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Trial record 65 of 158 for:    interstitial cystitis

Mindfulness-Based Therapy for Interstitial Cystitis/Bladder Pain Syndrome

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ClinicalTrials.gov Identifier: NCT02457182
Recruitment Status : Completed
First Posted : May 29, 2015
Results First Posted : October 8, 2018
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
Gregory Kanter, University of New Mexico

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Interstitial Cystitis
Mindfulness
Complementary Medicine
Painful Bladder Syndrome
Interventions Other: Mindfulness-based Stress Reduction (MBSR)
Other: Usual medical therapy
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mindfulness-based Stress Reduction (MBSR) Usual Care
Hide Arm/Group Description

Received usual care continuing current treatments in addition to MBSR

Mindfulness-based Stress Reduction (MBSR)

Usual medical therapy

Received usual care and continue current treatments

Usual medical therapy

Period Title: Overall Study
Started 9 11
Completed 8 11
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title Mindfulness-based Stress Reduction (MBSR) Usual Care Total
Hide Arm/Group Description

Will receive usual care continuing current treatments in addition to MBSR

Mindfulness-based Stress Reduction (MBSR)

Usual medical therapy

Will receive usual care and continue current treatments

Usual medical therapy

Total of all reporting groups
Overall Number of Baseline Participants 9 11 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 11 participants 20 participants
46.3  (15.2) 44.4  (13.9) 45.3  (14.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
Female
9
 100.0%
11
 100.0%
20
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 11 participants 20 participants
9 11 20
Time with IC diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 11 participants 20 participants
5.0  (5.3) 3.85  (5.1) 4.3  (4.96)
Time with IC symptoms  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 11 participants 20 participants
9.6  (9.9) 8.9  (7.1) 9.2  (8.3)
BMI (kg/m^2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 9 participants 11 participants 20 participants
28.0  (9.2) 26.4  (6.0) 27.1  (7.3)
Race  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
American Indian/Alaskan Native 0 2 2
Asian 0 1 1
Caucasian 9 5 14
Other 0 3 3
1.Primary Outcome
Title Global Response Assessment (GRA)
Hide Description 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.
Time Frame Within 2 weeks of 8-week class ending
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mindfulness-based Stress Reduction (MBSR) Usual Care
Hide Arm/Group Description:

Received usual care continuing current treatments in addition to MBSR

Mindfulness-based Stress Reduction (MBSR)

Usual medical therapy

Received usual care and continue current treatments

Usual medical therapy

Overall Number of Participants Analyzed 8 11
Measure Type: Number
Unit of Measure: participants
Markedly Improved 2 0
At least moderately improved 1 3
At least slightly improved 7 4
No improvement 1 7
2.Secondary Outcome
Title O'Leary Sant Symptom Problem Index (OSPI)
Hide Description

The 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.

Time Frame Baseline and within 2 weeks of 8-week class ending
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mindfulness-based Stress Reduction (MBSR) Usual Care
Hide Arm/Group Description:

Received usual care continuing current treatments in addition to MBSR

Mindfulness-based Stress Reduction (MBSR)

Usual medical therapy

Received usual care and continue current treatments

Usual medical therapy

Overall Number of Participants Analyzed 8 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
OSPI Total Before 26.4  (8.1) 25.4  (6.6)
OSPI Total After 18.9  (8.7) 24.0  (5.6)
OSPI Symptoms before 16.1  (5.3) 15.2  (2.9)
OSPI symptoms after 12.5  (4.8) 14.6  (2.3)
OSPI Problems before 10.3  (3.1) 10.2  (3.9)
OSPI Problems after 6.4  (4.0) 9.4  (3.6)
3.Secondary Outcome
Title Visual Analog (VAS) Pain Scale
Hide Description The 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.
Time Frame Baseline and within 2 weeks of 8-week class ending
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mindfulness-based Stress Reduction (MBSR) Usual Care
Hide Arm/Group Description:

Received usual care continuing current treatments in addition to MBSR

Mindfulness-based Stress Reduction (MBSR)

