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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05097469

Enrollment

120

Registered

2021-10-28

Start date

2021-10-04

Completion date

2023-11-30

Last updated

2022-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual Dysfunction

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.

Interventions

DEVICECarbon dioxide laser

3 consecutive sessions of carbon dioxide laser treatment

DEVICESham laser treatment

3 consecutive sessions of sham laser treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Israel

Contacts

Primary ContactRoy Lauterbach, MD

r_lauterbach@rambam.health.gov.il+972-52-9432416

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026