Interstitial Cystitis, Vulvar Diseases
Conditions
Keywords
interstitial cystitis, rare disease, renal and genitourinary disorders, vulvar vestibulitis
Brief summary
OBJECTIVES: I. Estimate the optimal safe dose of intravesical capsaicin in patients with interstitial cystitis. II. Evaluate the efficacy of 0.025% topical capsaicin in relieving chronic burning pain in patients with vulvar vestibulitis. III. Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar skin. IV. Evaluate the effect of C fiber depletion on urinary levels of histamine and prostaglandin.
Detailed description
PROTOCOL OUTLINE: This is a randomized study. Patients with interstitial cystitis are randomly assigned to 1 of 3 pain control therapies. The first group is treated with capsaicin. A second group is given individually titrated doses of capsaicin: the dose is increased as tolerated or until symptomatic response is acceptable. A control group receives a placebo. Therapy for all groups is administered intravesically every week for 5 weeks. Patients with vulvar vestibulitis are randomly assigned to 1 of 2 pain control therapies. One group applies topical capsaicin cream to the painful area 4 times a day for 6 weeks. The dose is individually titrated if burning discomfort persists and the patient is compliant with the application schedule. The control group applies a placebo. Patients with vulvar vestibulitis may continue or cross to capsaicin for 6 additional weeks.
Interventions
DRUGcapsaicin
DRUGPlacebo
Sponsors
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Women with interstitial cystitis by National Institute of Diabetes and Digestive and Kidney Diseases criteria Vulvar vestibulitis by International Society for the Study of Vulvar Disease, i.e.: Severe pain on touch or attempted entry of vagina Tenderness to pressure within the vulvar vestibule Vulvar erythema Duration of symptoms at least 6 months Absence of vulvovaginal infection, i.e.: No fungus No trichomonas No chlamydia No gonorrhea No clue cells in vaginal discharge
Countries
United States
Outcome results
None listed