Erbium Laser for Treatment of Vaginal Laxity.
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|ClinicalTrials.gov Identifier: NCT04228679|
Recruitment Status : Not yet recruiting
First Posted : January 14, 2020
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sexual Dysfunction||Device: Erbium laser||Not Applicable|
Patients suffering from vaginal laxity as a primary sexual dysfunction complaint will be recruited, sign an informed consent and will receive a thorough explanation regarding the side effects and possible beneficial affects the laser treatments may bestow.
Patients will undergo a series of 3 laser treatments and the affect of these treatments will be measure both by female sexual function index validated questionaires and by means of gynecological examination-the vaginal health index.
Follow up after treatment cessation will be for 12 months post-treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Affect of Erbium Laser Treatments on Vaginal Laxity in Female Pre-menopausal Female Individuals.|
|Estimated Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||April 1, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Experimental: Erbium laser treatment
Women suffering from vaginal laxity undergoing laser treatments.
Device: Erbium laser
Erbium laser device
- Female sexual function index. [ Time Frame: From recruitment up to 15 months. ]Changes in the female sexual function index scores pre- and post-treatment. Minimal score is 2, maximal score is 36. Thee higher the score, the improved the sexual function is.
- Vaginal health index. [ Time Frame: From recruitment up to 15 months. ]Changes in the vaginal health index scores pre- and post-treatment. Minimal score is 5, maximal score is 25, the higher the score the healthier the vagina is considered to be.
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): NCT04228679
|Contact: Roy Lauterbach, MDemail@example.com|
|Principal Investigator:||Roy Lauterbach, MD||Rambam healthcare campus|