Trial Outcomes & Findings for Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation (NCT NCT04820855)
NCT ID: NCT04820855
Last Updated: 2025-03-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
97 participants
Primary outcome timeframe
3 months
Results posted on
2025-03-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
48
|
|
Overall Study
COMPLETED
|
43
|
39
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
9
|
Baseline Characteristics
Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation
Baseline characteristics by cohort
| Measure |
Treatment
n=49 Participants
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.
|
Control
n=48 Participants
These are participants undergoing regular treatment for interstitial cystitis with their providers
Usual Cares: This is standard treatment for Interstitial cystitis with your provider.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 15 • n=5 Participants
|
50 years
STANDARD_DEVIATION 17 • n=7 Participants
|
49.3 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
48 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Education
HIgh schooil or high school equivalency certificate
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Education
Associate degree
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Education
4y college degree
|
19 participants
n=5 Participants
|
15 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Education
Graduate degree
|
12 participants
n=5 Participants
|
17 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Education
Unknown or not recorded
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Marital status
Single
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Marital status
Married
|
28 participants
n=5 Participants
|
25 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Marital status
Divorced, separated, widowed
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
History of substance use disorder
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Age of diagnosis of ICBPS
|
45 years
n=5 Participants
|
39 years
n=7 Participants
|
41.2 years
n=5 Participants
|
|
Interstitial Cystitis Symptom Index Score
|
11.7 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
13.2 units on a scale
STANDARD_DEVIATION 4.4 • n=7 Participants
|
12.4 units on a scale
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Interstitial Cystitis Problem Index Score
|
10 units on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
11.2 units on a scale
STANDARD_DEVIATION 3.3 • n=7 Participants
|
10.6 units on a scale
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Pain Visual Analog Scale Score
|
4.8 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 2.1 • n=7 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Hospital Anxiety and Depression anxiety score
|
9.7 units on a scale
STANDARD_DEVIATION 3.9 • n=5 Participants
|
9.1 units on a scale
STANDARD_DEVIATION 4.3 • n=7 Participants
|
9.4 units on a scale
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Hospital Anxiety and Depression depression score
|
5.3 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 4.3 • n=7 Participants
|
5.8 units on a scale
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
PROMIS Pain Interference Score
|
17.5 units on a scale
STANDARD_DEVIATION 5.6 • n=5 Participants
|
18.3 units on a scale
STANDARD_DEVIATION 6.0 • n=7 Participants
|
17.9 units on a scale
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Pain self efficacy score
|
7.1 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
7.2 units on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
7.15 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Prior treatments
Education, behavioral modification, stress management
|
23 participants
n=5 Participants
|
21 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Prior treatments
Medications, intravesical instillations, physical therapy
|
48 participants
n=5 Participants
|
48 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Prior treatments
Cystoscopic hydrodistension under general anesthesia
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Prior treatments
Intradetrusor botulinum toxin A, sacral neuromodulation
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThis 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.
Outcome measures
| Measure |
Treatment
n=43 Participants
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.
|
Control
n=39 Participants
These are participants undergoing regular treatment for interstitial cystitis with their providers
Usual Cares: This is standard treatment for Interstitial cystitis with your provider.
|
|---|---|---|
|
Number of Participants Designated as "Treatment Responders" Based on Global Response Assessment (GRA)
|
31 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: change from baseline to 3 monthsThis 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)
Outcome measures
| Measure |
Treatment
n=43 Participants
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.
|
Control
n=39 Participants
These are participants undergoing regular treatment for interstitial cystitis with their providers
Usual Cares: This is standard treatment for Interstitial cystitis with your provider.
|
|---|---|---|
|
O'Leary-Sant: Interstitial Cystitis Symptom Index
|
-3.4 score on a scale
Standard Deviation 3.7
|
-1.5 score on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: change from baseline to 3 monthsThe Interstitial Cystitis Problem Index Scale (ICPI) is a scale of point ranging from 0 to 16, with higher scores indicating WORSE OUTCOMES (more problems)
Outcome measures
| Measure |
Treatment
n=43 Participants
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.
|
Control
n=39 Participants
These are participants undergoing regular treatment for interstitial cystitis with their providers
Usual Cares: This is standard treatment for Interstitial cystitis with your provider.
|
|---|---|---|
|
O'Leary-Sant: Interstitial Cystitis Problem Index
|
-3.7 score on a scale
Standard Deviation 3.2
|
-1.9 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: change from baseline to 3 monthsThe 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)
Outcome measures
| Measure |
Treatment
n=43 Participants
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.
|
Control
n=39 Participants
These are participants undergoing regular treatment for interstitial cystitis with their providers
Usual Cares: This is standard treatment for Interstitial cystitis with your provider.
|
|---|---|---|
|
Pain VAS Score
|
-1.7 score on a scale
Standard Deviation 2.4
|
-0.3 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: change from baseline to 3 monthsHospital 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.
Outcome measures
| Measure |
Treatment
n=43 Participants
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.
|
Control
n=39 Participants
These are participants undergoing regular treatment for interstitial cystitis with their providers
Usual Cares: This is standard treatment for Interstitial cystitis with your provider.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale
|
-1.6 score on a scale
Standard Deviation 2.8
|
-0.6 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: change from baseline to 3 monthsHospital 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).
Outcome measures
| Measure |
Treatment
n=43 Participants
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.
|
Control
n=39 Participants
These are participants undergoing regular treatment for interstitial cystitis with their providers
Usual Cares: This is standard treatment for Interstitial cystitis with your provider.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) Depression Subscale
|
-1.6 score on a scale
Standard Deviation 2.6
|
-0.7 score on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: change froom baseline to 3 monthsThe 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).
Outcome measures
| Measure |
Treatment
n=43 Participants
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.
|
Control
n=39 Participants
These are participants undergoing regular treatment for interstitial cystitis with their providers
Usual Cares: This is standard treatment for Interstitial cystitis with your provider.
|
|---|---|---|
|
PROMIS Pain Interference Score
|
-5.5 score on a scale
Standard Deviation 5.9
|
-3.1 score on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: change from baseline to 3 monthsThe 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).
Outcome measures
| Measure |
Treatment
n=43 Participants
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.
|
Control
n=39 Participants
These are participants undergoing regular treatment for interstitial cystitis with their providers
Usual Cares: This is standard treatment for Interstitial cystitis with your provider.
|
|---|---|---|
|
Pain Self-efficacy-2 Score
|
1.5 score on a scale
Standard Deviation 3.2
|
0.9 score on a scale
Standard Deviation 3.4
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=49 participants at risk
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.
|
Control
n=48 participants at risk
These are participants undergoing regular treatment for interstitial cystitis with their providers
Usual Cares: This is standard treatment for Interstitial cystitis with your provider.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
2.0%
1/49 • Number of events 1 • Over 3 months during study participation.
Participants were contacted weekly during the study period and specifically asked if they experienced any adverse events and data was recorded.
|
0.00%
0/48 • Over 3 months during study participation.
Participants were contacted weekly during the study period and specifically asked if they experienced any adverse events and data was recorded.
|
Additional Information
Dr. Angela Dao
University of New Mexico Health Sciences Center
Phone: 5059678428
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place