Multicenter Prospective Non-randomised Trial of Bilateral Sacrospinous Colposuspension (BSC) in the Treatment of Female Genital Prolapse Accompanied by Urinary Urge Symptomatology
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change in score of standardized ICIQ documentation
研究概览
简要总结
Prospective non-randomised trial investigating the effect of vaginal vault Suspension on urge symptomatology in female patients with pelvic organ prolapse
详细描述
A multicenter multinational Trial is performed in 250 female patients with pelvic organ prolapse (POP) and symptoms of urinary urge incontinence.
Dependent on the presence or abscence of the uterus patients are treated with bilateral sacrospinous uterine or vaginal vault suspension (BSC) by means of a tape specifically designed for this purpose.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •urge urinary incontinence or symptoms thereof
- •18 years old or older
- •Compliance regarding data collection, therapy and follow-up
- •written informed consent
- •simultaneous performance of surgical colporrhaphy permitted
排除标准
- •pelvic organ prolapse without symptoms of urinary urge
- •age less than 18 years
- •no informed consent
- •lack of compliance
- •adverse reaction to polypropylene
- •life expectancy less than anticipated duration of protocol
结局指标
主要结局
Change in score of standardized ICIQ documentation
时间窗: Checked after 6 weeks, six months and twelve months
The International Consultation on Incontinence Questionnaire is used to evaluate Change in Quality of life and urge symptomatology
Influence of BSC placement on symptoms of urinary urge expressed by change in clinical examination
时间窗: Checked after 6 weeks, six months and twelve months
The change in symptoms after the surgical intervention is evaluated by clinical examination . The clinical examination is descriptive, not quantitative and no units are applicable or reportable.
次要结局
- Anatomical correction of female pelvic organ prolapse(Checked after 6 weeks, six months and twelve months)
研究者
Dirk G. Kieback, M.D., Ph.D
Head, Dept. of Obstetrics and Gynecology
Helios Medical Center Schleswig