Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
ID06966778

A Double Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy of Oxybutynin Chloride Extended-Release Tablets to Improve Early Continence Recovery After Robotic Prostatectomy

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

135

Participants Needed

1

Research Sites

N/A

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

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

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

AI-Screening

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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

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

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 tamsulosin, solifenacin, and combination therapy for the treatment of ureteral stent related discomforts.

Kyoung Taek Lim, Yong Tae Kim, Tchun Yong Lee...

https://pubmed.ncbi.nlm.nih.gov/21860770

Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT - a double-blind, placebo-controlled trial.

M D Vardy, H D Mitcheson, T-A Samuels...

https://pubmed.ncbi.nlm.nih.gov/19930331

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.

Jochen Walz, Jonathan I Epstein, Roman Ganzer...

https://pubmed.ncbi.nlm.nih.gov/26850969

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).

Laurent Salomon

https://pubmed.ncbi.nlm.nih.gov/18308133