Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2024

Interventions

  • 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: Usual Cares
    • This is standard treatment for Interstitial cystitis with your provider.

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: Control
    • These are participants undergoing regular treatment for interstitial cystitis with their providers

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of New Mexico
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kate Meriwether, MD, Principal Investigator, University of New Mexico
  • Overall Contact(s)
    • Kate M Meriwether, MD, 505-967-8428, meriwet2@salud.unm.edu

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