Stress Urinary Incontinence
Conditions
Brief summary
To compare the efficacy and complications of the TVT SECUR system (TVT S) and trans-vaginal obturator tape (TVT-O) procedures for the surgical management of female stress urinary incontinence.
Interventions
PROCEDUREtransvaginal obturator tape
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Female patients with symptoms of stress urinary incontinence and a positive cough test who require surgical management. Cough test is positive when leakage of urine is seen from the urethra synchronously with the patient performing a cough or valsalva manuver with a comfortably full bladder in the lying or standing position.
Exclusion criteria
* Women with predominantly symptoms of urge urinary incontinence * Presence of prolapse greater than Pelvic organ prolapse quantification (POPQ) Stage 1 or prolapse requiring surgery * Detrusor overactivity on cystometrogram at urodynamic testing * Previous surgery for incontinence * Intrinsic sphincter deficiency (MUCP\<20 cm H2O or Q -tip \<30o) * Voiding dysfunction with postvoid residual \>100 cc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective cure as defined by the cough test at one year from surgery | one year |
Countries
Canada
Outcome results
None listed