Low-Level Laser Therapy for Endometriosis

Recruiting at 5 trial locations

Overseen By Melissa K Gonzales

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Medstar Health Research Institute

Must not be taking: Light-sensitizing drugs

Disqualifiers: Pregnancy, Pelvic malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 3-4 weeks

6 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking light-sensitizing drugs.

How does transvaginal photobiomodulation differ from other treatments for endometriosis?

Transvaginal photobiomodulation is unique because it uses low-level laser therapy applied through the vaginal route to target endometriosis, which is different from traditional surgical or drug treatments. This method aims to reduce pain and inflammation by stimulating cellular processes without the need for incisions or systemic medication. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial tests if light therapy inside the vaginal area can help women with endometriosis who have pain during sex. The light is believed to heal tissues and reduce pain by improving blood flow and reducing inflammation.

Research Team

James Robinson, MD

Principal Investigator

Medstar Health Research Institute

Eligibility Criteria

This trial is for English-speaking women with confirmed endometriosis experiencing pain during intercourse, who are more than 6 weeks post any pelvic surgery. It's not suitable for those pregnant or trying to conceive, with a history of pelvic cancer, under treatment for such cancers, or taking drugs that increase light sensitivity.

Inclusion Criteria

I experience pain during intercourse.

I have a confirmed diagnosis of endometriosis and it's been over 6 weeks since my last pelvic surgery.

Exclusion Criteria

I am currently on medication that increases my sensitivity to light.

I have had or am being treated for cancer in my pelvic area.

Unable to comply with study protocol

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transvaginal photobiomodulation therapy or sham therapy over 9 sessions

3-4 weeks

9 visits (in-person)

Follow-up

Participants are monitored for changes in pelvic pain and sexual satisfaction scores

6 weeks

3 visits (in-person)

Treatment Details

Interventions

• Sham therapy
• Transvaginal photobiomodulation

Trial Overview The study tests transvaginal photobiomodulation therapy—a type of low-level laser treatment—against sham (placebo) therapy to see if it reduces pelvic pain and improves sexual satisfaction in endometriosis patients. Participants will undergo 9 sessions over 3-4 weeks.

Participant Groups

Group I: Transvaginal photobiomodulation Active Control 1 Intervention

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

Group II: Sham treatment Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials

202

Recruited

187,000+

Patty Brisben Foundation For Women's Sexual Health

Collaborator

Trials

7

Recruited

360+

Findings from Research

The argon laser effectively ablated endometrial implants in a study involving five rabbits, demonstrating its potential as a treatment for endometriosis.

Histological analysis showed complete removal of the endometriosis with minimal damage (only 0.25 mm) to the surrounding tissue, suggesting a safer option compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of the argon laser in the treatment of experimental endometriosis. Keye, WR., Matson, GA., Dixon, J.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

The use of the argon laser in the treatment of experimental endometriosis. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of rabbit endometrial transplants: a model for treatment of endometriosis. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Ablation of endometriotic implants in rabbits by hematoporphyrin derivative photoradiation therapy using the gold vapor laser. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, and moderate endometriosis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Impact on ovarian reserve and fertility using carbon dioxide laser for endometriosis treatment: a systematic review. [2022]