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Oxybutynin ER to Promote Early Continence Recovery After Robotic Prostatectomy: A Randomized Controlled Trial
Sponsor: National Taiwan University Hospital
Summary
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.
Official title: 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
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
135
Start Date
2025-09-15
Completion Date
2028-12-31
Last Updated
2026-03-16
Healthy Volunteers
No
Interventions
Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd.
The intervention being studied is oxybutynin chloride extended-release tablets (Oxbu), a muscarinic antagonist that is used to manage overactive bladder symptoms, including urinary incontinence. In this study, it is specifically evaluated for its potential to improve early continence recovery following robot-assisted radical prostatectomy (RARP) in patients with localized prostate cancer. This formulation is an extended-release version of oxybutynin, which allows for a slower, sustained release of the drug over time, ensuring more consistent therapeutic effects with reduced side effects compared to immediate-release formulations. The intervention involves a daily dose of 10 mg, administered as two 5 mg tablets, to assess its impact on postoperative continence recovery. The key distinction of this intervention is its focus on improving continence recovery after prostate cancer surgery, specifically through its targeted use in early post-surgical recovery, making it different from othe
Placebo (2 tab), PO, qd.
placebo, which is designed to look identical to the active drug but contains no therapeutic ingredient.
Locations (1)
National Taiwan University Hospital
Taipei, Taiwan