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

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.