5-Year Objective and Subjective Results of a Mid-Urethral Sling
|ClinicalTrials.gov Identifier: NCT01657916|
Recruitment Status : Completed
First Posted : August 6, 2012
Last Update Posted : June 9, 2017
|Condition or disease|
|Stress Urinary Incontinence|
|Study Type :||Observational|
|Actual Enrollment :||90 participants|
|Official Title:||5-Year Objective and Subjective Results of a Mid-Urethral Sling|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
5 year sling implants
Patients who underwent implant of the Align Urethral Support System between June 2007 and December 2008
- Cough stress test [ Time Frame: 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.
- Pelvic exam [ Time Frame: 5 year follow up appt ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657916
|United States, New Jersey|
|Atlantic Health System|
|Morristown, New Jersey, United States, 07960|