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

RecruitingNAAges 18 Years - anyMaleNational Taiwan University Hospital
NCT06966778 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 t

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📋 Eligibility rules (as published)
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 relaxants).
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What it tests

  • Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd.
  • Placebo (2 tab), PO, qd.
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Where

1 site
National Taiwan University Hospital
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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