Laparoscopic Burch Colposuspension Versus Transobturator Tape in the Treatment of Female Stress Urinary Incontinence. A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- success rate
研究概览
简要总结
The goal of this prospective interventional study is to compare the effectiveness of laparoscopic Burch colposuspension versus trans obturator tape in the treatment of stress urinary incontinence in adult females. The success rate will be compared between the two proceudres at 1, 3 and 6 months post operatively. Operative times, hospital stay and perioperative complications will be evaluated in both arms
Participants will be asked to:
- complete the ICIQ-UI-SF questionnaire pre operatively and at 1, 3 and 6 months post operatively
- undergo a pelvic examination pre operatively
- undergo cough stress test pre operatively and at 1, 3 and 6 months post operatively
- undergo a pressure flow study test pre operatively
- undergo pelviabdominal ultrasound with post void residual urine measurement pre operatively and at 1, 3 and 6 months post operatively
- undergo uroflowmetry at 1 month post operatively
详细描述
This is a prospective randomized study that is conducted at Theodor Bilharz research institute and Cairo university hospital. the study will include 60 female patients with genuine stress urinary incontinence allocated randomly to 2 groups; group A will undergo laparoscopic Burch colposuspension and group B which will undergo trans obturator tape fixation.
The investigators aim to evaluate the success rates of laparoscopic Burch colposuspension and TOT procedures in treatment of female SUI. Objective cure rates, assessed by cough stress test or pad weight test. ( A cure is defined as the absence of a subjective complaint of leakage and the absence of objective leakage during a 250-ml cough stress test. operation time and length of hospital stay as well as early outcomes, complications and continence rates at 1 month, 3 months and 6 months will be recorded and compared.
Inclusion criteria:
• Clinical Diagnosis of SUI: Symptoms include leakage during activities such as coughing, sneezing, laughing, or physical exertion.
- Documented stress urinary incontinence by physical examination and urodynamic testing.
- Adult female patients typically aged 18 years or older.
- Completed Non-Surgical Management:
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
- None
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
- •Clinical Diagnosis of SUI:
- •Symptoms include leakage during activities such as coughing, sneezing, laughing, or physical exertion.
- •Documented stress urinary incontinence by physical examination and urodynamic testing.
- •Adult female patients typically aged 18 years or older.
- •Completed Non-Surgical Management:
- •Patients who have tried and failed conservative management options, such as pelvic floor exercises, behavioral therapy.
- •Willingness to Undergo Surgery
排除标准
- •virgin female
- •mixed urinary Incontinence
- •Pelvic Organ Prolapse more than the 2nd degree according to Baden and Walker classification 1992
- •Previous Anti-Incontinence Surgery
- •Neurological Conditions:
- •Patients with neurogenic bladder or other neurologic disorders affecting bladder function, such as multiple sclerosis or spinal cord injury.
- •Pregnancy
- •Presence of active urinary tract infection (UTI) or other pelvic infections at the time of evaluation
- •Patients with interstitial cystitis, bladder tumors, or urethral diverticula that could complicate surgical outcomes
- •Previous history of radiotherapy to the pelvis.
- •Contraindications to surgery such as uncorrectable coagulation disorders
研究组 & 干预措施
group A laparoscopic Burch
laparoscopic Burch colposuspension
干预措施: laparoscopic Burch colposuspension (Procedure)
group B TOT
Trans obturator tape
干预措施: Trans obturator tape fixation (Procedure)
结局指标
主要结局
success rate
时间窗: at 1, 3 and 6 months post operative
the absence of a subjective complaint of leakage and the absence of objective leakage during a 250-ml cough stress test
次要结局
- operative time(day 1 post operative)
- complicatio rate(till 6 months post operative)
- hospital stay(2 days post operative)
研究者
Mohamed Fathi Mohamed Ahmed Badr-El-Din
Urology specialist
Theodor Bilharz Research Institute