Er:YAG Laser Treatment for Female Stress and Mixed Urinary Incontinence (IncontiLase)
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|ClinicalTrials.gov Identifier: NCT02418299|
Recruitment Status : Completed
First Posted : April 16, 2015
Last Update Posted : April 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Female Stress Urinary Incontinence Mixed Incontinence, Urge and Stress||Device: IncontiLase Er:YAG laser treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||175 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Single Centre Study of Er:YAG Laser Treatment for Female Stress and Mixed Urinary Incontinence (IncontiLase)|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Experimental: IncontiLase Er:YAG laser treatment
Er:YAG laser treatment for stress and mixed urinary incontinence
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)
Other Name: IncontiLase
- 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 ]
- VAS index for the assessment of pain [ Time Frame: at baat baseline and 2, 6 and 12 months after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02418299
|Principal Investigator:||Urška Bizjak-Ogrinc, Dr||Juna d.o.o.|