Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation (MYPAICE)
Primary Purpose
Interstitial Cystitis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment
Usual Cares
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Cystitis focused on measuring Interstitial cystitis, Complementary and Alternative medicine, Yoga, Meditation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- University of New MexicoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment
Control
Arm Description
This is an individual treatment program devised by a pelvic floor physical therapist including a daily yoga series and mindfulness via a Smartphone app.
These are participants undergoing regular treatment for interstitial cystitis with their providers
Outcomes
Primary Outcome Measures
Global Response Assessment
This is a validated single question that determines treatment response
Secondary Outcome Measures
O'Leary-Sant Symptom and Problem Index
This is a validated questionnaire to evaluate interstitial cystitis symptoms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04820855
Brief Title
Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation
Acronym
MYPAICE
Official Title
Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Mexico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis
Keywords
Interstitial cystitis, Complementary and Alternative medicine, Yoga, Meditation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
This is an individual treatment program devised by a pelvic floor physical therapist including a daily yoga series and mindfulness via a Smartphone app.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
These are participants undergoing regular treatment for interstitial cystitis with their providers
Intervention Type
Behavioral
Intervention Name(s)
Treatment
Other Intervention Name(s)
Mind/Body Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Cares
Other Intervention Name(s)
Standard Cares
Intervention Description
This is standard treatment for Interstitial cystitis with your provider.
Primary Outcome Measure Information:
Title
Global Response Assessment
Description
This is a validated single question that determines treatment response
Time Frame
3 months
Secondary Outcome Measure Information:
Title
O'Leary-Sant Symptom and Problem Index
Description
This is a validated questionnaire to evaluate interstitial cystitis symptoms.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kate M Meriwether, MD
Phone
505-967-8428
Email
meriwet2@salud.unm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Taylor, BA
Phone
505-272-7541
Email
kataylor@salud.unm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Meriwether, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Meriwether, MD
Email
meriwet2@salud.unm.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation
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