Table 1.

Study of BoNT-A for pelvic floor muscle pain in CPPS women.

Study	Javis [14]	Adelowo [36]	Nesbitt-Hawes [37]	Halder [38]	Morrissey [30]
Numbers	12	29	37 (single injection: 26; multiple injection: 11)	50	21
Age	31.1 (18–55)	55 (38–62)	Single injection: 30 Multiple injection: 31 (21–52 years)	44.5	35.1 (22–50)
Study Model	Prospective cohort study	Retrospective cohort study	Prospective cohort study	Retrospective case series	Prospective pilot open-label study
Follow-Up	12 weeks	Visit 1: <6 weeks post-injection Visit 2: ≥6 weeks post injection	26 weeks	6 weeks (2–192 weeks)	6 months
Criteria	Objective hypertonicity of PFM and 2-year history of CPP at least	Refractory myofascial pelvic pain	Objective overactivity of PFM and a two-year history of pelvic pain	CPP, trigger points of pelvic floor on examinations, and failure (with subsequent discontinuation) of one treatment modality at least including outpatient physical treatment and/or oral analgesics	CPP and HTPFD who have failed conventional therapy
Dose of BoNT-A	40 U	100–300 U	100 U	−	Up to 300 U
Injection Sites	Bilateral puborectalis and pubococcygeus muscles	PFMs (coccygeus, iliococcygeus, pubococcygeus, puborectalis, obturator, and pyriformis muscles)	Puborectalis and pubococcygeous muscles	Multiple areas of the perineum	Spastic PFM trigger points and deeper PFMs (pubococcygeus, iliococcygeus, coccygeus, and obturator internus muscles)
Outcomes	Median VAS scores presented improvements on dyspareunia (80 vs. 28, p = 0.01) and dysmenorrhea (67 vs. 28, p = 0.03). PFMs manometry showed a 37% reduction in resting pressure at week 4 and a 25% reduction maintained at week 12 (p < 0.0001). It showed significant improvements of sexual activity scores, with a reduction in discomfort (4.8 vs. 2.2, p = 0.02) and improvement in habit (0.2 vs. 1.9, p = 0.03).	79.3% improvement in pain. 51.7% female patients elected to have a second BoNT-A injection. The median time of the first injection to the second injection was 4.0 months (3.0–7.0 months).	26 (70%) women had one injection of BoNT-A and 11 (30%) had 2 or more injections. The median number of repeat injections was 3. The second injection was performed at the earliest at 26 weeks after the first, with subsequent injections having a median time to re-injection of 33.4 weeks (range 9.4–122.7 weeks). Single and repeated injections both significantly reduced dyspareunia by VAS scores (54 to 30, and 51 to 23, p = 0.001), non-menstrual pelvic pain VAS (37 to 25, p = 0.04), as well as vaginal pressures (40 vs. 34 cm H2O (p = 0.02).	Posttreatment, patients had lower average pelvic pain scores (6.4 to 3.7, p = 0.005), and fewer trigger pints (44% vs. 100%, p < 0.001)	61.9% improvement on GRA at 4 weeks. 80.9% improvement on GRA at 8, 12, and 24 weeks. Dyspareunia VAS significantly improved at weeks 12 (5.6, p = 0.011) and 24 (5.4, p = 0.004). Sexual dysfunction as measured by the FSDS significantly improved at 8 weeks (27.6, p = 0.005), 12 weeks (27.9, p = 0.006), and 24 weeks (22.6, p < 0.001) compared with baseline (34.5). Vaginal manometry demonstrated a significant decrease in resting pressures and in maximum contraction pressures at all follow-up visits (p < 0.05).

CPP: chronic pelvic pain. PFM: pelvic floor muscle. HTPFD: high-tone pelvic floor dysfunction GRA: global response assessment. FSDS: Female Sexual Distress Scale.