Oxybutynin ER to Promote Early Continence Recovery After Robotic Prostatectomy: A Randomized Cont… (NCT06966778) | Clinical Trial Compass
RecruitingNot Applicable
Oxybutynin ER to Promote Early Continence Recovery After Robotic Prostatectomy: A Randomized Controlled Trial
Taiwan135 participantsStarted 2025-09-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Surgical Complications: Participants who experience surgical complications during or after RARP requiring extraordinary medical or surgical treatment.
* Other Urinary Conditions: Participants with other diseases causing lower urinary tract symptoms (LUTS) or bladder pain, including:
* \- Benign prostatic hyperplasia (BPH), chronic prostatitis, interstitial cystitis, painful bladder syndrome, or urinary tract infection.
* \- Overactive bladder or any other condition affecting bladder function.
* Chronic Medication: Participants with long-term use of medications such as:
* \- Alpha-blockers, antimuscarinics, or anticholinergics.
* Glaucoma: Participants with narrow-angle glaucoma.
* Urinary Retention: Participants with a history of urinary retention.
* Gastrointestinal Motility Issues: Participants with severe conditions affecting gastrointestinal motility.
* Concurrent Medications: Participants who are taking medications that are prohibited by the study protocol (e.g., cholinergic drugs, azole antifungals, smooth muscle relaxan…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Achieving Urinary Continence (0-1 Pad/Day) Within 12 Months After RARP