Long-term Outcomes of Urethral Ligament Plication and Uterosacral Ligament Plication: a Multicenter Prospective Study
概览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- Alev Esercan
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The success (continence) rates after the operations
概览
简要总结
The aim of this study is to determine the long-term success and outcomes of urethral ligament plication surgeries in patients with stress incontinence and uterosacral ligament plication surgeries in patients with urge incontinence.
详细描述
For patients experiencing stress urinary incontinence during coughing and sneezing, which increases the intra-abdominal pressure, urethral ligament (pubourethral ligament/external urethral ligament) surgery will be performed. For patients with urge incontinence (inability to hold urine immediately) and posterior compartment syndrome (nocturia, constipation/fecal incontinence), uterosacral ligament plication surgery will be performed. For patients with both types of urinary incontinence, both surgeries will be performed, and the 2-year postoperative results will be evaluated.
This study will be a double-blind, prospective experimental study. Patients with stress urinary incontinence will undergo preoperative examination using an integral theory questionnaire to assess their symptoms and complaints anatomically and physiologically. The surgeon will always be the same person (Esercan A), and patients will be called for a follow-up examination two years after surgery (routine postoperative check-ups will be performed, but our study will focus on the results at the end of the second year). This examination will be conducted by the same surgeon, different from those who performed the surgery and published the findings, and the integral theory questionnaire will be used again for evaluation. Integral theory was defined in the literature by Professor Peter Emanuel Papa Petros from our research team, and he also provided the integral theory questionnaire. We already use this questionnaire in routine practice. Additionally, any postoperative complications will be recorded in detail.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients aged 18 and over with urinary incontinence (stress or urge incontinence, or both)
- •Agreement to undergo surgery
- •No contraindications for anesthesia for surgery
排除标准
- •Pregnancy
- •Being under 18 years of age
- •Suspicion of malignancy
- •Urinary incontinence due to neurogenic bladder
- •Presence of intrinsic sphincter (urethral) insufficiency
研究组 & 干预措施
Urinary incontinent patients will have surgeries according to their incontinence type "stress"
Urethral plication surgery (ULP) will be done for stress incontinence
干预措施: uterosacral ligament plication, urethral ligament plication (Procedure)
Urinary incontinent patients will have surgeries according to their incontinence type "urge"
USL for urge urinary incontinence will be done.
干预措施: uterosacral ligament plication, urethral ligament plication (Procedure)
结局指标
主要结局
The success (continence) rates after the operations
时间窗: At postoperative first and second year
Urinary incontinence status will be evaluated by Integral Theory Questionnaire and examinations at postoperative first and second year
次要结局
- The complications(At second postoperative year)
研究者
Alev Esercan
Assoc. Prof.
Sanliurfa Education and Research Hospital