Status:
NOT_YET_RECRUITING
Oxybutynin ER to Promote Early Continence Recovery After Robotic Prostatectomy: A Randomized Controlled Trial
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Synmosa Biopharma Corp.
Conditions:
Localized Prostate Cancer
Postoperative Urinary Incontinence
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 radic...
Detailed Description
Extended Description of the Protocol This study is a double-blind, randomized, placebo-controlled clinical trial designed to evaluate the efficacy of oxybutynin chloride extended-release tablets (Oxbu...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT06966778
Start Date
September 23 2025
End Date
December 31 2028
Last Update
September 29 2025
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