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OpenTrials
Completed

NCT Number: NCT04228679

Erbium Laser for Treatment of Vaginal Looseness and Sexual Dysfunction.

Patients with a primary complaint of vaginal looseness and sexual dysfunction, visiting a sexual dysfunction clinic at a tertiary medical center will undergo randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated questionaires and by means of gynecological examination.

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Key information

Conditions

Sexual Dysfunction Genital Diseases Sexual Dysfunction, Physiological Urogenital Diseases

Age range

30 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rambam health care campus

Haifa, Israel

About this study

Patients suffering from vaginal looseness and sexual dysfunction, as a primary sexual dysfunction complaint will be recruited, sign an informed consent and will receive a thorough explanation regarding the side effects and possible beneficial affects the laser treatments may bestow.

Patients will undergo randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated questionaires and by means of gynecological examination.

Follow up after treatment cessation will be for 12 months post-treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premenopausal women.
  • Women with vaginal looseness and sexual dysfunction as a primary complaint.

Exclusion criteria

  • Vaginal bleeding of unknown source.
  • Repeated vaginal infections.
  • Known or suspected cervical pre-malignant neoplasia.
  • Previous treatment with vaginal laser or other forms of energy-based treatment modalities.
  • Pregnancy.
  • Current pelvic inflammatory disease or urinary tract infection.
  • Vaginal surgery during the year preceding study participation.
  • Treatment with systemic or vaginal hormone replacement therapy.
  • Current pelvic floor physiotherapy.

Treatment and study plan

Erbium laser

Device

Erbium laser device

sham laser

Device

Sham laser device

Primary outcomes

  1. Female sexual function index.

    Time frame: From recruitment up to 15 months.

    Female sexual function index scores pre- and post-treatment. Minimal score is 2, maximal score is 36. Thee higher the score, the improved the sexual function is.

Secondary outcomes

  1. Vaginal health index

    Time frame: From recruitment up to 15 months.

    Vaginal health index score. The total VHI scores range between 5 and 25. A higher score indicates increased vaginal health.

  2. Pelvic floor disability index.

    Time frame: From recruitment up to 15 months.

    Changes in the pelvic floor disability index scores pre- and post-treatment. Minimal score is 0, maximal score is 300. The higher the score, the improved the worse pelvic floor dysfunction is.

  3. Vaginal laxity questionnaire.

    Time frame: From recruitment up to 15 months.

    Changes in the vaginal laxity questionnaire scores pre- and post-treatment. Minimal score is 1, maximal score is 7. The lower the score, the worse vaginal laxity is.

  4. Monthly sexual intercourse rate

    Time frame: From recruitment up to 15 months.

    Average monthly sexual intercourse rates.

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

The Affect of Erbium Laser Treatments on Vaginal Looseness and Sexual Dysfunction in Pre-menopausal Female Individuals.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 14, 2020
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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