search
Back to results

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
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
March 15, 2021
Last Updated
July 10, 2023
Sponsor
University of New Mexico
search

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

Learn more about this trial

Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation

We'll reach out to this number within 24 hrs