Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)

Urinary Incontinence, Stress Clinical Trial

Official title:

Tension-free Vaginal Tape Management of Stress Incontinence in Women: Randomized Trial of TVT Secur Versus TVT

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00685217
• Other study ID #: 21528
• Status: Terminated
• Phase: Phase 3
• First received: May 22, 2008
• Last updated: August 29, 2016
• Start date: May 2008
• Est. completion date: April 2012

Study information

• Verified date: August 2016
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 74
• Est. completion date: April 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• TVT Secur (Gynecare)
Sling device for stress urinary incontinence
• TVT (Gynecare)
Sling procedure for stress urinary incontinence

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	Penticton Regional Hospital	Penticton	British Columbia
Canada	Lions Gate Hospital	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Johnson & Johnson Medical Companies, University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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 tri — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardised pad test: "cure" is defined as less than 1g gain in pad weight over the duration of the test		12 months following surgery	No
Secondary	Subjective evidence of cure		12 months following surgery	No
Secondary	Incontinence-related quality of life (UDI-6, IIQ-7)		6 weeks and 12 months following surgery	No
Secondary	Sexual function (PISQ-12)		12 months following surgery	No
Secondary	Satisfaction with surgical outcome	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.	12 months following surgery	No
Secondary	Return to usual activities		up to 12 months following surgery	No
Secondary	Voiding dysfunction		12 months following surgery	Yes
Secondary	Surgical complications		up to 12 months following surgery	Yes
Secondary	Cost		up to 12 momths following surgery	No
Secondary	Utility (15-D)		6 weeks and 12 months following surgery	No