NCT04981834

Robot-Assisted Radical Prostatectomy With or Without Vesicopexy in Patients With Prostate Cancer

The Effect of Vesicopexy on Urinary Continence and Quality of Life Following Robotic-Assisted Radical Prostatectomy: A Phase III Randomized Clinical Trial

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase III trial compares the effects of robot-assisted radical prostatectomy (RARP) with or without vesicopexy on urinary continence (a person's ability to control their bladder) and quality of life in patients with cancer of the prostate. RARP is the most adopted surgical approach for treatment of prostate cancer that has not spread to other places in the body (non-metastatic). Urinary incontinence (inability to control the bladder) is one of the most common complications of RARP, impacting patients' quality of life and psychological well-being. Different techniques have been proposed to improve urinary continence following RARP. Vesicopexy is one technique that restores the bladder to its normal position in the body after RARP. This study aims to evaluate whether RARP with vesicopexy may improve urinary continence and quality of life after surgery in prostate cancer patients.

Detailed description

PRIMARY OBJECTIVE: I. To determine the 3-month (+/- 3 weeks) urinary continence following RARP with or without vesicopexy. SECONDARY OBJECTIVES: I. To evaluate the 3-month (+/- 3 weeks) quality of life following RARP with or without vesicopexy. II. To evaluate the 72-hour post-operative (postop) urinary continence following RARP with or without vesicopexy. III. To evaluate the 1-month (+/- 1 week) postop urinary continence following RARP with or without vesicopexy. IV. To evaluate sexual function at 3-month (+/- 3 weeks) following RARP with or without vesicopexy. V. To evaluate the operative time in patients undergoing RARP with or without vesicopexy. VI. To evaluate intraoperative complications in patients undergoing RARP with or without vesicopexy. VII. To evaluate 90-day post-operative complications in patients undergoing RARP with or without vesicopexy. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion. ARM II: Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion. After study completion, patients will be followed-up with at 24 hours, 1-month, and 3-months.

Conditions

• Stage I Prostate Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8
• Stage IIA Prostate Cancer AJCC v8
• Stage IIB Prostate Cancer AJCC v8
• Stage IIC Prostate Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8
• Stage IIIA Prostate Cancer AJCC v8
• Stage IIIB Prostate Cancer AJCC v8
• Stage IIIC Prostate Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Radical Prostatectomy	Undergo RARP
PROCEDURE	Vesicopexy	Undergo vesicopexy

Timeline

• Start date: 2021-10-27
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2021-07-29
• Last updated: 2026-01-16

Locations

1 site across 1 country: United States