Trial Outcomes & Findings for Mindfulness-Based Therapy for Interstitial Cystitis/Bladder Pain Syndrome (NCT NCT02457182)
NCT ID: NCT02457182
Last Updated: 2018-10-09
Results Overview
The GRA is a 7-point scale, with scores ranging from markedly, moderately or slightly worse to slightly, moderately or markedly improved. This measure is used in many types of research and is not specific to IC/BPS.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Within 2 weeks of 8-week class ending
Results posted on
2018-10-09
Participant Flow
Participant milestones
| Measure |
Mindfulness-based Stress Reduction (MBSR)
Received usual care continuing current treatments in addition to MBSR
Mindfulness-based Stress Reduction (MBSR)
Usual medical therapy
|
Usual Care
Received usual care and continue current treatments
Usual medical therapy
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
COMPLETED
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Mindfulness-based Stress Reduction (MBSR)
Received usual care continuing current treatments in addition to MBSR
Mindfulness-based Stress Reduction (MBSR)
Usual medical therapy
|
Usual Care
Received usual care and continue current treatments
Usual medical therapy
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Mindfulness-Based Therapy for Interstitial Cystitis/Bladder Pain Syndrome
Baseline characteristics by cohort
| Measure |
Mindfulness-based Stress Reduction (MBSR)
n=9 Participants
Will receive usual care continuing current treatments in addition to MBSR
Mindfulness-based Stress Reduction (MBSR)
Usual medical therapy
|
Usual Care
n=11 Participants
Will receive usual care and continue current treatments
Usual medical therapy
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
44.4 years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
45.3 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Time with IC diagnosis
|
5.0 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
3.85 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
4.3 years
STANDARD_DEVIATION 4.96 • n=5 Participants
|
|
Time with IC symptoms
|
9.6 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
8.9 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
9.2 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
BMI (kg/m^2)
|
28.0 kg/m^2
STANDARD_DEVIATION 9.2 • n=5 Participants
|
26.4 kg/m^2
STANDARD_DEVIATION 6.0 • n=7 Participants
|
27.1 kg/m^2
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Race
American Indian/Alaskan Native
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race
Caucasian
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race
Other
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 2 weeks of 8-week class endingThe GRA is a 7-point scale, with scores ranging from markedly, moderately or slightly worse to slightly, moderately or markedly improved. This measure is used in many types of research and is not specific to IC/BPS.
Outcome measures
| Measure |
Mindfulness-based Stress Reduction (MBSR)
n=8 Participants
Received usual care continuing current treatments in addition to MBSR
Mindfulness-based Stress Reduction (MBSR)
Usual medical therapy
|
Usual Care
n=11 Participants
Received usual care and continue current treatments
Usual medical therapy
|
|---|---|---|
|
Global Response Assessment (GRA)
Markedly Improved
|
2 participants
|
0 participants
|
|
Global Response Assessment (GRA)
At least moderately improved
|
1 participants
|
3 participants
|
|
Global Response Assessment (GRA)
At least slightly improved
|
7 participants
|
4 participants
|
|
Global Response Assessment (GRA)
No improvement
|
1 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Baseline and within 2 weeks of 8-week class endingThe OSPI is a Interstitial cystitis (IC/BPS)-specific scale composed of the symptom index and problem index as well as a total, which sums the symptom and problem scores caused by IC/BPS. Symptom scores range from 0-21. Problem scores range from 0-16 Higher scores indicate a worse condition. Total scores range 0-37, with higher scores indicating a worse condition.
