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

Not Applicable

Completed

• Conditions: Urinary Incontinence; Prostate Cancer
• Interventions: Procedure: SFUR-RARP; Procedure: Standard RARP

• Registration Number: NCT04037800
• Lead Sponsor: Changhai Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-07-27
• Study First Posted: 2019-07-30
• Study Start: 2019-12-08
• Primary Completion: 2021-01-10
• Study Completion: 2021-09-28
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 96

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SFUR-RARP	SFUR-RARP	Patients in which RARP with sustainable functional urethral reconstruction (SFUR) is performed.
Standard RARP	Standard RARP	Patients in which standard RARP is performed.

Primary Outcome Measures

Name	Time	Method
1-month urinary continence recovery rates	1 month after catheter removal	Continence defined as daily usage of 0-1 pad with 24-hour pad weights≤50g.

Secondary Outcome Measures

Name	Time	Method
Short-term urinary continence recovery	Within 3 month after catheter removal	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.
Peri and postoperative complications	1-year follow up	Clavien-Dindo classification.
Post-operative oncological outcomes	1-year follow up	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).
Short-term urinary function and urinary function-related quality of life	1-week, 2-week, 1-month, 3-month after catheter removal.	International Prostatic Symptom Score(IPSS) and the IPSS quality of life score.

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China