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

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 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: \[Take the assigned medication (oxybutynin chloride or placebo) daily for 1-3 months until continence recovery.\] \[Complete surveys (e.g., IPSS, IIEF, ICIQ) at several time points post-surgery, including before surgery, 10 days after Foley catheter removal, and up to 12 months.\] \[Record any adverse events or concomitant medication use.\] Safety and tolerability will be monitored, and statistical analyses will determine the efficacy and predictors of continence. The study adheres to ethical principles, local regulations, and GCP guidelines.

Eligibility

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).

Conditions3

Interventions1

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