De effectiviteit van botuline toxine A als injectie in de bekkenbodemspier bij patiënten met chronische bekkenpijn: een dubbel-geblindeerde, gerandomiseerde studie.

Chronic pelvic pain is common, affecting 15% of women aged 18-50. Pelvic floor muscle spasms resulting in chronic pelvic pain may occur as a primary event or secondary to a physical, psychological or pathological factor. First-line treatment consists of pelvic floor physiotherapy. When first-line treatment fails, more invasive interventions can be done. One previously published intervention is injection with botulinum toxin A (BTA) in the pelvic floor muscles. It produces a localized, partial, and reversible chemical denervation of the muscle which results in localized muscle weakness or paralysis. There is some evidence that injection of BTA in the hypertonic pelvic floor muscles decreases pelvic pain in patients with therapy resistant chronic pelvic pain; however this is not investigated in a randomized controlled trial.
This is a double-blinded randomized placebo-controlled cross-over trial in which intramuscular BTA will be compared with placebo in patients over 18 years with >6 months of chronic pelvic pain with pelvic floor muscle hypertonicity refractory to first-line pelvic floor physiotherapy, and in which no anatomical cause (such as endometriosis) was found. The main study parameters/endpoints: decrease of chronic pelvic pain, measured by a decrease in visual analog scale score (VAS score 0-10) with 33% and the PGI-I of 6 or 7 (better or much better).

Pelvic floor muscle spasms resulting in chronic pelvic pain may occur as a primary event or secondary to a physical, psychological or pathological factor. First-line treatment consists of pelvic floor physiotherapy. When first-line treatment fails, more invasive interventions can be done. One described intervention is injection with botulinum toxin A (BTA) in the pelvic floor muscles. It produces a localized, partial, and reversible chemical denervation of the muscle which results in localized muscle weakness or paralysis, and possibly pain reduction

baseline t=0, 4, 8, 12, 26 weeks after first injection, and t=30, 34, 38, 52 weeks after secondary injection

The pelvic floor muscles will be injected with either 100 IU BTA or placebo.