Clinical trial NCT00685217: Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)
Official title: Tension-free Vaginal Tape Management of Stress Incontinence in Women: Randomized Trial of TVT Secur Versus TVT
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Urinary Incontinence, Stress
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of Alberta
name: Johnson & Johnson Medical Companies
First posted: 2008-05-28
Enrollment: 74
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Standardised pad test: "cure" is defined as less than 1g gain in pad weight over the duration of the test
timeFrame: 12 months following surgery
Secondary outcomes:
measure: Subjective evidence of cure
timeFrame: 12 months following surgery
measure: Incontinence-related quality of life (UDI-6, IIQ-7)
timeFrame: 6 weeks and 12 months following surgery
measure: Sexual function (PISQ-12)
timeFrame: 12 months following surgery
measure: Satisfaction with surgical outcome
timeFrame: 12 months following surgery
measure: Return to usual activities
timeFrame: up to 12 months following surgery
measure: Voiding dysfunction
timeFrame: 12 months following surgery
measure: Surgical complications
timeFrame: up to 12 months following surgery
measure: Cost
timeFrame: up to 12 momths following surgery
measure: Utility (15-D)
timeFrame: 6 weeks and 12 months following surgery
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Penticton
country: Canada
facility: Penticton Regional Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Lions Gate Hospital
state: British Columbia
Study officials:
affiliation: University of Calgary
name: Sue Ross, PhD
role: STUDY_DIRECTOR
affiliation: University of Calgary
name: Magali Robert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Jane Schulz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ross S, Tang S, Schulz J, Murphy M, Goncalves J, Kaye S, Dederer L, Robert M. Single incision device (TVT Secur) versus retropubic tension-free vaginal tape device (TVT) for the management of stress urinary incontinence in women: a randomized clinical trial. BMC Res Notes. 2014 Dec 22;7:941. doi: 10.1186/1756-0500-7-941.