NCT03200327终止不适用
Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse
Centre Hospitalier Universitaire de Nīmes12 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2017年12月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 55
- 试验地点
- 12
- 主要终点
- Compare the rate of de novo problematic stress urinary incontinence, operable or not, between groups response
研究概览
简要总结
The investigators anticipate a reduced risk of post-operational de novo stress urinary incontinence following surgery for vaginal sacrospinofixation, associated with reduced costs, comparable functional and anatomical efficacy and no increase in morbidity and rate of dyspareunia with the new treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •Patient must be available for 12 month follow-up
- •Patient is ≥50 and <80 years old
- •Patient has pelvic prolapse stage 2 or above according to international POP-Q score, concerning the anterior and apical compartments, justifying surgical treatment
- •Patients not having preoperational stress urinary incontinence or having mild stress urinary incontinence not causing significant functional problems (response <2 to question 17 of PFDI-20 questionnaire). It is possible that patients with hidden stress urinary incontinence will be recruited
排除标准
- •The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- •The patient is under safeguard of justice or state guardianship
- •The subject refuses to sign the consent
- •Patient with communication issues preventing comprehension of information and administration of questionnaires
- •Pelvic prolapse not affect anterior and apical compartments, regardless of stage
- •Patient with preoperative dyspareunia (patients with mild sexual discomfort related to prolapse may be included
- •Patient presents with preoperative stress urinary incontinence responsible of significant functional incapacity (response ≥2 to question 17 of PFDI-20 questionnaire).
- •Indication for concomitant suburethral sling
- •Patient with previous history of surgery for stress urinary incontinence
- •Indication of concomitant perineorrhaphy surgery with or without myorrhaphy (in both groups).
- •Contra-indication for general anesthetic
- •Current urinary infection
- •Current vaginal infection
结局指标
主要结局
Compare the rate of de novo problematic stress urinary incontinence, operable or not, between groups response
时间窗: 12 months after intervention
≥ 2 to question 17 of PFDI-20 questionnaire
次要结局
- Compare quality of life associated to pelvic floor issues between groups(at 6 weeks and 12 months after intervention)
- Re-intervention for suburethral band (BSU) in de novo SUI between groups(up to 12 months after the initial intervention)
- Compare general quality of life between groups(at 6 weeks and 12 months after intervention)
- Compare global satisfaction between groups(at 6 weeks and 12 months after intervention)
- De novo dyspareunia rate the dyspareunia between groups(12 months after the initial intervention)
- Compare anatomical prolapse symptoms between groups(at 6 weeks and 12 months after intervention)
- Compare functional prolapse symptoms between groups(at 6 weeks and 12 months after intervention)
- Quality of sexual life between groups(12 months after the initial intervention)
- Compare perioperational morbidity between groups(at 6 weeks and 12 months after intervention)
- Compare direct and indirect costs of the 2 interventions(12 months after intervention)
研究者
研究点 (12)
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