An RCT to Compare Early Continence Recovery After RARP With or Without Sustainable Functional Urethral Reconstruction

Study Overview
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Brief Summary
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The study is a prospective randomized controlled trail to compare early urinary continence recovery after robotic-assisted radical prostatectomy with or without sustainable functional urethral reconstruction (SFUR).

Detailed Description
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Early urinary incontinence has always been a tricky problem for both patients and urologists, even though over 90% patients can recover 1 year after surgery. Many urologists are trying to modify the surgical technique to resolve this problem. Sustainable functional urethral reconstruction (SFUR) is a novel technique which may improve early urinary continence recovery for both local and locally advanced prostate cancer, and even for those with high volume prostate by providing adequate urethral length with bladder neck tubularization and making sustainable periurethral support with peritoneal flap. The purpose of this study is to verify the impact of this new technique on early recovery of urinary continence, as well as on urinary function and oncological outcomes.

Official Title
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Impact of Sustainable Functional Urethral Reconstruction on Early Continence Recovery After Robotic-assisted Radical Prostatectomy: a Randomized Controlled Trial

Conditions
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Prostate Cancer, Urinary Incontinence

Intervention / Treatment
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* Procedure: SFUR-RARP
* Procedure: Standard RARP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥40, but ≤75 years old； Histological confirmed prostate cancer； Localized or locally advanced prostate cancer； Presence of urinary continence prior to the procedure; Informed consent signed; Exclusion Criteria: Metastatic prostate cancer confirmed by ECT, PSMA or whole-body MRI; Presence of any prostatic surgery(such as transurethral resection, laser therapy, microwave therapy, radiofrequency ablation and so on) prior to the procedure; Radiation therapy of the prostate or pelvis prior to the procedure; Uncontrolled intercurrent illness that would limit compliance with study requirements; Any condition that contraindicates a radical prostatectomy;

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SFUR-RARP<br>Patients in which RARP with sustainable functional urethral reconstruction (SFUR) is performed. | Procedure: SFUR-RARP<br>* Robotic-assisted radical prostatectomy with sustainable functional urethral reconstruction (SFUR)<br>|
| Active Comparator: Standard RARP<br>Patients in which standard RARP is performed. | Procedure: Standard RARP<br>* Robotic-assisted radical prostatectomy with conventional RARP procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-month urinary continence recovery rates | Continence defined as daily usage of 0-1 pad with 24-hour pad weights≤50g. | 1 month after catheter removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term urinary continence recovery | Two definitions of urinary continence: daily usage of 0-1 pad with 24-hour pad weights gain≤50g, 0 pads per day. Besides, quantification of urine leakage with 24-hour pad weight. | Within 3 month after catheter removal | 
| Peri and postoperative complications | Clavien-Dindo classification. | 1-year follow up | 
| Post-operative oncological outcomes | Two assessment methods: positive surgical margin (PSM) rates and 1-year biochemical recurrence-free survival (BFS, defined as two consecutive PSA levels>0.2 ng/mL). | 1-year follow up | 
| Short-term urinary function and urinary function-related quality of life | International Prostatic Symptom Score(IPSS) and the IPSS quality of life score. | 1-week, 2-week, 1-month, 3-month after catheter removal. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Prostatectomy, Robotic surgery, Urinary incontinence, Sustainable functional urethral reconstruction