Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
318 participants
INTERVENTIONAL
2015-09-30
2020-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Babcock tensioning technique
Group for whom the retropubic mid-urethral sling was tensioned using a Babcock clamp.
Retropubic Midurethral Sling
Scissor spacer technique
Group for whom the retropubic mid-urethral sling was tensioned using a surgical scissor as a spacer.
Retropubic Midurethral Sling
Interventions
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Retropubic Midurethral Sling
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women who have elected for surgical management of symptomatic urinary incontinence
* Ability to read \& write in English
* Other prolapse surgery at time of sling placement is allowed
* Must consent to participation in trial
Exclusion Criteria
* Clinically obvious, but non-symptomatic stress urinary incontinence (latent stress incontinence)
* Declines participation in trial
* Women with existing urinary retention or significant overactive bladder (requiring medication)
18 Years
99 Years
FEMALE
Yes
Sponsors
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Boston Scientific Corporation
INDUSTRY
University of Calgary
OTHER
Responsible Party
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Erin Brennand
Dr.
Principal Investigators
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Erin A Brennand, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Foothills Hospital, University of Calgary
Calgary, Alberta, Canada
Countries
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References
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Brennand EA, Wu G, Houlihan S, Globerman D, Gagnon LH, Birch C, Hyakutake M, Carlson KV, Al-Shankiti H, Robert M, Lazare D, Kim-Fine S; Calgary Women's Pelvic Health Research Group. Two Intraoperative Techniques for Midurethral Sling Tensioning: A Randomized Controlled Trial. Obstet Gynecol. 2020 Sep;136(3):471-481. doi: 10.1097/AOG.0000000000004027.
Other Identifiers
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REB15-0455
Identifier Type: -
Identifier Source: org_study_id
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