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Completed

NCT Number: NCT01272284

The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study

An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI).

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHUS Hopital Fleurimont, Sherbrooke, Quebec, Canada

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About this study

An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI). Primary Objective: Improvement in continence measured by 24 hour pad weight test with at least a 50% reduction in weight from baseline at 6 months. Secondary Objectives: Cough stress test results at 6 months; Subject QoL as measured by validated questionnaires: PGI-I, improvements in UDI-6 and IIQ-7 scores from baseline at 6 months, 3 day voiding diary improvement from baseline at 6 months; Device and procedure related adverse events. Brief Entrance Criteria: Adult female with confirmed SUI through cough stress test or urodynamics; Failed two non-invasive incontinence therapies; No prior surgical SUI treatment; No prolapse POP-Q Stage 2 or higher; No concurrent pelvic floor procedure; No urge predominant incontinence; No incontinence due to neurological disorder/disease; No PVR > 100cc; and, No contraindication to the surgical procedure. Study visits will take place at baseline, implant/hospitalization, 3 months, 6 months, 1 year, and 2 years post operatively. This study will enroll up to 113 subjects at up to 17 investigative sites in the US and Internationally.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is female at least 18 years of age
  • Subject is able and willing to complete all procedures and follow-up visits indicated in this protocol
  • Subject has confirmed stress urinary incontinence (SUI) through cough stress test or urodynamics
  • The subject has failed two non-invasive incontinence therapies (such as Kegel exercise, behavior modification, pad use, biofeedback, etc) for >6 months

Exclusion criteria

  • Subject has an active urogenital infection or active skin infection in region of surgery
  • Subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading
  • Subject is having a concomitant pelvic floor procedure
  • Subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions)
  • Subject had a prior surgical SUI treatment
  • Subject has undergone radiation or brachy therapy to treat pelvic cancer
  • Subject has urge predominant incontinence
  • Subject has an atonic bladder or a post void residual (PVR) consistently about 100cc
  • Subject is pregnant and/or is planning to get pregnant in the future
  • Subject has a contraindication to the surgical procedure or the Altis Instructions For Use (IFU)
  • Subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function without the sponsor's approval

Treatment and study plan

Altis® Single Incision Sling System (SIS)

Device

The Altis® SIS is a permanently implantable synthetic sling for females placed at the mid-urethra to provide a scaffold for tissue in-growth and support for stress urinary incontinence.

Primary outcomes

  1. Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months

    Time frame: 6 months (compared to baseline)

    Primary endpoint defined as at least a 50% reduction in 24-hour pad weight from baseline to 6 months (including dry as defined as a pad weight of less than 1.3 grams during the 6-month test), in which the percent of subjects with at least 50% reduction in 24-hour pad weight is compared to a performance goal of 50%.

Secondary outcomes

  1. Percentage of Participants With Negative Cough Stress Test at 6 Months

    Time frame: 6 months

    Endpoint defined as a negative result at 6 months, as measured by the Cough Stress Test (CST), in which the percent of subjects with a negative CST is compared to a performance goal of 66%.

    The cough stress test was completed with the subject in the lithotomy and standing positions, filling bladder to maximum capacity with normal saline. The subject was then asked to cough 10 times and any leakage from the urethra was considered a positive test.

  2. Percentage of Participants With at Least 50% Improvement in Incontinence Via 3-Day Voiding Diary From Baseline to 6 Months

    Time frame: 6 months (compared to baseline)

    Endpoint defined as at least a 50% improvement from baseline to 6-months, as measured by 3-Day Voiding Diary, in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.

    Subjects completed a 3-Day Voiding Diary of controlled urinations and the number and amount of leaks experienced.

  3. Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months

    Time frame: 6 months (compared to baseline)

    Endpoint defined as at least a 50% improvement from baseline to 6 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6), in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.

  4. Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 6 Months

    Time frame: 6 months (compared to baseline)

    Endpoint defined as at least a 50% improvement from baseline to 6 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7), in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.

  5. Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 6 Months

    Time frame: 6 months

    Success defined as a response of "Very Much Better" or "Much Better" at 6 months, as measured by validated Patient Global Impression of Improvement (PGI-I).

  6. Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 12 Months

    Time frame: 12 months (compared to baseline)

    Success is defined as at least a 50% reduction in 24-hour pad weight from baseline to 12 months using the 24 hour pad weight test.

  7. Percentage of Participants With Negative Cough Stress Test at 12 Months

    Time frame: 12 months (compared to baseline)

    Success defined as a negative result at 12 months, as measured by the Cough Stress Test (CST).

    The cough stress test was completed with the subject in the lithotomy and standing positions, filling bladder to maximum capacity with normal saline. The subject was then asked to cough 10 times and any leakage from the urethra was considered a positive test.

  8. Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 12 Months

    Time frame: 12 months (compared to baseline)

    Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6)

  9. Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 12 Months

    Time frame: 12 months (compared to baseline)

    Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7)

  10. Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 12 Months

    Time frame: 12 months

    Success defined as a response of "Very Much Better" or "Much Better" at 12 months, as measured by validated Patient Global Impression of Improvement (PGI-I).

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Jan 7, 2011
Registry last updated
Feb 11, 2021

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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