NL-OMON33716
Completed
Not Applicable
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 sites400 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary incontinence
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 400
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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\).
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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