IncobotulinumtoxinA for Provoked Vestibulodynia With Overactive Pelvic Floor Muscle Dysfunction

Conditions

• Provoked Vestibulodynia

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Incobotulinum Toxin A — DRUG
  injections into pelvic floor muscles
• Placebo — DRUG
  placebo saline injection into pelvic floor muscles

Study Details

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.

Key Dates

Start date

Feb 27, 2026

Status verified

Mar 2026

Primary completion

Dec 20, 2026

Completion

Mar 3, 2027

Study Design

Enrollment

54 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: INA group
• Placebo Comparator: Placebo Group

Primary Outcome Measure

Dilator Maximum Tested Size [ Time Frame: baseline, week 24-30 (final visit) ]

Central Contacts

• Andrew Goldstein, MD
  202-887-0568
  [email protected]

Locations (2)

Find similar trials in Washington D.C., DC

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