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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657916
• Other study ID #: R12-01-005
• Status: Completed
• Phase: N/A
• First received: August 2, 2012
• Last updated: June 8, 2017
• Start date: June 2012
• Est. completion date: July 2015

Study information

• Verified date: June 2017
• Source: Atlantic Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• women

• complaint of stress urinary incontinence

• underwent Align urethral support system from June 2007-December 2008

Exclusion Criteria:

• concommitant procedures

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Locations

Country	Name	City	State
United States	Atlantic Health System	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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