NCT04228679

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

January 12, 2020

Last Update Submit

January 12, 2023

Conditions

Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Female sexual function index.

    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.

    From recruitment up to 15 months.

Secondary Outcomes (4)

  • Vaginal health index

    From recruitment up to 15 months.

  • Pelvic floor disability index.

    From recruitment up to 15 months.

  • Vaginal laxity questionnaire.

    From recruitment up to 15 months.

  • Monthly sexual intercourse rate

    From recruitment up to 15 months.

Study Arms (2)

Erbium laser treatment

EXPERIMENTAL

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

Device: Erbium laser

Sham laser treatment

SHAM COMPARATOR

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

Device: Sham Laser

Interventions

Erbium laserDEVICE

Erbium laser device

Erbium laser treatment
Sham LaserDEVICE

Sham laser device

Sham laser treatment

Eligibility Criteria

Age30 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Roy Lauterbach, MD

    Rambam healthcare campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 12, 2020

First Posted

January 14, 2020

Study Start

April 1, 2020

Primary Completion

January 1, 2022

Study Completion

March 31, 2022

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)