Prospective Randomized Comparison of the Trans-obturator Mid-urethral Sling and the Single-incision Sling in Women With Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 主要终点
- Patient Global Impression of Improvement (PGI-I) Score
研究概览
简要总结
Mid-urethral slings (MUS) now represent a gold standard in the treatment of female stress urinary incontinence (SUI). Second generation trans-obturator slings (TOT) have proven to be as effective as retropubic tension-free vaginal tape (TVT) with fewer major complications. A third generation of the MUS inserted through a single vaginal incision (SIS) has become a means to overcome significant post-operative groin pain. Novel types of SIS with a more robust and adjustable anchoring mechanism can assure adequate long-lasting attachment to the obturator membrane (OM). Objective of this study was to compare an inside-out TOT with an innovative fixation SIS in randomized controlled trial on patients undergoing their primary surgery for urodynamic SUI.
详细描述
Objective of this study was to compare an inside-out TOT (Gynecare TVT Obturator System, Ethicon) with an innovative fixation SIS (Ophira, Promedon) in randomized controlled trial on patients undergoing their primary surgery for urodynamic SUI.
A prospective randomized controlled trial (RCT) is performed in one tertiary referral urogynecology center from January 2015 thru December 2015. Study included women with pure or predominant urodynamic SUI confirmed during cystometry by positive standardized cough stress test (CST) with urinary bladder filling of 250 ml in lithotomy position. Study was carried out on a Caucasian Czech (central European) population. A study power analysis was calculated with an expected objective cure rate of minimum 80 % for both patient groups, false non-match rate (alpha) of 0.05, and false match rate (beta) of 0.10. A minimum sample size of 80 patients was required for each group.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with pure or predominant urodynamic stress urinary incontinence confirmed during filling cystometry by positive standardized cough stress test (CST) with urinary bladder filling of 250 ml in lithotomy position.
排除标准
- •patients with predominant urge incontinence
- •patients with intrinsic sphincter deficiency (MUCP<20 cmH2O)
- •pelvic organ prolapse (POP-Q>2)
- •previous urinary incontinence surgery
- •previous pelvic organ prolapse surgery
- •presence of other pelvic organ pathology.
结局指标
主要结局
Patient Global Impression of Improvement (PGI-I) Score
时间窗: four years
Patient Global Impression of Improvement (PGI-I) score four years after incontinence surgery. The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians 1. Very much better 2. Much better 3. A little better 4. No change 5. A little worse 6. Much worse 7. Very much worse
Percentage of Participants With Negative Cough Stress Test (CST)
时间窗: four years
Negative cough stress test four years after incontinence surgery.
次要结局
- Number of Participants With Major Postoperative Complications(four years)
- Number of Participants With Major Perioperative Complications(one month)
研究者
Martin Huser
professor
Brno University Hospital