Clinical trial NCT03390049: Randomized CO2 vs Sham Laser Treatment of Provoked Vestibulodynia
Official title: Randomized Controlled Trial of Fractional CO2 Laser vs Sham Laser for Women With Provoked Vestibulodynia Who Have Failed Conservative Management
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vestibulodynia
Keywords: SmartXide 2 V 2 LR
MonaLisa Touch
DEKA
Fractional CO2 Laser
Sham Laser
Vulvodynia
PVD
Provoked vestibulodynia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 prevalence is estimated at 7-8% in women between the ages of 18 and 40. Vulvodynia that is provoked and localized to the vestibule (provoked vestibulodynia \[PVD\]) appears to be the most commonly seen in clinical practice. The current treatment approach for PVD follows a trial-and-error strategy from one intervention to another if symptoms fail to remit. Treatment options include reducing vulvar irritation (e.g., by stopping the use of detergents), topical agents (e.g., lidocaine), oral medications, pelvic floor physical therapy, psychotherapy, locally injectable agents (e.g., botulinum toxin A), and surgery (vestibulectomy). Despite the number of available treatment options, treatment failure is common.

Fractional carbon-dioxide (CO2) laser is a technology widely used in dermatology for the treatment of various skin conditions. It has also been found to be an effective and safe treatment modality for symptoms of the genitourinary syndrome of menopause. A recent pilot study explored the use of fractional CO2 laser for the treatment of vestibulodynia in 37 subjects, 67.6% of which reported that their symptoms were "improved" or "very improved" after 3 fractional CO2 laser sessions. In addition, the subjects reported statistically-significant decreases in vulvar pain and dyspareunia scores. Though the results of this pilot study are promising, it was of small sample size and did not control for the placebo effect. In cases of PVD, the placebo effect has been found to have a significant impact on self-reported outcomes. Sham procedures, when performed correctly, can be ethically administered and can significantly reduce study bias.

The primary aim of this study, therefore, is to assess the difference in vulvar pain intensity scores, at baseline and at 6, 12, 16, and 24 weeks post-randomization, in women with refractory PVD assigned to fractional CO2 laser vs sham laser. This study will provide information about the efficacy of this treatment modality in women with a challenging clinical condition. Hypothesis: Administration of 3 sessions of fractional carbon-dioxide laser to the vulvar vestibule of women with refractory provoked vestibulodynia will result in a clinically-significant greater reduction in vulvar pain intensity scores than placebo (sham laser).


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Mean change from baseline in subjects' vulvar pain NRS scores
timeFrame: 24 weeks
Secondary outcomes:
measure: Mean change from baseline in subjects' scores on pain severity subscale VPAQ
timeFrame: 24 weeks
measure: Mean change from baseline in subjects' scores on pain severity subscale SF-MPQ
timeFrame: 24 weeks
measure: Mean change from baseline in subjects' scores on pain descriptors subscale VPAQ
timeFrame: 24 weeks
measure: Mean change from baseline in subjects' scores on the SF-36
timeFrame: 24 weeks
measure: Mean change from baseline in subjects' scores on the pain interference subscale of the BPI
timeFrame: 24 weeks
measure: Mean change from baseline in subjects' scores on the life interference subscale of the VPAQ
timeFrame: 24 weeks
measure: Mean change from baseline in subjects' scores on the life interference subscale of the FSFI
timeFrame: 24 weeks
measure: Mean change from baseline in subjects' scores on the sexual function interference subscale of the VPAQ
timeFrame: 24 weeks
measure: Mean change from baseline in subjects' scores on the sexual function interference subscale of the PHQ-9
timeFrame: 24 weeks
measure: Comparison of percentages of subjects in each treatment arm endorsing improvement in symptoms on the PGIC scale
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Professor or Ob/Gyn and Urology
name: Catherine A Matthews, MD
role: PRINCIPAL_INVESTIGATOR
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