Interstitial CystitisMYPAICENCT04820855
Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation
A study testing Treatment in people with Interstitial Cystitis, run by University of New Mexico at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- >=Age 18
- IC/BPS diagnosis
- English or Spanish reading/writing
- Own a Smartphone and able to watch online yoga tutorials
- Ability/willingness to participate in follow up questionnaires
- ICSI/ICPI >6 at baseline
- Physical exam in the past 2 years by urogynecology or gynecologist
Who cannot join
- Pregnancy or lactating
- Inability to speak/write in English/Spanish
- Known history of recurrent UTI
- Urinary retention ( PVR>150 ml)
- History of augmentation cystoplasty or urinary diversion.
- History of chemotherapy/radiation or radiation induced cystitis
Show all 13Show fewer
- Hunner's Ulcers demonstrated in last 6 months by cystoscopy
- Parkinsonism with neurogenic bladder
- Multiple Sclerosis with neurogenic bladder
- CVA with residual deficits
- Patients with severe mobility impairment and inability to perform yoga postures
- Patients who are hard of hearing or visually impaired
- Imprisoned patients
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87106
About this study
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.
Read the detailed description
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.
- Conditions
- Interstitial Cystitis
- Being tested
- Treatment, Usual Cares
- Keywords
- Interstitial cystitis, Complementary and Alternative medicine, Yoga, Meditation
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentBehavioural
Also called Mind/Body Therapy
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 CaresOther
Also called Standard Cares
This is standard treatment for Interstitial cystitis with your provider.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Treatment; Other: Usual Cares |
| Control | Active comparator | These are participants undergoing regular treatment for interstitial cystitis with their providers Receives: Other: Usual Cares |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (7)
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)
Measured: change from baseline to 3 months
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)
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: change from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start18 May 2021
- Primary completion30 Sep 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kate Meriwether, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820855
- Sponsor's protocol ID
- 20-664
- Acronym
- MYPAICE
- Status last verified
- Feb 2025
- First submitted
- 15 Mar 2021
- Last updated
- 5 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39746210
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation
- ClinicalTrials.gov ID
- NCT04820855
- Acronym / sponsor ID
- MYPAICE / 20-664
- Conditions
- Interstitial Cystitis
- Keywords
- Interstitial cystitis, Complementary and Alternative medicine, Yoga, Meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Posted 5 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Treatment, Other: Usual CaresThis 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 | Other: Usual CaresThese are participants undergoing regular treatment for interstitial cystitis with their providers |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female
- >=Age 18
- IC/BPS diagnosis
- English or Spanish reading/writing
- Own a Smartphone and able to watch online yoga tutorials
Key exclusion criteria (13 listed)
- Pregnancy or lactating
- Inability to speak/write in English/Spanish
- Known history of recurrent UTI
- Urinary retention ( PVR>150 ml)
- History of augmentation cystoplasty or urinary diversion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreatmentAlso: Mind/Body TherapyThis 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. | Behavioural | Treatment |
| Usual CaresAlso: Standard CaresThis is standard treatment for Interstitial cystitis with your provider. | Other | Control, Treatment |
Primary outcome
Number of Participants Designated as "Treatment Responders" Based on Global Response Assessment (GRA)
Time frame: 3 months
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.
7 secondary outcomes
O'Leary-Sant: Interstitial Cystitis Symptom Index
Time frame: change from baseline to 3 months
O'Leary-Sant: Interstitial Cystitis Problem Index
Time frame: change from baseline to 3 months
Pain VAS Score
Time frame: change from baseline to 3 months
Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale
Time frame: change from baseline to 3 months
Hospital Anxiety and Depression Scale (HADS) Depression Subscale
Time frame: change from baseline to 3 months
PROMIS Pain Interference Score
Time frame: change froom baseline to 3 months
Pain Self-efficacy-2 Score
Time frame: change from baseline to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39746210Dao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Meriwether, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with Interstitial Cystitis, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Designated as "Treatment Responders" Based on Global Response Assessment (GRA) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04820855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.