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Non-ablative Er:Yttrium Aluminum Garnet Laser for Stress Urinary Incontinence (SUI)

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laser
sham control
Sponsored by
Dr Adolf Lukanovič
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring stress urinary incontinence, sexual dysfunction, laser, Er:YAG, vaginal laser, vaginal tightening, non-ablative, minimally-invasive

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of stress urinary incontinence
  • sexually active
  • at least one vaginal delivery

Exclusion Criteria:

  • pelvic organ prolapse greater than stage I
  • urgency or mixed UI
  • infection
  • previous gynaecologic surgery or irradiation
  • refuse consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Laser

    Sham control

    Arm Description

    One session of non-ablative Er:YAG laser (2940 nm) treatment of the vaginal wall, introitus and vestibule.

    The sham control group was treated with the same procedure but with zero intensity settings - without receiving therapeutic irradiation (placebo).

    Outcomes

    Primary Outcome Measures

    Change from baseline in ICIQ-UI SF score
    International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form

    Secondary Outcome Measures

    Change from baseline in PISQ-12 score
    The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire
    Change from baseline in FSFI score
    The Female Sexual Function Index, a validated generalized questionnaire utilized to assess sexual function in women in a general population.
    Change from baseline in perineometry variable maximal contraction pressure
    Measured with Myomed 632 perineometer with the women in supine position.
    Change from baseline in perineometry variable average contraction pressure
    Measured with Myomed 632 perineometer with the women in supine position.
    Change from baseline in perineometry variable mean muscle endurance (stamina)
    Measured with Myomed 632 perineometer with the women in supine position.

    Full Information

    First Posted
    September 21, 2017
    Last Updated
    September 27, 2017
    Sponsor
    Dr Adolf Lukanovič
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03296241
    Brief Title
    Non-ablative Er:Yttrium Aluminum Garnet Laser for Stress Urinary Incontinence (SUI)
    Official Title
    Non-ablative Er:Yttrium Aluminum Garnet (Er:YAG) Laser Therapy Effect on Stress Urinary Incontinence (SUI) Related Quality of Life and Sexual Function: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2012 (Actual)
    Primary Completion Date
    August 30, 2013 (Actual)
    Study Completion Date
    August 30, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr Adolf Lukanovič

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Stress urinary incontinence (SUI) is a common complaint in women after childbirth. The aim of this study was to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy in the treatment of SUI and improvement of sexual gratification in parous women. 114 premenopausal parous women with SUI were randomized in two groups of 57 women; a laser intervention group and sham control (placebo) group. Both groups were treated according to the IncontiLaseTM clinical treatment protocol for SUI with non-ablative thermal-only Er:YAG laser, except that there was no energy output when treating the sham group. Patients were blinded to the allocation. At baseline and 3 months after treatment patients were clinically examined, answered questionnaires for SUI severity sexual function assessment and their pelvic floor muscle (PFM) function was assessed with perineometry. The improvement in the laser group will be compared to the improvement in the sham group.
    Detailed Description
    Stress urinary incontinence (SUI) is a common complaint in women after childbirth. It affects their quality of life and sexual satisfaction and is one of the major reasons for gynaecological surgery. There is a need for effective non-invasive treatment alternatives. The aim of this study was to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy in the treatment of SUI and improvement of sexual gratification in parous women. 114 premenopausal parous women with SUI were randomized in two groups of 57 women; a laser intervention group and sham control (placebo) group. Both groups were treated according to the IncontiLaseTM clinical treatment protocol for SUI with non-ablative thermal-only Er:YAG laser, except that there was no energy output when treating the sham group. Patients were blinded to the allocation. At baseline and 3 months after treatment patients were clinically examined, answered questionnaires for SUI severity sexual function assessment and their pelvic floor muscle (PFM) function was assessed with perineometry. Validated International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) was used as the primary outcome measure. The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire short form (PISQ-12) and The Female Sexual Function Index (FSFI) were used to assess the sexual function. Patients were monitored for discomfort and side-effects during treatment and follow up period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress Urinary Incontinence
    Keywords
    stress urinary incontinence, sexual dysfunction, laser, Er:YAG, vaginal laser, vaginal tightening, non-ablative, minimally-invasive

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients assigned randomly to two groups: laser-treatment group and sham (control) group
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Patients are unaware of the assignment. Both groups were treated according to the IncontiLaseTM clinical treatment protocol for SUI with non-ablative thermal-only Er:YAG laser, except that there was no energy output when treating the sham group.
    Allocation
    Randomized
    Enrollment
    114 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Laser
    Arm Type
    Experimental
    Arm Description
    One session of non-ablative Er:YAG laser (2940 nm) treatment of the vaginal wall, introitus and vestibule.
    Arm Title
    Sham control
    Arm Type
    Sham Comparator
    Arm Description
    The sham control group was treated with the same procedure but with zero intensity settings - without receiving therapeutic irradiation (placebo).
    Intervention Type
    Device
    Intervention Name(s)
    laser
    Other Intervention Name(s)
    IncontiLaseTM, IncontiLase
    Intervention Type
    Device
    Intervention Name(s)
    sham control
    Other Intervention Name(s)
    placebo
    Primary Outcome Measure Information:
    Title
    Change from baseline in ICIQ-UI SF score
    Description
    International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form
    Time Frame
    at 3 months after intervention
    Secondary Outcome Measure Information:
    Title
    Change from baseline in PISQ-12 score
    Description
    The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire
    Time Frame
    at 3 months after intervention
    Title
    Change from baseline in FSFI score
    Description
    The Female Sexual Function Index, a validated generalized questionnaire utilized to assess sexual function in women in a general population.
    Time Frame
    at 3 months after intervention
    Title
    Change from baseline in perineometry variable maximal contraction pressure
    Description
    Measured with Myomed 632 perineometer with the women in supine position.
    Time Frame
    at 3 months after intervention
    Title
    Change from baseline in perineometry variable average contraction pressure
    Description
    Measured with Myomed 632 perineometer with the women in supine position.
    Time Frame
    at 3 months after intervention
    Title
    Change from baseline in perineometry variable mean muscle endurance (stamina)
    Description
    Measured with Myomed 632 perineometer with the women in supine position.
    Time Frame
    at 3 months after intervention
    Other Pre-specified Outcome Measures:
    Title
    Side effects
    Description
    Monitoring for side effects during and after intervention
    Time Frame
    up to 3 months after intervention

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosis of stress urinary incontinence sexually active at least one vaginal delivery Exclusion Criteria: pelvic organ prolapse greater than stage I urgency or mixed UI infection previous gynaecologic surgery or irradiation refuse consent

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Non-ablative Er:Yttrium Aluminum Garnet Laser for Stress Urinary Incontinence (SUI)

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