An Open Randomized Controlled Multicenter Clinical Investigation With an Intra-vaginal Device for Stress Urinary Incontinence in Comparison to Using Standard of Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 8
- 主要终点
- Absolute reduction in leakage as measured by pad weight in gram
研究概览
简要总结
This is a prospective, randomized, controlled, two-armed multi-center pre-market trial. Nighty-six (96) subjects will be recruited at sites in Sweden. Patients with diagnosed stress urinary incontinence (SUI), will be considered as potential study participants. After written informed consent has been acquired, a medical and surgical history, a physical examination (including pelvic examination), and a confirmation of the diagnosis of SUI will be performed, followed by a confirmation of the inclusion/exclusion criteria. The study subjects fulfilling all the eligibility criteria will thereafter be randomized 3:1 into either the TVS group or the standard of care (SoC) group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Open Lable
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form
- •Over the age of 18 years
- •Women diagnosed with stress urinary incontinence
- •Normal voiding without residual urine ≤100mL
- •Leakage of at least 10 grams per 24 hours (based on pad-weight test)
- •Provoking test with leakage
排除标准
- •History of dominated urgency's symptoms
- •Any contraindication for the investigational device; such as hypersensitivity to silicon rubber
- •Unexplained pelvic bleeding or vaginal discharge
- •Is hysterectomized,has a history of incontinent surgery or surgery for prolapse correction.
- •The woman is currently using prolapse ring
- •Women with prolapse reaching the hymus during coughing.
- •Pregnant or suspicion of pregnancy
- •Urinary tract or vaginal infection
- •History of not being able to use tampons
- •Neurogenic bladder dysfunction
- •The patient is to start, or change an ongoing, pelvic floor training
- •If the patient does not have a well adjusted diuretica, or is to start, or change an ongoing, diuretic treatment
- •The patient is participating in another study on SUI
- •Any other condition that as judged by the investigator may make follow-up or investigations inappropriate
- •Any patient that according to the Declaration of Helsinki is unsuitable for enrollment
研究组 & 干预措施
Trans Vagina Support
Tension Free Vaginal Support (TVS):The subjects in the TVS Group used pads during week 1 (Baseline), fitted, trained and selected device size week 2 and used the selected device size during week 3 (treatment week).
干预措施: TVS (Device)
Standard Care
Standard of care (SoC): The subjects in the SoC group continued with conventional treatment i.e. using pads during week 1, 2 and 3. They were offered to use the TVS device for two weeks after completion of week 3.
结局指标
主要结局
Absolute reduction in leakage as measured by pad weight in gram
时间窗: 3 weeks
The primary endpoint will be the absolute reduction in pad weight from the run-in week (week 1) compared with the final week (week 3). The weight of the pad is defined as the mean weight over the entire week of measurement.
次要结局
- General impact on quality of life parameters(3 weeks)
- Success rate in % in reducing urinary leakage measured by pad weight(3 weeks)
- Reduction of urinary leakage episodes measured by subjective observations(3 weeks)
- Impact on disease specific qulity of life parameters(3 weeks)