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

Study Overview
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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.

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

Conditions
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Stress Urinary Incontinence

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 5 year sling implants<br>Patients who underwent implant of the Align Urethral Support System between June 2007 and December 2008 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough stress test | 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. | 5 year follow up appt | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic exam | Standardized pelvic exam will be performed to assess healing, palpability, mesh related pain and erosion of the sling. | 5 year follow up appt | 
| Stress urinary incontinence related symptoms | 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. | 5 year follow up appointment | 
| Urgency incontinence related symptoms | 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). | 5 year follow up appointment | 
| Quality of life and self-reported data | 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. | 5 year follow up appointment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mid-urethral sling, Align urethral support system, tension free vaginal tape, cough stress test, pelvic exam, PFDI-20, PFIQ, SSQ, Urinary retention, mesh erosion, urodynamics