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Interstitial cystitis/bladder pain syndrome (IC/BPS) is a poorly understood disease with unreliable treatments. Although it is not known what causes it for certain, we do know that life stressors may make the disease worse or cause flares. Mindfulness Based Stress Reduction (MBSR) is an 8 week class focused on meditation and other techniques that the investigators think may be helpful to people with IC/BPS. This trial will assign participants to an MBSR class or usual care for their IC/BPS to see if the MBSR class would be helpful for their disease.
BACKGROUND/SCIENTIFIC RATIONALE Interstitial cystitis/bladder pain syndrome (IC/BPS) is associated with significant morbidity and poorly understood underlying pathophysiology. IC/BPS comprises a symptom complex defined by the American Urological Association (AUA) as "An unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six weeks duration, in the absence of infection or other identifiable causes"(1). Up to 11% of women are affected by IC/BPS (2), and the disorder may be significantly underdiagnosed (3). A 2008 study (4) indicated that 43% of patients with IC/BPS require multimodal therapy with an average of 7-12 yearly clinic visits at a cost of $9,000/patient. Twenty percent of women report wage losses of >$4000 per year (5). Current theories for the cause of IC/BPS include infectious agents, a defective uroepithelium permeable to toxic substances, structural abnormalities, neurogenic inflammation, increased neurologic sensitivity, or an allergic response involving increased numbers of bladder mast cells (6). Despite these theories, reliable treatments remain elusive. Most IC/BPS treatments target one of these proposed mechanisms, involve trial and error of several therapies (1), and often utilize multiple modalities (7). Treatment success ranges from 47-93% for intravesical instillation to 21-64% for oral therapies, with discontinuation rates up to 80% due to intolerable side effects (1). Efficacious treatments for IC/BPS that apply to a greater proportion of patients with limited side effects are urgently needed.
Mindfulness Based Stress Reduction (MBSR), a Complementary Alternative Medicine (CAM)-based therapy, potentially fulfills this need. The Interstitial Cystitis Association (ICA), a patient-led organization, sponsored a survey of 2100 IC/BPS patients. They reported that 84% had tried CAM therapy and 55% of those surveyed reported that their physicians had recommended CAM (8). According to a 2007 National Health Interview survey (9), CAM is used by 38% of adults in the United States. MBSR has been successfully employed to treat chronic pain syndromes and has been used in disorders such as multiple chemical sensitivity, chronic fatigue syndrome, fibromyalgia (10), and irritable bowel syndrome (IBS) (11). These disorders may coexist in patients with IC/BPS (6). In IC/BPS, increases in stress are positively correlated with increased pain (12); and one study reported that up to 80% of IC/BPS patients found stress reduction decreased their symptoms (8). MBSR was found to be efficacious in the treatment of urgency urinary incontinence, a urinary disorder closely related to IC/BPS (13, 14). While MBSR has shown therapeutic promise in conditions that are similar to or coexist with IC/BPS, and has been rated as helpful by patients suffering from IC/BPS, rigorous randomized clinical trials investigating the efficacy of this intervention are lacking (8).
OBJECTIVES/AIMS/HYPOTHESES Ultimately, the investigators long-term goal is to provide a much-needed treatment for IC/BPS using patient-centered therapy such as MBSR. The objective of this research is to conduct a pilot RCT to explore whether MBSR is acceptable to patients and results in improved symptoms when added to IC/BPS 1st and 2nd-line treatments as recommended in the American Urological Association guidelines (see Table 1). The investigators hypothesize that an 8-week MBSR class will be acceptable to IC/BPS patients and that MBSR used in conjunction with traditional 1st and 2nd line therapies will improve symptoms compared to IC/BPS patients using traditional 1st and 2nd line therapies alone. If this pilot study demonstrates effectiveness and acceptance of MBSR, it would provide data to justify a larger randomized controlled trial. If the investigators' hypothesis is supported with this exploratory study, MBSR, an understudied and potentially underutilized therapy, will expand treatment options for IC/BPS patients. The investigators' aims in pursuit of this goal are; Aim #1: To determine whether the addition of MBSR to 1st and 2nd line therapies as recommended by AUA guidelines improves IC/BPS symptoms as measured by the primary outcome the Global Response Assessment (GRA), as well as the O'Leary-Sant Symptom and Problem Index (OSPI), and Visual Analog (VAS) pain scale. Hypothesis: The investigators hypothesize that MBSR will be an effective treatment for IC/BPS as measured by the validated GRA, O'Leary-Sant and VAS pain scales.
