Phase 4
N=25
Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis
Interstitial Cystitis
Bottom Line
View on ClinicalTrials.gov: NCT00919802 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Change From Baseline Measured as Global Response Assessment (GRA) Score at 6 and 24 Hours — .5; -.1 units on a scale — p=0.688
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxytocin (Drug); Saline as a nasal spray (Other)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Measured as Global Response Assessment (GRA) Score at 6 and 24 Hours |
.5; -.1 | 0.688 |
| SECONDARY Secondary Outcome Measures Will Include Change From Baseline in Verbal Reports of Anxiety 6 Hours After Drug/Placebo Administration |
-1.2; -1.0 | 0.7252 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00919802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.