Levator Ani Muscle Reconstruction for Urinary Incontinence Recovery in Prostate Cancer Patients
The Role of Levator Ani Muscle Reconstruction Technology in Urinary Incontinence Recovery After Robot Assisted Radical Prostatectomy: a Randomized Controlled Clinical Trial
This study tests if different ways of fixing pelvic muscles can help men with prostate cancer recover better from urinary incontinence after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06543420 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of levator ani muscle reconstruction techniques in improving urinary incontinence recovery among patients undergoing robot-assisted laparoscopic radical prostatectomy for prostate cancer. Participants are randomly assigned to one of three groups: lateral reconstruction, posterior reconstruction, or no reconstruction. The study collects various clinical data post-surgery, including daily urine pad usage and quality of life scores, to evaluate the impact of the different reconstruction methods on urinary control. The goal is to determine which approach offers the best outcomes for patients' quality of life after surgery.
Who should consider this trial
Good fit: Ideal candidates are men diagnosed with prostate cancer at clinical stages cT2 to T3aN0M0 who are eligible for robot-assisted radical prostatectomy.
Not a fit: Patients with a history of urinary incontinence, previous prostate surgeries, or contraindications for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve urinary control and quality of life for prostate cancer patients post-surgery.
How similar studies have performed: Other studies have explored surgical techniques for urinary incontinence recovery, but this specific approach to levator ani muscle reconstruction is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with prostate cancer and preoperative clinical stage of cT2\~T3aN0M0 * Complies with the indications for RARP surgery Exclusion Criteria: * History of urinary incontinence or urethral stricture * Previous prostate related surgical treatment * Contraindications for RARP surgery * The patient or their family members refuse to participate
Where this trial is running
Beijing, Beijing Municipality
- Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Kan Gong — Peking University First Hospital
- Study coordinator: Kan Gong, MD
- Email: kan.gong@bjmu.edu.cn
- Phone: (86)-010-83572075
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.