Clitoral Sensitivity Enhancement With Laser

NCT07152704 | Completed

• 1 other identifier: CLIT / 01
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Decreased Clitoral Sensitivity

Keywords

non-ablative; Er:YAG laser; clitoral atrophy; hyperstacking; sexual health; orgasm; clitoris

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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.

• Recording of frequency and severity of adverse effects related to laser treatment

  From Baseline to 2 months after last intervention

Study Arms (1)

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

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

Interventions

Active therapy with non-ablative Er:YAG laser DEVICE

three intravaginal and vulvar/clitoral treatments within 60 days

Active therapy with non-ablative Er:YAG laser

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• above 18 years
• sexually active at least once per month

You may not qualify if:

• 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

Sponsors & Collaborators

• Espacio Gaspar Clinic: lead

Study Sites (1)

Uroclinica

Mendoza, Argentina

Location

MeSH Terms

Conditions

Orgasm

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Adrian Gaspar, MD

  Espacio Gaspar Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: March 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)