NCT06966778
Oxybutynin ER to Promote Early Continence Recovery After Robotic Prostatectomy: A Randomized Controlled Trial
Recruiting · Not Applicable · National Taiwan University Hospital · registry updated 2026-03-16
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
- 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.