Clitoral Sensitivity Enhancement With Laser

Espacio Gaspar Clinic

Status: Completed

Conditions: Decreased Clitoral Sensitivity

Treatments: Device: Active therapy with non-ablative Er:YAG laser

Study type: Interventional

Funder types: Other

Identifiers

NCT07152704

CLIT / 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 133 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• above 18 years
• 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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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133 participants in 1 patient group

Active therapy with non-ablative Er:YAG laser

Experimental group

Description:

Patients underwent three laser sessions with non-ablative SMOOTH Er:YAG laser, with 20 days interval between sessions

Treatment:

Device: Active therapy with non-ablative Er:YAG laser