Prospective Double Blind randomised controlled trial assessing the effects of the cough-test versus no cough-test during the tension free vaginal tape procedure on post operative voiding difficulties.
Not Applicable
Recruiting
- Conditions
- the TVT- Tension free vaginal tape is a suburethral sling operation for stress incontinence in women.Surgery - Surgical techniques
- Registration Number
- ACTRN12608000597392
- Lead Sponsor
- St George Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 142
Inclusion Criteria
All patients with urodynamic and clinical evidence of mixed or stress incontinence.
Exclusion Criteria
Patients who are unwilling or unable to consent to study or who previously underwent a continence procedure. Patients who are unable to cough.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method differences in postoperative voiding difficulties. these will be characterised by number of trials of voiding after the procedure, number of days to remove the catheter, incidence of urinary retention, incidence of clean intermittent self catheterisation, incidence of catheter reinsertion.[6 weeks, 6 months and 12 months post operative.]
- Secondary Outcome Measures
Name Time Method Post operative pad test is assessing the amount/severity of urine leakage[6 weeks, 6 months and 12 months postoperative];Flowmetry and ultrasound post void residuals are assessing the degree of difficulty experienced in trying to fully empty the bladder and confirming that the bladder is empty after micturition.[6 weeks, 6 months and 12 months postoperative.];Subjective disease specific quality of life questionnaires[6 weeks, 6 months and 12 months postoperative.]