跳至主要内容
临床试验/NCT06232525
NCT06232525已完成不适用

A Randomized Comparison of Transobturator Tape With the Plication of Urethral Ligaments in the Treatment of Stress Urinary Incontinence

Alev Esercan2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
108
试验地点
2
主要终点
Objective finding of no urinary incontinence

研究概览

简要总结

The goal of this clinical trial is to compare the efficacy of transobturator tape (TOT) operation and urethral ligament plication operation in stress incontinence patients. The main question:

  • Which operation is more effective in treatment of stress incontinence?
  • Which operation has less complication and risks? Participants will be followed about 5 days, 2.5 months, 6 months and 1 year after the operation and asked about the continence status and complications.

详细描述

The study will be a double-blind, prospective experimental study. When examining patients with stress urinary incontinence complaints, POP-Q staging in terms of pelvic organ prolapse before surgery, symptom interrogation in the examination of the anterior/middle and posterior compartments based on the Integral Theory in the pelvic floor examination, Urogenital Distress Inventory (UDI-6) for the evaluation of urinary incontinence and Female sexual function scale (FSFI) scales will be filled in to evaluate sexual functions. One group of patients will undergo transobturator tape (TOT), and the other group will undergo urethral ligament plication surgery.

Patients who are decided to have surgery due to stress urinary incontinence will undergo TOT surgery and urethral plication surgery, without being told which surgery they will have (both surgeries will be performed with the mid-urethral approach and the patient will not be told whether mesh is used or not), with a draw system in which the computer program will decide on the surgeon who will perform the surgery. The surgeon will always be the same person (Esercan A), and on the morning of the surgery, he will be told about the surgery he will perform and will be asked not to share it with the patient.

At the end of the 5th day, 2.5 months, 6 months and 1 year after the surgery, the patients were called for control and examined by the same doctor, different from the doctors who wrote the surgery and the publication. POP-Q staging was performed again in terms of pelvic organ prolapse, based on the Integral Theory in the pelvic floor examination. During the examination of the anterior/middle and posterior compartments, symptom inquiry, Urogenital Distress Inventory (UDI-6) for the evaluation of urinary incontinence and Female Sexual Function Scale (FSFI) scales will be filled in for the evaluation of sexual functions. The FSFI survey has 19 questions; It evaluates 6 main factors: sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain/discomfort. The highest total raw score that can be obtained in this scale is 95, the lowest raw score is 4, and after multiplying the coefficients, the highest score is 36 and the lowest score is 2. Impact coefficients used to score the entire scale; It was determined as 0.6 for sexual desire, 0.3 for sexual arousal and lubrication, and 0.4 for orgasm, satisfaction and pain/discomfort. A FSFI score below 26.55 is defined as compatible with sexual dysfunction. Additionally, if there are any complications, they will be recorded in detail.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Patients who are decided to have surgery due to stress urinary incontinence will undergo TOT surgery and urethral plication surgery, without being told which surgery they will have (both surgeries will be performed with the mid-urethral approach and the patient will not be told whether mesh is used or not), with a draw system in which the computer program will decide on the surgeon who will perform the surgery. The surgeon will always be the same person (Esercan A), and on the morning of the surgery, he will be told about the surgery he will perform and will be asked not to share it with the patient.

At the end of the 5th day, 2.5 months, 6 months and 1 year after the surgery, patients will be called for a check-up and examined by the same doctor, different from the doctors who performed the surgery and wrote the publication.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Being 18 years or older
  • Presence of stress urinary incontinence symptoms
  • Agreeing to have surgery

排除标准

  • Being under 18 years of age
  • Suspicion of malignancy
  • History of previous mid-urethral sling or urinary incontinence surgery
  • Being diagnosed with intrinsic sphincter (urethral) insufficiency
  • Urinary incontinence due to neurological bladder

结局指标

主要结局

Objective finding of no urinary incontinence

时间窗: After the first day of the operation day and all of the follow-up(postoperative 5th day, 2.5 th month, 6th month and first year)

Tap test negativity (if the patient's bladder is filled with 300cc physiological saline and the patient is made to cough and no urine leakage is observed, it is considered negative)

Subjective finding of no urinary incontinence

时间窗: After the first day of the operation day and all of the follow-up (postoperative 5th day, 2.5 th month, 6th month and first year)

The patient has no urinary incontinence and a significant decrease in the UDI-6 score.

次要结局

  • complications(postoperative 5th day, 2.5 th month, 6th month and first year)

研究者

发起方
Alev Esercan
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Alev Esercan

Obstetrics and Gynecologist, MD

Sanliurfa Education and Research Hospital

研究点 (2)

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