search
Back to results

Trial Comparing TVT SECUR System and Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence

Primary Purpose

Stress Urinary Incontinence

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
transvaginal obturator tape
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • St. Boniface Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TVT SECURE

TVT O

Arm Description

sling

sling

Outcomes

Primary Outcome Measures

Objective cure as defined by the cough test at one year from surgery

Secondary Outcome Measures

Full Information

First Posted
September 10, 2007
Last Updated
January 8, 2016
Sponsor
University of Manitoba
search

1. Study Identification

Unique Protocol Identification Number
NCT00527696
Brief Title
Trial Comparing TVT SECUR System and Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence
Official Title
Randomized Clinical Trial Comparing TVT SECUR System (TVT S) and Trans Vaginal Obturator Tape (TVT-O) for Surgical Management of Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
statistical Significance was reached for primary outcome
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TVT SECURE
Arm Type
Active Comparator
Arm Description
sling
Arm Title
TVT O
Arm Type
Active Comparator
Arm Description
sling
Intervention Type
Procedure
Intervention Name(s)
transvaginal obturator tape
Primary Outcome Measure Information:
Title
Objective cure as defined by the cough test at one year from surgery
Time Frame
one year

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken D Maslow, MD
Organizational Affiliation
St. Boniface Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24452619
Citation
Maslow K, Gupta C, Klippenstein P, Girouard L. Randomized clinical trial comparing TVT Secur system and trans vaginal obturator tape for the surgical management of stress urinary incontinence. Int Urogynecol J. 2014 Jul;25(7):909-14. doi: 10.1007/s00192-013-2312-7. Epub 2014 Jan 23.
Results Reference
derived

Learn more about this trial

Trial Comparing TVT SECUR System and Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence

We'll reach out to this number within 24 hrs