Er:YAG Laser Treatment for Female Stress and Mixed Urinary Incontinence (IncontiLase)

Not Applicable

Completed

• Conditions: Female Stress Urinary Incontinence; Mixed Incontinence, Urge and Stress

• Registration Number: NCT02418299
• Lead Sponsor: Juna d.o.o.

Brief Summary

The purpose of this study was to evaluate the effect of a non-invasive Er:YAG thermal laser therapy in treating female stress and mixed urinary incontinence.

Detailed Description

Urinary incontinence (UI) is a common disorder that affects women of various ages and impacts all aspects of life. Therapeutic approaches range from conservative therapy, which is heavily dependent on patient compliance, to different, more invasive, surgical procedures.

The aim of the study was to evaluate the non-invasive erbium:yttrium-aluminum-garnet (Er:YAG) laser treatment (IncontiLase) as a potential treatment strategy for stress UI (SUI) and mixed UI (MUI). The treatment works by thermally affecting vaginal mucosa, with an emphasis on the anterior vaginal wall, resulting with partial denaturation of collagen fibres and stimulation if new collagen formation, all of which leads to firmer support for the urethra and the improvement of incontinence symptoms.

The investigators included 175 women with newly diagnosed SUI (66% of women) and MUI (34 %), respectively and performed on average 2.5±0.5 procedures in each woman separated by a two-month period, using Er:YAG laser. Patients were clinically examined and classified by incontinence types (SUI and MUI) and grades (mild, moderate, severe and very severe) using International Consultation on Incontinence Modular Questionnaire (ICIQ) and assessing Incontinence Severity Index (ISI): ISI before the therapy was 5.7±2.1 points. Treatment discomfort was measured at every session with visual analogue system pain scale, and adverse effects and patients' satisfaction were followed. Follow-ups were performed at two, six and twelve months after the treatment.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-04
• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-12
• Study First Posted: 2015-04-16
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 175

Inclusion Criteria

• clinically confirmed UI
• normal PAP smear (Papanicolaou cytology)
• negative urine culture
• integrity of the vaginal mucosa (without injuries or bleeding)

Exclusion Criteria

• pregnancy
• intake of photosensitive drugs
• vaginal injuries or vaginal bleeding
• infection in the treated area
• clinical diagnosis of pure urge urinary incontinence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in the Incontinence Severity Index (ISI) calculated from the ICIQ-UI short form questionnaire	at baseline and 2, 6 and 12 months after treatment

Secondary Outcome Measures

Name	Time	Method
VAS index for the assessment of pain	at baat baseline and 2, 6 and 12 months after treatment