Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis
Status: | Completed |
---|---|
Conditions: | Other Indications, Pain, Urology |
Therapuetic Areas: | Musculoskeletal, Nephrology / Urology, Other |
Healthy: | No |
Age Range: | 19 - 65 |
Updated: | 4/21/2016 |
Start Date: | June 2010 |
End Date: | September 2015 |
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.
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.
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.
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.
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
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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