Aim #2: To evaluate whether participation in a structured MBSR class will improve quality of life, sexual function and overall self-efficacy in patients with IC/BPS, based on changes in the Short Form Health Survey (SF-12), Female Sexual Function Index (FSFI), and the Pain Self-Efficacy Scale (SES). Hypothesis: The investigators' hypothesize that MBSR will improve quality of life, sexual function and impressions of self-efficacy as measured by these validated scales
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-based Stress Reduction | Experimental | Mindfulness-based Stress Reduction (MBSR) |
|
| Usual Care | Placebo Comparator | Usual medical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based Stress Reduction (MBSR) | Other |
| ||
| Usual medical therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Global Response Assessment (GRA) | 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. | Within 2 weeks of 8-week class ending |
| Measure | Description | Time Frame |
|---|---|---|
| O'Leary Sant Symptom Problem Index (OSPI) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Kanter, MD | Urogynecology Fellow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32734597 | Derived | Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness-based Stress Reduction (MBSR) | Received usual care continuing current treatments in addition to MBSR Mindfulness-based Stress Reduction (MBSR) Usual medical therapy |
| FG001 | Usual Care | Received usual care and continue current treatments Usual medical therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness-based Stress Reduction (MBSR) | Will receive usual care continuing current treatments in addition to MBSR Mindfulness-based Stress Reduction (MBSR) Usual medical therapy |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Global Response Assessment (GRA) | 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. | Posted | Number | participants | Within 2 weeks of 8-week class ending |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness-based Stress Reduction (MBSR) | Received usual care continuing current treatments in addition to MBSR Mindfulness-based Stress Reduction (MBSR) Usual medical therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregg Kanter, MD | University of New Mexico | 818-599-3456 | greggkanter@gmail.com |
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| Other |
|
| Baseline and within 2 weeks of 8-week class ending |
| Visual Analog (VAS) Pain Scale | 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. | Baseline and within 2 weeks of 8-week class ending |
| Short Form Health Survey (SF-12) | 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. | Baseline and within 2 weeks of 8-week class ending |
| Female Sexual Function Index (FSFI) | 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. Ranges: 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. | Baseline and within 2 weeks of 8-week class ending |
| Pain Self-Efficacy Scale (PSEQ) | 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. | Baseline and within 2 weeks of 8-week class ending |
Will receive usual care and continue current treatments
Usual medical therapy
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Time with IC diagnosis | Mean | Standard Deviation | years |
|
| Time with IC symptoms | Mean | Standard Deviation | years |
|
| BMI (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Race | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | O'Leary Sant Symptom Problem Index (OSPI) | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and within 2 weeks of 8-week class ending |
|
|
|
| Secondary | Visual Analog (VAS) Pain Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and within 2 weeks of 8-week class ending |
|
|
|
| Secondary | Short Form Health Survey (SF-12) | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and within 2 weeks of 8-week class ending |
|
|
|
| Secondary | Female Sexual Function Index (FSFI) | 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. Ranges: 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and within 2 weeks of 8-week class ending |
|
|
|
| Secondary | Pain Self-Efficacy Scale (PSEQ) | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and within 2 weeks of 8-week class ending |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Usual Care | Received usual care and continue current treatments Usual medical therapy | 0 | 11 | 0 | 11 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004191 |
| Behavioral Disciplines and Activities |
| OSPI Symptoms before |
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| OSPI symptoms after |
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| OSPI Problems after |
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| PCS Before |
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| PCS After |
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| Arousal before |
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| Arousal after |
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| Lubrication before |
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| Orgasm before |
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| Orgasm after |
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| Satisfaction before |
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| Satisfaction after |
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| Pain before |
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| Pain after |
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| Total before |
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| Total after |
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