Multicentered Randomized Controlled Trail to Test the Cost Effectiveness of Urodynamics in Women With Symptoms of Stress Urinary Incontinence in Whom Surgical Treatment is Considered
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Non inferiority among the two groups as far as the improvement in the UDI at two years after treatment is concerned.
研究概览
简要总结
To test the value of preoperatively performed urodynamics with regard to outcome of surgery for stress urinary incontinence (SUI) and to examine whether not performing urodynamics preoperatively is more cost effective than performing urodynamics preoperatively using the non-inferiority assumption.
详细描述
Design: multidisciplinary and multicentre randomized controlled trial
Study population/inclusion criteria : all women, not previously operated for stress incontinence, seeking help for urinary stress incontinence where conservative therapy in particular physiotherapy has failed and are opting and candidates for surgical therapy will be asked to participate in our study. Incontinence must have been demonstrated on physical examination and/or micturition diary. Patients can be included by gynaecologists or urologists who are cooperating in the study.
Intervention: consists of the non performance of urodynamics in the studygroup. The control group will undergo urodynamics as is at present the norm.
In all patients the next items will be recorded at inclusion:
- History and clinical examination
- 48h-Bladder(voiding and incontinence) diary,
- 48h-Pad test
- Validated Quality of Life questionnaires (SF 36, Euroqol 5D, UDI, IIQ)
- Urinalysis for the detection of urinary tract infection.
- Residual urine measured by ultrasound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Symptoms of stress urinary incontinence and/or mixed urinary incontinence, predominantly stress incontinence
- •Signs of stress urinary incontinence on physical examination or voiding-diary
- •Patient is a candidate for surgical treatment (as based on history and physical examination)
- •Patient has attended at least 3 months of physiotherapy
- •Patient accepts randomisation
- •Patient is capable to fill out bladder diary's, pad tests and questionnaires
- •Patient understands the Dutch written and spoken language
- •ASA 1 or 2
排除标准
- •Previous incontinence surgery
- •Mixed urinary incontinence, urge component is predominant
- •Prolapse >= 1cm beyond the hymen on Valsalva in supine position
- •Postvoid urinary residual > 150ml
- •Present urinary tract infection
- •The need for additional pelvic surgery (prolapse and/or hysterectomy)
- •Patient is or wants to become pregnant
- •Prior pelvic radiotherapy
结局指标
主要结局
Non inferiority among the two groups as far as the improvement in the UDI at two years after treatment is concerned.
次要结局
- Cure of incontinence as measured by the pad test and voiding diary. Complications of surgery for stress urinary incontinence, in particular re-operations and overactive bladder symptoms. Quality of life as measured by RAND-36, Euroqol and IIQ.