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This study is examining impact of pain on daily life, the ability to function and treatments used for patients with interstitial cystitis/painful bladder syndrome before and after a program of mindfulness and yoga, in comparison to patients who are undergoing treatment with their providers.
This is a randomized control trial comparing women diagnosed with interstitial cystitis/painful bladder syndrome (ICPBS) receiving usual ICPBS care to those treated with usual care supplemented with meditation and yoga. Both groups continued their current ICPBS treatment regimens. Participants in the intervention group additionally received a commercially available meditation application and a yoga tutorial video. Women in either group were followed weekly for three months. Validated questionnaires were used to compare treatment response from baseline to 12 weeks of intervention for both groups. The primary outcome was the patient report on the global response assessment (GRA), and we required a sample size of 82 patients (41 per group) to detect a difference of 30% with a 10% margin of error (alpha of 0.05) with 80% power. Other questionnaires collected included the PROMIS pain interference scale, the interstitial cystitis problem index and symptom index (ICPI and ICSI), the VAS pain scale, treatment compliance, and treatment escalation.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
University of New Mexico
Albuquerque, New Mexico, United States
Start Date
May 18, 2021
Primary Completion Date
September 30, 2023
Completion Date
December 31, 2023
Last Updated
March 5, 2025
97
ACTUAL participants
Treatment
BEHAVIORAL
Usual Cares
OTHER
Lead Sponsor
University of New Mexico
NCT07391306
NCT05726786
Data Source & Attribution
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