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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-08

Study Completion Date

2021-09-28

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).

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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.

Conditions

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Prostate Cancer Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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SFUR-RARP

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

Group Type EXPERIMENTAL

SFUR-RARP

Intervention Type PROCEDURE

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

Standard RARP

Patients in which standard RARP is performed.

Group Type ACTIVE_COMPARATOR

Standard RARP

Intervention Type PROCEDURE

Robotic-assisted radical prostatectomy with conventional RARP procedures.

Interventions

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SFUR-RARP

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

Intervention Type PROCEDURE

Standard RARP

Robotic-assisted radical prostatectomy with conventional RARP procedures.

Intervention Type PROCEDURE

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;

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No