A Double Blind, Placebo Controlled Study of IncobotulinumtoxinA in Patients With Provoked Vestibulodynia Associated With Overactive Pelvic Floor Muscle Dysfunction
This is a double-blind, placebo-controlled study evaluating the safety and efficacy of incobotulinumtoxinA (Merz) for the treatment of provoked vestibulodynia (PVD) associated with overactive pelvic floor muscle dysfunction. Eligible participants are premenopausal females aged 18 years and older with a confirmed diagnosis of PVD with hypertonic pelvic floor muscles, established by both an expert physician and an expert pelvic floor physical therapist. Participants must have bilateral provoked pain at the posterior vestibule on cotton swab testing and a pain score of 5 or greater on an 11-point Numeric Rating Scale (NRS) during standardized dilator testing at baseline. Key outcome measures include change in pain during dilator testing and Patient Global Impression of Change (PGI-C). Participants with anterior vestibular pain, prior botulinum toxin injection in the genitopelvic area within the past 12 months, or significant genitourinary conditions that may confound assessment are excluded.
• Female, 18 years or older.
‣ Willing to provide a written informed consent prior to any study related procedures.
⁃ Premenopausal.
⁃ Have vulvodynia with provoked vestibulodynia with overactive pelvic floor muscle dysfunction for at least 3 months duration and for no more than 15 years.
⁃ Have provoked pain at the posterior vestibule on a cotton swab test, with pain at positions 4, 6 and 8 o'clock (must be bilateral pain) at the Baseline Visit.
⁃ Have independently confirmed diagnoses of provoked vestibulodynia PVD with overactive pelvic floor muscle dysfunction (hypertonic pelvic floor muscles) confirmed by both an expert physician and expert pelvic floor physical therapist.
⁃ Are able to tolerate the smallest dilator size (diameter 0.5 inches) at the Baseline Visit, i.e. agree to the next successive dilator size to be tested for pain response (i.e. the two smallest sized dilators (#1 and 2) are to be tested).
⁃ Pain score ≥5 on an 11-point Numeric Rating Scale (NRS) for the Dilator Maximum Tested Size (DMTS) at the Baseline Visit.
⁃ Willing and able to comply with study restrictions, able to attend the clinic for the required duration of assessments during the study period and willing to return to the clinic for the follow-up evaluation as specified in the protocol.
⁃ If the subject has received oral antidepressants, anxiolytics or anti-epileptics, then the dose of these medications should have been stable for at least 3 months prior to the Baseline Visit and expected to remain stable throughout the study.
⁃ If the subject is currently undergoing pelvic floor physical therapy then the frequency of visits should be stable for at least 8 weeks prior to the Baseline visit and expected to remain stable throughout the study.
⁃ If the subject has vaginal/vulvar infections (bacterial vaginosis, presence of candidiasis or trichomoniasis) at Baseline Visit (provider will take a vaginal culture swab to test for infection), they may still participate as long as they undergo treatment for the infection (as prescribed by study provider).