Trial to Compare Urinary Continence Recovery After Robotic Radical Prostatectomy With or Without Rhabdosphincter Reconstruction.

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomized controlled trail to assess early urinary continence recovery rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter reconstruction is performed or not. A hundred forty-six patients with clinically localized and histological confirmed prostate cancer will be enrolled. Continence recovery is defined in the present study as declared urinary continence (absence of incontinence episodes) in the physician interview as no pad use. Continence rates will be explored also by EPIC, ICIQ-SF, IPSS questionnaires 1, 6 and 12 months after the procedure. The sexual function as the secondary objective will be assessed by SHIM questionnaire.

Official Title
-----------------
Prospective Randomized Controlled Trial to Compare Early Urinary Continence Recovery After Robotic Assisted Radical Prostatectomy With or Without Posterior Rhabdosphincter Reconstruction.

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Procedure: Radical prostatectomy with posterior rhabdosphincter reconstruction
* Procedure: Radical prostatectomy without posterior rhabdosphincter reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological confirmation of prostate cancer Localized or locally advanced prostate cancer Informed consent signed Exclusion Criteria: Presence of urinary incontinence prior to the procedure Previous radiation therapy of the prostate or pelvis Presence of any prostatic surgery prior to the procedure Prior medical history of psychiatric diseases or drug addiction Any condition that contraindicates a radical prostatectomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective randomized controlled trial to assess early urinary continence recovery rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter reconstruction is performed or not.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Posterior Rhabdosphincter Reconstruction<br>Patients in who posterior rhabdosphincter reconstruction is performed | Procedure: Radical prostatectomy with posterior rhabdosphincter reconstruction<br>* To suture the Denonvilliers fascia and bladder to the median dorsal raphe according to Rocco technique.<br>* Other names: Rocco Stitch;|
| Active Comparator: Standard Technique<br>Patients in who posterior rhabdosphincter reconstruction is NOT performed, Standard technique. | Procedure: Radical prostatectomy without posterior rhabdosphincter reconstruction<br>* Standard technique with a running suture to perform the urethrovesical anastomosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 1st monthNumber of patients using 0-1 PAD/d (EPIC-26 question_5) at 1st month | Absence of urinary incontinence (number of PADs/d) | 1 month after surgery | 
| Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 6th month | Absence of urinary incontinence (number of PADs/d) | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early urinary recovery quantification in Grams (PAD-test 24h) | PAD-test during the first month after surgery | one day before catheter removal, 2 weeks before and 1 month before | 
| Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 12th month | Absence of urinary incontinence (number of PADs/d) | 12 months after surgery | 
| Erectile function | SHIM assessment | 1, 6 and 12 months | 
| Quality of life I: urinary and bowel function | EPIC-26 urinary and digestive function | 1, 6 and 12 months | 
| Quality of life II: urinary function | ICIQ-SF assessment of urinary function | 1, 6 and 12 months | 
| Quality of life III: urinary function | IPSS assessment of urinary function | 1, 6 and 12 months | 
| Oncological outcome: Biochemical free-recurrence status | serum PSA assessment. Biochemical free-recurrence status = PSA <0.2 | 1, 6 and 12 months | 
| Anatomopathological parameters: Surgical margins | Surgery margins in prostatectomy specimens | 1 month | 
| Anatomopathological parameters: pTNM classification | Pathological pTNM in prostatectomy specimens | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Urinary incontinence, Radical prostatectomy, Rhabdosphincter, Robotic Surgery