Status:
COMPLETED
Study of Biomarkers and the Relaxation Response Using Guided Imagery in Women With IC
Lead Sponsor:
Corewell Health East
Conditions:
Interstitial Cystitis
Pelvic Pain
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Interstitial cystitis (IC) affects more than one million women in the United States. It has been thought that IC patients who have been unable to obtain adequate relief from medical remedies would val...
Detailed Description
This is a randomized pilot study. Women who are referred to the Nurse Practitioner for treatment will be invited to enroll. If the patient meets the study criteria, the study will be explained. If the...
Eligibility Criteria
Inclusion
- Established diagnosed IC patient
- Women at least 18 years of age
- Self reported pelvic pain
- Capable of giving informed consent
- Capable and willing to follow all study related procedures (e.g. keep voiding diary, pain diary, complete questionnaires, listening to CD, obtaining salivary samples).
- Participants must have a stable medication regimen.
- Neuromodulation (if present) must stay stable throughout the study.
Exclusion
- Currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function. Patients with neuromodulation devices are excluded for the first 3 months after insertion of the device.
- Use of this guided imagery CD within the past 30 days.
- Diagnosed depression
- Pregnancy or intending to become pregnant during the study
- Cannot independently comprehend and complete the questionnaires.
- The subject is deemed unsuitable for enrollment in this study by the investigators based on their history.
- Men are excluded
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00420550
Start Date
January 1 2007
End Date
December 1 2007
Last Update
March 21 2012
Active Locations (1)
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1
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073