What side effects are associated with this type of intervention?

Common treatments for endometriosis include hormonal therapies such as estrogen-progestin contraceptives, GnRH agonists and antagonists, and progestins like dienogest. These treatments can have side effects such as weight gain, mood changes, decreased bone density, and hot flashes. Surgical options, including laparoscopy and cystectomy, may lead to complications like infection, bleeding, and damage to surrounding organs. Light-based therapies, such as pulsed high-intensity laser therapy, have shown effectiveness in reducing pain and adhesions with minimal side effects, primarily limited to mild discomfort during treatment. Transvaginal Photobiomodulation Therapy, which is still under investigation, aims to reduce inflammation and promote tissue healing with potentially fewer side effects compared to more invasive treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for endometriosis, primarily focusing on hormonal therapies to manage pain and reduce lesion size. These include gonadotropin-releasing hormone (GnRH) agonists and antagonists, such as leuprolide and elagolix, which suppress ovarian hormone production. Additionally, oral contraceptives and progestins like dienogest are commonly used. While Transvaginal Photobiomodulation Therapy, which uses light to reduce inflammation and promote tissue healing, is a novel approach, it is not yet FDA-approved for endometriosis. Current FDA-approved treatments do not include light-based therapies, but ongoing research may expand future options.

What other types of research exist?

Promising novel alternatives to Transvaginal Photobiomodulation Therapy for endometriosis patients include: 1) Low-dose oral contraceptives or progestins, which help regulate menstrual cycles and reduce endometrial growth. 2) Gonadotropin-releasing hormone (GnRH) antagonists, which lower estrogen levels and reduce endometrial tissue. 3) Aromatase inhibitors, which decrease estrogen production and are often used in combination with other hormonal therapies. 4) Laparoscopic surgery, which can remove or destroy endometrial tissue and adhesions. 5) Immunomodulatory treatments, which target the immune response involved in endometriosis. Patients should discuss these options with their healthcare provider to determine the best course of action based on their individual condition and treatment response.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.

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

0 / 4Eligibility criteria met

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.