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

Purpose

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.

Conditions

  • Endometriosis
  • Dyspareunia
  • Pelvic Pain

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Proficient English-speaking females - Pathology proven endometriosis, >6 weeks from prior pelvic surgery - Current dyspareunia

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Transvaginal photobiomodulation
Participants will undergo active transvaginal photobiomodulation therapy per clinic protocol, using the SoLa Pelvic Therapy system. This includes 9 treatments, each lasting about 3-5 minutes. A sterile narrow vaginal probe is inserted into the vagina, the low-level laser is activated, and the probe is slowly moved along the vaginal walls for the indicated period of time, via a surface area power calculation based on the measured vaginal length at the beginning of the procedure. The 9 treatments must be completed in 3-4 weeks. Intervention: Active SoLa Low-level laser therapy
  • Device: Transvaginal photobiomodulation
    Low light laser therapy applied transvaginally using a small vaginal wand with sterile disposable wand covers. The intervention last 3-5 minutes based on a surface area calculation performed at the beginning of the intervention, and involves a gentle in and out motion of the wand to deliver light energy to the muscles of the pelvic floor.
    Other names:
    • SoLa Pelvic Therapy
Sham Comparator
Sham treatment
Participants will undergo sham transvaginal photobiomodulation therapy, following the same protocol as the active arm, without activation of the machine. This includes 9 treatments, lasting 3-5 minutes each. A sterile narrow vaginal probe is inserted into the vagina, the machine is NOT activated, and the inactive probe is slowly moved along the vaginal walls for 3-5 minutes. The 9 treatments must be completed in 3-4 weeks. Intervention: Mock treatment with inactivated probe
  • Device: Sham therapy
    Use of the same vaginal wand as active arm, but without activation of the machine. The intervention last 3-5 minutes, and involves a gentle in and out motion of the wand to massage the muscles of the pelvic floor, without delivery of light therapy.

Recruiting Locations

MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Rebecca Thompson, MD
rebecca.e.thompson@medstar.net

MedStar Georgetown University Hospital
Washington, District of Columbia 20057
Contact:
Rebecca Thompson, MD
rebecca.e.thompson@medstar.net

MedStar Lafayette Center
Washington, District of Columbia 20036
Contact:
Rebecca Thompson, MD
rebecca.e.thompson@medstar.net

MedStar Mitchellville Clinic
Mitchellville, Maryland 20721
Contact:
Rebecca Thompson, MD
rebecca.e.thompson@medstar.net

MedStar Rockville Clinic
Rockville, Maryland 20852
Contact:
Rebecca Thompson, MD
rebecca.e.thompson@medstar.net

MedStar McLean Clinic
McLean, Virginia 22101
Contact:
Rebecca Thompson, MD
rebecca.e.thompson@medstar.net

More Details

Status
Recruiting
Sponsor
Medstar Health Research Institute

Study Contact

Melissa K Gonzales
2028776502
Melissa.K.Gonzales@medstar.net

Detailed 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.