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

Changhai Hospital96 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Prostate Cancer Urinary Incontinence

Interventions

SFUR-RARPPROCEDURE

Robotic-assisted radical prostatectomy with sustainable functional urethral reconstruction (SFUR)

Standard RARPPROCEDURE

Robotic-assisted radical prostatectomy with conventional RARP procedures.

Eligibility

Sex: MALEMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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;

Locations (1)

Changhai Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

1-month urinary continence recovery rates

Continence defined as daily usage of 0-1 pad with 24-hour pad weights≤50g.

Time frame: 1 month after catheter removal

Secondary Outcomes

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.

Time frame: Within 3 month after catheter removal

Peri and postoperative complications

Clavien-Dindo classification.

Time frame: 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).

Time frame: 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.

Time frame: 1-week, 2-week, 1-month, 3-month after catheter removal.

Data from ClinicalTrials.gov

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