Transvaginal Low-level Laser Therapy to Improve Pelvic Pain and Sexual Function in Patients with Endometriosis.

Last updated: February 17, 2025
Sponsor: Medstar Health Research Institute
Overall Status: Terminated

Phase

N/A

Condition

Endometriosis

Dysmenorrhea (Painful Periods)

Treatment

Transvaginal photobiomodulation

Sham therapy

Clinical Study ID

NCT05540353
STUDY00005330
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

Dyspareunia is defined as pain with penetrative sexual intercourse. Women with endometriosis have a nine-fold increased risk of dyspareunia, when compared to the general female population.

A prospective single-blinded randomized controlled trial will be performed evaluating the change in pelvic pain and sexual satisfaction scores from baseline to 6 weeks after treatment with transvaginal photobiomodulation therapy or sham therapy. Treatment will involve 9 planned treatment sessions over 3-4 weeks. 40 women will be included in the study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Proficient English-speaking females

  • Pathology proven endometriosis, >6 weeks from prior pelvic surgery

  • Current dyspareunia

Exclusion

Exclusion Criteria:

  • Unable to comply with study protocol

  • Pregnant or attempting to become pregnant

  • History of or active treatment for pelvic malignancy

  • Currently taking light-sensitizing drugs

Study Design

Total Participants: 6
Treatment Group(s): 2
Primary Treatment: Transvaginal photobiomodulation
Phase:
Study Start date:
May 02, 2023
Estimated Completion Date:
July 01, 2024

Study Description

Active intervention: Transvaginal photobiomodulation (TV-PBM) Control intervention: Sham transvaginal probe

All subjects will complete 9 treatments over 3-4 weeks and all treatments will be performed with a sheet over the patient's pelvic area to prevent the subject from seeing the probe light, as well as a screen blocking the patient's view of the machine. Subjects randomized to active therapy will undergo TV-PBM treatment during each session per standard TV-PBM treatment protocol. Subjects randomized to sham will undergo blinded sham therapy using an identical probe but without photobiomodulation. Sham therapy will involve the same regimen as the active arm but with the machine turned off. Instead, there will be a recording of the usual noise of the machine to mimic the activation that occurs when stepping on the pedal with the machine on for TV-PBM treatment.

Connect with a study center

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20057
    United States

    Site Not Available

  • MedStar Lafayette Center

    Washington, District of Columbia 20036
    United States

    Site Not Available

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • MedStar Mitchellville Clinic

    Mitchellville, Maryland 20721
    United States

    Site Not Available

  • MedStar Rockville Clinic

    Rockville, Maryland 20852
    United States

    Site Not Available

  • MedStar McLean Clinic

    McLean, Virginia 22101
    United States

    Site Not Available

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