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

NCT ID: NCT02418299

Last Updated: 2015-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-11-30

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.

Conditions

Female Stress Urinary Incontinence; Mixed Incontinence, Urge and Stress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IncontiLase Er:YAG laser treatment

Er:YAG laser treatment for stress and mixed urinary incontinence

Group Type: EXPERIMENTAL

IncontiLase Er:YAG laser treatment

Intervention Type: DEVICE

Each patient will receive 2-3 sessions of Er:YAG laser treatment for stress and mixed urinary incontinence (IncontiLase)

Interventions

IncontiLase Er:YAG laser treatment

Each patient will receive 2-3 sessions of Er:YAG laser treatment for stress and mixed urinary incontinence (IncontiLase)

Intervention Type: DEVICE

Other Intervention Names

IncontiLase

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Juna d.o.o.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Urška Bizjak-Ogrinc, Dr

Role: PRINCIPAL_INVESTIGATOR

Juna d.o.o.

Related Links

http://www.juna.si

The Juna Clinic

Other Identifiers

J013

Identifier Type: -

Identifier Source: org_study_id