Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis
Information source: University of Alabama at Birmingham
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Interstitial Cystitis; Painful Bladder Disorder
Intervention: Oxytocin (Drug); Saline as a nasal spray (Other)
Phase: N/A
Status: Not yet recruiting
Sponsored by: University of Alabama at Birmingham Official(s) and/or principal investigator(s):
Meredith T Robbins, PhD, Principal Investigator, Affiliation: University of Alabama at Birmingham
Overall contact:
Debbie M Owen, BS, Phone: 205-975-2088, Email: debbieo@uab.edu
Summary
Anecdotal evidence suggests female patients with painful bladder disorder interstitial
cystitis (IC) can experience a significant attenuation of their systems while breastfeeding.
Since it has been shown that postpartum lactation is a time associated with decreased
levels of stress, and stress has been shown to exacerbate IC-related pain, the investigators
have developed an interest in the effects of the hormones involved in postpartum lactation
on stress and pain. Based on a series of pre-clinical experiments, the investigators
believe the hormone oxytoxin has both analgesic and anxiolytic properties which make it a
potentially useful agent for the treatment of stress-exacerbated chronic pain syndrome such
as IC. Therefore, the investigators propose a double-blinded, placebo-controlled crossover
trial of intranasal oxytocin vs. intranasal saline for bladder pain in a cohort of patients
with IC and some degree of continuous, daily pain.
Clinical Details
Official title: Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Our primary outcome measure will be the global response assessment(GRA)score
Secondary outcome: Secondary outcome measures will include verbal reports of anxiety and pain, micturition frequency, and concomitant medication use for pain and/or anxiety.
Eligibility
Minimum age: 19 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 19 - 65 years of age
- Must meet the current National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) diagnostic criteria for interstitial cystitis and have some degree
of continuous daily pain
Exclusion Criteria:
- Pregnancy
- Under the age of 19
- Older that the age of 65
- Breastfeeding women
- Uncontrolled hypertension
- History of significant cardiac or pulmonary disease (including arrhythmias)
- Known allergy to oxytocin
- Severe psychiatric disease
- Patients who have undergone procedural interventions within the past month related to
their interstitial cystitis
Locations and Contacts
Debbie M Owen, BS, Phone: 205-975-2088, Email: debbieo@uab.edu
University of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Additional Information
Starting date: November 2009
Ending date: November 2010
Last updated: June 11, 2009
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