Evaluation of a novel deep tissue transvaginal near-infrared laser and applicator in an ovine model

Abstract

Photobiomodulation therapy (PBMT) is an effective means of treating muscle spasm and pain. A novel near-infrared laser system has been commercialized for the treatment of myofascial pelvic pain in women (SoLá Therapy, UroShape, LLC). This study was undertaken to determine if this device is capable of delivering therapeutic levels of irradiance to the pelvic muscles and to identify the surface irradiance required to achieve this goal. This novel class IV near-infrared laser and transvaginal applicator were used to deliver near-infrared light energy through the vaginal mucosa of an adult Suffolk/Dorset Ewe. Irradiance was measured on the surface of the levator ani muscle, inside the levator ani muscle, and inside the bladder. Measurements were taken at powers of 5 W and 0.5 W. 3.0% of vaginal surface irradiance was measured inside of the levator ani muscle. 4.4% of vaginal surface irradiance was measured inside the bladder. At 5 W, the novel laser system provided a surface irradiance of 738 mW/cm². At 0.5 W, the system provided a surface irradiance of 74 mW/cm². A novel class IV near-infrared laser and 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 bladder should consider power settings that exceed 0.5 W and or irradiance of ≥ 75 mW/cm².

Keywords: Irradiance; Pain; Pelvis; Photobiomodulation; Therapy.

Fig. 1

The SoLá Pelvic Therapy Laser System and its transvaginal delivery system. The delivery system consists of a reusable handpiece and proprietary laser fiber that radiates energy perpendicular to the fiber. The distal handpiece is covered by a single-use, sterile, wand with a bulbous tip. Inset is the BK 2712 Precision Multimeter with a custom B&W Tek near-infrared Power sensor. These sensors were implanted in the subject