5-Year Objective and Subjective Results of a Mid-Urethral Sling

NCT ID: NCT01657916

Last Updated: 2017-06-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-07-31

Brief Summary

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Evaluate 5-year objective and subjective cure rates after implant of the retropubic Align Urethral Support System.

Detailed Description

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Between June 2007 and December 2008, the investigators performed 155 Align mid-urethral slings in patients who were only receiving this operation. Very few studies have outcomes at 5 years of greater. The aim of this prospective cohort study is to evaluate five-year objective and subjective cure rates. Secondary endpoints will assess failure risk factors and describe any complications of the retropublic Align Urethral Support System five years postoperatively.

Conditions

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Stress Urinary Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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5 year sling implants

Patients who underwent implant of the Align Urethral Support System between June 2007 and December 2008

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* women
* complaint of stress urinary incontinence
* underwent Align urethral support system from June 2007-December 2008

Exclusion Criteria

* concommitant procedures
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Atlantic Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atlantic Health System

Morristown, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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R12-01-005

Identifier Type: -

Identifier Source: org_study_id

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