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Stress Urinary Incontinence

Non-ablative Er:YAG Laser Therapy Effect on Stress Urinary Incontinence Related to Quality of Life and Sexual Function: A Randomized Controlled Trial

Authors: M. Blaganje, D. Scepanovic, L. Zgur, I. Verdenik, F. Pajk and A. Lukanovic

Published in: European Journal of Obstetrics & Gynecology and Reproductive Biology. 2018;224:153-158





1. FIST EVER RANDOMIZED CONTROLLED TRIAL OF INCONTILASE® TREATMENT

The study presents the first ever randomized controlled trial which evaluates the efficacy and safety of non-ablative Er:YAG laser therapy as an alternative, non-invasive treatment of SUI and the improvement of sexual gratification in parous women.

2. STUDY EXAMINES A LARGE NUMBER OF PATIENTS

114 premenopausal parous women with SUI were randomized in two groups of 57 women: a laser intervention group and a placebo group. Both groups were treated according to the IncontiLase® clinical treatment protocol for SUI developed by Fotona, with an Er:YAG laser, except that there was no energy output when treating the placebo group and patients were not aware of this fact. At baseline and 3 months after treatment, patients were clinically examined, answered questionnaires for SUI severity and sexual function assessment and their pelvic floor muscle function was assessed with perineometry. ICIQ-UI SF was used as the primary outcome measure. PISQ-12 and FSFI were used to assess the sexual function. Patients were monitored for discomfort and side-effects during treatment and in the follow-up period.

3. RESULTS SHOW SIGNIFICANT IMPROVEMENT IN THE LASER GROUP

3 months after treatment the ICIQ-UI SF (p < 0.001), PISQ-12 (p = 0.014) and FSFI (p = 0.025) scores collected were significantly more improved in the laser group than in the placebo control group. 21% of laser-treated patients were completely dry at follow up (ICIQ-UI SF = 0), compared to only 4% of the placebo control patients. No serious adverse effects were observed or reported.

4. INCONTILASE® IS A MINIMALLY-INVASIVE SAFE TREATMENT ALTERNATIVE FOR SUI

The results of this randomized trial reveal that a single session of IncontiLase® treatment improves the impact of SUI symptoms on quality of life and sexual function in premenopausal parous women significantly better than a placebo treatment.

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