Study of Oxybutynin Extended-Release Tablets to Help Early Urinary Control After Robotic Prostate Surgery for Localized Prostate Cancer
Led by National Taiwan University Hospital · Updated on 2026-03-16
135
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether oxybutynin chloride extended-release tablets can improve early continence recovery after robot-assisted radical prostatectomy RARP in patients with localized prostate cancer. This double-blind, randomized, placebo-controlled study aims to compare oxybutynin chloride with a placebo and identify factors that predict continence recovery.
Participants are randomly assigned to receive either oxybutynin chloride extended-release tablets at a dose of 10 mg per day two 5 mg tablets or placebo tablets that look identical. Treatment lasts from 1 to 3 months or until participants regain complete continence, defined as needing no urinary pads and less than one episode of incontinence per week.
During the study, participants complete surveys measuring urinary symptoms, erectile function, and incontinence at multiple time points before and after surgery, including up to 12 months post-surgery. Researchers will monitor adverse events and medication use, assessing continence outcomes and treatment safety over the study period.
CONDITIONS
Brief Title
Oxybutynin ER to Promote Early Continence Recovery After Robotic Prostatectomy: A Randomized Controlled Trial
Research Team
K
Kuo-How Huang Kuo-How Huang, Professor
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Diagnosis of localized prostate cancer and scheduled for robot-assisted radical prostatectomy (RARP)
Male participants aged 18 years or older with no upper age limit
Able to provide written informed consent prior to any study procedures
Able to follow the study protocol throughout the trial duration
You will not qualify if you...
Surgical complications during or after RARP requiring extraordinary medical or surgical treatment
Presence of other diseases causing lower urinary tract symptoms or bladder pain such as benign prostatic hyperplasia, chronic prostatitis, interstitial cystitis, painful bladder syndrome, or urinary tract infection
Diagnosis of overactive bladder or any condition affecting bladder function
Long-term use of alpha-blockers, antimuscarinics, or anticholinergics
History of narrow-angle glaucoma
History of urinary retention
Severe gastrointestinal motility disorders
Use of prohibited medications such as cholinergic drugs, azole antifungals, or smooth muscle relaxants
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 1 to 3 months or until complete continence is achieved
Participants receive either oxybutynin chloride extended-release tablets or placebo daily to improve early continence recovery after robotic prostatectomy.
Visits at baseline (pre-surgery), 10 days post-Foley catheter removal, and scheduled intervals up to 3 months
Follow-up
Duration - Up to 12 months post-surgery
Participants are monitored for continence outcomes and safety for up to 12 months post-surgery.
Visits at intervals up to 12 months post-surgery
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT - a double-blind, placebo-controlled trial.
A Critical Analysis of the Current Knowledge of Surgical Anatomy of the Prostate Related to Optimisation of Cancer Control and Preservation of Continence and Erection in Candidates for Radical Prostatectomy: An Update.
Re: Bianco FJ, Scardino PT, and Eastham JA: Radical prostatectomy: long-term cancer control and recovery of sexual and urinary function ("Trifecta") (Urology 66(5 suppl): 83-94, 2005).