NCT00196521已完成不适用
A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 38
- 主要终点
- Overall incidence of treatment success.
研究概览
简要总结
Stress urinary incontinence affects nearly 30 million women worldwide and the main goal of surgical treatment is to stop urinary incontinence (urinary leakage) that occurs with physical activity, coughing, sneezing, etc.Patients in the study will have an operation to improve urinary incontinence symptoms. This will involve inserting a mesh sling to help support the urethra (tube leading into your bladder). During the operation, the study doctor will use tension-free vaginal obturator system. The study will include women diagnosed with Stress Urinary Incontinence who have completed their families.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
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
- •Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with ISD. Objective testing includes: standing stress test, urodynamics evaluation, or pad test.
- •Patient is age 18 or older.
- •Patient had a hysterectomy, tubal ligation or is otherwise incapable of pregnancy, or had a negative pregnancy test prior to study entry and has decided to cease childbearing.
- •Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the IRB/EC-approved informed consent.
排除标准
- •Patient has an associated or suspected neurological disease.
- •Patient is on anti-coagulation therapy.
- •Patient has received an investigational drug or device in the past 60 days.
- •For patients having URP measurements at selected sites:
- •Patient has an active lesion or present injury to perineum or urethra.Patient has a urethral obstruction.
- •Patient has an unreduced cystocele > Stage
- •(Reduction of prolapse prior to URP testing is required.) Reduction of Cystocele (if applicable). Patients should be seated in a semi-fowler's position with head of bed at 40-60 degrees.
- •Carefully place a half of a speculum into the vagina, reducing prolapse to less than stage
- •Be careful not to over extend or elongate the vaginal length.
- •The half of a speculum must be placed with pressure emphasis on the posterior and apical areas. Anterior wall pressure or urethral pressure must be avoided at all times.
- •The subject has active infection upon urine dipstick analysis, defined as ≥+1 leukocytes or ≥+1 nitrates (Must reschedule appointment after UTI resolves.)
结局指标
主要结局
Overall incidence of treatment success.
次要结局
- Assessment of unresolved de novo urgency post-treatment.
- No additional surgery required to correct SUI post-treatment
- Intraoperative and postoperative complications
- Quality-of-life measurements
- Return to usual activity
- Patient satisfaction
研究者
研究点 (38)
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