Erbium Laser for Treatment of Vaginal Looseness and Sexual Dysfunction.

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04228679

Enrollment

106

Registered

2020-01-14

Start date

2020-04-01

Completion date

2022-03-31

Last updated

2023-01-17

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

Conditions

Sexual Dysfunction

Brief summary

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.

Detailed description

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.

Interventions

DEVICEErbium laser

Erbium laser device

DEVICESham Laser

Sham laser device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Female sexual function index.	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

Measure	Time frame	Description
Vaginal health index	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.
Pelvic floor disability index.	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.
Vaginal laxity questionnaire.	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.
Monthly sexual intercourse rate	From recruitment up to 15 months.	Average monthly sexual intercourse rates.

Countries

Israel

Outcome results

None listed

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