Photobiomodulation for Chronic Pelvic Pain

(VOICE Trial)

Recruiting at 4 trial locations

Overseen By Pilar Garcia, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: SoLa Pelvic Therapy

Must not be taking: Heat-sensitive, Light-sensitive

Disqualifiers: Cancer history, Autoimmune conditions, Vaginal trauma, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 4 weeks

126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether photobiomodulation, which uses near-infrared laser energy, can reduce chronic pelvic pain in women. Researchers are also assessing if it can alleviate pain during activities like standing, sitting, and urinating. Participants will receive either the actual laser treatment or a sham light therapy without laser energy. Women who have experienced pelvic pain for 3 months or more and find everyday activities significantly uncomfortable might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

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 taking drugs that react to heat or light. It's best to discuss your specific medications with the trial team.

What prior data suggests that photobiomodulation is safe for treating chronic pelvic pain?

Research has shown that light therapy using the SoLá Pelvic Therapy system is generally easy for people to handle. In one study, 60.9% of participants reported little to no pelvic pain after eight treatments. This indicates that the treatment is both effective and safe for most people. Furthermore, previous studies have not identified any major negative effects or harmful side effects, which supports its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic pelvic pain?

Unlike standard treatments for chronic pelvic pain, which often rely on medications like pain relievers and hormone therapy, SoLa Pelvic Therapy uses a unique method called photobiomodulation. This technique involves applying near-infrared light (810-980nm) to the vaginal area, which may offer pain relief by stimulating cellular repair and reducing inflammation without medication. Researchers are excited because this non-invasive approach could provide a new option for patients seeking relief without the side effects associated with traditional drugs. Moreover, the trial includes a sham-light group to rigorously test the effectiveness, adding credibility to any positive outcomes.

What evidence suggests that photobiomodulation is effective for chronic pelvic pain?

Research has shown that SoLá Pelvic Therapy, which uses a special type of light therapy, can significantly reduce chronic pelvic pain. One small study found that 60.9% of participants reported little to no pelvic pain after eight treatments, compared to just 27% at the beginning. This trial will compare the effects of Vaginal photobiomodulation, which uses near-infrared light energy, with a Sham-Light treatment that does not use focused laser energy. The therapy relaxes tight pelvic muscles that often cause pain, and the light energy helps trigger the body's natural healing processes. Early results suggest this method can help reduce pain during activities like standing, sitting, and even during intercourse. ^{1 2 3 4 5}

Who Is on the Research Team?

Georgine Lamvu, MD, MPH

Principal Investigator

SoLá Pelvic Therapy

Are You a Good Fit for This Trial?

This trial is for women experiencing chronic pelvic pain, including discomfort during standing, sitting, urination, bowel movements, and intercourse. Specific eligibility details are not provided.

Inclusion Criteria

My pelvic muscle pain level is 4 or higher.

I have had pelvic pain for more than 3 months.

I have experienced significant pelvic pain in the past week.

Exclusion Criteria

Positive pregnancy test or planning to get pregnant during the study

I have or might have had early-stage cancer in my cervix, vagina, uterus, bladder, or vulva.

I have had laser therapy on my vagina or vulva before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 8 treatments with photobiomodulation or sham, administered twice a week

4 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SoLa Pelvic Therapy

Trial Overview The study tests if 8 sessions of SoLa Pelvic Therapy using near-infrared laser energy can reduce chronic pelvic pain in women.

How Is the Trial Designed?

Group I: Vaginal photobiomodulation Active Control 1 Intervention

Vaginal photobiomodulation with near-infrared (810-980nm wavelength) energy.

Group II: Sham-Light without laser energy. Placebo Group 1 Intervention

Vaginal light therapy without focused laser energy.

SoLa Pelvic Therapy is already approved in United States for the following indications:

Approved in United States as SoLá Pelvic Therapy for:

• Chronic Pelvic Pain
• Myofascial Pelvic Pain

Who Is Running the Clinical Trial?

SoLa Pelvic Therapy

Lead Sponsor

Trials

1

Recruited

130+

Uroshape LLC

Collaborator

Trials

1

Recruited

130+

Published Research Related to This Trial

In a study of 128 women undergoing trans-vaginal photobiomodulation therapy (TV-PBMT) for chronic pelvic pain, 64.5% reported significant improvements in overall pain and pain during various activities after nine treatments.

TV-PBMT was effective in reducing pain levels, achieving a minimal clinically important difference of -2.4 on a 0-10 pain scale, and was associated with no serious adverse events, indicating it is a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An observational cohort study of pelvic floor photobiomodulation for treatment of chronic pelvic pain. Kohli, N., Jarnagin, B., Stoehr, AR., et al.[2021]

In a pilot study involving 13 women with chronic pelvic pain, transvaginal photobiomodulation (TV-PBM) significantly reduced pain levels, with 60% of participants showing improvement after nine treatments.

