Prospective Review of Laparoscopic Burch Urethropexy Compared With a Novel Technique of Laparoscopic Obturator Urethropexy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Subjective Continence Rates
研究概览
简要总结
Stress urinary incontinence (SUI) is a highly prevalent concern within the female population. Although mid urethral slings (MUS) have been the first line treatment for SUI for almost twenty years, due to recent FDA warnings and many countries banning the use of vaginal mesh, a significant portion of patients now request non-mesh anti-incontinence procedures. In such cases, Burch colposuspension would be the next option discussed with patients.
In the short term, the efficacy of Burch colposuspension is comparable to MUS. However, the noteworthy disadvantages of Burch colposuspension include a high rate of urinary retention. This increased risk of urinary retention is due to the acute angle of the stitches, and is a problem that Burch colposuspension shares with the retropubic sling, a type of acutely-angled MUS. A variant of the retropubic sling, the transobturator tape (TOT), has shown that a rounder angle of elevation significantly reduces the risk of urinary retention. As such, this study proposes a novel technique of laparoscopic obturator urethropexy (LOU) as an alternative to the traditional Burch colposuspension.
In this new proposed technique, stitches are placed into the obturator internus fascia rather than Cooper's ligament, reducing the angle of elevation of the bladder neck, aiming to lower the risk of post-operative urinary retention. The aim of our randomized control trial is to assess the effectiveness of LOU compared to Burch colposuspension in terms of urinary continence. Our secondary aim is to report on perioperative and postoperative complications, functional outcomes including urinary retention, recurrent urinary tract infection, recurrent/persistent urgency, de novo urgency, recurrent SUI, and sexual function, as well as overall quality of life.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Upon recruitment to the study, the surgeon will then open a sequentially numbered, opaque, sealed envelope that will randomize the patient to either receiving Burch colposuspension or LOU. The patient will not be made aware of the group they were allocated to.
A clinical staff who was not involved with the surgery and blinded to the allocation of the patient will complete the Post-operative Follow-up Form at each visit.
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
- •At least 18 years of age and be able to read and write English
- •Women with symptomatic SUI, stress predominant mixed urinary incontinence symptoms confirmed on urodynamic study (UDS), or occult SUI (i.e. demonstrable urinary leakage on preoperative urodynamics with prolapse reduction in a patient without overt urinary incontinence symptoms), including women undergoing concomitant pelvic organ prolapse (POP) surgery or MUS sling removal
排除标准
- •Known or suspected disease that affects bladder function (e.g. multiple sclerosis, Parkinson disease), including a known diagnosis of voiding dysfunction
- •Pregnancy
- •Desired fertility
- •Urethral diverticulum
- •History of radical pelvic surgery or pelvic radiation therapy
- •Current chemotherapy or radiation therapy for malignancy
结局指标
主要结局
Subjective Continence Rates
时间窗: 1 year
Patient reported symptoms of incontinence
次要结局
- Perioperative and postoperative complications(6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years)
- Objective continence rates(6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years)
- Recurrent/persistent/de novo urgency(6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years)
- Recurrent SUI(6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years)
- Sexual function(6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years)
- Urinary retention(6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years)
- Recurrent urinary tract infection(6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years)
- Overall quality of life(6 weeks, 3 months, 6 months, 1 year and yearly up to 10 years)
研究者
Dr. Nucelio Luiz de Barros Moreira Lemos MD, PhD
Principal Investigator
Mount Sinai Hospital, Canada