Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation

Not Applicable

Completed

Conditions: Interstitial Cystitis

Interventions: Behavioral: Treatment
Other: Usual Cares

Registration Number: NCT04820855

Lead Sponsor: University of New Mexico

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 97

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	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.
Treatment	Usual Cares	This is an individual treatment program devised by a pelvic floor physical therapist including a daily yoga series and mindfulness via a Smartphone app.
Control	Usual Cares	These are participants undergoing regular treatment for interstitial cystitis with their providers

Primary Outcome Measures

Name	Time	Method
Number of Participants Designated as "Treatment Responders" Based on Global Response Assessment (GRA)	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 Outcome Measures

Name	Time	Method
O'Leary-Sant: Interstitial Cystitis Symptom Index	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)
Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale	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.
O'Leary-Sant: Interstitial Cystitis Problem Index	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)
Pain VAS Score	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)
Hospital Anxiety and Depression Scale (HADS) Depression Subscale	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).
PROMIS Pain Interference Score	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).
Pain Self-efficacy-2 Score	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).