The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence (EASY)

Coloplast

Status

Completed

Conditions

Stress Urinary Incontinence

Treatments

Device: Altis Single Incision Sling System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02049840

SU016

Details and patient eligibility

About

This is a prospective, post-market, single arm, multicenter study comparing Baseline data to the 12 month and 36 month data in 136 female patients with Stress Urinary Incontinence

Full description

This study is a prospective, European Post-Market, one non-controlled arm, multi-centre clinical trial conducted at up to 10 centers in Europe. It is designed to get more clinical information for users (uro-gynecologists) of the Altis Single Incision Sling System for female stress urinary incontinence treatment in terms of objective and subjective cure rate, quality of life improvement, patient satisfaction and safety, especially in long term follow-up (3 years). Clinical data will be collected at baseline, implantation procedure, post-operative at 6 weeks, 6 months, 1, 2 and 3 years

Enrollment

153 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The subject is female at least 18 years of age
The subject uses a method of contraception considered effective by the investigator or is not of child-bearing potential
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 at baseline.
The subject has failed first line treatments (non-invasive therapies, eg. behavioral modification, Pelvic Floor/Kegel exercises, or biofeedback) with good compliance for the treatment

Exclusion criteria

The subject had a prior surgical SUI treatment (including bulking agent).
The subject is having a concomitant Pelvic Organ Prolapse repair or hysterectomy during Altis 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 has predominant or uncontrolled or primary urge incontinence according to investigator judgment
The patient has detrusor overactivity determined through urodynamics
The subject has intrinsic sphincter deficiency defined urodynamically as a Maximal Urethral Closure Pressure < 20 cm H2O and/or Valsalva Leak Point Pressure < 60 cm H2O
The subject has atonic bladder, a persistent post void residual (PVR) > 100 ml or chronic urinary retention.
The subject has untreated urinary malignancy
The subject has undergone radiation or brachy therapy or chemotherapy to treat pelvic cancer.
The subject has urethrovaginal fistula or urethral diverticulum or congenital urinary anomalies
The subject has serious bleeding disorder or requires anticoagulant therapy
The subject is pregnant and/or is planning to get pregnant in the future.
The subject has a Body Mass Index ≥ 35 (obese class II).
The subject has a contraindication to the surgical procedure according to the the Altis SIS System IFU.
The subject has an active urogenital infection or active skin infection in region of surgery mainly at the time of implantation.
The subject is enrolled in a concomitant clinical trial.