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

Hospital Universitari Vall d'Hebron Research Institute156 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

156

Conditions

Urinary Incontinence

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 6 months after surgery

Secondary Outcomes

early urinary recovery quantification in Grams (PAD-test 24h)

PAD-test during the first month after surgery

Time frame: 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)

Time frame: 12 months after surgery

Erectile function

SHIM assessment