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