Usual medical therapy

Received usual care and continue current treatments

Usual medical therapy

Overall Number of Participants Analyzed 8 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
VAS Before 5.9  (2.4) 5.7  (2.2)
VAS After 4.9  (2.0) 4.6  (2.1)
4.Secondary Outcome
Title Short Form Health Survey (SF-12)
Hide Description The 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.
Time Frame Baseline and within 2 weeks of 8-week class ending
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mindfulness-based Stress Reduction (MBSR) Usual Care
Hide Arm/Group Description:

Received usual care continuing current treatments in addition to MBSR

Mindfulness-based Stress Reduction (MBSR)

Usual medical therapy

Received usual care and continue current treatments

Usual medical therapy

Overall Number of Participants Analyzed 8 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
MCS Before 39.0  (4.5) 36.6  (6.9)
MCS After 47.0  (8.9) 40.8  (8.1)
PCS Before 46.5  (8.6) 44.1  (9.3)
PCS After 46.3  (10.3) 46.5  (9.3)
5.Secondary Outcome
Title Female Sexual Function Index (FSFI)
Hide Description

The 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.

Time Frame Baseline and within 2 weeks of 8-week class ending
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mindfulness-based Stress Reduction (MBSR) Usual Care
Hide Arm/Group Description:

Received usual care continuing current treatments in addition to MBSR

Mindfulness-based Stress Reduction (MBSR)

Usual medical therapy

Received usual care and continue current treatments

Usual medical therapy

Overall Number of Participants Analyzed 8 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Desire before 2.9  (1.6) 2.7  (1.4)
Desire after 3.5  (1.6) 2.6  (1.5)
Arousal before 2.6  (2.1) 2.0  (2.2)
Arousal after 3.3  (2.3) 2.3  (2.2)
Lubrication before 3.2  (2.7) 1.6  (2.2)
Lubrication after 3.4  (2.4) 3.1  (2.5)
Orgasm before 3.0  (2.7) 2.2  (2.3)
Orgasm after 2.5  (2.5) 2.3  (2.1)
Satisfaction before 2.8  (2.3) 2.8  (1.9)
Satisfaction after 3.8  (1.9) 3.4  (1.8)
Pain before 2.5  (2.4) 2.1  (2.3)
Pain after 3.1  (2.6) 2.8  (2.4)
Total before 16.7  (12.8) 13.8  (10.9)
Total after 19.5  (12.0) 16.4  (10.9)
6.Secondary Outcome
Title Pain Self-Efficacy Scale (PSEQ)
Hide Description

The 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.

Time Frame Baseline and within 2 weeks of 8-week class ending
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mindfulness-based Stress Reduction (MBSR) Usual Care
Hide Arm/Group Description:

Received usual care continuing current treatments in addition to MBSR

Mindfulness-based Stress Reduction (MBSR)

Usual medical therapy

Received usual care and continue current treatments

Usual medical therapy

Overall Number of Participants Analyzed 8 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
PSEQ Before 34.3  (4.5) 30.8  (10.7)
PSEQ After 45.8  (4.9) 33.5  (9.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mindfulness-based Stress Reduction (MBSR) Usual Care
Hide Arm/Group Description

Received usual care continuing current treatments in addition to MBSR

Mindfulness-based Stress Reduction (MBSR)

Usual medical therapy

Received usual care and continue current treatments

Usual medical therapy

All-Cause Mortality
Mindfulness-based Stress Reduction (MBSR) Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Mindfulness-based Stress Reduction (MBSR) Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mindfulness-based Stress Reduction (MBSR) Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/11 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Gregg Kanter, MD
Organization: University of New Mexico
Phone: 818-599-3456
Responsible Party: Gregory Kanter, University of New Mexico
ClinicalTrials.gov Identifier: NCT02457182     History of Changes
Other Study ID Numbers: 14-141
First Submitted: January 8, 2015
First Posted: May 29, 2015
Results First Submitted: June 3, 2016
Results First Posted: October 8, 2018
Last Update Posted: October 8, 2018