Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04820855

Acronym

MYPAICE

Enrollment

Registered

2021-03-29

Start date

2021-05-18

Completion date

2023-12-31

Last updated

2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Cystitis

Keywords

Interstitial cystitis, Complementary and Alternative medicine, Yoga, Meditation

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.

Interventions

BEHAVIORALTreatment

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.

OTHERUsual Cares

This is standard treatment for Interstitial cystitis with your provider.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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) 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 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)
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).
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).

Countries

United States

Participant flow

Participants by arm

Arm	Count
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: 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 Cares: This is standard treatment for Interstitial cystitis with your provider.	49
Control These are participants undergoing regular treatment for interstitial cystitis with their providers Usual Cares: This is standard treatment for Interstitial cystitis with your provider.	48
Total	97

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	6	9

Baseline characteristics

Characteristic	Treatment	Control	Total
Age, Continuous	49 years STANDARD_DEVIATION 15	50 years STANDARD_DEVIATION 17	49.3 years STANDARD_DEVIATION 15.8
Age of diagnosis of ICBPS	45 years	39 years	41.2 years
Education 4y college degree	19 participants	15 participants	34 participants
Education Associate degree	9 participants	8 participants	17 participants
Education Graduate degree	12 participants	17 participants	29 participants
Education HIgh schooil or high school equivalency certificate	9 participants	7 participants	16 participants
Education Unknown or not recorded	0 participants	1 participants	1 participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants	11 Participants	22 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants	34 Participants	70 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants	3 Participants	5 Participants
History of substance use disorder	3 participants	2 participants	5 participants
Hospital Anxiety and Depression anxiety score	9.7 units on a scale STANDARD_DEVIATION 3.9	9.1 units on a scale STANDARD_DEVIATION 4.3	9.4 units on a scale STANDARD_DEVIATION 4.1
Hospital Anxiety and Depression depression score	5.3 units on a scale STANDARD_DEVIATION 3.6	6.3 units on a scale STANDARD_DEVIATION 4.3	5.8 units on a scale STANDARD_DEVIATION 4
Interstitial Cystitis Problem Index Score	10 units on a scale STANDARD_DEVIATION 3.2	11.2 units on a scale STANDARD_DEVIATION 3.3	10.6 units on a scale STANDARD_DEVIATION 3.3
Interstitial Cystitis Symptom Index Score	11.7 units on a scale STANDARD_DEVIATION 3.6	13.2 units on a scale STANDARD_DEVIATION 4.4	12.4 units on a scale STANDARD_DEVIATION 4.1
Marital status Divorced, separated, widowed	11 participants	11 participants	22 participants
Marital status Married	28 participants	25 participants	53 participants
Marital status Single	10 participants	12 participants	22 participants
Pain self efficacy score	7.1 units on a scale STANDARD_DEVIATION 2.5	7.2 units on a scale STANDARD_DEVIATION 2.4	7.15 units on a scale STANDARD_DEVIATION 2.4
Pain Visual Analog Scale Score	4.8 units on a scale STANDARD_DEVIATION 2.3	5.0 units on a scale STANDARD_DEVIATION 2.1	4.9 units on a scale STANDARD_DEVIATION 2.2
Prior treatments Cystoscopic hydrodistension under general anesthesia	2 participants	3 participants	5 participants
Prior treatments Education, behavioral modification, stress management	23 participants	21 participants	44 participants
Prior treatments Intradetrusor botulinum toxin A, sacral neuromodulation	1 participants	1 participants	2 participants
Prior treatments Medications, intravesical instillations, physical therapy	48 participants	48 participants	96 participants
PROMIS Pain Interference Score	17.5 units on a scale STANDARD_DEVIATION 5.6	18.3 units on a scale STANDARD_DEVIATION 6	17.9 units on a scale STANDARD_DEVIATION 5.8
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	2 Participants	3 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	2 Participants	3 Participants
Race (NIH/OMB) White	46 Participants	44 Participants	90 Participants
Region of Enrollment United States	49 participants	48 participants	97 participants
Sex: Female, Male Female	49 Participants	48 Participants	97 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 49	0 / 48
other Total, other adverse events	1 / 49	0 / 48
serious Total, serious adverse events	0 / 49	0 / 48

Outcome results

Primary

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment	Number of Participants Designated as Treatment Responders Based on Global Response Assessment (GRA)	31 Participants
Control	Number of Participants Designated as Treatment Responders Based on Global Response Assessment (GRA)	10 Participants

Secondary

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.