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

Last updated: April 19, 2022
Sponsor: Rambam Health Care Campus
Overall Status: Active - Recruiting

Phase

N/A

Condition

Impotence

Sexual Dysfunction

Erectile Dysfunction

Treatment

N/A

Clinical Study ID

NCT05097469
0290-20-RMB
  • Ages 30-70
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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 studycompliance.
  • Any vaginal bleeding of unknown reason.

Study Design

Total Participants: 120
Study Start date:
October 04, 2021
Estimated Completion Date:
November 30, 2023

Study 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.

Connect with a study center

  • Rambam health care campus

    Haifa,
    Israel

    Active - Recruiting

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