Vulvar Vestibulitis, Vulvodynia
Conditions
Keywords
vulvodynia, vulvar vestibulitis, chronic vulvar pain, generalized vulvodynia, localized vulvodynia
Brief summary
The purpose of this study is to determine whether pregabalin is effective in the treatment of vulvodynia.
Detailed description
Vulvodynia is a condition exclusive to women and involves mostly burning, rawness, and itching of the external genitourinary tract that often results in painful intercourse. Vulvodynia rarely results in severe morbidity or mortality; rather it causes symptoms of the lower genital, urinary, and gastrointestinal tracts that can impact a woman's daily activities and negatively affect her quality of life. Despite the fact that chronic vulvovaginal symptoms are one of the most common reasons for visits to a gynecology clinic, epidemiologic studies of the incidence and prevalence of these conditions are rare and available population-based studies are limited. Approximately 16% of women will experience chronic vulvar pain at some point in their lifetime; with 5% experiencing this condition before age 25. Treatment approaches include behavioral changes, medical management, and surgery, specifically vulvar vestibulectomy. Prior to considering surgical intervention, all medical treatment options should be exhausted. Although vulvodynia is quite prevalent and can be a debilitating disease, there are few studies that critically evaluate the medical management of vulvodynia. Pregabalin is an anticonvulsant that has proven efficacy in the treatment of diabetic neuropathy, post-herpetic neuralgia, and fibromyalgia. Anecdotal data and one case report provide hope that this medication may also be effective in the treatment of vulvodynia.
Interventions
DRUGpregabalin
pregabalin 150mg twice daily for 4 weeks
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult women age 18 or greater * Vulvodynia as defined as chronic vulvar discomfort or pain, characterized by burning, stinging, irritation or rawness of the female genitalia in cases in which there is no infection or skin disease of the vulva or vagina causing these symptoms. Pain may be constant or intermittent, localized or diffuse. Symptoms may be consistent with either Generalized Vulvodynia (diffuse or focal and constant or unremitting symptoms present in the labia majora, labia minora, and/or the vestibule that are not necessarily caused by touch or pressure to the vulva) or Vulvar Vestibulitis Syndrome (pain only in the vestibule and only during or after touch or pressure is applied). * Pain ≥ 40 on 100mm VAS * Practicing reliable form of birth control defined as sterilization, hormonal contraception, abstinence, IUD * Must be able to attend follow up visits and are not likely to leave the area during the study period
Exclusion criteria
* Atrophic vaginitis, active bacterial vaginosis, yeast, and herpetic infections * Current pregnancy diagnosed by positive serum or urine pregnancy test * Current breastfeeding * Seizure disorder or other chronic neurologic disease * Diagnosis of chronic renal insufficiency defined as creatinine \>1.4 * Unable to read and speak English * Contraindication to pregabalin or history of prior use of pregablin * Chronic narcotic or benzodiazepine use * Chronic alcohol abuse * Other chronic pain disorders, (ie. chronic pelvic pain, endometriosis, interstitial cystitis) * Chronic neuropathic pain or anything affecting sensation (ie. MS, stroke)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Average Pain Over the Last 7 Days of Each Arm Using an 11-point Scale (0-10) | 4 weeks | The primary objective of this protocol is to compare the reduction in pain using an 11-point scale (0-10) at four weeks of treatment. A responder will be defined as a subject noting a ≥50% reduction in pain using this scale. The NRS is an 11-point scale comprising a number from 0 through 10; 0 indicates no pain, and 10 indicates the worst imaginable pain. Outcomes measure not assessed due to early discontinuation because of poor recruitment. As such, the study was terminated prior to the designated follow up interval. Therefore, no outcomes data was collected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on Anxiety and Depression in Women With Vulvodynia Based on the Kessler Psychological Distress Scale (K10) | 4 weeks | Subjects will complete the Kessler Psychological Distress Scale (K10). It is a measure of psychological distress. Scores will range from 10 to 50, with the higher the score, the higher the mental distress Data not measured due to early discontinuation of the study prior to the designated follow up time frame. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin First 4 Weeks pregabalin and placebo given using a cross-over design
pregabalin: pregabalin 150mg twice daily for 4 weeks | 8 |
| Placebo First 4 Weeks placebo and pregabalin given using a cross-over design
pregabalin: pregabalin 150mg twice daily for 4 weeks | 8 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Phase 1: Initial Intervention | Early study termination, poor enrollment | 8 | 8 |
Baseline characteristics
| Characteristic | Pregabalin First 4 Weeks | Placebo First 4 Weeks | Total |
|---|---|---|---|
| Age, Continuous | 35.0 years STANDARD_DEVIATION 8.9 | 36.3 years STANDARD_DEVIATION 13.1 | 35.6 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 8 participants | 8 participants | 16 participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Reduction in Average Pain Over the Last 7 Days of Each Arm Using an 11-point Scale (0-10)
The primary objective of this protocol is to compare the reduction in pain using an 11-point scale (0-10) at four weeks of treatment. A responder will be defined as a subject noting a ≥50% reduction in pain using this scale. The NRS is an 11-point scale comprising a number from 0 through 10; 0 indicates no pain, and 10 indicates the worst imaginable pain. Outcomes measure not assessed due to early discontinuation because of poor recruitment. As such, the study was terminated prior to the designated follow up interval. Therefore, no outcomes data was collected.
Time frame: 4 weeks
Population: Outcomes measure not assessed due to early discontinuation because of poor recruitment. As such, the study was terminated prior to the designated follow up interval. Therefore, no outcomes data was collected.
Secondary
Effect on Anxiety and Depression in Women With Vulvodynia Based on the Kessler Psychological Distress Scale (K10)
Subjects will complete the Kessler Psychological Distress Scale (K10). It is a measure of psychological distress. Scores will range from 10 to 50, with the higher the score, the higher the mental distress Data not measured due to early discontinuation of the study prior to the designated follow up time frame.
Time frame: 4 weeks
Population: Data not measured due to early discontinuation of the study prior to the designated follow up time frame.