Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

Recruiting

I'm Interested

Trial ID: NCT02348112

Purpose

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.

Official 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

Stanford Investigator(s)

Eric R. Sokol, MD
Eric R. Sokol, MD

Professor of Obstetrics and Gynecology (Gynecology-Urogynecology) and, by courtesy, of Urology

Eligibility


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.

Intervention(s):

device: Transobturator or Retropubic Sling

device: Altis Single Incision Sling

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kathryn Batham
650-724-7846