Urinary Incontinence, Stress
Conditions
Brief summary
This randomized multi-centre trial will recruit women with stress urinary incontinence who need surgical treatment for their condition. 300 women will be allocated either to receive a TVT Secur or a standard TVT surgical procedure. The main outcome is effectiveness of the procedure, determined using a 1-hour pad test (which tests for urine leakage) 12 months after surgery. The study will be carried out in 4 to 6 centers and will involve urogynaecologists, urologists and general obstetrician-gynaecologists: all clinicians will have received adequate training.
Interventions
PROCEDURETVT Secur (Gynecare)
Sling device for stress urinary incontinence
PROCEDURETVT (Gynecare)
Sling procedure for stress urinary incontinence
Sponsors
University of Alberta
Johnson & Johnson Medical Companies
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Women with stress incontinence, defined as leaking with increased abdominal pressure * Eligible for both types of surgery
Exclusion criteria
Women who: * Have vaginal prolapse requiring surgical repair * Have had previous incontinence surgery * Have overactive bladder or incontinence is caused only by bladder overflow * Intend to have further children * Have Alzheimer's or Parkinson's disease, progressive neurological disease such as multiple sclerosis, or are immunocompromised * Are unable to understand English * Will be unavailable for follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standardised pad test: cure is defined as less than 1g gain in pad weight over the duration of the test | 12 months following surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incontinence-related quality of life (UDI-6, IIQ-7) | 6 weeks and 12 months following surgery | — |
| Sexual function (PISQ-12) | 12 months following surgery | — |
| Satisfaction with surgical outcome | 12 months following surgery | Patients will be asked about the expectations they had before surgery, and asked if the outcome had met expectations. Women will be asked about satisfaction with the surgical outcome, if they would have the same operation again under the same circumstances, and if they would recommend the same operation to someone else with the same problem. |
| Return to usual activities | up to 12 months following surgery | — |
| Subjective evidence of cure | 12 months following surgery | — |
| Surgical complications | up to 12 months following surgery | — |
| Cost | up to 12 momths following surgery | — |
| Utility (15-D) | 6 weeks and 12 months following surgery | — |
| Voiding dysfunction | 12 months following surgery | — |
Countries
Canada
Outcome results
None listed