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

Sponsor

Changhai Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04037800

Collaborator

(none)

Enrollment

Location

Arms

21.7

Actual Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Urinary Incontinence	Procedure: SFUR-RARP Procedure: Standard RARP	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 8, 2019

Actual Primary Completion Date :

Jan 10, 2021

Actual Study Completion Date :

Sep 28, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: SFUR-RARP

Patients in which RARP with sustainable functional urethral reconstruction (SFUR) is performed.

Procedure: SFUR-RARP

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

Active Comparator: Standard RARP

Patients in which standard RARP is performed.

Procedure: Standard RARP

Robotic-assisted radical prostatectomy with conventional RARP procedures.

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

1-year urinary continence recovery [1-year from the intervention]
Two definitions of urinary continence: daily usage of 0-1 pad with 24-hour pad weights gain≤50g, 0 pads per day.
1-year urinary function and urinary function-related quality of life [1-year from the intervention]
International Prostatic Symptom Score(IPSS) and the IPSS quality of life score.
Evaluation of urinary continence with ICIQ-UI-SF [1-week, 2-week, 1-month, 3-month after catheter removal]
International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF).
Post-operative sexual function [1-year from the intervention]
Sexual Health Inventory for Men (SHIM) score >=17.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts 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;