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

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: Completed
• Conditions: Interstitial Cystitis
• Intervention / Treatment: Behavioral: Treatment; Other: Usual Cares

Detailed Description

This is a randomized control trial comparing women diagnosed with interstitial cystitis/painful bladder syndrome (ICPBS) receiving usual ICPBS care to those treated with usual care supplemented with meditation and yoga. Both groups continued their current ICPBS treatment regimens. Participants in the intervention group additionally received a commercially available meditation application and a yoga tutorial video. Women in either group were followed weekly for three months. Validated questionnaires were used to compare treatment response from baseline to 12 weeks of intervention for both groups. The primary outcome was the patient report on the global response assessment (GRA), and we required a sample size of 82 patients (41 per group) to detect a difference of 30% with a 10% margin of error (alpha of 0.05) with 80% power. Other questionnaires collected included the PROMIS pain interference scale, the interstitial cystitis problem index and symptom index (ICPI and ICSI), the VAS pain scale, treatment compliance, and treatment escalation.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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
Number of Participants Designated as "Treatment Responders" Based on Global Response Assessment (GRA)	This is a validated single question that determines treatment response. Participants were considered "treatment responders" if they answered "markedly improved/moderately improved" on the GRA at 12 weeks.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
O'Leary-Sant: Interstitial Cystitis Symptom Index	This is a validated questionnaire to evaluate interstitial cystitis symptoms. The Interstitial Cystitis Symptoms Index Scale (ICSI) is a scale of point ranging from 0 to 20, with higher scores indicating WORSE OUTCOMES (more symptoms)	change from baseline to 3 months
O'Leary-Sant: Interstitial Cystitis Problem Index	The Interstitial Cystitis Problem Index Scale (ICPI) is a scale of point ranging from 0 to 16, with higher scores indicating WORSE OUTCOMES (more problems)	change from baseline to 3 months
Pain VAS Score	The Pain Visual Analog Scale (VAS) Score ranges from 1 to 10, with patients ranking their pain from no pain (score of 0) to most severe pain imaginable (score of 10), with high scores indicating WORSE OUTCOMES (more pain)	change from baseline to 3 months
Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale	Hospital Anxiety and Depression Scale (HADS) anxiety subscale has a score range from 0 to 21, with higher scores indicating greater anxiety levels (WORSE OUTCOMES). Each item on the scale is scored from 0 to 3, contributing to the total possible score of 21 for the anxiety subscale at most (highest level of anxiety). A score of 0-7 is generally considered normal, 8-10 as mild anxiety, 11-14 as moderate anxiety, and 15 or higher as severe anxiety.	change from baseline to 3 months
Hospital Anxiety and Depression Scale (HADS) Depression Subscale	Hospital Anxiety and Depression Scale (HADS) depression subscale has a score ranging 0 to 21, with higher scores indicating greater levels of depression (WORSE OUTCOME). Each item on the scale is scored from 0 to 3, contributing to the total possible score of 21 for the depression subscale at most (highest level of depression).	change from baseline to 3 months
PROMIS Pain Interference Score	The PROMIS Pain Interference Scale (PIS) has a raw score ranging from 5 to 30, with higher scores indicating a greater level of pain interference in life (WORSE OUTCOMES).	change froom baseline to 3 months
Pain Self-efficacy-2 Score	The Pain Self-Efficacy Questionnaire (PSEQ) score ranges from 0 to 60, with higher scores indicating a greater belief in one's ability to manage pain and function (BETTER OUTCOMES).	change from baseline to 3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2021
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): December 31, 2023

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 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Yoga; Meditation; Interstitial cystitis; Complementary and Alternative medicine
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Cystitis; Cystitis, Interstitial
• Other Study ID Numbers: 20-664

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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