Comparing the effectiveness of functional electrical stimulation via sexual cognitive/behavioral therapy of pelvic floor muscles versus local injection of botulinum toxin on the sexual functioning of patients with primary vaginismus: a randomized clinical trial

Botulinum toxin injection for chronic pelvic pain: A systematic review

“…41 The in six domains of the Female Sexual Function Index (botulinum toxin mean differences 0.02-1.57, physiotherapy mean differences 1.07-3.18, P < .001-0.005, refer to Table S1 for outline of full results). 28 In both of the RCTs for vulvodynia, there were no statistically significant inter-group differences between the botulinum toxin group and the saline placebo group. 38,39 Adverse effects from botulinum toxin injections are listed in and two RCTs showed some concerns about risk of bias, 27,38 both in the domain of the randomization process.…”

“…Information Tables S1 and S2. Definitions of CPP varied among the studies but they could be grouped into two main categories: myofascial hypertonic disorders (three RCTs 11,27,28 and 10 observational studies 19,[29][30][31][32][33][34][35][36][37], and vulvodynia (two RCTs 38,39 and two observational studies 40,41 ). Given the heterogeneity in case definitions, interventions, metrics, designs, settings and outcome measures, the results from the RCTs could not be pooled into a meta-analysis.…”

“…Where specified, the length of prior CPP required for a patient to be included in a study varied from 3 months 27,35 to 2 years. 11,34 Data had been collected prospectively in 14 studies, 11,19,[27][28][29][30][31][34][35][36][37][38][39][40] and retrospectively in three studies. 32,33,41 The number of women included in the different studies ranged from 12 36 to 241.…”

“…Where specified by the authors, the muscles injected varied among the studies, including piriformis, 32 and pelvic floor muscles of obturator internus, 31,32 puborectalis, 11,28,29,32,34,36,40 puboccocygeus, 31,32,34,36 bulbospongiosus, 19,39,41 iliococcygeus, 31,32 and coccygeus. 31,32 One RCT and one observational study on vulvodynia both described injections into the submucous layer but not into the muscles themselves.…”

“…31,33 One study used general anesthesia 33 and five studies used conscious sedation during the injections. 19,28,29,35,36 Five studies included physiotherapy as part of the intervention. 19,27,33,34,40 The follow-up durations ranged from 12 weeks to 12 months post-injection in the RCTs, 27,39 and from 2 weeks to 24 months 30,37 post-injection in the observational studies.…”