Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation (MYPAICE)

March 11, 2024 updated by: University of New Mexico
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Other Names:
  • Mind/Body Therapy
Other: Usual Cares
This is standard treatment for Interstitial cystitis with your provider.
Other Names:
  • Standard Cares
Active Comparator: Control
These are participants undergoing regular treatment for interstitial cystitis with their providers
Other: Usual Cares
This is standard treatment for Interstitial cystitis with your provider.
Other Names:
  • Standard Cares

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Response Assessment
Time Frame: 3 months
This is a validated single question that determines treatment response
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
O'Leary-Sant Symptom and Problem Index
Time Frame: 3 months
This is a validated questionnaire to evaluate interstitial cystitis symptoms.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Investigators

  • Principal Investigator: Kate Meriwether, MD, University of New Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 15, 2021

First Submitted That Met QC Criteria

March 26, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-664

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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