Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress (SITOT)
Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress Incontinence (SITOT)
研究概览
详细说明
Single incision tension-free sub-urethral vaginal tapes procedures8 have been recently described in an attempt to avoid the blind passage of the trochars through the groin & the adductor muscles and consequently reducing the incidence & severity of postoperative leg pain. The obvious advantages would be shorter hospital stay, early recovery, early resumption of day to day activities & earlier return to work. A number of small prospective audits and case-series have been presented in international conferences reporting on the safety & outcomes for these procedures. However all these studies were for preliminary reports for proof of concept and therefore the studies populations were 15-70 women with short term follow-up of 2-3 month9-11.These studies have shown low perioperative complication rates: bladder injury 0-1%, vaginal erosion 1-3% & one study showing 1.3% pain at 6 weeks follow-up. The patient reported success rates were 77-93% at 2-3 month follow-up9-12.
Objectives:
- Establish the feasibility of the "Single incision sub-urethral tapes" to be done under local anaesthesia.
- The feasibility of randomisation to the standard surgical treatment TVT-O / TVT.
- To compare the surgical approach in this relatively new procedure against the standard procedures as regard: Peri-operative complication rates, Postoperative pain, Time to discharge from the hospital,
- To compare the outcomes as regard: Patient-reported cure rates, Patient satisfaction, Impact on Quality of life (QoL) and sexual function at 3 month & 1 -year follow-up. The objective cure rates will be assessed at 3 month follow-up.
Design:
A pilot prospective randomised study within participating urogynaecology units of the "Scottish Pelvic Floor Network".
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Aberdeenshire
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Aberdeen、Aberdeenshire、英国、AB25 2ZD
- (Grampian) Aberdeen Royal Infermary
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- USI
- Mixed incontinence symptoms with predominantly bothering stress component (No DO on UDS).
- Primary Incontinence Surgery.
- BMI < 35
- Ability to understand the information leaflet and sign an informed consent form in English.
- All would have had failed or declined PFMT.
Exclusion Criteria:
- Mixed incontinence with pre-dominant OAB and/or Neurological conditions e.g. MS.
- Detrusor Overactivity on Urodynamics.
- Inability to understand English.
- Un-willing for randomisation.
- Concomitant surgery.
- Patient requiring postoperative hospital-stay for medical or social reasons
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Single-incision Mini-slings (SIMS- Ajust)
AjustTM has polypropylene fixing anchors (one is fixed and the other adjustable) which are anchored onto the obturator membrane.
The pulley like system enables adjustment of the tension once the arms have been anchored.
Once in place, the anchors rest at right angles to insertion which is claimed to reduce the chances of anchor dislodgment
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Tension free vaginal tape vs. single incision sub-urethral tension free vaginal tape
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其他:standared med urethral sling (SMUS)
standard med urethral sling (SMUS)TVT-O, was done as originally described by Deleval et al.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
• Feasibility of the single incision sub-urethral tape to be done under local anaesthesia
大体时间:1 year
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1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
• Patient-reported Success rates
大体时间:1 year
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Patient-reported Success rates o Assessed by PGI-I "Very Much Improved/ Much Improved." |
1 year
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合作者和调查者
调查人员
- 首席研究员:Mohamed Abdel-Fattah, MRCOG、University of Aberdeen
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
sub-urethral tape (TVT-O)的临床试验
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Federal University of São PauloJohnson & Johnson完全的
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South Glasgow University Hospitals NHS TrustHenry Smith Grant未知
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Peking Union Medical College Hospital未知