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Completed

NCT Number: NCT01657916

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • concommitant procedures

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 6, 2012
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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