Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Altis Single Incision Sling
* Device: Transobturator or Retropubic Sling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Altis arm<br>Subjects will have an Altis sling placed to treat stress urinary incontinence. | Device: Altis Single Incision Sling<br>* 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.<br>|
| Comparator arm<br>Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence. | Device: Transobturator or Retropubic Sling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint | Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50% at 6 months. | 6 months | 
| Primary Safety Endpoint | Observed device and/or procedure-related serious adverse events through 36 months. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Altis 522, stress urinary incontinence, urinary incontinence