Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Oxytocin; Saline as a nasal spray
Intervention type(s): Drug; Other
Intervention description(s): 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.; 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.
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Interstitial cystitis (IC); Oxytocin; Bladder; Void