Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation

N/ACompletedNCT04820855

University of New Mexico97 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Interstitial Cystitis

Interventions

TreatmentBEHAVIORAL

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.

Usual CaresOTHER

This is standard treatment for Interstitial cystitis with your provider.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of New Mexico

Albuquerque, New Mexico, United States

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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.

Time frame: change from baseline to 3 months

Data from ClinicalTrials.gov

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