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Completed

NCT Number: NCT04820855

Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation

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.

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Key information

Conditions

Interstitial Cystitis Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico

Albuquerque, New Mexico, 87106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment

Behavioral

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

Usual Cares

Other

This is standard treatment for Interstitial cystitis with your provider.

Other names: Standard Cares

Primary outcomes

  1. Number of Participants Designated as "Treatment Responders" Based on Global Response Assessment (GRA)

    Time frame: 3 months

    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.

Secondary outcomes

  1. O'Leary-Sant: Interstitial Cystitis Symptom Index

    Time frame: change from baseline to 3 months

    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)

  2. O'Leary-Sant: Interstitial Cystitis Problem Index

    Time frame: change from baseline to 3 months

    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)

  3. Pain VAS Score

    Time frame: change from baseline to 3 months

    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)

  4. Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale

    Time frame: change from baseline to 3 months

    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.

  5. Hospital Anxiety and Depression Scale (HADS) Depression Subscale

    Time frame: change from baseline to 3 months

    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).

  6. PROMIS Pain Interference Score

    Time frame: change froom baseline to 3 months

    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).

  7. Pain Self-efficacy-2 Score

    Time frame: change from baseline to 3 months

    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).

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Acronym: MYPAICE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2021
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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