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.
National Taiwan University Hospital
Lead sponsor
Synmosa Biopharma Corp.
Collaborator