NCT06966778Recruiting
Oxybutynin ER to Promote Early Continence Recovery After Robotic Prostatectomy: A Randomized Controlled Trial
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
Source: ClinicalTrials.gov · Last updated 16 Mar 2026
Brief summary (registry, in English)
The goal of this double-blind, randomized, placebo-controlled study is to evaluate whether oxybutynin chloride extended-release tablets can improve early continence recovery after robot-assisted radical prostatectomy (RARP) in patients with localized prostate cancer. The main questions it aims to answer are: \[Does oxybutynin chloride improve continence recovery after RARP compared to a placebo?\] \[What are the predictors of continence recovery?\] Researchers will compare the treatment group (oxybutynin chloride 10 mg/day) with the control group (placebo) to assess differences in continence outcomes. Participants will: \[Take the assigned medication (oxybutynin chloride or placebo) daily for 1-3 months until continence recovery.\] \[Complete surveys (e.g., IPSS, IIEF, ICIQ) at several time points post-surgery, including before surgery, 10 days after Foley catheter removal, and up to 12 months.\] \[Record any adverse events or concomitant medication use.\] Safety and tolerability will be monitored, and statistical analyses will determine the efficacy and predictors of continence. The study adheres to ethical principles, local regulations, and GCP guidelines.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 135 (estimated)
- First submitted
- 4 May 2025
- Start date
- 15 Sept 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT06966778
What you commit to
- Study type: Interventional
- Planned participants: 135
- From 15 Sept 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgical Complications: Participants who experience surgical complications during or after RARP requiring extraordinary medical or surgical treatment.
- Chronic Medication: Participants with long-term use of medications such as:
- Concurrent Medications: Participants who are taking medications that are prohibited by the study protocol (e.g., cholinergic drugs, azole antifungals, smooth muscle relaxants).
Other illness
- 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.
- Urinary Retention: Participants with a history of urinary retention.
- Gastrointestinal Motility Issues: Participants with severe conditions affecting gastrointestinal motility.
Other
- \- Alpha-blockers, antimuscarinics, or anticholinergics.
- Glaucoma: Participants with narrow-angle glaucoma.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.