Efficacy and Safety of Transobturator Subtrigonal Tape vs Transobturator Tension-free Suburethral Tape for the Correction of Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Stress urinary incontinence resolution, without postoperative obstruction
研究概览
简要总结
Introduction:
Minimally invasive procedures TOT (tension-free suburethral tape using transobturator approach)have been the standard for correction of SUI. However, around 28% of these patients exhibit alteration of urinary flow. Recently, in 40 patients who underwent open surgery, an abdominal fascia tape was placed in a subtrigonal position with a success rate of 87.5% without obstruction. Our intention is to make the most of the idea of subtrigonal position in minimally invasive procedures with transobturator polypropylene vaginal tape (S-TOT).
Object of the Study: To evaluate the efficacy and security of S-TOT compared with TOT.
Materials and Methods:
Study Population:
Patients of the Mexican Institute of Social Security (IMSS) with an SUI diagnosis. Eligibility requirements: history of at least 3 months with symptoms of isolated SUI or symptoms of SUI associated with urge urinary incontinence (mixed UI). The size of the sample was estimated 34 subjects are required per group.
Study Design:
It is a parallel group randomized clinical trial. Success (efficacy) will be defined as when the SUI has been corrected with negative pad test and normal urinary flow.
The results (efficacy) will be compared between the two groups using chi2 (group a/b versus success/lack of success). In all cases, p <0.05 will be considered significant.
The data will be obtained with clinical evaluation, laboratory and radiological/imaging tests and the respective questionnaires during the visits before surgery, and at 2 and 6 weeks, and 6, 12, and 24 months after surgery.
详细描述
THEORETICAL FRAMEWORK:
Urinary incontinence affects between 27.9% and 46.5% of adult women in our country and up to 50% in other parts of the world; 85% have loss of urine associated with physical stress (SUI).
TOT (Trans-Obturator Tape) is the standard treatment of SUI. The success ranges between 59.7% and 99%. The most frequent inconvenience of the placement of tapes in suburethral position is urinary obstruction. Kristensen reported that 56% of their patients had micturition difficulties and 16.6% had acute urinary retention. Other series have reported urinary obstruction in between 11.6% and 25.8% of patients. Sander reported that 77% of the patients with TVT had difficulty in micturition at one year post-op and 63% continued to have this difficulty at 3.5 years of follow-up.
In our experience, the subtrigonal position of the pubic fascial sling significantly reduces the possibility of obstruction of the flow and its consequences. It is worth noting that the tape in this position also achieves the objective of curing SUI by stabilizing the middle urethra during stress, thus correcting the excessive mobility of the urethra and allowing the muscles of the pelvic floor to contract over the urethral sphincter (middle urethra). This hypothesis was demonstrated previously with the pubic fascial subtrigonal sling.
We propose to measure the success of the surgery by its capacity to correct SUI without obstructing urinary flow; this is the measure of true efficacy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Self-report of SUI symptoms lasting at least 3 months as shown on ICIQ-SF questionnaire
- •Observation of urinary leakage following a cough and stress test with a cough and/or Valsalva maneuver, with bladder volume <300ml.
- •Bladder capacity >200ml
- •Post-void residual bladder volume <100ml
排除标准
- •Inability to walk (allowed with walking aids)
- •Positive pregnancy test
- •Prolapse of pelvic organs beyond the vaginal vestibule during stress
- •Current chemotherapy or history of pelvic radiotherapy
- •Systemic disease affecting bladder function (i.e., Parkinson's disease, multiple sclerosis, bifid spinal, spinal cord injury or any trauma)
- •Urethral diverticulum, current or previous
- •History of augmentation cystoplasty or artificial sphincter
- •Nerve stimulator implant for urinary symptoms
- •History of synthetic vaginal sling for SUI or vaginal reconstruction
- •Less than 12 months since giving birth
- •Pelvic surgery, open or laparoscopic, <3 months ago
- •Current evaluation or treatment for chronic pelvic pain
- •Participation in other intervention study for treatment that may interfere with the results of this study
- •Need for concomitant surgery that requires an open or laparoscopic abdominal incision
- •The use of synthetic material or the use of biological material in the anterior compartment
- •History of previous anti-incontinence surgery
- •Intrinsic sphincter deficiency
研究组 & 干预措施
Transobturator suburethral tape (TOT)
transobturator approaches for the placement in mid-urethral position of polypropylene tape that is 1.5cm wide
干预措施: Transobturator suburethral tape (TOT) (Procedure)
S-TOT
transobturator subtrigonal tape: S-TOT
干预措施: transobturator subtrigonal tape S-TOT (Procedure)
结局指标
主要结局
Stress urinary incontinence resolution, without postoperative obstruction
时间窗: six month
Resolution of SUI: Negative 1/h pad test and regular urination (without change or obstruction in the Blaivas Nomogram and/or the Female Urinary Symptom Score). Negative pad test, \<3g/1 hours. -Postoperative Obstruction: Female Urinary Symptom Score (FUSS): 1-7 points = mild obstruction, 8-18 = moderate obstruction, and \>19 = severe obstruction AND/ OR Ascending change in the level of obstruction provided that there is an increase of ≥ 5 points compared to the baseline AND/ OR Qmax: ≤20ml/s, provided there is a reduction compared to the baseline AND/ OR Blaivas Nomogram: The intersection of Qmax (abscissa) and maximum contraction of the detrusor (ordinate) will fall in one of four possible areas: not obstructed, mild obstruction, moderate obstruction or severe obstruction
次要结局
- Complications(Two Years)
研究者
Eduardo Serrano Brambila
Master in Science
Coordinación de Investigación en Salud, Mexico