The Effect of Vesicopexy on Urinary Continence and Quality of Life Following Robotic-Assisted Radical Prostatectomy: A Phase III Randomized Clinical Trial
Description
Brief 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.
Phase
N/AInclusion and Exclusion Criteria
- 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)
- Any history of psychiatric, neurologic or cognitive disease
- Any history of neuropathic bladder
- Any drug or alcohol addiction
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.