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The purpose of this clinical trial is to evaluate whether non-ablative Er:YAG laser treatment can improve decreased clitoral sensitivity in adult women who report this concern. Effectiveness and safety will be assessed after each laser session and again at a 2-month follow-up visit.
This study is designed to investigate whether non-ablative Er:YAG laser treatment can improve clitoral sensitivity in adult women who report decreased sensitivity. Reduced clitoral sensitivity can negatively impact sexual response, orgasm, and quality of life, yet effective treatment options are limited.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active therapy with non-ablative Er:YAG laser | Experimental | Patients underwent three laser sessions with non-ablative SMOOTH Er:YAG laser, with 20 days interval between sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active therapy with non-ablative Er:YAG laser | Device | three intravaginal and vulvar/clitoral treatments within 60 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of bothersome symptoms (decreased intensity of clitoral/vaginal response, decreased time of good sexual response, decreased orgasm sensation) | Evaluation of clitoral sensitivity change was performed 2 months after the last treatment session. Patients answered a five-point Likert scale (from 0 to 4) questionnaire. | Change from Baseline at 2 months after last intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with 5-point Likert scale | Patients were asked to assess their global satisfaction with the treatment on a 5-point Likert scale (1-Very unsatisfied, 2-Unsatisfied, 3-Neutral, 4-Satisfied, 5-Very satisfied). | Each visit included recording of any adverse effect. Patients were instructed to report and adverse effect that may have occured during the whole duration of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Gaspar, MD | Espacio Gaspar Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uroclinica | Mendoza | Argentina |
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| ID | Term |
|---|---|
| D009948 | Orgasm |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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| Recording of frequency and severity of adverse effects related to laser treatment | Each visit included recording of any adverse effect. Patients were instructed to report and adverse effect that may have occured during the whole duration of the study. | From Baseline to 2 months after last intervention |