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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
Sponsored by
Juna d.o.o.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

    First Posted
    April 8, 2015
    Last Updated
    April 16, 2015
    Sponsor
    Juna d.o.o.
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    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
    No

    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
    No
    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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