Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

Trial ID or NCT#

NCT02348112

Status

recruiting iconRECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.
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Investigator(s)

Eric R. Sokol, MD
Eric R. Sokol, MD
Urogynecologist, Pelvic surgeon, Minimally invasive gynecologic surgeon, Pelvic reconstructive surgeon, Obstetrician and Gynecologist (OB-GYN)
Associate Professor of Obstetrics and Gynecology (Gynecology-Urogynecology) and, by courtesy, of Urology

Contact us to find out if this trial is right for you.

Contact

Kathryn Batham
650-724-7846

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View on ClinicalTrials.gov