Erbium Laser for Treatment of Vaginal Laxity.

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04228679

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients with a primary complaint of vaginal laxity 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.

Condition or Disease	Intervention/Treatment	Phase
Sexual Dysfunction	Device: Erbium laser Device: Sham Laser	N/A

Detailed Description

Patients suffering from vaginal laxity 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

The Affect of Erbium Laser Treatments on Vaginal Laxity in Female Pre-menopausal Female Individuals.

Actual Study Start Date :

Apr 1, 2020

Actual Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Erbium laser treatment Women with vaginal laxity treated with real laser.	Device: Erbium laser Erbium laser device
Sham Comparator: Sham laser treatment Women with vaginal laxity treated with sham laser.	Device: Sham Laser Sham laser device

Arm

Intervention/Treatment

Experimental: Erbium laser treatment

Women with vaginal laxity treated with real laser.

Device: Erbium laser

Erbium laser device

Sham Comparator: Sham laser treatment

Women with vaginal laxity treated with sham laser.

Device: Sham Laser

Sham laser device

Outcome Measures

Primary Outcome Measures

Female sexual function index. [From recruitment up to 15 months.]
Changes in the 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.
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.

Secondary Outcome Measures

Pelvic muscle strength. [From recruitment up to 15 months.]
Changes in the pelvic muscle strength scores pre- and post-treatment. Minimal score is 0, maximal score is 15. The higher the score, the higher muscle strength is.
Patient global impression of improvement. [From recruitment up to 15 months.]
Changes in the patient global impression of improvement scores pre- and post-treatment. Minimal score is 1, maximal score is 7. The higher the score, the higher the subjective improvement is.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Premenopausal women.
Women with vaginal laxity as a primary complaint.

Exclusion Criteria:

Vaginal bleeding of unknown source.
Repeated vaginal infections.
Known or suspected cervical pre-malignant neoplasia.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam health care campus	Haifa		Israel

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator: Roy Lauterbach, MD, Rambam healthcare campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ROY LAUTERBACH MD, Principal investigator, Rambam Health Care Campus

ClinicalTrials.gov Identifier:

NCT04228679

Other Study ID Numbers:

0309-19-RMB

First Posted:

Jan 14, 2020

Last Update Posted:

Jan 21, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 21, 2022