Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

Coloplast

Status

Completed

Conditions

Stress Urinary Incontinence

Treatments

Device: Altis Single Incision Sling

Device: Transobturator or Retropubic Sling

Study type

Observational

Funder types

Industry

Identifiers

NCT02348112

SU020

Details and patient eligibility

About

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.

Full description

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.

Enrollment

416 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.