Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Accrual goal reached and suspended for analysis purposes.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IIA Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIC Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Radical Prostatectomy | Procedure | — | UNRESOLVED |
| Vesicopexy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (radical prostatectomy, vesicopexy)
- description
- Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
- interventionNames
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Procedure: Radical Prostatectomy
- Procedure: Vesicopexy
- type
- ACTIVE_COMPARATOR
- label
- Arm II (radical prostatectomy)
- description
- Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
- interventionNames
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Procedure: Radical Prostatectomy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion 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) Exclusion Criteria: * Any history of psychiatric, neurologic or cognitive disease * Any history of neuropathic bladder * Any drug or alcohol addiction
References
Publications (0)
Data not yet available