Tests oxybutynin tablets for urine control after prostate surgery
Tests oxybutynin tablets against a placebo in men after robotic prostate surgery.
Plain-language title generated from the registry record
Registry title: Oxybutynin ER to Promote Early Continence Recovery After Robotic Prostatectomy: A Randomized Controlled Trial
Key facts
- Where
- Taipei, TaiwanSee the site
Where in Taiwan
- National Taiwan University HospitalTaipei, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Taiwan University Hospital
- Trial code
- NCT06966778
- Record updated
- 16 March 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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 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; - Alpha-blockers, antimuscarinics, or anticholinergics; Glaucoma: Participants with narrow-angle glaucoma.