5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

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.

Study Overview

• Status: Terminated
• Conditions: Vulvar Vestibulitis
• Intervention / Treatment: Drug: 5% topical lidocaine ointment; Drug: Placebo cream

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo cream	Drug: Placebo cream; hydrophilic petrolatum, dime-sized amount, applied nightly.
Experimental: 5% Lidocaine cream; 5% topical lidocaine cream.	Drug: 5% topical lidocaine ointment; Lidocaine 5% in hydrophilic petrolatum, dime-sized amount, applied nightly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Report the Ability to Have Intercourse	Participants' response upon inquiry.	baseline, week 8
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.	baseline, week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, week 8
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).	baseline, week 8

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Study Director: Jacqueline Rohl, MD, UNC Division of Advanced Laparoscopy and Pelvic Pain; Principal Investigator: Denniz Zolnoun, MD MPH, UNC- Division of Advanced Laparoscopy and Pelvic Pain; Study Chair: John Steege, MD, UNC Division of Advanced Laparoscopy and Pelvic Pain

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: March 21, 2007
• First Submitted That Met QC Criteria: March 21, 2007
• First Posted (Estimate): March 22, 2007

Study Record Updates

• Last Update Posted (Estimate): July 16, 2012
• Last Update Submitted That Met QC Criteria: June 12, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: vestibulitis; vulvar vestibulitis
• Additional Relevant MeSH Terms: Vulvar Diseases; Vulvitis; Vulvar Vestibulitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 05-2332