Abstract
INTRODUCTION AND OBJECTIVE: Therapeutic options for the management of painful high-tone pelvic floor dysfunction (HTPFD) are limited. We sought to determine whether the addition of pelvic floor chemodenervation to an established regimen of pelvic floor physical therapy (PFPT) for HTPFD improves patients’ subjective outcomes. METHODS: Subjects were recruited from an FPMRS practice. Inclusion criteria included a 6 month history of PFPT-refractory HTPFD. Exclusion criteria included pregnancy or any contraindication to onabotulinumtoxinA (BTX-A) injection. Pelvic floor BTX-A injections were offered following a standard template at either 50, 100, or 150 units. Following injection, patients continued PFPT and were followed for 12 months. Patient reported outcome measures were assessed with visual analog scale (VAS) pain indices of non-menstrual pelvic pain and dyspareunia, Patient Global Impression of Severity (PGI-S), the Pelvic Floor Distress Inventory (PFDI), and the Female Sexual Function Index (FSFI). The Patient Global Impression of Improvement (PGI-I) was also assessed following intervention. Appropriate statistical analyses were used to compare changes in survey responses over time. RESULTS: Twenty patients were enrolled. Of these, 40, 25, and 35% underwent injection with 50, 100, and 150 u, respectively. The average age was 42.8 years (range: 22-78) and BMI was 24.7 (SD: 6.1), with 90% of the subjects being Caucasian and 55% tolerating vaginal penetration prior to BTX-A injection. PGI-S scores showed significant improvement at 2 weeks through 12 months (baseline: 3.01 vs. 2.0-2.1, p<0.01). VAS rated pelvic pain showed >50% improvement at all follow up points; peak improvement was at 3 months (baseline 4.9 vs. 1.6, p<0.01). VAS rated dyspareunia showed significant improvement at 3 through 12 months following injection (baseline: 6.9 vs 2.2-3.4, p<0.01), and PFDI scores showed significant improvement at 3 through 6 months following injection (baseline: 63.3 vs 26.5-27.8, p=0.038-0.045). No significant changes (favorable or unfavorable) were noted with FSFI results. No major adverse events were documented. CONCLUSIONS: The addition of pelvic floor BTX-A to a PFPT regimen is effective in significantly reducing HTPFD-related pelvic pain and dyspareunia while improving health-related quality of life. Peak efficacy was noted 3 months after injection, and no detriment was seen to existing urinary, defecatory, or other sex-related complaints. Further study is needed, but the addition of pelvic floor BTX-A injection appears to be a promising adjunctive treatment for this clinically-challenging condition. Source of Funding: SUFU Chemodenervation Grant
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