Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis

NCT ID: NCT00919802

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2015-09-30

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.

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.

Conditions

Interstitial Cystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oxytocin

Oxytocin, 40 IU intranasally, once

Group Type: ACTIVE_COMPARATOR

Oxytocin

Intervention Type: DRUG

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.

Saline as a nasal spray

Saline, 4ml intranasally, once

Group Type: PLACEBO_COMPARATOR

Saline as a nasal spray

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Syntocinon

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Tim Ness, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meredith T Robbins, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

UAB0001

Identifier Type: -

Identifier Source: org_study_id