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Mid-Urethral Sling Tensioning Trial

NCT02480231 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2020-04-01

No results posted yet for this study

Summary

Prospective randomized clinical trial comparing two methods of intra-operative tensioning of retropubic midurethral slings for stress urinary incontinence. Primary outcome is rate of abnormal bladder function. Secondary outcomes include validated quality of life scores, physical exam findings, and rates of immediate post operative voiding dysfunction.

Conditions

  • Urinary Stress Incontinence

Interventions

DEVICE

Retropubic Midurethral Sling

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • University of Calgary

    lead OTHER

Principal Investigators

  • Erin A Brennand, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-04-30
Completion
2020-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02480231 on ClinicalTrials.gov