The mean pain score decreased from 19.7 at baseline to 8.2 at 6 months post-treatment, indicating sustained pain relief, with a high effect size (d = 1.9), suggesting that TV-PBM could be a promising new therapy for chronic pelvic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transvaginal Photobiomodulation for the Treatment of Chronic Pelvic Pain: A Pilot Study. Zipper, R., Pryor, B., Lamvu, G.[2021]

In a preliminary study involving 9 patients with sacroiliac joint pain, low level laser therapy (LLLT) demonstrated significant pain relief in 8 out of 9 participants and improved trunk mobility in 6 patients after 5 weeks of treatment.

The effectiveness of LLLT may be attributed to enhanced blood circulation in the ligaments supporting the sacroiliac joint, activation of pain-inhibiting pathways, and smoothing of joint surfaces, suggesting a promising non-invasive treatment option for this type of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low level laser therapy (LLLT) for patients with sacroiliac joint pain. Ohkuin, I., Ushigome, N., Harada, T., et al.[2021]

In a pilot study involving 34 patients with provoked vestibulodynia (PVD), 78% of those receiving low-level laser therapy (LLLT) reported improvement in pain compared to 44% in the placebo group, indicating potential efficacy of LLLT for this condition.

No side effects were reported during the study, suggesting that LLLT is a safe treatment option; however, the study's small sample size and lack of improvement in other measurable outcomes highlight the need for larger trials to better understand its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia-A Randomized, Placebo-Controlled Pilot Trial. Lev-Sagie, A., Kopitman, A., Brzezinski, A.[2018]

Vaginal laser therapy is used to treat various gynecologic and pelvic conditions, such as vaginal atrophy and urinary incontinence, despite ongoing controversy regarding its efficacy and safety.

The commentary highlights the critical difference between ablative and non-ablative lasers, emphasizing the need for healthcare professionals to understand these distinctions before incorporating this technology into their practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal laser therapy for gynecologic conditions: re-examining the controversy and where do we go from here. Zipper, R., Lamvu, G.[2022]

In a pilot study involving 30 postmenopausal women with superficial dyspareunia, both treatment groups showed significant improvement in symptoms, indicating the effectiveness of laser therapy for this condition.

The group receiving combined treatment with Nd:YAG and vaginal erbium laser experienced greater and more sustained relief from dyspareunia compared to those receiving only the erbium laser, suggesting that the combination therapy may be more beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effects of an erbium/neodymium laser combination in superficial dyspareunia: a pilot study. Gambacciani, M., Fidecicchi, T.[2022]

Low level laser therapy (LLLT) effectively promotes tissue repair and reduces inflammation, making it a valuable tool for enhancing wound healing.

LLLT works by regulating cell behavior through light, influencing cell proliferation and the release of bioactive substances, which contributes to its therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Advancement in the research of effect of low level laser therapy on wound healing]. Mao, HS., Yao, M., Fang, Y.[2015]

Low-level laser therapy (LLLT) effectively reduces pain and promotes healing by using coherent light in the 600 to 1000 nm wavelength range, which triggers biochemical changes in cells and has been supported by numerous clinical and experimental studies.

LLLT has shown significant analgesic and anti-inflammatory effects, making it a promising complementary treatment option for managing symptoms in patients with osteoarthritis and chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Literature on Low-level Laser Therapy Benefits for Nonpharmacological Pain Control in Chronic Pain and Osteoarthritis. Dima, R., Tieppo Francio, V., Towery, C., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06673108

Vaginal Photobiomodulation for Chronic Pelvic Pain The goal of this clinical study is to determine if 8 treatments with photobiomodulation using near-infrared laser energy can help reduce chronic pelvic pain ...

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

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

3. solapelvictherapyprovider.com solapelvictherapyprovider.com/

Provider SoLá Pelvic Therapy has been developed to address hypertonic pelvic muscles found in up to 85% of patients whose CPP. The hypertonic pelvic floor is identified ...

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

SoLá Pelvic Therapy: A novel photobiomodulation ... Additionally, 60.9% of the cohort reported minimal or no overall pelvic pain at the end of 8 treatments compared with 27.0% at baseline, ...

5. solapelvictherapy.com solapelvictherapy.com/the-data/

The Data - SoLá Pelvic Therapy With SoLá Pelvic Therapy, you're empowering your own body to break the pain cycle with a safe, proven light energy to activate healing within your cells.