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

NCT06966778 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-03-16

No results posted yet for this study

Summary

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

Interventions

DRUG

Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd.

The 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

DRUG

Placebo (2 tab), PO, qd.

placebo, which is designed to look identical to the active drug but contains no therapeutic ingredient.

Sponsors & Collaborators

  • Synmosa Biopharma Corp.

    collaborator INDUSTRY

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06966778 on ClinicalTrials.gov