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

Primary Purpose

Female Stress Urinary Incontinence, Mixed Incontinence, Urge and Stress

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

IncontiLase Er:YAG laser treatment

About this trial

This is an interventional treatment trial for Female Stress Urinary Incontinence focused on measuring urinary incontinence, Er:YAG laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IncontiLase Er:YAG laser treatment

Arm Description

Er:YAG laser treatment for stress and mixed urinary incontinence

Outcomes

Primary Outcome Measures

Change in the Incontinence Severity Index (ISI) calculated from the ICIQ-UI short form questionnaire

Secondary Outcome Measures

VAS index for the assessment of pain

Full Information

NCT ID

NCT02418299

First Posted

April 8, 2015

Last Updated

April 16, 2015

Sponsor

Juna d.o.o.

1. Study Identification

Unique Protocol Identification Number

NCT02418299

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Juna d.o.o.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Female Stress Urinary Incontinence, Mixed Incontinence, Urge and Stress

Keywords

urinary incontinence, Er:YAG laser

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

175 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IncontiLase Er:YAG laser treatment

Arm Type

Experimental

Arm Description

Er:YAG laser treatment for stress and mixed urinary incontinence

Intervention Type

Device

Intervention Name(s)

IncontiLase Er:YAG laser treatment

Other Intervention Name(s)

IncontiLase

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in the Incontinence Severity Index (ISI) calculated from the ICIQ-UI short form questionnaire

Time Frame

at baseline and 2, 6 and 12 months after treatment

Secondary Outcome Measure Information:

Title

VAS index for the assessment of pain

Time Frame

at baat baseline and 2, 6 and 12 months after treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Urška Bizjak-Ogrinc, Dr

Organizational Affiliation

Juna d.o.o.

Official's Role

Principal Investigator

12. IPD Sharing Statement

Links:

URL

http://www.juna.si

Description

The Juna Clinic

Learn more about this trial

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

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