Intraurethral/Intravaginal 2940 Nm Erbium Laser Treatment for Stress Urinary Incontinence

Inclusion Criteria: * Female between 18 and 80 years * SUI or MUI with predominantly stress symptoms for more than 6 months * Has failed 2 previous non-invasive therapies for three (3) months each (e.g. behavioural modification, electrical stimulation, pelvic muscle exercise, biofeedback, and/or drug therapy) * Confirmed SUI through cough stress test or urodynamics * Has at least one incontinence episode per 24 hour period measured over three days * Valsalva leak-point pressure (VLPP) ≤100 cm H2O * Has a baseline 24h pad weight test ≥ 10 gm * Has maximum cystometric capacity ≥250 mL * No pelvic surgery within last 6 months (including prolapse repair, subjects who have residual or recurrent SUI following colposuspension or a sling procedure may be included in the study if the procedure was conducted at least 6 months prior to screening /baseline visit) * Willing to give informed consent and complete the follow up schedule Exclusion Criteria: * Active urinary tract or vaginal infection or other active infections of urinary tract or bladder (urethritis, cystitis or vaginitis) * Has had three (3) or more cultured-proven bacterial urinary tract infection (UTI) in the last 12 months * Clinical diagnosis of urge incontinence or urge predominant mixed incontinence * Has detrusor overactivity on urodynamics * postvoiding residual (PVR) \> 100 ml * Has had previous urethral surgery (i.e. fistula or diverticula) * Grade 2 or higher Pelvic organ prolapse (POP) or Pelvic organ prolapse grade \> 2 as defined by POP-Q and symptomatic * Suffers from known polyuria (\>3l/24h) * Has a BMI ≤35 kg/m2 * Has unevaluated hematuria * Has a neurogenic bladder * Evidence of dysplasia in a Pap smear (done in the last 24 months) * Tumours of the Urinary tract * Previous radiation or brachytherapy to treat pelvic cancer * Has uncontrolled diabetes * Has active herpes genitalis * Pregnancy, lactating, or not practicing adequate contraception and/or planning to get pregnant in the next 12 months * Had a vaginal delivery within 6 months prior to the Screening/Baseline Visit * Is currently participating in any other clinical trial, or has participated in another clinical trial within 3 months prior to the Screening/Baseline Visit