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

April 19, 2022 updated by: ROY LAUTERBACH MD, Rambam Health Care Campus

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Haifa, Israel
        • Recruiting
        • Rambam health care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laser treatment
Carbon dioxide laser treatment
Device: Carbon dioxide laser
3 consecutive sessions of carbon dioxide laser treatment
Sham Comparator: Sham treatment
Sham laser treatment
Device: Sham laser treatment
3 consecutive sessions of sham laser treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal health index
Time Frame: From treatment up to 12 months post treatment
Change in total and specific vaginal health index scores
From treatment up to 12 months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Female sexual function index
Time Frame: From treatment up to 12 months post treatment
Change in total and specific female sexual function index questionnaire scores
From treatment up to 12 months post treatment
Sexual intercourse
Time Frame: From treatment up to 12 months post treatment
Change in monthly sexual intercourse rate
From treatment up to 12 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

November 30, 2023

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

October 19, 2021

First Posted (Actual)

October 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 0290-20-RMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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