NCT00685217

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2008

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

2.8 years

First QC Date

May 22, 2008

Last Update Submit

August 29, 2016

Conditions

Urinary Incontinence, Stress

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Subjective evidence of cure

    12 months following surgery

  • 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

  • Return to usual activities

    up to 12 months following surgery

  • +4 more secondary outcomes

Study Arms (2)

TVT Secur surgical device

EXPERIMENTAL

Single incision tape device

Procedure: TVT Secur (Gynecare)

TVT surgical device

ACTIVE COMPARATOR

Usual care retropubic tape device

Procedure: TVT (Gynecare)

Interventions

TVT Secur (Gynecare)PROCEDURE

Sling device for stress urinary incontinence

TVT Secur surgical device
TVT (Gynecare)PROCEDURE

Sling procedure for stress urinary incontinence

TVT surgical device

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women with stress incontinence, defined as leaking with increased abdominal pressure
  • Eligible for both types of surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Foothills Medical Centre

Calgary, Alberta, T2N 1C5, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Penticton Regional Hospital

Penticton, British Columbia, V2A 3G6, Canada

Location

Lions Gate Hospital

Vancouver, British Columbia, V7L 2L7, Canada

Location

Related 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 trial. BMC Res Notes. 2014 Dec 22;7:941. doi: 10.1186/1756-0500-7-941.

    PMID: 25532604RESULT

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sue Ross, PhD

    University of Calgary

    STUDY DIRECTOR

  • Magali Robert, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

  • Jane Schulz, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

May 22, 2008

First Posted

May 28, 2008

Study Start

May 1, 2008

Primary Completion

March 1, 2011

Study Completion

April 1, 2012

Last Updated

August 31, 2016

Record last verified: 2016-08

Locations

CA(4)