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 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 through cough stress test or urodynamics. - The subject has failed two non-invasive incontinence therapies (such as Kegal 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 neurological causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinsons disease, or similar conditions). - The subject had a prior surgical stress urinary incontinence 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 of 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