A randomised controlled trial comparing the cost-effectiveness of pelvic floor muscle exercise versus the TVT(O) procedure for female moderate to severe stress urinary incontinence. - PORTRET study (Physiotherapie OR Tvt Randomised Efficacy Trial

niversitair Medisch Centrum Utrecht0 个研究点目标入组 400 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•A. All women aged 35-80 years who present with symptoms of moderate to severe, predominant stress urinary incontinence. This severity is established by means of the so called Sandvik index.
•B. The predominance of stress urinary incontinence is assessed with the Stress/Urge Incontinence Questionnaire (S/UIQ). Two questions are asked. *How many times in the last seven days have you had an accidental leakage of urine onto your clothing, underwear, or pad*.
•- During an activity such as coughing, sneezing, laughing, running, exercising or lifting? Symptom of stress urinary incontinence (SUI).
•- With a sudden strong need to pass water that you could not reach the toilet in time? Symptom of urge urinary incontinence (UUI).
•For predominant stress urinary incontinence the number of SUI events should outnumber the number of UUI.
•C. Moderate to severe stress incontinence according to the Sandvik severity index.[15] The index is calculated by multiplying the reported frequency (four levels, 1 to 4) by the amount of leakage (two levels, 1 and 2). The resulting index value (1-8) is further categorized into slight (1-2), moderate (3-4) and severe (6-8).

•1. No confirmation of stress urinary incontinence during gynaecological examination or on a stress test with at least 300 ml bladder filling
•2. A post voiding bladder volume of more than 100 ml, as determined by bladder catheterisation or ultrasound (Bladderscan®)
•3. History of anti-incontinence surgery
•4. PFMT exercises by a specialised physiotherapist for urinary incontinence in the previous 6 months
•5. Genital prolapse Stage 2 or more according to the POP-Q classification. (ref)
•6. Patients desire for future pregnancy and childbirth.
•7. Co-morbidity which is associated with increased surgical risks, for instance women with ASA 3 or 4 classification. Up to the physician to decide.
•8. History of recurrent lower urinary tract infection (> 3 times/year).
•9. Insufficient knowledge or understanding of the Dutch language.
•10. The use of drugs that affect bladder function
•11. History of or current major psychiatric illness as subjectively assessed by the physician.
•12. History of chronic neurological disease, like spinal chord injury, multiple sclerosis, cerebro-vascular incidents.

发起方

niversitair Medisch Centrum Utrecht