Hybrid Versus Synthetic Transobturator Tape for Treatment of Female Stress Urinary Incontinence: Prospective Randomised Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dryness
研究概览
简要总结
This prospective study is conducted on female patients presenting with SUI at Alexandria main university hospital. Patients with neurogenic voiding dysfunction, history of anti-incontinence surgery, urge-predominant MUI, urogenital cancer, pelvic irradiation, body mass index more than 40 kg/m2 and more than stage 1 POP are excluded. Patients are randomized into 2 groups, one group will be subjected to h_TOT, and the second group to conventional TOT. Patients are subjected to PGI and UDI-6 questionnaires and a urodynamic study before and 6 months after the both surgery. Success is defined as: no subjective complaint of SUI, negative cough stress test and no leakage on UDS.
详细描述
The present study will be a single center randomized clinical trial. Recruitment will be performed among women presented to Alexandria Main University Hospital urology clinic complaining of urinary stress incontinence, in whom surgery was regarded as the treatment of choice.
Women will be eligible if they have a positive stress test. The stress test will be performed in a semi lithotomy position with a semi full bladder. Women will be randomized into the groups by using Sealed Opaque Envelope System. Patients will be randomized into 2 groups of 25 patient each. One group will be subjected to hybrid TOT, and the second to conventional TOT.
Preoperative and post-operative (at 3 and 6 months) will include:
- Clinical examination including cough stress test.
- Patient global impression questionnaire (PGI)
- Patient questionnaire for incontinence (UDI-6)
- Urodynamic (pressure-flow study)
No concomitant surgery will be performed on women enrolled in the trial. All patients will give a written informed consent.
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)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinically proven SUI or stress-predominant mixed urinary incontinence by cough stress test.
排除标准
- •• Patients with neurogenic voiding dysfunction.
- •History of anti-incontinence surgery.
- •Presence of urge-predominant mixed urinary incontinence.
- •Peripheral neuropathy.
- •Multiple sclerosis.
- •History of urogenital cancer.
- •Pelvic irradiation
- •Body mass index more than 40 kg/m2
- •The presence of more than stage 2 pelvic organ prolapse as per pelvic organ prolapse quantification (POP-Q) system score.
- •Active urinary tract infection
- •Pregnant women
研究组 & 干预措施
Hybrid transobturator tape
Anterior rectus fascia will be exposed and an approximately 8-10 cm × 1 cm strip of rectus fascia will be marked out. The sling will be harvested using sharp dissection. Thereafter, a Polyprolene monofilamentous mesh of 15 cm x 1 cm will be sutured to each edge of the rectus fascia sling that had been harvested.
Then, a 2-cm midline incision over the anterior vaginal wall at the level of mid-urethra. A combination of blunt and sharp dissection will be carried out to the obturator foramen bilaterally.
Next, a stab incision will be made at a point approximately 2.5 cm infero-lateral to the pubic tubercle bilaterally, corresponding to the level of clitoris. A trocar will be passed through each obturator foramen (outside-in) and the edge of the mesh will be retracted through the incision. Next, the retraction of both meshes will continue until the rectus fascia sling remain flushed with the urethra.
干预措施: Transobturator tape (Procedure)
Conventional transobturator tape
The conventional mesh using mid urethral sling through the trans obturator route
干预措施: Transobturator tape (Procedure)
结局指标
主要结局
Dryness
时间窗: 6 months
Absence of clinical and urodynamic stress incontinence
次要结局
未报告次要终点