Evaluate 5-year objective and subjective cure rates after implant of the retropubic Align Urethral Support System.
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 Type
OBSERVATIONAL
Enrollment
90
Atlantic Health System
Morristown, New Jersey, United States
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.
Time frame: 5 year follow up appt
Pelvic exam
Standardized pelvic exam will be performed to assess healing, palpability, mesh related pain and erosion of the sling.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 5 year follow up appointment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.