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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Number of Participants Achieving Urinary Continence (0-1 Pad/Day) Within 12 Months After RARP
研究概览
简要总结
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.
详细描述
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) in improving early continence recovery following robot-assisted radical prostatectomy (RARP) in patients with localized prostate cancer.
Study Design and Structure
The study involves 135 patients, with 120 expected to complete all study procedures. Participants will be randomly assigned to one of two groups:
Treatment group: Receives 10 mg/day of oxybutynin chloride extended-release tablets.
Control group: Receives a placebo (identical in appearance to active drug). The treatment period lasts from 1 to 3 months, or until participants achieve complete continence, defined as no need for urinary pads and less than one episode of incontinence per week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
In this study, study coordinators and data analysts are also masked to ensure that there is no bias in the data collection and analysis process. This further ensures that the evaluation of outcomes, such as the effectiveness of the treatment and the assessment of adverse events, is unbiased and objective.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd.
Description: Participants in this arm will receive oxybutynin chloride extended-release tablets (10 mg/day) to assess its effectiveness in improving early continence recovery after robot-assisted radical prostatectomy (RARP) for localized prostate cancer.
Intervention: Drug: Oxybutynin chloride extended-release tablets (10 mg/day).
干预措施: Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd. (Drug)
Control
Description: Participants in this arm will receive placebo tablets, identical in appearance to the active drug, to compare the effects of oxybutynin chloride with no active intervention.
Intervention: Placebo: Placebo tablets (identical in appearance to the active drug).
干预措施: Placebo (2 tab), PO, qd. (Drug)
结局指标
主要结局
Number of Participants Achieving Urinary Continence (0-1 Pad/Day) Within 12 Months After RARP
时间窗: Up to 12 months post-surgery
次要结局
未报告次要终点