Status:
WITHDRAWN
Randomized CO2 vs Sham Laser Treatment of Provoked Vestibulodynia
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Vestibulodynia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Vulvodynia is a debilitating chronic vulvar pain lasting at least 3 months without a clear identifiable cause that is challenging to treat effectively. Vulvodynia is a common pain condition: its preva...
Eligibility Criteria
Inclusion
- Aged 18 or older
- Meets the 2015 terminology for the diagnosis of PVD, either type 1 (chronic vulvar pain since first attempts at intercourse and/or other penetrative activities) or type 2 (chronic vulvar pain with intercourse and/or other penetrative activities following a period of no vulvar pain)
- Vulvar pain is localized to the vestibule and provoked by vaginal intercourse, other penetrative activities (e.g., tampon insertion, self-stimulation) and/or pressure exerted on the vestibule (e.g., due to tight-fitting clothing, cycling)
- Vestibular pain is elicited with cotton-swab test during screening medical examination
- Subject did not experience significant symptom improvement with prior therapy following a minimum of 2 standard-of-care treatments for PVD
Exclusion
- Currently receiving any type of treatment for PVD, including topical agents (e.g., lidocaine), oral medications (e.g., tricyclic antidepressants, anticonvulsants), pelvic floor physical therapy, psychotherapy, or locally injectable agents (e.g., botulinum toxin A)
- Generalized vulvar pain
- Unprovoked vulvar pain
- History of vestibulectomy
- Any medical, gynecologic, or iatrogenic condition (e.g., vulvar surgery) that could explain the presence of chronic vulvar pain (e.g., genitourinary syndrome of menopause, lichen sclerosus, vaginismus, significant pelvic organ prolapse, pudendal neuralgia)
- Active vulvar and/or vaginal infection that is not due to bacterial vaginosis, Chlamydia, Trichomonads or Candida (if diagnosed with any of these infections, treat and re-evaluate after negative test of cure)
- Active urinary tract infection
- Currently pregnant or breastfeeding
- Recent vaginal delivery (within 3 months post-partum)
- Medical or psychiatric condition not under control
- Scoring of 10 or above on the PHQ-9 and/or scoring 1 or above on the question asking about "thoughts that you would be better off dead, or of hurting yourself in some way"
- History of treatment with fractional CO2 laser to the vulvar vestibule and/or vagina
- History of radiation to vaginal/colorectal tissue, reconstructive pelvic surgery with "mesh kits", impaired wound healing or keloid formation, and/or thromboembolic condition
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03390049
Start Date
August 1 2018
End Date
November 1 2019
Last Update
June 10 2019
Active Locations (1)
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1
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27104