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

Completed

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT01657916
• Lead Sponsor: Atlantic Health System

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-08-02
• Study First Submitted QC: 2012-08-03
• Study First Posted: 2012-08-06
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-08
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

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

Exclusion Criteria

• concommitant procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cough stress test	5 year follow up appt	Patient will void and their post-void residual amount of urine will be obtained by a catheter. That same catheter will be left in place and used to fill the bladder with 250ml sterile saline. The patient will then be asked to vigorously cough in the upright sitting and standing positions. A positive "cough test" will be defined as any leakage of urine that is visualized during coughing in the sitting or standing position.

Secondary Outcome Measures

Name	Time	Method
Urgency incontinence related symptoms	5 year follow up appointment	Patients will be assessed for de novo, stable and improved urgency incontinence using the IIQ-7 subject of PFDI-20 (questions 15, 16, and 18).
Stress urinary incontinence related symptoms	5 year follow up appointment	Validated stress urinary incontinence related questionnaires were completed prior to surgery by all of these patients, and will be completed 5 years after surgery as well. The specific forms used will be PFDI-20 and incontinence severity index. Question 17 of the pelvic floor distress inventory will be used to assess subjective cure.
Pelvic exam	5 year follow up appt	Standardized pelvic exam will be performed to assess healing, palpability, mesh related pain and erosion of the sling.
Quality of life and self-reported data	5 year follow up appointment	Validated questionnaires (Incontinence outcome questionnaire, surgical satisfaction questionaire) will be used to assess patient's surgery satisfaction, subjective self-assessment before and 5 years after the surgery.

Trial Locations

Locations (1)

Atlantic Health System; 🇺🇸 Morristown, New Jersey, United States