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The Effect of Additional Laser Treatments.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111952
Recruitment Status : Completed
First Posted : October 2, 2019
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
ROY LAUTERBACH MD, Rambam Health Care Campus

Brief Summary:
Women previously treated with vaginal CO2 laser (a sum of 3 treatments) will receive either a fourth treatment 6 months after cessation of previous laser treatment or a sham laser treatment. The efficacy and safety of the additional treatment will be assessed.

Condition or disease Intervention/treatment Phase
Lax Vaginal Introitus Device: CO2 laser Device: Sham laser Not Applicable

Detailed Description:
The following study is intended to evaluate the efficacy and safety of an additional 4th laser treatment for women previously treated for gynecological indications with 3 consecutive laser treatments. Women will be randomized to one of 2 groups: 1. Study group-additional single laser treatment. 2. Control group-single sham laser treatment. All women will fill out validated questionnaires regarding sexual function, urinary stress incontinence and satisfaction after treatment. All women will be followed for an additional 6 months to evaluate the length of effect.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of an Additional Vaginal Laser Treatment in Women Previously Treated With Laser for Gynecological Indications.
Actual Study Start Date : November 1, 2019
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : August 31, 2020

Arm Intervention/treatment
Experimental: Additional laser treatment
Women receiving a single laser treatment.
Device: CO2 laser
A single session of CO2 vaginal laser treatment

Sham Comparator: Sham laser treatment
Women receiving sham laser treatment.
Device: Sham laser
A single session of sham laser treatment.




Primary Outcome Measures :
  1. Length of effect [ Time Frame: From the treatment session up to 6 months post-treatment ]
    The duration of symptom improvement.


Secondary Outcome Measures :
  1. Female sexual function index [ Time Frame: From the treatment session up to 6 months post-treatment ]
    Changes in the female sexual function index questionnaire score (range 0-35)

  2. Sexual intercourse [ Time Frame: From the treatment session up to 6 months post-treatment ]
    Improvement in the monthly rate of sexual intercourse

  3. Urinary distress index [ Time Frame: From the treatment session up to 6 months post-treatment ]
    Changes in the urinary distress index questionnaire score (range 0-15)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously treated with 3 laser treatments.
  • Clear PAP test from the last 3 years.

Exclusion Criteria:

  • Vaginal bleeding of unknown source.
  • Vaginal surgery in the past 9 months.

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): NCT04111952


Locations
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Israel
Rambam health care campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Roy Lauterbach, MD Rambam Health Care Campus
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Responsible Party: ROY LAUTERBACH MD, Principal Investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT04111952    
Other Study ID Numbers: 0349-19-RMB
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No