A newly published, pathologist-blinded study in a porcine model, examines the histopathology changes after non-ablative radiofrequency (NARF) to smooth muscle as delivered by Stretta therapy for GERD and Secca therapy for fecal incontinence. Radiofrequency therapy is commonly thought of in terms of ablation, where tissue destruction occurs. In contrast, this study shows that this unique low power, low temperature non-ablative type of radiofrequency (NARF) improves the smooth-muscle sphincters of the GI tract, as well as the skeletal muscle of the external anal sphincter. The investigation confirms multiple mechanisms that may regenerate and improve the function of the treated sphincter muscles, offering symptom improvement for patients suffering from these debilitating disorders.
The study documented the following advantages of NARF in the presence of a compromised sphincter:
- Hypertrophy of both smooth and skeletal muscle fibers
- Smooth muscle size and muscle bundle increase
- Interstitial Cells of Cajal (ICCs) decrease
- Collagen I synthesis promotion, with an increase in the Collagen I/Collagen III ratio
- Fibrosis is diminished, due to a regression of excessive collagen deposition
- Similar effect on Type I and II fibers as reinervation (nerve regrowth)
Study senior author Dr. Steven Wexner, Director of the Digestive Disease Center and Chairman of the Department of Colorectal Surgery at Cleveland Clinic Florida, and a paid consultant for Mederi Therapeutics Inc., commented: “The results of this study should allow us to help patients with GERD and fecal incontinence, as the regeneration we see here clarifies the mechanism of action of radiofrequency treatment.”
The randomized study was performed on an animal model of fecal incontinence with three study arms: an experimental model of fecal incontinence with damage to the sphincter muscle, which remained untreated; a group with sphincter damage, treated with NARF; a control group without a damaged sphincter and without treatment. After 10 weeks the treated tissue was excised and preserved. The resulting H&E and trichrome slides were examined by two pathologists, who were blinded to the tissue sample origin.
Study principal author Dr. Mariana Berho, Director of the Pathology and Laboratory Medicine Center and of the Center for Research at Cleveland Clinic Florida and a paid consultant for Mederi Therapeutics Inc. explained: “The results of this animal model study are extremely valuable as they may reflect the changes that take place in the human lower esophageal sphincter as well as the internal anal sphincter after the administration of radiofrequency.”
This investigation concluded that non-ablative radiofrequency application appeared to induce profound morphological changes in the sphincter muscle that lead to an anatomical state reminiscent of the baseline sphincter structure. Further, the regeneration of muscle explains how NARF therapies, Stretta and Secca work to improve the symptoms that accompany GERD and fecal incontinence.
SOURCE: Mederi Therapeutics Inc.