Why SoLá Pelvic Therapy
Chronic pelvic pain affects up to 24% of women worldwide and about 15% in the U.S., yet care is often split across gynecology, urology, gastroenterology, and primary care with limited effective treatment options.
01
The Shared Driver
Whether the diagnosis is endometriosis, interstitial cystitis, irritable bowel syndrome, pudendal neuralgia or other as many as 90% of women with pelvic pain also have tender, dysfunctional pelvic muscles that feed pain sensitization.
02
The Mechanism
Near-infrared photobiomodulation is thought to boost mitochondrial ATP, release nitric oxide, increase perfusion, and relax hypertonic muscle. The challenge has always been reaching muscles deep in the pelvis.
03
The Delivery
SoLá delivers non-ablative near-infrared energy transvaginally. The patented SoLá method allows clinicians to deliver the energy to deep pelvic structures, overcoming the anatomic barriers to treatment of CPP. Automated dosing facilitates simple office based treatments.
SoLá Pelvic Therapy is a promising new treatment currently being studied for chronic pelvic pain. SoLá is an innovative, gentle therapy that uses near-infrared laser energy (photobiomodulation) applied internally to target pelvic pain. Our mission is to connect scientific research with real relief for patients. To date, we have tracked outcomes from more than 10,000 SoLá treatments and tested the therapy in a rigorous clinical trial across multiple medical centers.
Please note: SoLá is an investigational therapy that has not yet received FDA clearance to treat chronic pelvic pain or other conditions. Today, it is available exclusively through an approved clinical registry at select clinics across the United States.
THE VOICE RANDOMIZED CONTROLLED TRIAL (RCT)
A quadruple-masked, sham-controlled trial of 119 women in 11 U.S. clinics, with an average of 7.5 years of moderate-to-severe pain (NCT06673108).
• 66.1% vs 45.0% reached clinically meaningful relief (≥2-point reduction) at 3 months (P=.02)
• 45.8% vs 21.7% reported no or mild pain at 3 months (P=.02)
• 49.2% vs 18.3% reached a ≥3-point reduction (P=.01)
We hold ourselves to the highest standards
REAL-WORLD EVIDENCE (RWE)
RWE studies confirm the VOICE RCT results. Compared with baseline, 64.5% of women showed improvement in overall pain, pain with bowel movement, intercourse, exercise, urination, sitting and vulvar pain. These results were reported even in women with chronic pelvic pain due to conditions like endometriosis, bladder pain syndrome, and irritable bowel syndrome.
SAFETY PROFILE
Zero serious SoLá Pelvic Therapy related adverse events were reported in our clinical studies. The treatment is minimally invasive, painless, and has been designated as Non-Significant Risk by the Institutional Review Board (IRB) that oversees research. The VOICE RCT showed that 8/10 women who received SoLá were 'satisfied' or 'very satisfied' after treatment with 93% protocol adherence.
Specifications
Utilizing advanced, proprietary laser technology and patented therapeutic methods to deliver targeted care for chronic pelvic pain relief.
- Class IV 15W 810nm and 980 nm laser
- Non-Ablative non-thermal mechanism of action
- Touch Screen Interface
- Collects and displays graphics of patient's symptomatic progress.
- 360 degree red-light array
- 2-cm diameter disposable finger-sized wand.
Latest News & Updates
Stay informed with the latest clinical evidence, RWE findings, and expert insights from our team of pelvic health specialists.
Frequently Asked Questions
Is photobiomodulation safe for all women?
Our treatments are designed to be safe and non-invasive. We use low-level laser therapy that has been extensively studied for its safety profile in clinical settings. Learn More
How does the treatment work?
Photobiomodulation works by stimulating cellular activity. The low-level light energy is absorbed by mitochondria, leading to increased ATP production, Nitric Oxide release, muscle relaxation, improved blood flow and reduced inflammation. Learn More
What are the expected results?
Results vary depending on individual factors, but many patients report improved pelvic floor function and reduced discomfort within the first few treatments. In the VOICE randomized controlled trial, nearly 50 percent of women achieved a level of either no-pain or mild pain. The majority of patients experienced improvement. Learn More
Are there any side effects?
Photobiomodulation is generally well-tolerated. The single-use disposable wand has a 2 cm diameter and is approximately the size of a single finger. In the VOICE randomized controlled trial, there was a 1.7% incidence of increased pelvic muscle spasm. There was a 3.3% incidence of increased urgency of urination.
How many sessions are needed?
The standard protocol involves 1-2 treatments per week for a total of 8 treatments. Most patients begin to see results after 3-5 treatments.
How long does a treatment take?
Although the actual active laser time is typically 2-4 minutes, you should plan on 15-20 minutes as you will be inputting pain scores into the user interface and reviewing the computer generated graphics of pain scores with the patient prior to activating the laser.
Can a NP or PA administer treatment?
In most states, Nurse Practitioners (NPs) and Physician Assistants (PAs) may perform SoLá Pelvic Therapy if it is within their scope of practice and consistent with state law. Because SoLá Pelvic Therapy uses a non-ablative Class IV near-infrared laser (generally considered a non-surgical modality), many jurisdictions permit delegation to qualified NPs and PAs with appropriate training; however, supervision requirements—ranging from direct to indirect—vary by state and practice setting. Additional Information
Is the treatment covered by insurance?
SoLá Pelvic Therapy has been assigned a Category III CPT code (1026T) by the American Medical Association, which means it can be submitted to insurance. However, there are currently no established reimbursement policies from Medicare (CMS) or private insurers. As a result, many providers offer this treatment on a cash-pay basis. If a claim is submitted and reimbursement is obtained, providers may issue a credit or refund to the patient. Our team can assist with claim submission and share insights based on feedback from providers and patients across more than 10,000 treatments to date.
How do I get started providing treatment?
SoLá Pelvic Therapy is currently only offered through an IRB-approved patient registry. Enrollment is straightforward and designed to integrate seamlessly into your existing clinical workflow. Practices approved to participate in the registry are provided with loaner laser systems, allowing them to begin offering treatment without any upfront capital investment. Learn More