Outcome measures
| Measure |
Mindfulness-based Stress Reduction (MBSR)
n=8 Participants
Received usual care continuing current treatments in addition to MBSR
Mindfulness-based Stress Reduction (MBSR)
Usual medical therapy
|
Usual Care
n=11 Participants
Received usual care and continue current treatments
Usual medical therapy
|
|---|---|---|
|
O'Leary Sant Symptom Problem Index (OSPI)
OSPI Total Before
|
26.4 units on a scale
Standard Deviation 8.1
|
25.4 units on a scale
Standard Deviation 6.6
|
|
O'Leary Sant Symptom Problem Index (OSPI)
OSPI Total After
|
18.9 units on a scale
Standard Deviation 8.7
|
24.0 units on a scale
Standard Deviation 5.6
|
|
O'Leary Sant Symptom Problem Index (OSPI)
OSPI Symptoms before
|
16.1 units on a scale
Standard Deviation 5.3
|
15.2 units on a scale
Standard Deviation 2.9
|
|
O'Leary Sant Symptom Problem Index (OSPI)
OSPI symptoms after
|
12.5 units on a scale
Standard Deviation 4.8
|
14.6 units on a scale
Standard Deviation 2.3
|
|
O'Leary Sant Symptom Problem Index (OSPI)
OSPI Problems before
|
10.3 units on a scale
Standard Deviation 3.1
|
10.2 units on a scale
Standard Deviation 3.9
|
|
O'Leary Sant Symptom Problem Index (OSPI)
OSPI Problems after
|
6.4 units on a scale
Standard Deviation 4.0
|
9.4 units on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Baseline and within 2 weeks of 8-week class endingThe VAS scale is a 10-point scale ranging from 0 (no pain) to 10 (unbearable pain). 0 is considered better while 10 is considered worse.
Outcome measures
| Measure |
Mindfulness-based Stress Reduction (MBSR)
n=8 Participants
Received usual care continuing current treatments in addition to MBSR
Mindfulness-based Stress Reduction (MBSR)
Usual medical therapy
|
Usual Care
n=11 Participants
Received usual care and continue current treatments
Usual medical therapy
|
|---|---|---|
|
Visual Analog (VAS) Pain Scale
VAS Before
|
5.9 units on a scale
Standard Deviation 2.4
|
5.7 units on a scale
Standard Deviation 2.2
|
|
Visual Analog (VAS) Pain Scale
VAS After
|
4.9 units on a scale
Standard Deviation 2.0
|
4.6 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline and within 2 weeks of 8-week class endingThe short form health survey (SF-12) is a scale used to evaluate chronic conditions. It is composed of a mental component and physical component. Each is made up of 12 questions totaling a score of 100 points. A zero score indicates the lowest level of health measured and 100 indicates the highest level of health.
Outcome measures
| Measure |
Mindfulness-based Stress Reduction (MBSR)
n=8 Participants
Received usual care continuing current treatments in addition to MBSR
Mindfulness-based Stress Reduction (MBSR)
Usual medical therapy
|
Usual Care
n=11 Participants
Received usual care and continue current treatments
Usual medical therapy
|
|---|---|---|
|
Short Form Health Survey (SF-12)
MCS Before
|
39.0 units on a scale
Standard Deviation 4.5
|
36.6 units on a scale
Standard Deviation 6.9
|
|
Short Form Health Survey (SF-12)
MCS After
|
47.0 units on a scale
Standard Deviation 8.9
|
40.8 units on a scale
Standard Deviation 8.1
|
|
Short Form Health Survey (SF-12)
PCS Before
|
46.5 units on a scale
Standard Deviation 8.6
|
44.1 units on a scale
Standard Deviation 9.3
|
|
Short Form Health Survey (SF-12)
PCS After
|
46.3 units on a scale
Standard Deviation 10.3
|
46.5 units on a scale
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Baseline and within 2 weeks of 8-week class endingThe FSFI measures sexual function. It is composed of 6 individual domain scores (desire, arousal, lubrication, orgasm, satisfaction and pain), which are summed to create a total score. Higher scores indicate better sexual function. Ranges: Desire 2-10 Arousal 0-20 Lubrication 0-20 Orgasm 0-15 Satisfaction 2-15 Pain 0-15 Total score ranges from 4-95 and is calculated by adding the 6 domains together. Again, higher scores indicate better sexual function.
