Actively Recruiting
IncobotulinumtoxinA for Provoked Vestibulodynia With Overactive Pelvic Floor Muscle Dysfunction
Led by Center for Vulvovaginal Disorders · Updated on 2026-03-23
54
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Center for Vulvovaginal Disorders
Lead Sponsor
M
Merz Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IncobotulinumtoxinA for Provoked Vestibulodynia With Overactive Pelvic Floor Muscle Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, 18 years or older
- Premenopausal
- Willing to provide written informed consent
- Diagnosed with provoked vestibulodynia with overactive pelvic floor muscle dysfunction for 3 months to 15 years
- Bilateral provoked pain at the posterior vestibule on cotton swab test at positions 4, 6, and 8 o'clock at baseline
- Confirmed diagnosis by expert physician and pelvic floor physical therapist
- Able to tolerate smallest dilator size (0.5 inches) and agree to test next dilator size
- Pain score of 5 or greater on 11-point Numeric Rating Scale during baseline dilator testing
- Willing and able to comply with study restrictions and attend all clinic visits
- Stable dose of oral antidepressants, anxiolytics, or anti-epileptics for at least 3 months prior and expected to remain stable
- Stable frequency of pelvic floor physical therapy visits for at least 8 weeks prior and expected to remain stable
- If vaginal/vulvar infections are present at baseline, willing to undergo treatment prescribed by study provider
You will not qualify if you...
- Provoked pain on cotton swab test at anterior vestibule at baseline
- Able to tolerate 6th dilator size (1 1/4 inches) with pain score less than 5 at baseline
- Genitourinary or gastrointestinal conditions that may interfere with treatment or outcome assessment
- Skin diseases at the vestibule such as lichen sclerosus, lichen planus, vaginal or vulvar atrophy, desquamative inflammatory vaginitis, allergic vulvitis
- Severe endometriosis requiring regular medications other than hormonal contraceptives and NSAIDs
- Pudendal neuralgia with significant tenderness
- Genitourinary or rectal cancer
- Congenital urogenital abnormalities
- Pain in urethra
- Symptomatic urogenital prolapse on physical exam
- History of traumatic or post-radiotherapy vulvar lesions
- Previous surgeries that may impact study outcomes including vaginal hysterectomy, vestibulectomy, urologic surgery, perianal surgery, genital trauma or mutilation
- Current vaginal/vulvar infections and unwilling or unable to take oral medication
- Significant history of alcohol or drug abuse within last 24 weeks or dependence within 2 years (excluding caffeine or nicotine)
- Pelvic floor physical therapy initiated, stopped, or modified within 8 weeks prior to baseline
- Use of muscle relaxants within 2 weeks prior
- Treatment for anterior vestibular pain with hormonal creams within 1 week prior unless stable regimen
- Current treatment for stress or urge urinary incontinence
- Steroid injections in vulva within 4 weeks prior or planned during study
- Botulinum toxin injections in genitopelvic area within 12 months prior
- Treatment with investigational drugs within 4 weeks prior or planned during study
- Likely to require prohibited drugs during study
- Mental conditions impairing understanding or cooperation
- Pregnant, planning pregnancy, or breastfeeding; must use acceptable contraception if sexually active
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Center for VulvoVaginal Disorders
Washington D.C., District of Columbia, United States, 21012
Actively Recruiting
2
Centers for Vulvovaginal Disorders, NY
New York, New York, United States, 10036
Actively Recruiting
Research Team
A
Andrew Goldstein, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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