Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06966778

Oxybutynin ER to Promote Early Continence Recovery After Robotic Prostatectomy: A Randomized Controlled Trial

Led by National Taiwan University Hospital · Updated on 2026-03-16

135

Participants Needed

1

Research Sites

171 weeks

Total Duration

On this page

Sponsors

N

National Taiwan University Hospital

Lead Sponsor

S

Synmosa Biopharma Corp.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Oxybutynin ER to Promote Early Continence Recovery After Robotic Prostatectomy: A Randomized Controlled Trial

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with localized prostate cancer and scheduled for robot-assisted radical prostatectomy (RARP)
  • Male aged 18 years or older
  • Provided written informed consent before any study procedures
  • Able to follow study procedures throughout the trial
Not Eligible

You will not qualify if you...

  • Experienced surgical complications during or after RARP that require extraordinary medical or surgical treatment
  • Have other urinary diseases causing lower urinary tract symptoms or bladder pain, including benign prostatic hyperplasia, chronic prostatitis, interstitial cystitis, painful bladder syndrome, or urinary tract infection
  • Have overactive bladder or any other condition affecting bladder function
  • Use long-term medications such as alpha-blockers, antimuscarinics, or anticholinergics
  • Have narrow-angle glaucoma
  • Have a history of urinary retention
  • Have severe gastrointestinal motility disorders
  • Are taking prohibited medications such as cholinergic drugs, azole antifungals, or smooth muscle relaxants

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan, 100

Actively Recruiting

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Research Team

K

Kuo-How Huang Kuo-How Huang, Professor

CONTACT

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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