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

Female Stress Urinary Incontinence Clinical Trial

Official title:

Prospective, Single Centre Study of Er:YAG Laser Treatment for Female Stress and Mixed Urinary Incontinence (IncontiLase)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418299
• Other study ID #: J013
• Status: Completed
• Phase: N/A
• First received: April 8, 2015
• Last updated: April 16, 2015
• Start date: March 2012
• Est. completion date: November 2013

Study information

• Verified date: April 2015
• Source: Juna d.o.o.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Female Stress Urinary Incontinence
• Mixed Incontinence, Urge and Stress
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence, Urge

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Juna d.o.o.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	VAS index for the assessment of pain		at baat baseline and 2, 6 and 12 months after treatment	Yes

External Links

•   The Juna Clinic