Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
133 participants
INTERVENTIONAL
2022-03-01
2022-12-31
Brief Summary
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Detailed Description
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The primary goal of this clinical trial is to determine the effectiveness and safety of non-ablative Er:YAG laser treatment for women experiencing decreased clitoral sensitivity. Specifically, the study aims to assess:
The degree to which laser treatment enhances vaginal and clitoral sexual response, the time required to achieve noticeable improvements in sexual response, the impact of treatment on orgasmic function and patient satisfaction with the treatment process and outcomes.
Participants will undergo three laser treatment sessions, with evaluations conducted at a 2-month follow-up. Both effectiveness (improvements in sexual response and satisfaction) and safety outcomes will be carefully monitored.
By exploring this minimally-invasive therapeutic option, the study seeks to provide new insights into the management of decreased clitoral sensitivity and to help identify safe and effective approaches for improving sexual health in women.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active therapy with non-ablative Er:YAG laser
Patients underwent three laser sessions with non-ablative SMOOTH Er:YAG laser, with 20 days interval between sessions
Active therapy with non-ablative Er:YAG laser
three intravaginal and vulvar/clitoral treatments within 60 days
Interventions
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Active therapy with non-ablative Er:YAG laser
three intravaginal and vulvar/clitoral treatments within 60 days
Eligibility Criteria
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Inclusion Criteria
* sexually active at least once per month
Exclusion Criteria
* pregnancy
* urinary tract infections
* genital infectious diseases of other etiology (HPV, molluscum contagiosum, syphilis, HIV, etc.)
* genital bleeding
* collagenopathies
* ongoing chemotherapy
* active genital cancer
* patients undergoing pelvic radiotherapy
* any genital or extragenital pathology that may interfere with treatment
* patients who have limitations in performing a follow-up to this study
* patients with psychiatric disorders that may be difficult to treat
* patients who have a contraindication to vaginal laser treatments
18 Years
FEMALE
No
Sponsors
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Espacio Gaspar Clinic
OTHER
Responsible Party
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Adrian Gaspar
Principal Investigator
Principal Investigators
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Adrian Gaspar, MD
Role: PRINCIPAL_INVESTIGATOR
Espacio Gaspar Clinic
Locations
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Uroclinica
Mendoza, , Argentina
Countries
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Other Identifiers
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CLIT / 01
Identifier Type: -
Identifier Source: org_study_id
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