Low-Level Laser Therapy for Endometriosis
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.12345
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.12346
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive transvaginal photobiomodulation therapy or sham therapy over 9 sessions
Follow-up
Participants are monitored for changes in pelvic pain and sexual satisfaction scores
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?
2
Treatment groups
Active Control
Placebo Group
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
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medstar Health Research Institute
Lead Sponsor
Patty Brisben Foundation For Women's Sexual Health
Collaborator
Published Research Related to This Trial
Citations
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 ...
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 ...
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.
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-painSoLá 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_StudyTransvaginal Photobiomodulation for the Treatment of ...
Of 93 eligible participants, 65% showed clinically significant improvement in pelvic pain and pain with sitting, standing, urination, defecation ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.