Robot-assisted surgery for prostate cancer with or without bladder support
The Effect of Vesicopexy on Urinary Continence and Quality of Life Following Robotic-Assisted Radical Prostatectomy: A Phase III Randomized Clinical Trial
This study is testing if adding bladder support during robot-assisted surgery for prostate cancer helps men keep better control of their urine three months after the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Southern California Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04981834 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the outcomes of robot-assisted radical prostatectomy (RARP) with and without the addition of vesicopexy in men diagnosed with non-metastatic prostate cancer. The primary goal is to assess urinary continence three months post-surgery, while secondary objectives include evaluating quality of life, sexual function, and postoperative complications. Patients will be randomized into two groups: one receiving RARP with vesicopexy and the other receiving RARP without it. Follow-up assessments will occur at 24 hours, one month, and three months after the procedure.
Who should consider this trial
Good fit: Ideal candidates are men over 18 years old with clinical stage less than 4 prostate cancer who are undergoing RARP at the University of Southern California.
Not a fit: Patients with a history of psychiatric, neurologic, or cognitive diseases, or those with neuropathic bladder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved urinary continence and quality of life for prostate cancer patients after surgery.
How similar studies have performed: Other studies have explored similar surgical techniques, but the specific combination of RARP with vesicopexy is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Hooman Djaladat, MD — University of Southern California
- Study coordinator: Ileana Aldana
- Email: Ileana.aldana@med.usc.edu
- Phone: 323-865-3700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.