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

Not Applicable

• Conditions: Sexual Dysfunction
• Interventions: Device: Carbon dioxide laser; Device: Sham laser treatment

• Registration Number: NCT05097469
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-10-04
• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-10-28
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-20
• Primary Completion: 2022-12-31
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser treatment	Carbon dioxide laser	Carbon dioxide laser treatment
Sham treatment	Sham laser treatment	Sham laser treatment

Primary Outcome Measures

Name	Time	Method
Vaginal health index	From treatment up to 12 months post treatment	Change in total and specific vaginal health index scores

Secondary Outcome Measures

Name	Time	Method
Sexual intercourse	From treatment up to 12 months post treatment	Change in monthly sexual intercourse rate
Female sexual function index	From treatment up to 12 months post treatment	Change in total and specific female sexual function index questionnaire scores

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel