Irritable Bowel Syndrome Clinical Trial
Official title:
Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments
Verified date | June 2024 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Vestibulodynia (VBD) is a complex chronic vulvar pain condition that impairs the psychological, physical, and sexual health of 1 in 6 reproductive aged women in the United States. Here, the investigators plan to conduct a randomized, double-blinded, placebo-controlled clinical trial to 1) compare the efficacy of peripheral (lidocaine/estradiol cream), centrally-targeted (nortriptyline), and combined treatments in alleviating pain and improving patient-reported outcomes and 2) determine cytokine and microRNA biomarkers that predict treatment response in women with distinct VBD subtypes. Positive findings from this study will readily translate to improved patient care, permitting the millions of women with VBD, their partners, and their clinicians to make more informed decisions about pain management.
Status | Completed |
Enrollment | 223 |
Est. completion date | May 30, 2024 |
Est. primary completion date | March 13, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria 1. Female 2. Age 18-50 years 3. English-literate 4. Willingness to provide informed consent 5. Meeting criteria for diagnosis of VBD based on: 1. self-report of 3 continuous months of insertional (entryway) dyspareunia, and/or pain to touch/tampon insertion 2. pain score of = 3 on the tampon insertion test Exclusion Criteria 1. Use of daily topical lidocaine, or estradiol, or lidocaine/estradiol to the vulvar vestibule within the past three months 2. Use of nortriptyline or other TCA medications within the past three months 3. Use of pregabalin or gabapentin within the past three months 4. Presence of active dermatologic vulvar disease or vaginal infection 5. Untreated atrophic vaginitis (participants may undergo treatment and re-evaluation for enrollment if the condition is resolved) 6. Previous vestibulectomy 7. Pregnant or planning on becoming pregnant during the study period. Within the first six months of the postpartum period. Currently breastfeeding/lactating, or within three months of discontinuing breastfeeding/lactation. 8. Active incarceration 9. Cancer within the past year. 10. Chemotherapy and/or radiation treatment within the past year. 11. Unstable medical condition (e.g., renal impairment, significant hematological disease, cardiovascular disease, hepatic insufficiency, neurological disorder, autoimmune disease, or respiratory illness) 12. Clear inflammatory states (e.g., morbid obesity) 13. Use of immunosuppressant medications 14. History of intolerance to nortriptyline, topical lidocaine, or topical estradiol 15. Contraindications to use of nortriptyline: current use, or use within the past 3 months, of MAOIs, SSRIs, SNRIs, NDRIs; recent (within the past year) myocardial infarction, active psychotic or suicidal thoughts, narrow angle closure glaucoma 16. Contraindications to the use of lidocaine or local anesthetics 17. Contraindications to the use of topical estrogen therapy 18. Post-menopausal, defined as no menses for 12 consecutive months or surgical removal of both ovaries. (Hysterectomy is not an exclusion) 19. Have not had Botox of the pelvic floor muscles in the last 12 months, or pelvic nerve blocks in the last three months. 20. Are not currently enrolled or planning to enroll in another clinical trial during the course of this trial. 21. Are not currently receiving pelvic physical therapy |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | University of California, Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Duke University | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in pain score during the tampon test | The Tampon Test will provide a self-reported numeric rating scale of pain with self-tampon insertion, performed by the patient and reported to the research nurse. Participants will be asked to verbally rate the pain on a scale of 0-10, with 0 meaning no pain and 10 meaning the worst possible pain. | Baseline, 16 weeks | |
Primary | Change in self-reported pain via the Short Form- McGill Pain Questionnaire (SF-MPQ) | The SF-MPQ will be used to create a summary score. The SF-MPQ measures perceived sensory qualities of pain using 11 describers and affective qualities related to pain using 5 describers. Responses on 4-point scales are summed to compute scores for each section. | Baseline, 16 weeks | |
Primary | Change in self-reported physical/mental health via SF-12 Health Survey (SF12v2) | The SF-12 assesses 6 domains: global health, physical functioning, physical roles, emotional functioning, emotional roles and pain interference using an algorithm based on answers to 12 physical and mental health-related questions. | Baseline, 16 weeks | |
