Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Sexual Dysfunction.

Sexual Dysfunction Clinical Trial

Official title:

Randomized, Double-blind, Sham-controlled Clinical Trial for Evaluating the Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Female Sexual Dysfunction.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05097469
• Other study ID #: 0290-20-RMB
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: April 2022
• Source: Rambam Health Care Campus
• Contact: Roy Lauterbach, MD
• Phone: +972-52-9432416
• Email: r_lauterbach[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with sexual dysfunction. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.

Description:

Following a screening visit, eligible subjects will be enrolled into the study. Subjects will be randomized into either laser treatment or sham treatment. Each subject will receive 3 treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last treatment. Further demographic information and patient history will be obtained from the subjects' electronic files.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Negative urine analysis.
• Normal Pap smear test from the recent 3 years.
• No previous gynecological laser treatments.
• Able and willing to comply with the treatment/follow-up schedule and requirements.

Exclusion Criteria:

• Active genital infection.
• Subject presenting abnormal Pap result from the last three years.
• Recurring urinary tract infection or recurring infection of genital herpes or candida (> 2 episodes in the recent year).
• Transvaginal mesh implant.
• Serious systemic disease or any chronic condition that could interfere with study compliance.
• Any vaginal bleeding of unknown reason.

Related Conditions & MeSH terms

• Sexual Dysfunction

Intervention

Device:
• Carbon dioxide laser
3 consecutive sessions of carbon dioxide laser treatment
• Sham laser treatment
3 consecutive sessions of sham laser treatment

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal health index	Change in total and specific vaginal health index scores	From treatment up to 12 months post treatment
Secondary	Female sexual function index	Change in total and specific female sexual function index questionnaire scores	From treatment up to 12 months post treatment
Secondary	Sexual intercourse	Change in monthly sexual intercourse rate	From treatment up to 12 months post treatment