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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | This is an individual treatment program devised by a pelvic floor physical therapist including a daily yoga series and mindfulness via a Smartphone app. |
|
| Control | Active Comparator | These are participants undergoing regular treatment for interstitial cystitis with their providers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment | Behavioral | This is the treatment program devised win conjunction with a pelvic floor physical therapist. It is a daily yoga series and mindfulness with a Smartphone app. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Designated as "Treatment Responders" Based on Global Response Assessment (GRA) | This is a validated single question that determines treatment response. Participants were considered "treatment responders" if they answered "markedly improved/moderately improved" on the GRA at 12 weeks. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| O'Leary-Sant: Interstitial Cystitis Symptom Index | This is a validated questionnaire to evaluate interstitial cystitis symptoms. The Interstitial Cystitis Symptoms Index Scale (ICSI) is a scale of point ranging from 0 to 20, with higher scores indicating WORSE OUTCOMES (more symptoms) | change from baseline to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kate Meriwether, MD | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Albuquerque | New Mexico | 87106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39746210 | Derived | Dao AN, Komesu YM, Jansen SM, Petersen TR, Meriwether KV. Augmentation of Interstitial Cystitis-Bladder Pain Syndrome Treatment With Meditation and Yoga: A Randomized Controlled Trial. Obstet Gynecol. 2025 Feb 1;145(2):186-195. doi: 10.1097/AOG.0000000000005820. Epub 2025 Jan 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | This is an individual treatment program devised by a pelvic floor physical therapist including a daily yoga series and mindfulness via a Smartphone app. Treatment: This is the treatment program devised win conjunction with a pelvic floor physical therapist. It is a daily yoga series and mindfulness with a Smartphone app. Usual Cares: This is standard treatment for Interstitial cystitis with your provider. |
| FG001 | Control | These are participants undergoing regular treatment for interstitial cystitis with their providers Usual Cares: This is standard treatment for Interstitial cystitis with your provider. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | This is an individual treatment program devised by a pelvic floor physical therapist including a daily yoga series and mindfulness via a Smartphone app. Treatment: This is the treatment program devised win conjunction with a pelvic floor physical therapist. It is a daily yoga series and mindfulness with a Smartphone app. Usual Cares: This is standard treatment for Interstitial cystitis with your provider. |
| 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 | Number of Participants Designated as "Treatment Responders" Based on Global Response Assessment (GRA) | This is a validated single question that determines treatment response. Participants were considered "treatment responders" if they answered "markedly improved/moderately improved" on the GRA at 12 weeks. | Posted | Count of Participants | Participants | 3 months |
|
Over 3 months during study participation.
Participants were contacted weekly during the study period and specifically asked if they experienced any adverse events and data was recorded.
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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 | Treatment | This is an individual treatment program devised by a pelvic floor physical therapist including a daily yoga series and mindfulness via a Smartphone app. Treatment: This is the treatment program devised win conjunction with a pelvic floor physical therapist. It is a daily yoga series and mindfulness with a Smartphone app. Usual Cares: This is standard treatment for Interstitial cystitis with your provider. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Patient diagnosed with COVID-19 during course of study; did not require hospitalization or have subsequent sequelae at end of study. Adverse event deemed likely not related to study participation or intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Angela Dao | University of New Mexico Health Sciences Center | 5059678428 | angela.dao@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2023 | May 15, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 19, 2021 | Jun 5, 2024 | ICF_001.pdf |
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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 |
|---|---|
| D013812 | Therapeutics |
| D026441 | Mind-Body Therapies |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
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|
| Usual Cares | Other | This is standard treatment for Interstitial cystitis with your provider. |
|
|
| O'Leary-Sant: Interstitial Cystitis Problem Index |
The Interstitial Cystitis Problem Index Scale (ICPI) is a scale of point ranging from 0 to 16, with higher scores indicating WORSE OUTCOMES (more problems) |
| change from baseline to 3 months |
| Pain VAS Score | The Pain Visual Analog Scale (VAS) Score ranges from 1 to 10, with patients ranking their pain from no pain (score of 0) to most severe pain imaginable (score of 10), with high scores indicating WORSE OUTCOMES (more pain) | change from baseline to 3 months |
| Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale | Hospital Anxiety and Depression Scale (HADS) anxiety subscale has a score range from 0 to 21, with higher scores indicating greater anxiety levels (WORSE OUTCOMES). Each item on the scale is scored from 0 to 3, contributing to the total possible score of 21 for the anxiety subscale at most (highest level of anxiety). A score of 0-7 is generally considered normal, 8-10 as mild anxiety, 11-14 as moderate anxiety, and 15 or higher as severe anxiety. | change from baseline to 3 months |
| Hospital Anxiety and Depression Scale (HADS) Depression Subscale | Hospital Anxiety and Depression Scale (HADS) depression subscale has a score ranging 0 to 21, with higher scores indicating greater levels of depression (WORSE OUTCOME). Each item on the scale is scored from 0 to 3, contributing to the total possible score of 21 for the depression subscale at most (highest level of depression). | change from baseline to 3 months |
