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Mindfulness and Yoga for Interstitial Cystitis (MYPAICE Trial)
N/A
Recruiting
Led By Kate Meriwether, MD
Research Sponsored by University of New Mexico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
MYPAICE Trial Summary
This trial is studying how well mindfulness and yoga work in treating patients with interstitial cystitis/painful bladder syndrome.
Who is the study for?
This trial is for women over 18 with interstitial cystitis who've had a physical exam by a urogynecologist or gynecologist in the last two years. Participants must score above six on specific IC symptom scales, be able to read and write English or Spanish, own a smartphone, and commit to follow-up questionnaires. It excludes pregnant women, those unable to communicate in English/Spanish, have recurrent UTIs or certain medical conditions that affect bladder function.Check my eligibility
What is being tested?
The study compares the effects of mindfulness and yoga on pain management and quality of life against usual care provided by healthcare providers for patients with interstitial cystitis/painful bladder syndrome. The focus is on how these approaches impact daily functioning before and after the program.See study design
What are the potential side effects?
While not explicitly stated for this trial, typical side effects from participating in mindfulness and yoga programs may include muscle soreness or strain. However, these activities are generally considered low-risk.
MYPAICE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Global Response Assessment
Secondary outcome measures
O'Leary-Sant Symptom and Problem Index
MYPAICE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment2 Interventions
This is an individual treatment program devised by a pelvic floor physical therapist including a daily yoga series and mindfulness via a Smartphone app.
Group II: ControlActive Control1 Intervention
These are participants undergoing regular treatment for interstitial cystitis with their providers
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment
2013
Completed Phase 2
~13740
Find a Location
Who is running the clinical trial?
University of New MexicoLead Sponsor
372 Previous Clinical Trials
3,528,669 Total Patients Enrolled
3 Trials studying Interstitial Cystitis
376 Patients Enrolled for Interstitial Cystitis
Kate Meriwether, MDPrincipal InvestigatorUniversity of New Mexico
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your ICSI/ICPI score is higher than 6 at the beginning of the study.You have been diagnosed with interstitial cystitis/bladder pain syndrome.You have had Hunner's ulcers shown in a cystoscopy in the past 6 months.You have Parkinson's disease and a bladder control problem caused by nerve damage.You have multiple sclerosis with bladder problems caused by nerve issues.You have had a stroke and still have some lasting issues from it.You have difficulty moving around and cannot do yoga poses.You have difficulty hearing or seeing.You have had surgery to change the way urine is stored or removed from your body.You have had chemotherapy or radiation treatment in the past, or have developed bladder inflammation due to radiation.You have a history of getting urinary tract infections often.You have trouble emptying your bladder completely.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum capacity of participants in this clinical trial?
"Affirmative. Clinicaltrials.gov records indicate that this medical experiment, initially posted on May 18th 2021, is actively searching for participants from a single site with the goal of recruiting 120 patients in total."
Answered by AI
Is registration for this trial currently available to individuals?
"As seen on clinicaltrials.gov, this medical experiment is actively seeking participants and was initially posted to the database on May 18th 2021 with a recent update published on March 2nd 2022."
Answered by AI
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