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

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Men with age \> 18 years

• Prostate cancer patients undergoing RARP with anterior approach at University of Southern California (USC) urology

• Ability to understand and the willingness to sign a written informed consent

• Clinical stage \< 4 and (M0) prostate cancer

• Eastern Cooperative Oncology Group (ECOG) performance score 0-1

• Pre-operative (op) urinary continence

• Negative history of pelvic radiation and/or previous local therapy for prostate cancer (i.e., radiation or focal therapy)

Locations
United States
California
USC / Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Contact Information
Primary
Ileana Aldana
Ileana.aldana@med.usc.edu
323-865-3700
Time Frame
Start Date: 2021-10-27
Estimated Completion Date: 2026-10-27
Participants
Target number of participants: 196
Treatments
Experimental: Arm I (radical prostatectomy, vesicopexy)
Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
Active_comparator: Arm II (radical prostatectomy)
Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
Related Therapeutic Areas
Sponsors
Leads: University of Southern California
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials