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Clitoral Sensitivity Enhancement With Laser

Not Applicable
Completed
Conditions
Clitoral Hypoesthesia
Decreased Clitoral Sensitivity
Clitoral Atrophy
Registration Number
NCT07152704
Lead Sponsor
Espacio Gaspar Clinic
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
133
Inclusion Criteria
  • above 18 years old and sexually active at least once per month
Exclusion Criteria
  • anorgasmia, 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 other 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Improvement of bothersome symptoms (decreased intensity of clitoral/vaginal response, decreased time of good sexual response, decreased orgasm sensation)Improvement from Baseline at 2 months after last intervention

Evaluation of clitoral sensitivity improvement was performed 2 months after the last treatment session. Patients answered a five-point Likert scale (from 0 to 4) questionnaire.

Secondary Outcome Measures
NameTimeMethod
Patient satisfaction with 5-point Likert scaleEach 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.

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).

Recording of frequency and severity of adverse effects related to laser treatmentFrom Baseline to 2 months after last intervention

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.

Trial Locations

Locations (1)

Uroclinica

🇦🇷

Mendoza, Argentina

Uroclinica
🇦🇷Mendoza, Argentina

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