The Effect of Additional Laser Treatments.
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|ClinicalTrials.gov Identifier: NCT04111952|
Recruitment Status : Completed
First Posted : October 2, 2019
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lax Vaginal Introitus||Device: CO2 laser Device: Sham laser||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- Length of effect [ Time Frame: From the treatment session up to 6 months post-treatment ]The duration of symptom improvement.
- 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)
- Sexual intercourse [ Time Frame: From the treatment session up to 6 months post-treatment ]Improvement in the monthly rate of sexual intercourse
- 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)
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
|Rambam health care campus|
|Principal Investigator:||Roy Lauterbach, MD||Rambam Health Care Campus|