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New treatment option for Localized Prostate Cancer
Official title Oxybutynin ER to Promote Early Continence Recovery After Robotic Prostatectomy: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06966778
What this study is testing
What is Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd.?
Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd. is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for localized prostate cancer.
Also referred to as Oxybutynin Extended-Release Tablets, Oxbu.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.