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

University of New Mexico (UNM)

Status: Completed

Conditions: Interstitial Cystitis

Treatments: Behavioral: Treatment; Other: Usual Cares

Study type: Interventional

Funder types: Other

Identifiers

NCT04820855

20-664

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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97 participants in 2 patient groups

Treatment

Experimental group

Description:

This is an individual treatment program devised by a pelvic floor physical therapist including a daily yoga series and mindfulness via a Smartphone app.

Treatment:

Other: Usual Cares

Behavioral: Treatment

Control

Active Comparator group

Description:

These are participants undergoing regular treatment for interstitial cystitis with their providers

Treatment:

Other: Usual Cares