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Completed

NCT Number: NCT02348112

Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.

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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 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

Observational

Primary location

CHUS Hopital Fleurimont, Sherbrooke, Quebec, Canada

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About this study

This study is a prospective, post-market, multi-center, cohort assessment comparing Altis SIS (n=178) and transobturator and/or retropubic slings (n=178) in the treatment of stress urinary incontinence at up to 40 U.S. and international sites. Subjects will be followed for a total of 36 months with scheduled visits at 6, 12, 18, 24 and 36 months. The study population will consist of adult female subjects with stress urinary incontinence who are clinically indicated for surgical intervention with a mesh sling.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The subject is female and at least 18 years of age.
  • The subject is able and willing to complete all procedures and follow-up visits indicated in this protocol.
  • The 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

  • The subject has an active urogenital infection or active skin infection in region of surgery.
  • The subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading.
  • The subject is having a concomitant pelvic floor procedure.
  • The 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).
  • The subject had a prior surgical stress urinary incontinence (SUI) treatment.
  • The subject has undergone radiation or brachy therapy to treat pelvic cancer.
  • The subject has urge predominant incontinence by MESA assessment.
  • The subject has an atonic bladder or post void residual (PVR) above 100 cc on ≥ 2 occasions.
  • The subject is pregnant and/or is planning to get pregnant in the future.
  • The subject has a contraindication to the surgical procedure or the product Instructions for Use (IFU).
  • The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function, without the sponsors approval.

Treatment and study plan

Altis Single Incision Sling

Device

Altis is a minimally invasive, adjustable incontinence sling that is placed through a single incision in the vaginal wall and anchored inside the body. The sling has an integrated tensioning system eliminating the need for additional skin exits.

Transobturator or Retropubic Sling

Device

Both transobturator and retropubic slings are a hammock-like mesh placed underneath the urethra to provide support. A single incision is made in the vaginal wall and two incisions in the abdomen. Tensioning of the sling is achieved by pulling the sling through the abdominal incisions.

Primary outcomes

  1. Primary Effectiveness Endpoint

    Time frame: 6 months

    Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50% at 6 months.

  2. Primary Safety Endpoint

    Time frame: 36 months

    Observed device and/or procedure-related serious adverse events through 36 months.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

A Post-Market Evaluation of the Altis® Single Incision Sling System Versus Transobturator or Retropubic Mesh Sling in the Treatment of Female Stress Urinary Incontinence

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jan 28, 2015
Registry last updated
Dec 4, 2023

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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