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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
Sponsor:
Information provided by (Responsible Party):
Juna d.o.o.

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.

Condition or disease Intervention/treatment Phase
Female Stress Urinary Incontinence Mixed Incontinence, Urge and Stress Device: IncontiLase Er:YAG laser treatment Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Measures :
  1. VAS index for the assessment of pain [ Time Frame: at baat baseline and 2, 6 and 12 months after treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Juna d.o.o.
Investigators
Principal Investigator: Urška Bizjak-Ogrinc, Dr Juna d.o.o.

Additional Information:
Responsible Party: Juna d.o.o.
ClinicalTrials.gov Identifier: NCT02418299     History of Changes
Other Study ID Numbers: J013
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015

Keywords provided by Juna d.o.o.:
urinary incontinence
Er:YAG laser

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders