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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

Brief Summary:
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a poorly understood disease with unreliable treatments. Although it is not known what causes it for certain, we do know that life stressors may make the disease worse or cause flares. Mindfulness Based Stress Reduction (MBSR) is an 8 week class focused on meditation and other techniques that the investigators think may be helpful to people with IC/BPS. This trial will assign participants to an MBSR class or usual care for their IC/BPS to see if the MBSR class would be helpful for their disease.

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Mindfulness Complementary Medicine Painful Bladder Syndrome Other: Mindfulness-based Stress Reduction (MBSR) Other: Usual medical therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness-Based Therapy for Interstitial Cystitis/Bladder Pain Syndrome
Study Start Date : November 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mindfulness-based Stress Reduction
Mindfulness-based Stress Reduction (MBSR)
Other: Mindfulness-based Stress Reduction (MBSR)
Other: Usual medical therapy
Placebo Comparator: Usual Care
Usual medical therapy
Other: Usual medical therapy



Primary Outcome Measures :
  1. Global Response Assessment (GRA) [ Time Frame: Within 2 weeks of 8-week class ending ]
    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.


Secondary Outcome Measures :
  1. O'Leary Sant Symptom Problem Index (OSPI) [ Time Frame: Baseline and within 2 weeks of 8-week class ending ]

    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.


  2. Visual Analog (VAS) Pain Scale [ Time Frame: Baseline and within 2 weeks of 8-week class ending ]
    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.

  3. Short Form Health Survey (SF-12) [ Time Frame: Baseline and within 2 weeks of 8-week class ending ]
    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.

  4. Female Sexual Function Index (FSFI) [ Time Frame: Baseline and within 2 weeks of 8-week class ending ]

    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.


  5. Pain Self-Efficacy Scale (PSEQ) [ Time Frame: Baseline and within 2 weeks of 8-week class ending ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Actively utilizing but are incomplete responders to the AUA guideline's 1st or 2nd line therapies
  • Non-pregnant women ≥18 years old
  • Meets IC/BPS diagnosis by AUA guidelines, OSPI >8
  • Negative UA or Urine Culture at time of diagnosis or within 2 months if no change in symptoms over that period
  • Able to speak and understand English
  • Currently undergoing 1st or 2nd-line treatment as per AUA guidelines, for at least 4 weeks duration

Exclusion Criteria:

  • Untreated Urinary tract infection
  • Unevaluated Hematuria
  • Urinary retention
  • Pregnant or lactating women
  • History of cystectomy, augmentation cystoplasty or urinary diversion
  • History of cystitis potentially due to pelvic radiation or Cytoxan
  • Inability to speak and understand English
  • Either treatment naïve for IC/BPS or on 3rd line or higher treatment per AUA guidelines

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457182


Locations
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United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
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Principal Investigator: Gregory Kanter, MD Urogynecology Fellow

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Responsible Party: Gregory Kanter, Urogynecology Fellow, University of New Mexico
ClinicalTrials.gov Identifier: NCT02457182     History of Changes
Other Study ID Numbers: 14-141
First Posted: May 29, 2015    Key Record Dates
Results First Posted: October 8, 2018
Last Update Posted: October 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Syndrome
Cystitis
Cystitis, Interstitial
Disease
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases