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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01657916
Recruitment Status : Completed
First Posted : August 6, 2012
Last Update Posted : June 9, 2017
Information provided by (Responsible Party):
Atlantic Health System

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

Condition or disease
Stress Urinary Incontinence

Detailed 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.

Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

5 year sling implants
Patients who underwent implant of the Align Urethral Support System between June 2007 and December 2008

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
women who suffered from stress urinary incontinence (leakage of urine will laughing/coughing/sneezing/exercising)

Inclusion Criteria:

  • women
  • complaint of stress urinary incontinence
  • underwent Align urethral support system from June 2007-December 2008

Exclusion Criteria:

  • concommitant procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01657916

United States, New Jersey
Atlantic Health System
Morristown, New Jersey, United States, 07960
Sponsors and Collaborators
Atlantic Health System

Responsible Party: Atlantic Health System Identifier: NCT01657916     History of Changes
Other Study ID Numbers: R12-01-005
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017

Keywords provided by Atlantic Health System:
mid-urethral sling
Align urethral support system
tension free vaginal tape
cough stress test
pelvic exam
Urinary retention
mesh erosion

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders