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NCT00527696 Clinical Trial

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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00527696
Other study ID # B2007:044
Secondary ID
Status Terminated
Phase Phase 3
First received September 10, 2007
Last updated January 8, 2016
Start date May 2008
Est. completion date October 2011

Study information
Verified date January 2016
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 106
Est. completion date October 2011
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• transvaginal obturator tape

Locations
Country Name City State
Canada St. Boniface Hospital Winnipeg Manitoba

Sponsors (1)
Lead Sponsor Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Objective cure as defined by the cough test at one year from surgery one year No
See also
  Status Clinical Trial Phase
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Completed NCT05493735 - Lidocaine for Pessary Check Pain Reduction Phase 3
Completed NCT04512053 - A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence Phase 2
Active, not recruiting NCT06224335 - Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)
Recruiting NCT05304312 - The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women N/A
Not yet recruiting NCT05527665 - Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
Not yet recruiting NCT04558762 - Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence
Withdrawn NCT02524366 - A Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement N/A
Completed NCT01924728 - Efficacy of Magnetic Stimulation for Stress Urinary Incontinence N/A
Completed NCT01676662 - Solace European Confirmatory Trial N/A
Unknown status NCT01455779 - Lyrette: Renewing Continence Objective and Subjective Efficacy Study N/A
Terminated NCT01029106 - Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI) N/A
Completed NCT01123096 - Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence? N/A
Withdrawn NCT00573703 - Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence Phase 4
Completed NCT01770691 - Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence N/A
Completed NCT00234754 - Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women N/A
Completed NCT00441454 - Retropubic vs. Transobturator Tension-free Vaginal Tape N/A
Completed NCT03985345 - Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence. N/A
Active, not recruiting NCT03671694 - Laser Vaginal Treatment for SUI N/A
Completed NCT04097288 - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects Phase 1