Interstitial Cystitis
Conditions
Keywords
Interstitial cystitis (IC), Oxytocin, Bladder, Void
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.
Interventions
DRUGOxytocin
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.
OTHERSaline 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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Measured as Global Response Assessment (GRA) Score at 6 and 24 Hours | 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome Measures Will Include Change From Baseline in Verbal Reports of Anxiety 6 Hours After Drug/Placebo Administration | 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 |
Countries
United States
Participant flow
Recruitment details
Protocol Open to Accrual: June 2010, Primary Completion Date: September 2015 and Study Completion Date: September 2015. Recruitment location: University of Alabama at Birmingham.
Pre-assignment details
The major goal of this project was to evaluate the efficacy of intranasal oxytocin in relieving bladder pain in a cohort of patients with interstitial cystitis.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Patients will be randomized to receive a single dose of oxytocin 40 IU (20 IU to each nostril) or saline. 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. The patient will be asked to return within a one-week period at which time the patient 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. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Change From Baseline Measured as Global Response Assessment (GRA) Score at 6 and 24 Hours
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
Time frame: 6 and 24 hours post drug or placebo administration - the data below reflects 6 hour data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Change From Baseline Measured as Global Response Assessment (GRA) Score at 6 and 24 Hours | .5 units on a scale | Standard Error 0.2 |
| Saline as a Nasal Spray | Change From Baseline Measured as Global Response Assessment (GRA) Score at 6 and 24 Hours | -.1 units on a scale | Standard Error 0.2 |
Comparison: Global Response Assessment (GRA) scores were obtained 6 and 24 hours post oxytocin or saline administration.p-value: 0.688t-test, 2 sided
Secondary
Secondary Outcome Measures Will Include Change From Baseline in Verbal Reports of Anxiety 6 Hours After Drug/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
Time frame: 6 hours post drug or placebo administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Secondary Outcome Measures Will Include Change From Baseline in Verbal Reports of Anxiety 6 Hours After Drug/Placebo Administration | -1.2 units on a scale | Standard Error 0.4 |
| Saline as a Nasal Spray | Secondary Outcome Measures Will Include Change From Baseline in Verbal Reports of Anxiety 6 Hours After Drug/Placebo Administration | -1.0 units on a scale | Standard Error 0.4 |
p-value: 0.7252t-test, 2 sided