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

Naval Military Medical University

Status

Completed

Conditions

Prostate Cancer

Urinary Incontinence

Treatments

Procedure: Standard RARP

Procedure: SFUR-RARP

Study type

Interventional

Funder types

Other

Identifiers

NCT04037800

CH-URO2019001

Details and patient eligibility

About

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).

Full 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.

Enrollment

96 patients

Sex

Male

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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;