Muscle Cell Mediated Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery: An Investigation of Cook MyoSite Autologous Muscle Derived Cells
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 10
- 主要终点
- Volume of Post-void Residual (PVR) Urine
研究概览
简要总结
To study the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) for patients that have undergone prior prostate surgery.
详细描述
This preliminary, prospective, single-arm clinical study will evaluate the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) that develops following prostate surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male, at least 18 years old, with primary symptoms of SUI following prostate surgery,
- •Patient has undergone prostate surgery but has not undergone radiation therapy, cryotherapy, or high-intensity focused ultrasound of the prostate,
- •SUI severity should be ≥10 g and <400 g of urine leakage over 24 hours,
- •Patient has failed to achieve acceptable resolution of SUI symptoms following prior therapy.
排除标准
- •Symptoms of only urge urinary incontinence,
- •Symptoms of stress urinary incontinence prior to prostate surgery,
- •Routinely has more than 2 episodes of awakening to void during normal sleeping hours,
- •Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy,
- •Previously treated with a periurethral balloon or adjustable sling for urinary incontinence,
- •Symptoms of overflow incontinence
- •Additional medical restrictions as specified in the Clinical Investigation Plan,
- •Additional anatomical restrictions as specified in the Clinical Investigation Plan.
结局指标
主要结局
Volume of Post-void Residual (PVR) Urine
时间窗: 1, 3, 6, and 12 months
Post void residual volume (PVR) was assessed through 12 months post-treatment to monitor potential retention or obstruction.
Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events
时间窗: 24 months
Safety of AMDC-USR following treatment of SUI in male patients who have undergone prior prostate surgery was determined by the frequency and severity of adverse events related to study procedures and study product through 24 months following treatment of SUI in male patients who have undergone prior prostate surgery.
次要结局
- Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire(Baseline, 1, 3, 6, and 12 months)
- Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire(1, 3, 6, and 12 months)
- Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire(1, 3, 6, and 12 months)
- Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight)(1, 3, 6, and 12 months)
- Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight)(1, 3, 6, and 12 months)
- Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ)(Baseline, 1, 3, 6, and 12 months)
- Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire(1, 3, 6, and 12 months)
- Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire(Baseline, 1, 3, 6, and 12 months)