Erbium Laser for Treatment of Vaginal Looseness and Sexual Dysfunction.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2022-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Sexual Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Erbium laser treatment

Women with vaginal looseness and sexual dysfunction treated with real laser.

Group Type EXPERIMENTAL

Erbium laser

Intervention Type DEVICE

Erbium laser device

Sham laser treatment

Women with vaginal looseness and sexual dysfunction treated with sham laser.

Group Type SHAM_COMPARATOR

Sham Laser

Intervention Type DEVICE

Sham laser device

Interventions

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Erbium laser

Erbium laser device

Intervention Type DEVICE

Sham Laser

Sham laser device

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No