NCT01799122

Brief Summary

Randomized comparison of two surgeries for the treatment of female stress urinary incontinence.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

First QC Date

February 22, 2013

Last Update Submit

January 8, 2016

Conditions

Stress Urinary IncontinenceUrethral Sling Surgery

Outcome Measures

Primary Outcomes (1)

  • Cough test at one year from surgery

    One year

Secondary Outcomes (1)

  • Subjective symptoms, QOL questionaires

    1 & 2 years post surgery

Study Arms (1)

Precise sling vs TVT-O sling

ACTIVE COMPARATOR
Device: Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)

Interventions

Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)DEVICE
Precise sling vs TVT-O sling

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women with stress urinary incontinence with a positive cough test
  • patient request surgery for treatment

You may not qualify if:

  • prodominantely overactive bladder
  • previous failed procedure
  • MUCP \<20 cm H2O
  • presence of vaginal prolapse \> stage 1
  • voiding dysfunction (PVR\>100 mL)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ken Maslow

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (1)

  • 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: 37888839DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistent Professor

Study Record Dates

First Submitted

February 22, 2013

First Posted

February 26, 2013

Primary Completion

February 1, 2017

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

CA(1)