Vulvar Vestibulitis
Conditions
Keywords
vulvar vestibulitis, vestibulitis
Brief summary
* Study Hypothesis: Use of 5% topical lidocaine ointment will result in improved ability to have sexual intercourse and decreased pain scores in women with vestibulitis when compared to placebo. * This is a study to assess if topical lidocaine will improve symptoms in women with vulvar vestibulitis. It compares use of nightly 5% topical lidocaine ointment to placebo ointment. The duration of the study is 8 weeks. 28 women will be in each arm for a total of 56 women in the study.
Detailed description
* After consent is obtained patients will undergo the following treatment plan: randomization to treatment with 5% lidocaine ointment or placebo for vestibulitis. There will be 56 women total (28 in each arm).The placebo used will be hydrophilic petrolatum. Randomization will be performed using computer generated permuted blocks. A standard history and physical exam incorporating assessment of skin allodynia (testing with q-tip swab) on the vestibule and pressure measurements of the pelvic floor muscles (how much tenderness there is on perineal muscles with palpation) will be performed. Baseline questionnaires that will evaluate sexual frequency, sexual function survey (Female sexual function index), the modified Gracely pain scale of intercourse related pain, and psychometric evaluation including evaluation of anxiety, somatization (State-Trait Anxiety Inventory and Brief Symptom Inventory). Depression can also be evaluated with the Brief Symptom Inventory. Lastly, overall quality of health can be assessed with the SF-12. There is a baseline, 2 week and 6 week visit. Women will abstain from intercourse during these 6 weeks. Women will have a physical exam evaluation of the vestibule at each visit. They will then be able to have intercourse and will repeat surveys of sexual frequency, function, pain scale of intercourse related pain and the SF-12 at 8 weeks. * Aim 1: To assess if lidocaine ointment produces a superior treatment response to placebo. * Hypothesis 1: Use of topical lidocaine, compared with placebo, will result in improved sexual function and self-reported pain scores. This is to be measured as the ability to have successful intercourse. Secondarily, sexual function, quality of life and scores for intercourse related pain will be evaluated. * Aim 2: To assess if there are predictors of response to treatment such as demographics, duration of disease, primary or secondary vulvar vestibulitis, or psychometric assessments (anxiety and somatization). * Hypothesis 2: There are predictors of response to treatment of vulvar vestibulitis based upon patient characteristics, characteristics of the disease and psychometric assessments.
Interventions
DRUG5% topical lidocaine ointment
Lidocaine 5% in hydrophilic petrolatum, dime-sized amount, applied nightly.
DRUGPlacebo cream
hydrophilic petrolatum, dime-sized amount, applied nightly.
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* women with the clinical diagnosis of vvs who have dyspareunia as their primary complaint. They must have a current sexual partner.
Exclusion criteria
* postmenopausal * pure vaginismus * generalized vulvodynia * pudendal neuralgia * pregnant, breastfeeding * less than 2 months post delivery * diagnosis of dermatologic condition on biopsy * positive fungal culture * currently on treatment for vvs * history of lidocaine treatment for vvs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Report the Ability to Have Intercourse | baseline, week 8 | Participants' response upon inquiry. |
| Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8 | baseline, week 8 | Visual Analog Scale (VAS) scores (range 0-100 mm; 0 = none, 100 = worst pain) were recorded for pain during intercourse during baseline and week 8 of the study, for lidocaine treated subjects and controls. The mean listed for each group is average week 8 score subtracted from the average baseline score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-12 Quality of Life Scores | baseline, week 8 | The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, and age. |
| Modified Gracely Pain Scale | baseline, week 8 | The Modified Gracely Pain Scale consists of two components: 1) three numerical scales scored 0-100 for lowest, average, and highest pain level during during the preceding week, and 2) two word choice scales measuring affective and intensity levels. Each word in the word choice scales has an assigned number. Change scores on each subscale can thus be calculated over time (baseline v. week 8). |
Countries
United States
Participant flow
Recruitment details
A total of 14 subjects were recruited via advertisement and clinical referrals from within the medical center and from the community of referring physicians.
Participants by arm
| Arm | Count |
|---|---|
| 5% Lidocaine Cream 5% topical lidocaine cream. | 7 |
| Placebo Cream | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | Placebo Cream | 5% Lidocaine Cream | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 14 Participants |
| Age Continuous | 29.4 years STANDARD_DEVIATION 5.7 | 30.9 years STANDARD_DEVIATION 8.5 | 29.9 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 7 participants | 7 participants | 14 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 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 / 4 | 0 / 6 |
| serious Total, serious adverse events | 0 / 4 | 0 / 6 |
Outcome results
Primary
Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8
Visual Analog Scale (VAS) scores (range 0-100 mm; 0 = none, 100 = worst pain) were recorded for pain during intercourse during baseline and week 8 of the study, for lidocaine treated subjects and controls. The mean listed for each group is average week 8 score subtracted from the average baseline score.
Time frame: baseline, week 8
Population: three lidocaine subjects and one control subject failed to complete the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5% Lidocaine Cream | Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8 | 2.5 units on a scale | Standard Deviation 10.3 |
| Placebo Cream | Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8 | 19.7 units on a scale | Standard Deviation 24.3 |
Primary
Number of Participants Who Report the Ability to Have Intercourse
Participants' response upon inquiry.
Time frame: baseline, week 8
Population: Three lidocaine subjects and one control subject failed to complete the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5% Lidocaine Cream | Number of Participants Who Report the Ability to Have Intercourse | 4 participants |
| Placebo Cream | Number of Participants Who Report the Ability to Have Intercourse | 6 participants |
Secondary
Modified Gracely Pain Scale
The Modified Gracely Pain Scale consists of two components: 1) three numerical scales scored 0-100 for lowest, average, and highest pain level during during the preceding week, and 2) two word choice scales measuring affective and intensity levels. Each word in the word choice scales has an assigned number. Change scores on each subscale can thus be calculated over time (baseline v. week 8).
Time frame: baseline, week 8
Population: The study terminated due to lack of funding and difficulties with recruitment. More extensive data analysis to include secondary outcome measures was not performed due to inability to fund statistical programming and analysis efforts.
Secondary
SF-12 Quality of Life Scores
The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, and age.
Time frame: baseline, week 8
Population: The study terminated due to lack of funding and difficulties with recruitment. More extensive data analysis to include secondary outcome measures was not performed due to inability to fund statistical programming and analysis efforts.