Study Stopped
statistical Significance was reached for primary outcome
Trial Comparing TVT SECUR System and Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence
Randomized Clinical Trial Comparing TVT SECUR System (TVT S) and Trans Vaginal Obturator Tape (TVT-O) for Surgical Management of Stress Urinary Incontinence
1 other identifier
interventional
106
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2008
Typical duration for phase_3
1 active site
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
First Submitted
Initial submission to the registry
September 10, 2007
CompletedFirst Posted
Study publicly available on registry
September 11, 2007
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedJanuary 12, 2016
January 1, 2016
3.3 years
September 10, 2007
January 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Objective cure as defined by the cough test at one year from surgery
one year
Study Arms (2)
TVT SECURE
ACTIVE COMPARATORsling
TVT O
ACTIVE COMPARATORsling
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
Related Publications (2)
Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
PMID: 37888839DERIVEDMaslow 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.
PMID: 24452619DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ken D Maslow, MD
St. Boniface Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
September 10, 2007
First Posted
September 11, 2007
Study Start
May 1, 2008
Primary Completion
September 1, 2011
Study Completion
October 1, 2011
Last Updated
January 12, 2016
Record last verified: 2016-01