Clinical trial NCT04820855: Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation
Official title: Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Cystitis
Keywords: Interstitial cystitis
Complementary and Alternative medicine
Yoga
Meditation
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Designated as "Treatment Responders" Based on Global Response Assessment (GRA)
timeFrame: 3 months
Secondary outcomes:
measure: O'Leary-Sant: Interstitial Cystitis Symptom Index
timeFrame: change from baseline to 3 months
measure: O'Leary-Sant: Interstitial Cystitis Problem Index
timeFrame: change from baseline to 3 months
measure: Pain VAS Score
timeFrame: change from baseline to 3 months
measure: Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale
timeFrame: change from baseline to 3 months
measure: Hospital Anxiety and Depression Scale (HADS) Depression Subscale
timeFrame: change from baseline to 3 months
measure: PROMIS Pain Interference Score
timeFrame: change froom baseline to 3 months
measure: Pain Self-efficacy-2 Score
timeFrame: change from baseline to 3 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Kate Meriwether, MD
role: PRINCIPAL_INVESTIGATOR
References: