Study of IncobotulinumtoxinA Injections for Treating Provoked Vestibulodynia with Overactive Pelvic Floor Muscles in Premenopausal Women

What this Trial Is About

Researchers are evaluating incobotulinumtoxinA for treating provoked vestibulodynia PVD linked to overactive pelvic floor muscle dysfunction. This phase 2, double-blind, placebo-controlled study focuses on premenopausal females aged 18 years or older who have a confirmed diagnosis of PVD with hypertonic pelvic floor muscles. The study aims to assess the safety and effectiveness of this treatment compared to a placebo saline injection. Participants are randomly assigned to receive either incobotulinumtoxinA injections or placebo saline injections into the pelvic floor muscles. The study includes treatment and follow-up periods lasting up to 24 to 30 weeks, during which participants undergo pain assessments using dilator testing. The study evaluates changes in pain levels and the Patient Global Impression of Change PGI-C. During the study, participants attend clinic visits for pain testing and physical evaluations, including cotton swab testing and dilator testing at baseline and final visits. Researchers monitor pain scores, treatment effects, and any side effects. Participants must comply with study restrictions and return for follow-up assessments. The primary outcome is the maximum dilator size tolerated at baseline and at the final visit around 24 to 30 weeks after treatment.

IncobotulinumtoxinA for Provoked Vestibulodynia With Overactive Pelvic Floor Muscle Dysfunction