IUL Study A Randomized Sham - Controlled Clinical Study

Intraurethral Laser Therapy for Stress Urinary Incontinence: A Randomized Sham - Controlled Clinical Study

Primary aim of the study is to compare the impact of SUI on the VAS (visual analogue scale) 3 months after laser therapy versus sham laser therapy.

Background: Stress urinary incontinence (SUI) has a huge impact on the quality of life (QoL) in women and its treatment is challenging. Intraurethral laser may be an additional treatment option.

Study aim: The aim is to study the effectiveness of intraurethral laser therapy in women with SUI.

Design: randomized double blinded sham - controlled clinical study

Study population: women which have been diagnosed with SUI I-II°, aged between 18-80 years.

Study groups: Participants will be randomized (1:1), without stratification. The Intervention group will receive 2 treatments of intraurethral laser therapy and the Control group will receive 2 treatments of intraurethral SHAM laser therapy.

Sample size: A sample size of 20 women, 8 per group including a 20% Drop Out Rate, was calculated.

Primary outcome: impact of SUI on the VAS scale 3 months after laser therapy versus sham laser therapy.

Secondary study outcomes were defined as subjective SUI, objective SUI, QoL, treatment satisfaction, intraurethral microbiome, 3 months after laser therapy versus sham laser therapy.

Inclusion Criteria:

• Female between 18 and 80 years
• Confirmed SUI through cough stress test within the last 24 months
• SUI I-II° for more than 6 months
• At least one incontinence episode per 24 hour period measured over three days according to a bladder diary
• Valsalva leak-point pressure (VLPP) ≤60 cm H2O
• 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)
• BMI (body mass index) ≤35 kg/m2
• Willing to give informed consent and complete the follow up schedule

Exclusion Criteria:

• Active lower urinary tract infections (urethritis, cystitis or vaginitis)
• Three (3) or more cultured-proven bacterial urinary tract infection (UTI) in the last 12 months
• Detrusor overactivity on urodynamics
• Postvoiding residual (PVR) > 100 ml
• Previous urethral surgery (i.e. fistula or diverticula)
• Pelvic organ prolapse grade > 3 as defined by POP-Q and symptomatic
• Known polyuria (>3l/24h)
• Unevaluated macro hematuria
• 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
• Uncontrolled diabetes
• Active herpes genitalis
• Pregnancy
• Vaginal delivery within 6 months prior to the Screening/Baseline Visit