Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis

• ClinicalTrials.gov Identifier: NCT00919802
• Recruitment Status: Completed
• First Posted: June 12, 2009
• Results First Posted: May 23, 2017
• Last Update Posted: May 23, 2017
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Tim Ness, MD, University of Alabama at Birmingham

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Interstitial Cystitis	Drug: Oxytocin; Other: Saline as a nasal spray	Phase 4

Detailed Description:

Fifty patients will be enrolled in a double-blinded, placebo-controlled single-dose crossover trial comparing intranasal oxytocin to intranasal saline. At the time of enrollment, patients will complete a series of standardized questionnaires detailing information about their IC-related symptoms at baseline as well as comorbid conditions, coping mechanisms (specifically catastrophizing), and baseline ratings of overall pain, depression, anxiety, and global functioning. Once this information is obtained, the patient will receive a one-time dose of intranasal oxytocin or an equivalent volume of intranasal saline. The patients will be monitored for one hour by a physician investigator for toxicities and efficacy and then contacted for follow-up information at 2, 4, 6, and 24 hours. At each of these time points, the patient will be asked to report a verbal pain report, a verbal anxiety report, the number of voids since last contact with an investigator, and the use of any additional medications for pain control or anxiety. In addition, a global response assessment (GRA) score will be obtained at 6 and 24 hours. The patient will be asked to return within a one week period at which time he/she will receive the alternative intranasal agent. Following the second dose, the patient will be monitored for one hour and contact made at 2, 4, 6, and 24 hours as previously described.

The primary outcome measure will be the GRA score, which will be analyzed using a Chi-square analysis followed by Fischer's exact test. Secondary outcome measures will be analyzed via ANOVA.

If this study indicates that intranasal oxytocin is efficacious for pain control, this could provide for an alternative to current ineffective or invasive treatments for IC-related pain. It is also possible it could eventually be utilized for other forms of chronic pain as well.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis
• Study Start Date: June 2010
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: September 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Oxytocin; Oxytocin, 40 IU intranasally, once	Drug: Oxytocin; A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of saline as an alternate agent on the second day if needed.; Other Name: Syntocinon
Placebo Comparator: Saline as a nasal spray; Saline, 4ml intranasally, once	Other: Saline as a nasal spray; A single dose of saline will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of oxytocin 40 IU as an alternate agent on the second day if needed.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline Measured as Global Response Assessment (GRA) Score at 6 and 24 Hours [ Time Frame: 6 and 24 hours post drug or placebo administration - the data below reflects 6 hour data ]
   This is a seven-point symmetric scale previously validated for use in IC studies in which patients are asked relative to baseline (over the last 6 hours for purposes of this study), -3 -are you markedly worse, -2 -moderately worse, -1 -slightly worse, 0-no change, +1-slightly improved, +2-moderately improved, or +3-markedly improved. A +2 or +3 can be defined categorically as a positive treatment response

Secondary Outcome Measures :

1. Secondary Outcome Measures Will Include Change From Baseline in Verbal Reports of Anxiety 6 Hours After Drug/Placebo Administration [ Time Frame: 6 hours post drug or placebo administration ]
   A verbal anxiety report (VAR; 0-10 with 0 being no anxiety and 10 being the worst possible anxiety); a change from baseline measure was calculated for value measured 6 hours post drug/placebo administration

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

• Principal Investigator: Meredith T Robbins, PhD; University of Alabama at Birmingham

More Information

• Responsible Party: Tim Ness, MD, MD, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT00919802
• Other Study ID Numbers: UAB0001
• First Posted: June 12, 2009
• Results First Posted: May 23, 2017
• Last Update Posted: May 23, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified raw data will be made available on request by contacting contact investigator at tness@uabmc.edu

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tim Ness, MD, University of Alabama at Birmingham:

Interstitial cystitis (IC); Oxytocin; Bladder; Void

Additional relevant MeSH terms:

Cystitis; Cystitis, Interstitial; Urinary Bladder Diseases; Urologic Diseases; Oxytocin; Oxytocics; Reproductive Control Agents; Physiological Effects of Drugs