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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Atlantic Health System
Sponsor:
Information provided by (Responsible Party):
Jennifer Pagnillo, Atlantic Health System
ClinicalTrials.gov Identifier:
NCT01657916
First received: August 2, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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


Condition
Stress Urinary Incontinence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 5-Year Objective and Subjective Results of a Mid-Urethral Sling

Resource links provided by NLM:


Further study details as provided by Atlantic Health System:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 150
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)
Groups/Cohorts
5 year sling implants
Patients who underwent implant of the Align Urethral Support System between June 2007 and December 2008

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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)

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • concommitant procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657916

Contacts
Contact: Jennifer Pagnillo, MD 973-971-7426 jennifer.pagnillo@atlantichealth.org
Contact: Emil Gurshumov, MD 973-971-7267 emil.gurshumov@atlantichealth.org

Locations
United States, New Jersey
Atlantic Health System Recruiting
Morristown, New Jersey, United States, 07960
Contact: Jennifer Pagnillo, MD    973-971-7426    jennifer.pagnillo@atlantichealth.org   
Principal Investigator: Patrick Culligan, MD         
Sponsors and Collaborators
Atlantic Health System
  More Information

No publications provided

Responsible Party: Jennifer Pagnillo, PI, Atlantic Health System
ClinicalTrials.gov Identifier: NCT01657916     History of Changes
Other Study ID Numbers: R12-01-005
Study First Received: August 2, 2012
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Atlantic Health System:
mid-urethral sling
Align urethral support system
tension free vaginal tape
cough stress test
pelvic exam
PFDI-20
PFIQ
SSQ
Urinary retention
mesh erosion
urodynamics

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014