Oxybutynin ER to help early urinary continence after robotic prostatectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a double-blind, randomized, placebo-controlled trial enrolling about 135 men undergoing robot-assisted radical prostatectomy for localized prostate cancer. Participants are assigned to oxybutynin ER 10 mg daily or matching placebo and will take the medication for 1–3 months or until they reach continence. Continence and related outcomes are measured with standard questionnaires (IPSS, IIEF, ICIQ) at baseline, after catheter removal, and up to 12 months, while adverse events and concomitant medications are recorded. The study also examines predictors of continence recovery and excludes patients with other lower urinary tract disorders or conflicting chronic medications.

Why it matters

Who can join: the full rules

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).

Where it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Kuo-How Huang Kuo-How Huang, Professor
• Email: khhuang123@ntu.edu.tw
• Phone: +886-2-2312-3456

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.