Low-Level Laser Therapy for Endometriosis

No longer recruiting at 8 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for women with endometriosis who experience painful intercourse. It compares real low-level laser therapy, known as transvaginal photobiomodulation, to a placebo to determine if the real treatment reduces pain and improves sexual satisfaction. Participants will undergo nine treatment sessions over 3-4 weeks. Women diagnosed with endometriosis and experiencing pain during sex may be suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for endometriosis-related pain.

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.

What prior data suggests that transvaginal photobiomodulation is safe for treating endometriosis?

Research has shown that transvaginal photobiomodulation, a therapy using light, is generally considered safe. One study found that many women experienced significant pain relief with this treatment, and no major safety issues were reported. In fact, over 1.5 million of these light therapy procedures occur every month, suggesting patients tolerate it well. While more research is needed to confirm these findings, current evidence supports its safety for use in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for endometriosis—such as hormonal therapies and surgical interventions—transvaginal photobiomodulation offers a non-invasive approach that uses low-level laser therapy to target pain and inflammation. Researchers are excited about this treatment because it potentially provides relief without the side effects often associated with hormones or the recovery time required after surgery. This innovative method can be applied directly to the affected area, potentially offering faster and more localized symptom relief.

What evidence suggests that transvaginal photobiomodulation might be an effective treatment for dyspareunia in women with endometriosis?

This trial will compare transvaginal photobiomodulation, also known as low-level laser therapy, with a sham treatment to evaluate its effectiveness in reducing pelvic pain in women with endometriosis. Research has shown that this special type of light therapy can help reduce pelvic pain. In one study, women who used the SoLá Pelvic Therapy System reported a significant drop in their pelvic pain. Another study found that this light therapy provided more pain relief than physical therapy or fake treatments. This therapy likely works by relaxing tight pelvic muscles, which often cause pain. Early results suggest it could be a promising option for those experiencing painful intercourse due to endometriosis. ^{1 2 3 4 6}

Who Is on the Research Team?

James Robinson, MD

Principal Investigator

Medstar Health Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8617585/

Transvaginal Photobiomodulation for the Treatment of Chronic ... Transvaginal PBM administered with the SoLá Pelvic Therapy System significantly reduced pelvic pain in this pilot study population. This effect ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05540353

Transvaginal Low-level Laser Therapy to Improve Pelvic ... Women with endometriosis have a nine-fold increased risk of dyspareunia, when compared to the general female population. A prospective single-blinded randomized ...

3. becarispublishing.com becarispublishing.com/doi/10.2217/cer-2021-0187

An observational cohort study of pelvic floor ... This research is the first to evaluate the effectiveness of trans-vaginal photobiomodulation therapy (TV-PBMT) for chronic pelvic pain.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0090429522007816

Transvaginal Photobiomodulation Improves Pain in ... TV-PBM treatment was able to achieve pain relief in a higher percentage of patients when compared to published results of pelvic PT or placebo and has the ...

5. contemporaryobgyn.net contemporaryobgyn.net/view/sol-pelvic-therapy-a-novel-photobiomodulation-therapy-for-treatment-of-myofascial-pelvic-pain

SoLá Pelvic Therapy: A novel photobiomodulation ... Recent studies suggest that up to 85% of women with CPP have a component of hypertonic pelvic floor dysfunction also known as myofascial pain.

6. researchgate.net researchgate.net/publication/356486680_Transvaginal_Photobiomodulation_for_the_Treatment_of_Chronic_Pelvic_Pain_A_Pilot_Study

Transvaginal Photobiomodulation for the Treatment of ... Of 93 eligible participants, 65% showed clinically significant improvement in pelvic pain and pain with sitting, standing, urination, defecation ...