Outcome measures
| Measure |
Mindfulness-based Stress Reduction (MBSR)
n=8 Participants
Received usual care continuing current treatments in addition to MBSR
Mindfulness-based Stress Reduction (MBSR)
Usual medical therapy
|
Usual Care
n=11 Participants
Received usual care and continue current treatments
Usual medical therapy
|
|---|---|---|
|
Female Sexual Function Index (FSFI)
Desire before
|
2.9 units on a scale
Standard Deviation 1.6
|
2.7 units on a scale
Standard Deviation 1.4
|
|
Female Sexual Function Index (FSFI)
Desire after
|
3.5 units on a scale
Standard Deviation 1.6
|
2.6 units on a scale
Standard Deviation 1.5
|
|
Female Sexual Function Index (FSFI)
Arousal before
|
2.6 units on a scale
Standard Deviation 2.1
|
2.0 units on a scale
Standard Deviation 2.2
|
|
Female Sexual Function Index (FSFI)
Arousal after
|
3.3 units on a scale
Standard Deviation 2.3
|
2.3 units on a scale
Standard Deviation 2.2
|
|
Female Sexual Function Index (FSFI)
Lubrication before
|
3.2 units on a scale
Standard Deviation 2.7
|
1.6 units on a scale
Standard Deviation 2.2
|
|
Female Sexual Function Index (FSFI)
Lubrication after
|
3.4 units on a scale
Standard Deviation 2.4
|
3.1 units on a scale
Standard Deviation 2.5
|
|
Female Sexual Function Index (FSFI)
Orgasm before
|
3.0 units on a scale
Standard Deviation 2.7
|
2.2 units on a scale
Standard Deviation 2.3
|
|
Female Sexual Function Index (FSFI)
Orgasm after
|
2.5 units on a scale
Standard Deviation 2.5
|
2.3 units on a scale
Standard Deviation 2.1
|
|
Female Sexual Function Index (FSFI)
Satisfaction before
|
2.8 units on a scale
Standard Deviation 2.3
|
2.8 units on a scale
Standard Deviation 1.9
|
|
Female Sexual Function Index (FSFI)
Satisfaction after
|
3.8 units on a scale
Standard Deviation 1.9
|
3.4 units on a scale
Standard Deviation 1.8
|
|
Female Sexual Function Index (FSFI)
Pain before
|
2.5 units on a scale
Standard Deviation 2.4
|
2.1 units on a scale
Standard Deviation 2.3
|
|
Female Sexual Function Index (FSFI)
Pain after
|
3.1 units on a scale
Standard Deviation 2.6
|
2.8 units on a scale
Standard Deviation 2.4
|
|
Female Sexual Function Index (FSFI)
Total before
|
16.7 units on a scale
Standard Deviation 12.8
|
13.8 units on a scale
Standard Deviation 10.9
|
|
Female Sexual Function Index (FSFI)
Total after
|
19.5 units on a scale
Standard Deviation 12.0
|
16.4 units on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Baseline and within 2 weeks of 8-week class endingThe PSEQ is a scale describing how patients rate their abilities to complete daily activities. It is a 60 point scale (scores range from 0-60) composed of 10 questions. Higher numbers signify better functioning or less limit by disease. A total score is calculating by summing individual items.
Outcome measures
| Measure |
Mindfulness-based Stress Reduction (MBSR)
n=8 Participants
Received usual care continuing current treatments in addition to MBSR
Mindfulness-based Stress Reduction (MBSR)
Usual medical therapy
|
Usual Care
n=11 Participants
Received usual care and continue current treatments
Usual medical therapy
|
|---|---|---|
|
Pain Self-Efficacy Scale (PSEQ)
PSEQ Before
|
34.3 units on a scale
Standard Deviation 4.5
|
30.8 units on a scale
Standard Deviation 10.7
|
|
Pain Self-Efficacy Scale (PSEQ)
PSEQ After
|
45.8 units on a scale
Standard Deviation 4.9
|
33.5 units on a scale
Standard Deviation 9.3
|
Adverse Events
Mindfulness-based Stress Reduction (MBSR)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place