A Double Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy of Oxybutynin Chloride Extended-Release Tablets to Improve Early Continence Recovery After Robotic Prostatectomy

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · May 4, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether a medication called oxybutynin chloride can help men recover their ability to control urination more quickly after a specific type of prostate surgery known as robotic-assisted radical prostatectomy (RARP). The study will compare the effects of oxybutynin to a placebo (a pill that looks the same but doesn't contain active medication) to see if it makes a difference in how soon participants regain urinary control after surgery. The researchers will also try to find out what factors might help predict who will recover their continence better.

To participate in this study, men aged 18 and older who have localized prostate cancer and are scheduled for RARP may be eligible, as long as they do not have other urinary issues or certain medical conditions that could interfere with the study. Participants will take either the medication or the placebo every day for 1 to 3 months after surgery and will fill out surveys at different times to track their recovery. The trial will ensure safety and monitor any side effects throughout the process. It's important to note that the study is not recruiting participants yet, but it aims to follow ethical guidelines to ensure a responsible approach to research.

Gender

MALE

Eligibility criteria

• 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).