the altis® single incision sling system for female stress urinary incontinence study

Conditions: Stress Urinary Incontinence

Summary: an international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the coloplast altis single incision sling system for females with stress urinary incontinence (sui).

an international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the coloplast altis single incision sling system for females with stress urinary incontinence (sui). primary objective: improvement in continence measured by 24 hour pad weight test with at least a 50% reduction in weight from baseline at 6 months. secondary objectives: cough stress test results at 6 months; subject qol as measured by validated questionnaires: pgi-i, improvements in udi-6 and iiq-7 scores from baseline at 6 months, 3 day voiding diary improvement from baseline at 6 months; device and procedure related adverse events. brief entrance criteria: adult female with confirmed sui through cough stress test or urodynamics; failed two non-invasive incontinence therapies; no prior surgical sui treatment; no prolapse pop-q stage 2 or higher; no concurrent pelvic floor procedure; no urge predominant incontinence; no incontinence due to neurological disorder/disease; no pvr \> 100cc; and, no contraindication to the surgical procedure. study visits will take place at baseline, implant/hospitalization, 3 months, 6 months, 1 year, and 2 years post operatively. this study will enroll up to 113 subjects at up to 17 investigative sites in the us and internationally.

Eligibility criteria:
inclusion criteria: * subject is female at least 18 years of age * subject is able and willing to complete all procedures and follow-up visits indicated in this protocol * 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: * subject has an active urogenital infection or active skin infection in region of surgery * subject has confirmed pelvic organ prolapse (pop) of stage 2 or higher as determined by pop-q prolapse grading * subject is having a concomitant pelvic floor procedure * 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) * subject had a prior surgical sui treatment * subject has undergone radiation or brachy therapy to treat pelvic cancer * subject has urge predominant incontinence * subject has an atonic bladder or a post void residual (pvr) consistently about 100cc * subject is pregnant and/or is planning to get pregnant in the future * subject has a contraindication to the surgical procedure or the altis instructions for use (ifu) * subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function without the sponsor's approval

Keywords: female stress urinary incontinence mini sling single incision sling urinary incontinence mixed urinary incontinence additional relevant mesh terms: stress urinary incontinence, stress pathological processes urination disorders urological disorders urological manifestations signs and symptoms