title: Minimally invasive, non-ablative Er:YAG laser treatment of stress urinary incontinence in women--a pilot study.
abstract: The study presents an assessment of mechanism of action and a pilot clinical study of efficacy and safety of the Er:YAG laser for the treatment of stress urinary incontinence (SUI). The subject of this study is a treatment of SUI with a 2940 nm Er:YAG laser, operating in a special SMOOTH mode designed to increase temperature of the vaginal mucosa up to maximally 60-65 °C without ablating the epidermis. Numerical modelling of the temperature distribution within mucosa tissue following an irradiation with the SMOOTH mode Er:YAG laser was performed in order to determine the appropriate range of laser parameters. The laser treatment parameters were further confirmed by measuring in vivo temperatures of the vaginal mucosa using a thermal camera. To investigate the clinical efficacy and safety of the SMOOTH mode Er:YAG laser SUI treatment, a pilot clinical study was performed. The study recruited 31 female patients suffering from SUI. Follow-ups were scheduled at 1, 2, and 6 months post treatment. ICIQ-UI questionnaires were collected as a primary trial endpoint. Secondary endpoints included perineometry and residual urine volume measurements at baseline and all follow-ups. Thermal camera measurements have shown the optimal increase in temperature of the vaginal mucosa following treatment of SUI with a SMOOTH mode Er:YAG laser. Primary endpoint, the change in ICIQ-UI score, showed clinically relevant and statistically significant improvement after all follow-ups compared to baseline scores. There was also improvement in the secondary endpoints. Only mild and transient adverse events and no serious adverse events were reported. The results indicate that non-ablative Er:YAG laser therapy is a promising minimally invasive non-surgical option for treating women with SUI symptoms.
authors: Ob/Gyn Clinic, University Hospital Merkur, Zagreb, Croatia.
authors: Nikola
authors: N
authors: Fistonić
authors: Ob/Gyn and Menopause Clinic, Zagreb, Croatia.
authors: Ivan
authors: I
authors: Fistonić
authors: Ob/Gyn and Menopause Clinic, Zagreb, Croatia.
authors: Štefica Findri
authors: ŠF
authors: Guštek
authors: Medical School University of Rijeka, Rijeka, Croatia.
authors: Iva Sorta Bilajac
authors: IS
authors: Turina
authors: Department of Obstetrics and Gynecology, General Hospital Sveti Duh, Zagreb, Croatia.
authors: Ingrid
authors: I
authors: Marton
authors: Fotona d.o.o., Stegne 7, 1000, Ljubljana, Slovenia.
authors: Zdenko
authors: Z
authors: Vižintin
authors: Fotona d.o.o., Stegne 7, 1000, Ljubljana, Slovenia.
authors: Marko
authors: M
authors: Kažič
authors: Fotona d.o.o., Stegne 7, 1000, Ljubljana, Slovenia. irena.hreljac@fotona.com.
authors: Irena
authors: I
authors: Hreljac
authors: Fotona d.o.o., Stegne 7, 1000, Ljubljana, Slovenia.
authors: Tadej
authors: T
authors: Perhavec
authors: Fotona d.o.o., Stegne 7, 1000, Ljubljana, Slovenia.
authors: Matjaž
authors: M
authors: Lukač
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D053844:Lasers, Solid-State / Q000627:therapeutic use*; D028022:Low-Level Light Therapy; D008875:Middle Aged; D010865:Pilot Projects; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000532:radiotherapy*
keywords: Er:YAG laser; Minimally invasive SUI therapy; Stress urinary incontinence