Transvaginal Photobiomodulation for Chronic Pelvic Pain: The VOICE RCT
The VOICE Randomized Controlled Trial represents a landmark multi-center study evaluating the efficacy of SoLá Pelvic Therapy's transvaginal photobiomodulation protocol. Designed to establish gold-standard evidence, the trial compares SoLá 's targeted light therapy against a sham-control laser for the management of chronic pelvic pain (CPP).
Endpoints
- Primary Endpoints: Change in pain level (using a 0-10 NPRS) at 1 week and 3 months after therapy compared to baseline. Percentage of women achieving Minimal Clinically Significant Important Difference (MCID). Superiority threshold defined a priori as ≥30% difference in the % of women reaching MCID between groups.
- Secondary Endpoints: Pain frequency and interference, QoL, need for additional therapy, satisfaction, global impression of change, adherence, adverse events, and changes in symptom-specific pelvic pain
- Safety Profile: Identification and analysis of treatment-related adverse events
Preliminary Results (Pending Publication)
- Superior Pain Improvement: SoLá PBM demonstrated significantly greater pain reduction than the sham control at both 1-week and 3-month intervals, outperforming the control despite the known strong placebo effect in the pain literature.
- Clinical Significance: At 3 months median pain reduction was 3 points in the TV-PBM group compared to 1 point in the sham group (median difference, -2.0 points [95% CI, -3.0 to -1.0]; P = .01).
- Rate of Improvement: A Linear Mixed-Effects Model confirmed that the SoLá PBM group improved at a faster rate over time than the sham control.
- Success in Achieving MCID of 2: At 3 months, 66% of the SoLá PBM group achieved a Minimal Clinically Important Difference (MCID) of≥ 2 points, compared to 45 % in the sham group (p < 0.02).
- Success in Achieving MCID of 3: At 3 months, 49% of the SoLá PBM group achieved a Minimal Clinically Important Difference (MCID) of≥ 3 points, compared to 18 % in the sham group (p < 0.01).
- At 3 months more than double the number of SoLá PBM patients were in the mild to no-pain category compared to sham laser (45.8%) in the TV-PBM group had no pain or mild pain compared to 13 of 60 (21.7%) in the sham group. P=0.02)
Citation: [Publication pending peer review. Link to full publication will be available here soon.]
SoLá vs Sham Laser
0, 1, and 3 Month Mean Pain Score
Distribution of Pelvic Pain
Severity Scores Over Time
Published Real-World Evidence Analyses
SoLá Pelvic Therapy is supported by real-world data, with safety and efficacy tracked across over 10,000 treatments to date. Below you will find peer-reviewed publications on SoLá Pelvic Therapy.
Journal of comparATIve effectiveness research | 2021
An observational cohort study of pelvic floor photobiomodulation for treatment of chronic pelvic pain
This research is the first to evaluate the effectiveness of trans-vaginal photobiomodulation therapy (TV-PBMT) for chronic pelvic pain.
Results: Compared with baseline, 64.5% of women showed improvement in overall pain, pain with bowel movement, intercourse, exercise, urination, sitting and vulvar pain (Minimal Clinically important Difference = -2.4, -2.0, -2.4, -2.1, -2.1, -2.0, -3.1; Cohens D: 0.9, 0.7, 0.9, 0.7, 0.7, 0.7, 0.9
UROLOGY | 2022
Women with Pelvic Muscle Tenderness and Interstitial Cystitis/Bladder Pain Syndrome: A Preliminary Observational Study
Interstitial Cystitis/ Bladder Pain Syndrome (IC/BPS) is characterized by pelvic/bladder pain, associated with pelvic muscle tenderness, urgency, frequency, and dysuria. The objective of the authors was to obtain preliminary data on treatment effect and adherence, in women with IC/BPS who selected TV-PBM therapy for management of pelvic pain.
Results: Meaningful improvement (≥2 points) was reported by 63.9% (n=53) after 8 treatments. In this group, patients with severe / moderate pain decreased from 83.1% (n=44) to 38.5% (n=20); p<0.001. Pain levels decreased as follows: overall pelvic pain MCID=-2.7, d=1.07, pain with urination MCID=-2.6, d=1.0; pain with exercise MCID=-2.6, d=0.91, pain with intercourse MCID=-2.5, Cohens d=0.82.
NEUROUROLOGY | 2021
Treatment of Myofascial Pelvic Pain with a Novel Transvaginal Photobiomodulation Laser
The prevalence of myofascial pelvic pain among women with chronic pelvic pain likely exceeds fifty percent. This paper provides an analysis of real-world patient reported outcomes, following treatment of female myofascial chronic pelvic pain with a novel photobiomodulation therapy.
Results: Mean overall pain NRS reduction of 1 and 2 points was achieved by final treatment for 80% and 68% of patients respectively (p<.0001, p<.0004). These patients experienced a mean decrease in overall pain of 50% and 55%. By treatment number nine, NRS reductions of >2 were achieved in 67% of those with levator myalgia, 71% with interstitial cystitis, 69% with endometriosis, 77% with vulvodynia, 68% with dyspareunia, and 100% with vaginismus. AII changes reached statistical significance (p < .05).
Lasers Med Sci | 2021
Evaluation of a novel deep-tissue transvaginal near-infrared laser and applicator in an ovine model
This study was undertaken to determine if the SoLá Pelvic Therapy device is capable of delivering therapeutic levels of irradiance to the pelvic muscles and to identify the surface irradiance required to achieve this goal.
Results: The device with its transvaginal applicator delivered therapeutic irradiance to the levator ani muscle and bladder of an anesthetized ewe at a power setting of 5 W. A power setting of 0.5 W failed to deliver therapeutic energy into either the levator ani muscle or bladder. Clinical applications targeting deeper tissues such as the pelvic muscles and or the bladder should consider power settings that exceed 0.5 w and or irradiance of 75 mW/cm2.
womens health report | 2021
Transvaginal Photobiomodulation
for the Treatment of Chronic Pelvic Pain: A Pilot Study
Chronic pelvic pain (CPP) is a common and debilitating condition that affects millions of U.S. women. Innovative new therapies are desperately needed. Large, controlled studies show that photobiomodulation (PBM) can reduce pain in patients with other chronic pain conditions. The objective of this pilot study was to determine if transvaginal PBM (TV-PBM) can reduce pain in women with CPP.
Results: At baseline, the mean SF-MPQ score was 19.7 (SD 5.9). Compared with base-line, the mean SF-MPQ score decreased to 8.2 (SD -8.1, p=0.002, d=l.9) at 6 months. Transvaginal PBM provided significant and sustained pain relief to women with CPP up to 6 months.
pain Reports | 2021
Transvaginal photobiomodulation for vulvodynia: a
pilot report from real-world clinical settings
This research is the first to evaluate the effectiveness of trans-vaginal photobiomodulation therapy (TV-PBMT) for vulvodynia in real-world clinical settings.
Results: 99 women who had completed at least their first two treatments were eligible to participate; The mean pre-treatment score of vulvar pain was 6.5 (SD± 2.6). Compared to baseline, pain scores at treatment 9 changed as follows (Fig 1): vulvar pain from 6.5 (SD±2.6) to 4.5 (SD±2.5), MCID= -2, d=0.8; dyspareunia from 6.6 (SD±2.5) to 4.9 (SD±3.1), MCID-1.7, d=0.6; overall pelvic pain 6.5 (SD±2.3) to 4.5 (SD±2.5), MCID=-2, d=0.8. In this cohort of women with vulvodynia, significant improvement in vulvar pain, dyspareunia, and overall pelvic pain was observed after 9 TV-PBM treatments.