Status:

COMPLETED

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

Lead Sponsor:

Changhai Hospital

Conditions:

Prostate Cancer

Urinary Incontinence

Eligibility:

MALE

40-75 years

Phase:

NA

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 reconst...

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 s...

Eligibility Criteria

Inclusion

  • ≥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

  • 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;

Key Trial Info

Start Date :

December 8 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 28 2021

Estimated Enrollment :

96 Patients enrolled

Trial Details

Trial ID

NCT04037800

Start Date

December 8 2019

End Date

September 28 2021

Last Update

May 18 2022

Active Locations (1)

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Changhai Hospital

Shanghai, Shanghai Municipality, China, 200082