Prospective Study of the sensiTVT (Midurethral Sling) for the Surgical Treatment of Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- objective success of stress urinary incontinence
研究概览
简要总结
sensiTVT is a relatively new tape. The aim of this study is to analyze the objective and subjective outcome at one year follow-up.
详细描述
Stress urinary incontinence (SUI) is defined as the involuntary leakage during physical activity and situations that result in an increase of abdominal pressure like sneezing, coughing or laughing and affects up to 25% of women. Currently there are a number of tapes on the market with GYNECARE TVT EXACT® (Tension free Vaginal Tape) and TVT- Obturator being one of the tapes with the highest subjective and objective cure rates and relatively low adverse events in women with normal sphincter pressure. Due to the recent FDA announcements several tapes have been withdrawn from the market and several new ones have been designed. Data from other tapes are available, however data especially from newer tapes is lacking.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
objective success of stress urinary incontinence
时间窗: one year
determined by a standardized cough stress test at 300 ml bladder, a negative cough stress test is a success.
次要结局
- Peri- and postoperative complications(3 months+ one year)
- Subjective incontinence cure rate using the Incontinence Outcome Questionnaire(3 months+ one year)
- Patient satisfaction measured using a visual analogue scale(3 months+ one year)
- De novo urgency(3 months+ one year)
- Sexual health using the Pelvic Organ Prolapse Incontinence Sexual Questionnaire(3 months+ one year)
- Subjective success as determined using the Patient Global Impression of Improvement questionnaire.(3 months+ one year)
- quality of life using the Kings Health Questionnaire(3 months+ one year)
- Subjective bother using the Patient Global Impression of Severity(3 months+ one year)
- Reoperation rate(3 months+ one year)
- Erosion rate(3 months+ one year)
- De novo pain in the operated region(3 months+ one year)