| PROMIS Pain Interference Score | The PROMIS Pain Interference Scale (PIS) has a raw score ranging from 5 to 30, with higher scores indicating a greater level of pain interference in life (WORSE OUTCOMES). | change froom baseline to 3 months |
| Pain Self-efficacy-2 Score | The Pain Self-Efficacy Questionnaire (PSEQ) score ranges from 0 to 60, with higher scores indicating a greater belief in one's ability to manage pain and function (BETTER OUTCOMES). | change from baseline to 3 months |
| BG001 | Control | These are participants undergoing regular treatment for interstitial cystitis with their providers Usual Cares: This is standard treatment for Interstitial cystitis with your provider. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Number | participants |
|
| Marital status | Number | participants |
|
| History of substance use disorder | Number | participants |
|
| Age of diagnosis of ICBPS | Median | Inter-Quartile Range | years |
|
| Interstitial Cystitis Symptom Index Score | The Interstitial Cystitis Symptoms Index Scale (ICSI) is a scale of point ranging from 0 to 20, with higher scores indicating WORSE OUTCOMES (more symptoms) | Mean | Standard Deviation | units on a scale |
|
| Interstitial Cystitis Problem Index Score | The Interstitial Cystitis Problem Index Scale (ICPI) is a scale of point ranging from 0 to 16, with higher scores indicating WORSE OUTCOMES (more problems) | Mean | Standard Deviation | units on a scale |
|
| Pain Visual Analog Scale Score | The Pain Visual Analog Scale (VAS) Score ranges from 1 to 10, with patients ranking their pain from no pain (score of 0) to most severe pain imaginable (score of 10), with high scores indicating WORSE OUTCOMES (more pain) | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety and Depression anxiety score | Hospital Anxiety and Depression Scale (HADS) anxiety subscale has a score range from 0 to 21, with higher scores indicating greater anxiety levels (WORSE OUTCOMES). Each item on the scale is scored from 0 to 3, contributing to the total possible score of 21 for the anxiety subscale at most (highest level of anxiety). A score of 0-7 is generally considered normal, 8-10 as mild anxiety, 11-14 as moderate anxiety, and 15 or higher as severe anxiety. | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety and Depression depression score | Hospital Anxiety and Depression Scale (HADS) depression subscale has a score ranging 0 to 21, with higher scores indicating greater levels of depression (WORSE OUTCOME). Each item on the scale is scored from 0 to 3, contributing to the total possible score of 21 for the depression subscale at most (highest level of depression). | Mean | Standard Deviation | units on a scale |
|
| PROMIS Pain Interference Score | The PROMIS Pain Interference Scale (PIS) has a raw score ranging from 5 to 30, with higher scores indicating a greater level of pain interference in life (WORSE OUTCOMES). | Mean | Standard Deviation | units on a scale |
|
| Pain self efficacy score | The Pain Self-Efficacy Questionnaire (PSEQ) score ranges from 0 to 60, with higher scores indicating a greater belief in one's ability to manage pain and function (BETTER OUTCOMES). | Mean | Standard Deviation | units on a scale |
|
| Prior treatments | Number | participants |
|
| Control |
These are participants undergoing regular treatment for interstitial cystitis with their providers Usual Cares: This is standard treatment for Interstitial cystitis with your provider. |
|
|
| Secondary | O'Leary-Sant: Interstitial Cystitis Symptom Index | This is a validated questionnaire to evaluate interstitial cystitis symptoms. The Interstitial Cystitis Symptoms Index Scale (ICSI) is a scale of point ranging from 0 to 20, with higher scores indicating WORSE OUTCOMES (more symptoms) | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 3 months |
|
|
|
| Secondary | O'Leary-Sant: Interstitial Cystitis Problem Index | The Interstitial Cystitis Problem Index Scale (ICPI) is a scale of point ranging from 0 to 16, with higher scores indicating WORSE OUTCOMES (more problems) | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 3 months |
|
|
|
| Secondary | Pain VAS Score | The Pain Visual Analog Scale (VAS) Score ranges from 1 to 10, with patients ranking their pain from no pain (score of 0) to most severe pain imaginable (score of 10), with high scores indicating WORSE OUTCOMES (more pain) | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 3 months |
|
|
|
| Secondary | Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale | Hospital Anxiety and Depression Scale (HADS) anxiety subscale has a score range from 0 to 21, with higher scores indicating greater anxiety levels (WORSE OUTCOMES). Each item on the scale is scored from 0 to 3, contributing to the total possible score of 21 for the anxiety subscale at most (highest level of anxiety). A score of 0-7 is generally considered normal, 8-10 as mild anxiety, 11-14 as moderate anxiety, and 15 or higher as severe anxiety. | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 3 months |
|
|
|
| Secondary | Hospital Anxiety and Depression Scale (HADS) Depression Subscale | Hospital Anxiety and Depression Scale (HADS) depression subscale has a score ranging 0 to 21, with higher scores indicating greater levels of depression (WORSE OUTCOME). Each item on the scale is scored from 0 to 3, contributing to the total possible score of 21 for the depression subscale at most (highest level of depression). | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 3 months |
|
|
|
| Secondary | PROMIS Pain Interference Score | The PROMIS Pain Interference Scale (PIS) has a raw score ranging from 5 to 30, with higher scores indicating a greater level of pain interference in life (WORSE OUTCOMES). | Posted | Mean | Standard Deviation | score on a scale | change froom baseline to 3 months |
|
|
|
| Secondary | Pain Self-efficacy-2 Score | The Pain Self-Efficacy Questionnaire (PSEQ) score ranges from 0 to 60, with higher scores indicating a greater belief in one's ability to manage pain and function (BETTER OUTCOMES). | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 3 months |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 1 |
| 49 |
| EG001 | Control | These are participants undergoing regular treatment for interstitial cystitis with their providers Usual Cares: This is standard treatment for Interstitial cystitis with your provider. | 0 | 48 | 0 | 48 | 0 | 48 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |