Vulvar Vestibulitis Clinical Trial
Official title:
Use of 5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis
- 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.
- 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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