Mindfulness-Based Therapy for Interstitial Cystitis/Bladder Pain Syndrome

January 2, 2018 updated by: Gregory Kanter, University of New Mexico
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

BACKGROUND/SCIENTIFIC RATIONALE Interstitial cystitis/bladder pain syndrome (IC/BPS) is associated with significant morbidity and poorly understood underlying pathophysiology. IC/BPS comprises a symptom complex defined by the American Urological Association (AUA) as "An unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six weeks duration, in the absence of infection or other identifiable causes"(1). Up to 11% of women are affected by IC/BPS (2), and the disorder may be significantly underdiagnosed (3). A 2008 study (4) indicated that 43% of patients with IC/BPS require multimodal therapy with an average of 7-12 yearly clinic visits at a cost of $9,000/patient. Twenty percent of women report wage losses of >$4000 per year (5). Current theories for the cause of IC/BPS include infectious agents, a defective uroepithelium permeable to toxic substances, structural abnormalities, neurogenic inflammation, increased neurologic sensitivity, or an allergic response involving increased numbers of bladder mast cells (6). Despite these theories, reliable treatments remain elusive. Most IC/BPS treatments target one of these proposed mechanisms, involve trial and error of several therapies (1), and often utilize multiple modalities (7). Treatment success ranges from 47-93% for intravesical instillation to 21-64% for oral therapies, with discontinuation rates up to 80% due to intolerable side effects (1). Efficacious treatments for IC/BPS that apply to a greater proportion of patients with limited side effects are urgently needed.

Mindfulness Based Stress Reduction (MBSR), a Complementary Alternative Medicine (CAM)-based therapy, potentially fulfills this need. The Interstitial Cystitis Association (ICA), a patient-led organization, sponsored a survey of 2100 IC/BPS patients. They reported that 84% had tried CAM therapy and 55% of those surveyed reported that their physicians had recommended CAM (8). According to a 2007 National Health Interview survey (9), CAM is used by 38% of adults in the United States. MBSR has been successfully employed to treat chronic pain syndromes and has been used in disorders such as multiple chemical sensitivity, chronic fatigue syndrome, fibromyalgia (10), and irritable bowel syndrome (IBS) (11). These disorders may coexist in patients with IC/BPS (6). In IC/BPS, increases in stress are positively correlated with increased pain (12); and one study reported that up to 80% of IC/BPS patients found stress reduction decreased their symptoms (8). MBSR was found to be efficacious in the treatment of urgency urinary incontinence, a urinary disorder closely related to IC/BPS (13, 14). While MBSR has shown therapeutic promise in conditions that are similar to or coexist with IC/BPS, and has been rated as helpful by patients suffering from IC/BPS, rigorous randomized clinical trials investigating the efficacy of this intervention are lacking (8).

OBJECTIVES/AIMS/HYPOTHESES Ultimately, the investigators long-term goal is to provide a much-needed treatment for IC/BPS using patient-centered therapy such as MBSR. The objective of this research is to conduct a pilot RCT to explore whether MBSR is acceptable to patients and results in improved symptoms when added to IC/BPS 1st and 2nd-line treatments as recommended in the American Urological Association guidelines (see Table 1). The investigators hypothesize that an 8-week MBSR class will be acceptable to IC/BPS patients and that MBSR used in conjunction with traditional 1st and 2nd line therapies will improve symptoms compared to IC/BPS patients using traditional 1st and 2nd line therapies alone. If this pilot study demonstrates effectiveness and acceptance of MBSR, it would provide data to justify a larger randomized controlled trial. If the investigators' hypothesis is supported with this exploratory study, MBSR, an understudied and potentially underutilized therapy, will expand treatment options for IC/BPS patients. The investigators' aims in pursuit of this goal are; Aim #1: To determine whether the addition of MBSR to 1st and 2nd line therapies as recommended by AUA guidelines improves IC/BPS symptoms as measured by the primary outcome the Global Response Assessment (GRA), as well as the O'Leary-Sant Symptom and Problem Index (OSPI), and Visual Analog (VAS) pain scale. Hypothesis: The investigators hypothesize that MBSR will be an effective treatment for IC/BPS as measured by the validated GRA, O'Leary-Sant and VAS pain scales.

Aim #2: To evaluate whether participation in a structured MBSR class will improve quality of life, sexual function and overall self-efficacy in patients with IC/BPS, based on changes in the Short Form Health Survey (SF-12), Female Sexual Function Index (FSFI), and the Pain Self-Efficacy Scale (SES). Hypothesis: The investigators' hypothesize that MBSR will improve quality of life, sexual function and impressions of self-efficacy as measured by these validated scales

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Within 2 weeks of 8-week class ending

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and within 2 weeks of 8-week class ending
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.
Baseline and within 2 weeks of 8-week class ending
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.
Baseline and within 2 weeks of 8-week class ending
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.
Baseline and within 2 weeks of 8-week class ending
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.
Baseline and within 2 weeks of 8-week class ending

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of New Mexico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gregory Kanter, MD, Urogynecology Fellow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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