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Photobiomodulation

Low-Level Laser Therapy for Endometriosis

N/A
Recruiting
Led By James Robinson, MD
Research Sponsored by Medstar Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Proficient English-speaking females
Current dyspareunia
Must not have
Currently taking light-sensitizing drugs
History of or active treatment for pelvic malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the specific side effects are not detailed here, similar therapies may cause mild discomfort or irritation at the application site. Since this is a low-level laser therapy, risks tend to be lower compared to invasive procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman who speaks English fluently.
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I experience pain during intercourse.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on medication that increases my sensitivity to light.
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I have had or am being treated for cancer in my pelvic area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean change in pelvic pain
Secondary study objectives
Change in Female Sexual Function Index (FSFI) scores
Change in Short Form-McGill Pain Questionnaire (SF-MPQ)
Change in clinic pain scores
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Transvaginal photobiomodulationActive Control1 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 treatmentPlacebo Group1 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for endometriosis include hormonal therapies, surgical interventions, and emerging treatments like photobiomodulation therapy. Hormonal therapies, such as GnRH agonists and progestins, work by suppressing ovarian hormone production, thereby reducing endometrial tissue growth and alleviating pain. Surgical options, including laparoscopic excision or ablation, aim to remove or destroy endometrial lesions, providing symptom relief and improving fertility. Emerging treatments like transvaginal photobiomodulation therapy use light to reduce inflammation and promote tissue healing, offering a non-invasive option to manage pain and improve quality of life. These treatments are crucial for endometriosis patients as they target the underlying mechanisms of the disease, providing symptom relief and improving overall well-being.
Assessment of ovarian reserve after cystectomy versus 'one-step' laser vaporization in the treatment of ovarian endometrioma: a small randomized clinical trial.Effect of Pulsed High-Intensity Laser Therapy on Pain, Adhesions, and Quality of Life in Women Having Endometriosis: A Randomized Controlled Trial.Co-operation between the AKT and ERK signaling pathways may support growth of deep endometriosis in a fibrotic microenvironment in vitro.

Find a Location

Who is running the clinical trial?

Medstar Health Research InstituteLead Sponsor
196 Previous Clinical Trials
185,939 Total Patients Enrolled
Patty Brisben Foundation For Women's Sexual HealthOTHER
6 Previous Clinical Trials
355 Total Patients Enrolled
James Robinson, MDPrincipal InvestigatorMedstar Washington Hospital Center
1 Previous Clinical Trials
300 Total Patients Enrolled

Media Library

Transvaginal photobiomodulation (Photobiomodulation) Clinical Trial Eligibility Overview. Trial Name: NCT05540353 — N/A
Transvaginal photobiomodulation (Photobiomodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05540353 — N/A
Endometriosis Research Study Groups: Sham treatment, Transvaginal photobiomodulation
Endometriosis Clinical Trial 2023: Transvaginal photobiomodulation Highlights & Side Effects. Trial Name: NCT05540353 — N/A
~15 spots leftby Dec 2025