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MYPAICE: Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation

Sponsor
University of New Mexico (Other)
Overall Status
Recruiting
CT.gov ID
NCT04820855
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
24.1
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Treatment
  • Other: Usual Cares
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation
Actual Study Start Date :
May 18, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
May 23, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Global Response Assessment [3 months]

      This is a validated single question that determines treatment response

    Secondary Outcome Measures

    1. O'Leary-Sant Symptom and Problem Index [3 months]

      This is a validated questionnaire to evaluate interstitial cystitis symptoms.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of New Mexico Albuquerque New Mexico United States 87106

    Sponsors and Collaborators

    • University of New Mexico

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of New Mexico
    ClinicalTrials.gov Identifier:
    NCT04820855
    Other Study ID Numbers:
    • 20-664
    First Posted:
    Mar 29, 2021
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of New Mexico
    Interstitial cystitis
    Complementary and Alternative medicine
    Yoga
    Meditation
    Additional relevant MeSH terms:
    Cystitis
    Cystitis, Interstitial

    Study Results

    No Results Posted as of Mar 3, 2022