NCT02337374

Brief Summary

Purpose The aim of this study is to investigate the contribution of preoperative urodynamics to mid-urethral slings (MUS) success for developing an algorithm that uses conventional and easily accessible tools Methods Women with stress urinary incontinence and who desired surgical correction of their incontinence were included in the study. The selection of the procedure was according to an algorithm used in an institution developed by a chief of urogynecology department who had 25 years of urogynecology experience. Urodynamic and baseline factors that may be associated with surgery failure were analyzed in MUS failure.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
242

participants targeted

Target at P75+ for all trials

Status
completed

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

Study Start

First participant enrolled

June 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
Last Updated

January 13, 2015

Status Verified

January 1, 2015

Enrollment Period

1.7 years

First QC Date

January 9, 2015

Last Update Submit

January 9, 2015

Conditions

Urinary Incontinence, Stress

Keywords

UrodynamicsMidurethral slingTransobturator tape (TOT)Tension free vaginal tape (TVT)

Outcome Measures

Primary Outcomes (1)

  • Mid urethral sling surgery failure

    after june 2010

Interventions

Midurethral sling meshDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women with stress urinary incontinence and who desired surgical correction of their incontinence

You may qualify if:

  • Documented pure or predominant SUI symptoms for at least 3 months, along with a positive standardized urinary stress test

You may not qualify if:

  • prior incontinence surgery, post-void residual volumes of greater than 100 ml, a history of chronic inguinal or vulvar abscess, hidradenitis suppurativa, genitourinary fistula or urethral diverticulum, reversible cause of incontinence (i.e., drug effect), or any contraindication to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 13, 2015

Study Start

June 1, 2010

Primary Completion

February 1, 2012

Last Updated

January 13, 2015

Record last verified: 2015-01