5-Year Objective and Subjective Results of a Mid-Urethral Sling
Evaluate 5-year objective and subjective cure rates after implant of the retropubic Align Urethral Support System.
Stress Urinary Incontinence
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||5-Year Objective and Subjective Results of a Mid-Urethral Sling|
- Cough stress test [ Time Frame: 5 year follow up appt ] [ Designated as safety issue: No ]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.
- Pelvic exam [ Time Frame: 5 year follow up appt ] [ Designated as safety issue: Yes ]Standardized pelvic exam will be performed to assess healing, palpability, mesh related pain and erosion of the sling.
- Stress urinary incontinence related symptoms [ Time Frame: 5 year follow up appointment ] [ Designated as safety issue: No ]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.
- Urgency incontinence related symptoms [ Time Frame: 5 year follow up appointment ] [ Designated as safety issue: No ]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).
- Quality of life and self-reported data [ Time Frame: 5 year follow up appointment ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
5 year sling implants
Patients who underwent implant of the Align Urethral Support System between June 2007 and December 2008
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657916
|Contact: Jennifer Pagnillo, MDfirstname.lastname@example.org|
|Contact: Emil Gurshumov, MDemail@example.com|
|United States, New Jersey|
|Atlantic Health System||Recruiting|
|Morristown, New Jersey, United States, 07960|
|Contact: Jennifer Pagnillo, MD 973-971-7426 firstname.lastname@example.org|
|Principal Investigator: Patrick Culligan, MD|