Clitoral Sensitivity Enhancement With Laser
- Conditions
- Clitoral HypoesthesiaDecreased Clitoral SensitivityClitoral 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
- above 18 years old and sexually active at least once per month
- 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
Name Time Method 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
Name Time Method Patient satisfaction with 5-point Likert scale 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. 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 treatment From 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