Mindfulness-Based Therapy for Interstitial Cystitis/Bladder Pain Syndrome
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|ClinicalTrials.gov Identifier: NCT02457182|
Recruitment Status : Completed
First Posted : May 29, 2015
Results First Posted : October 8, 2018
Last Update Posted : October 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Interstitial Cystitis Mindfulness Complementary Medicine Painful Bladder Syndrome||Other: Mindfulness-based Stress Reduction (MBSR) Other: Usual medical therapy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mindfulness-Based Therapy for Interstitial Cystitis/Bladder Pain Syndrome|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: Mindfulness-based Stress Reduction
Mindfulness-based Stress Reduction (MBSR)
Other: Mindfulness-based Stress Reduction (MBSR)
Other: Usual medical therapy
Placebo Comparator: Usual Care
Usual medical therapy
Other: Usual medical therapy
- Global Response Assessment (GRA) [ Time Frame: Within 2 weeks of 8-week class ending ]The GRA is a 7-point scale, with scores ranging from markedly, moderately or slightly worse to slightly, moderately or markedly improved. This measure is used in many types of research and is not specific to IC/BPS.
- O'Leary Sant Symptom Problem Index (OSPI) [ Time Frame: Baseline and within 2 weeks of 8-week class ending ]
The OSPI is a Interstitial cystitis (IC/BPS)-specific scale composed of the symptom index and problem index as well as a total, which sums the symptom and problem scores caused by IC/BPS.
Symptom scores range from 0-21. Problem scores range from 0-16 Higher scores indicate a worse condition. Total scores range 0-37, with higher scores indicating a worse condition.
- Visual Analog (VAS) Pain Scale [ Time Frame: Baseline and within 2 weeks of 8-week class ending ]The VAS scale is a 10-point scale ranging from 0 (no pain) to 10 (unbearable pain). 0 is considered better while 10 is considered worse.
- Short Form Health Survey (SF-12) [ Time Frame: Baseline and within 2 weeks of 8-week class ending ]The short form health survey (SF-12) is a scale used to evaluate chronic conditions. It is composed of a mental component and physical component. Each is made up of 12 questions totaling a score of 100 points. A zero score indicates the lowest level of health measured and 100 indicates the highest level of health.
- Female Sexual Function Index (FSFI) [ Time Frame: Baseline and within 2 weeks of 8-week class ending ]
The FSFI measures sexual function. It is composed of 6 individual domain scores (desire, arousal, lubrication, orgasm, satisfaction and pain), which are summed to create a total score. Higher scores indicate better sexual function.
Desire 2-10 Arousal 0-20 Lubrication 0-20 Orgasm 0-15 Satisfaction 2-15 Pain 0-15 Total score ranges from 4-95 and is calculated by adding the 6 domains together. Again, higher scores indicate better sexual function.
- Pain Self-Efficacy Scale (PSEQ) [ Time Frame: Baseline and within 2 weeks of 8-week class ending ]
The PSEQ is a scale describing how patients rate their abilities to complete daily activities.
It is a 60 point scale (scores range from 0-60) composed of 10 questions. Higher numbers signify better functioning or less limit by disease. A total score is calculating by summing individual items.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457182
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Gregory Kanter, MD||Urogynecology Fellow|