Primary | Change in sexual health via Patient-Reported Outcomes Measurement Information System (PROMIS) | The PROMIS score is based on a 96-item form developed by the NIH that measures 11 domains of biopsychosocial function and includes an assessment of sexual function measures (e.g., desire, frequency, fear, and pain) related to sexual intercourse. | Baseline, 16 weeks | |
Primary | Change in inflammation as measured by cytokine expression levels | Cytokine expression levels will be measured via mesoscale discovery assays. | Baseline, 16 weeks | |
Primary | Change in regulators of pro-pain and pro-inflammatory genes, as measured by microRNA expression levels | MicroRNA expression levels will be measured via sequencing read. | Baseline, 16 weeks | |
Secondary | Change in pain level as measured by Vaginal Vestibule Pressure Pain Intensities (PPI) | Vaginal Vestibule PPIs will be determined using a cotton swab applied to 6 externally-accessed sites (at 12, 10, 7, 6, 5, 2 o'clock on the vestibule) for 1-2 seconds. Upon application of cotton swab at each site, participants will rate their pain intensity on a scale from 0-10. | Baseline, 8 weeks, 16 weeks, and 24 weeks | |
Secondary | Levator Muscle Complex Pressure Pain Thresholds (PPTs) | Levator Muscle Complex PPTs will be determined using a digital vestibular algometer applied internally to the right, midline, and left puborectalis levator muscles sites (5, 6, and 7 o'clock) just lateral to the perineum. | Baseline, 8 weeks, 16 weeks, and 24 weeks | |
Secondary | Change in pain level as measured by Remote Bodily PPTs | Remote Bodily PPTs will be determined by applying the algometer to 3 'neutral' non-pelvic body sites (deltoid, shin, and trapezius), right and left, beginning at 1N and increasing until the participant's first sensation of pain. A composite score will be calculated. | Baseline, 8 weeks, 16 weeks, and 24 weeks | |
Secondary | Change in degree of overlapping pain, as measured by COPC follow-up survey | The COPC survey consists of 2 questions used to determine the change in degree of overlapping pain. | Baseline, 8 weeks, 16 weeks, and 24 weeks | |
Secondary | Change in mood as measured by the Symptom Checklist-27 (SCL-27) | Symptom Check List 27 (SCL-27) questionnaire will be used to measure a broad range of psychological symptoms (e.g., anxiety and depression). | Baseline, 8 weeks, 16 weeks, and 24 weeks | |
Secondary | Change in somatic awareness via Pennebaker Index of Limbic Languidness (PILL) | Pennebaker Index of Limbic Languidness (PILL) is used to create a summary score of somatic symptoms (e.g., itchy eyes, dizziness). Symptom frequency is recorded on a five-point Likert scale ranging from "never" to "more than once a week". | Baseline, 8 weeks, 16 weeks, and 24 weeks | |
Secondary | Change in perceived stress via Perceived Stress Scale (PSS) | The Perceived stress scale (PSS) is a 10-item scale that measures the impact of personal stress on thoughts and feelings. | Baseline, 8 weeks, 16 weeks, and 24 weeks | |
Secondary | Change in sleep as measured by the sleep scale | The sleep scale is a 12-item scale that measures amount of sleep and ease/difficulty of initiating and maintaining sleep. | Baseline, 8 weeks, 16 weeks, and 24 weeks | |
Secondary | Change in in pain score during the tampon test at other time points | Change in pain score during the tampon test will be measured as described above. | 8 weeks and 24 weeks | |
Secondary | Change in in pain score via the SF-MPQ at other time points | Change in pain score via the SF-MPQ will be measured as described above. | 8 weeks and 24 weeks | |
Secondary | Change in self-reported health on the SF12v2 at other time points | Change in self-reported health on the SF12v2 will be measured as described above. | 8 weeks and 24 weeks | |
Secondary | Change in self-reported health on the PROMIS at other time points | Change in self-reported outcomes on the PROMIS will be measured. The PROMIS score is based on a 96-item form developed by the NIH that measures 11 domains of biopsychosocial function and includes an assessment of sexual function measures (e.g., desire, frequency, fear, and pain) related to sexual intercourse. | 8 weeks and 24 weeks | |
Secondary | Change in cytokine biomarkers at other time points | Change in cytokine levels will be measured as described above. | 8 weeks and 24 weeks | |
Secondary | Change in microRNA biomarkers at other time points | Change in microRNA levels will be measured as described above. | 8 weeks and 24 weeks |
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