Mindfulness-Based Therapy for Interstitial Cystitis/Bladder Pain Syndrome

NCT02457182 | Completed Results

• 1 other identifier: 14-141
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Cystitis; Mindfulness; Complementary Medicine; Painful Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

• Global Response Assessment (GRA)

  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 Outcomes (5)

• O'Leary Sant Symptom Problem Index (OSPI)

  Baseline and within 2 weeks of 8-week class ending

• Visual Analog (VAS) Pain Scale

  Baseline and within 2 weeks of 8-week class ending

• Short Form Health Survey (SF-12)

  Baseline and within 2 weeks of 8-week class ending

• Female Sexual Function Index (FSFI)

  Baseline and within 2 weeks of 8-week class ending

• Pain Self-Efficacy Scale (PSEQ)

  Baseline and within 2 weeks of 8-week class ending

Study Arms (2)

Mindfulness-based Stress Reduction

EXPERIMENTAL

Mindfulness-based Stress Reduction (MBSR)

Other: Mindfulness-based Stress Reduction (MBSR); Other: Usual medical therapy

Usual Care

PLACEBO COMPARATOR

Usual medical therapy

Other: Usual medical therapy

Interventions

Mindfulness-based Stress Reduction (MBSR) OTHER

Mindfulness-based Stress Reduction

Usual medical therapy OTHER

Mindfulness-based Stress Reduction; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (1)

• Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.

  PMID: 32734597 DERIVED

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Gregg Kanter, MD
• Organization: University of New Mexico

greggkanter@gmail.com

818-599-3456

Study Officials

• Gregory Kanter, MD

  Urogynecology Fellow

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urogynecology Fellow

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: May 29, 2015
• Study Start: November 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 9, 2018
• Results First Posted: October 9, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)