Purpose: Interstitial Cystitis/ Bladder Pain Syndrome (IC/BPS) is characterized by pelvic/bladder pain, associated with pelvic muscle tenderness, urgency, frequency, and dysuria. Prior studies show that transvaginal photobiomodulation (TV-PBM) reduces pain in women with chronic pelvic pain (CPP). Our objective 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.
Materials and methods: Before-and-after observational cohort study of women with IC/BPS who received TV-PBM in 17 US practices. Pain was measured using a 0-10 numeric rating scale (NRS). The primary outcome was a minimal clinical important difference (MCID); reduction of overall pelvic pain severity by ≥2 NRS points from baseline compared to after 8 treatments. Cohen d coefficient measured effect size (low effect size d<0.2, medium 0.2<d<0.8, and high d>0.8).
Results: Of 140 patients with IC/BPS who self-selected to start TV-PBM therapy, 89.3% (n=125) completed 4 treatments and 59.3% (n=83) completed 8. Improvement ≥1 NRS point was reported by 73.5% (n=61) and 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, d=0.82.
Conclusion: In real-world clinical settings, 2/3 women with IC/BPS who opted to undergo TV-PBM therapy reported significant decrease in pelvic pain and dysuria. These findings are promising; however, controlled studies are needed.
Published by Elsevier Inc.