Oxybutynin ER to help early urinary continence after robotic prostatectomy
A Double Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy of Oxybutynin Chloride Extended-Release Tablets to Improve Early Continence Recovery After Robotic Prostatectomy
This trial will test whether taking a daily extended-release oxybutynin pill helps men regain urinary control sooner after robot-assisted prostate removal.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06966778 on ClinicalTrials.gov |
What this trial studies
This is a double-blind, randomized, placebo-controlled trial enrolling about 135 men undergoing robot-assisted radical prostatectomy for localized prostate cancer. Participants are assigned to oxybutynin ER 10 mg daily or matching placebo and will take the medication for 1–3 months or until they reach continence. Continence and related outcomes are measured with standard questionnaires (IPSS, IIEF, ICIQ) at baseline, after catheter removal, and up to 12 months, while adverse events and concomitant medications are recorded. The study also examines predictors of continence recovery and excludes patients with other lower urinary tract disorders or conflicting chronic medications.
Who should consider this trial
Good fit: Ideal candidates are men with localized prostate cancer who are scheduled for robot-assisted radical prostatectomy, able to take oral medication, and willing to complete follow-up questionnaires.
Not a fit: Patients with preexisting bladder diseases or overactive bladder, those who experience significant surgical complications, or those who must take prohibited medications are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the medication could shorten the time to regain urinary continence after prostate removal and reduce pad use, improving patient quality of life.
How similar studies have performed: Antimuscarinic drugs like oxybutynin are effective for overactive bladder, but randomized evidence specifically showing faster continence recovery after prostatectomy is limited, so this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis: Patients with localized prostate cancer who are scheduled to undergo robot-assisted radical prostatectomy (RARP). * Age: Participants must be 18 years or older, with no upper age limit. * Consent: Participants must provide written informed consent before undergoing any study procedures. * Ability to Follow Protocol: Participants must be able to follow the protocol procedures throughout the study. Exclusion Criteria: * Surgical Complications: Participants who experience surgical complications during or after RARP requiring extraordinary medical or surgical treatment. * Other Urinary Conditions: Participants with other diseases causing lower urinary tract symptoms (LUTS) or bladder pain, including: * \- Benign prostatic hyperplasia (BPH), chronic prostatitis, interstitial cystitis, painful bladder syndrome, or urinary tract infection. * \- Overactive bladder or any other condition affecting bladder function. * Chronic Medication: Participants with long-term use of medications such as: * \- Alpha-blockers, antimuscarinics, or anticholinergics. * Glaucoma: Participants with narrow-angle glaucoma. * Urinary Retention: Participants with a history of urinary retention. * Gastrointestinal Motility Issues: Participants with severe conditions affecting gastrointestinal motility. * Concurrent Medications: Participants who are taking medications that are prohibited by the study protocol (e.g., cholinergic drugs, azole antifungals, smooth muscle relaxants).
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Kuo-How Huang Kuo-How Huang, Professor
- Email: khhuang123@ntu.edu.tw
- Phone: +886-2-2312-3456
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.