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.
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.
Surgical Complications: Participants who experience surgical complications during or after RARP requiring extraordinary medical or surgical treatment.
- Benign prostatic hyperplasia (BPH), chronic prostatitis, interstitial cystitis, painful bladder syndrome, or urinary tract infection.
- Overactive bladder or any other condition affecting bladder function.
- Alpha-blockers, antimuscarinics, or anticholinergics.
Parallel
Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd.
DrugThe 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.
Drugplacebo, which is designed to look identical to the active drug but contains no therapeutic ingredient.
Number of Participants Achieving Urinary Continence (0-1 Pad/Day) Within 12 Months After RARP
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National Taiwan University Hospital
Lead sponsor
Synmosa Biopharma Corp.
Collaborator
