Clinical trial NCT00450242: 5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis
Official title: Use of 5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Vulvar Vestibulitis
Keywords: vulvar vestibulitis
vestibulitis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2007-03-22
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Report the Ability to Have Intercourse
timeFrame: baseline, week 8
measure: Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8
timeFrame: baseline, week 8
Secondary outcomes:
measure: SF-12 Quality of Life Scores
timeFrame: baseline, week 8
measure: Modified Gracely Pain Scale
timeFrame: baseline, week 8
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: UNC Division of Advanced Laparoscopy and Pelvic Pain
name: Jacqueline Rohl, MD
role: STUDY_DIRECTOR
affiliation: UNC- Division of Advanced Laparoscopy and Pelvic Pain
name: Denniz Zolnoun, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC Division of Advanced Laparoscopy and Pelvic Pain
name: John Steege, MD
role: STUDY_CHAIR
References: