An Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 7
- 主要终点
- Improvement in quality of life as assessed by pad weight tests assessments and questionnaires
研究概览
简要总结
The Solace European Confirmatory (SOLECT) Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.
详细描述
Subject will undergo treatment with the Solace Bladder Control System or a sham procedure, with the results being compared at 3 months.
All patients undergoing sham treatment are treated at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female 18 years of age or older with stress urinary incontinence (SUI)
- •Experienced SUI for at least 12 months and attempted and failed prior noninvasive treatment
- •Willing to undergo cystoscopic procedures required and 36 month follow-up
- •On stable medication for a minimum of 3 months
- •Free of local genital skin infection
- •Positive Pad Weight Test
- •Free of impassable urethral strictures, trauma or necrosis
排除标准
- •(must answer NO):
- •Pregnant or planning to become pregnant during the study period
- •Non-ambulatory or bedridden or physically unable to complete test exercises
- •Morbidly obese (defined as BMI ≥ 40 kg/m2)
- •Bladder infection (including bladder inflammation or edema) or UTI within 3 months
- •History of recurrent urinary tract infections
- •Prior surgical procedure for incontinence within the past 6 months
- •Is taking medications for urinary incontinence other than anticholinergics
- •History of kidney stones
- •Has a prosthetic heart valve
- •Unable to tolerate any form of antibiotic
- •Taking anticoagulation therapy, other than aspirin
- •Has urinary incontinence due to Intrinsic Sphincter Deficiency (ISD)
研究组 & 干预措施
Treatment on Day 0
Subjects who are treated with the Solace Bladder Control System upon entry into the trial.
干预措施: Solace Bladder Control System (Device)
Sham Treatment on Day 0
Patients who undergo a sham procedure upon entry into the trial, with treatment with the Solace Bladder Control System at 3 months after the sham procedure.
干预措施: Solace Bladder Control System (Device)
Sham Treatment on Day 0
Patients who undergo a sham procedure upon entry into the trial, with treatment with the Solace Bladder Control System at 3 months after the sham procedure.
干预措施: Solace Sham Treatment (Device)
结局指标
主要结局
Improvement in quality of life as assessed by pad weight tests assessments and questionnaires
时间窗: 3 Months
Comparison of increases in pad weight test and patient reported outcomes on questionnaires.
次要结局
- Incidence of treatment-related adverse events(3 Months)
- Severity of treatment-related adverse events(3 Months)