Interstitial Cystitis Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
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