An interventional study of Quality-of-Life Assessment and Questionnaire Administration in Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8 and Stage IIA Prostate Cancer AJCC v8, sponsored by University of Southern California. Suspended at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 196 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Procedure: Radical Prostatectomy · Procedure: Vesicopexy
Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Procedure: Radical Prostatectomy
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Undergo RARP
Also known as: Prostatovesiculectomy
Undergo vesicopexy
Also known as: Cystopexy, Vesicofixation
3-month (+/- 3 weeks) urinary continence rate following RARP with or without vesicopexy
Defined continence as 0-1 safety pad usage. Use the "pictorial pad usage questionnaire."
Time frame: 3 months post-operative
3-month (+/- 3 weeks) quality of life following surgery
Use the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ-PR25).
Time frame: 3 months post-operative
72-hour postop urinary continence following surgery
Defined continence as 0-1 safety pad usage. Assessed with the "pictorial pad usage questionnaire."
Time frame: 72 hours post-operative
1-month (+/- 1 week) post-operative urinary continence following surgery
Defined continence as 0-1 safety pad usage. Assessed with the "pictorial pad usage questionnaire."
Time frame: 1 month post-operative
Sexual function at 3-month (+/- 3 weeks) following surgery
Sexual Health Inventory for Men (SHIM) questionnaire is used for the evaluation of sexual function.
Time frame: 3 months post-operative
Operative time
Time frame: Duration of operation
Intra-operative complications
Time frame: Duration of operation
90-day post-operative complications
Time frame: 90 days post-operative
This study is suspended, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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University of Southern California