visit were will be explain to patients and care giver the pelvic floor anatomy and biomechanics and how perform the exercises to be follow at home focusing on pelvic muscles awareness and contraction. Patients and care giver will receive a daily exercise diary to fill at home and will be advised to follow the exercise program. | Other: Pre operative exercise<br>* After randomization participants will be allocated in two groups. The educational pelvic floor intervention group will receive two months before surgery a physiotherapy visit were will be explain to patients and care giver the pelvic floor anatomy and biomechanics and how perform the exercises to be follow at home focusing on pelvic muscles awareness and contraction.<br>|
| Active Comparator: Control group<br>The control group will be just informed about the study protocol and will not receive any pre-operative intervention. | Other: Control Group<br>* The control group will be just informed about the study protocol and will not receive any pre-operative intervention.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported urinary continence | Continence (completely dry patient) will be defined as the sum of no urinary leakage reported by the patient in his bladder diary | 1,3,6 months and 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of urinary incontinence. | Assesment of the degree of urinary incontinence based on a 24 hours pad test. | 1,3,6 months and 1 year after surgery | 
| Quality of life instrument | Assesment of quality of life using the The Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. | 1,3,6 months and 1 year after surgery | 
| Assesment of the post traumatic distress using the Impact of event Scale (IES). | Scale range from 0 to 4 with lower values representing better outcomes | 1,3,6 months and 1 year after surgery | 
| Assesment of the individual resilience with the resilience scale for adults (RSA). | Scale range from 1 to 5 with lower values representing better outcomes | 1,3,6 months and 1 year after surgery | 
| Assesment of the urinary status with the International Consultation on Incontinence (ICIQ) Questionnaire. | Summed of sub scales range from 0 to 3, 0 to 6 and 1 to 10. Minimum score of 1 and maximum score of 19, with lower values representing better outcomes | 1,3,6 months and 1 year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rehabilitation, Prostatectomy, Pelvic Floor Disorders, Robotic Surgical Procedures