N/A N=20 Randomized Treatment

Mindfulness-Based Therapy for Interstitial Cystitis/Bladder Pain Syndrome

Interstitial Cystitis · Mindfulness · Complementary Medicine · Painful Bladder Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02457182 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Global Response Assessment (GRA) — 2; 0; 1; 3 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Mindfulness-based Stress Reduction (MBSR) (Other); Usual medical therapy (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of New Mexico
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Global Response Assessment (GRA)	2; 0; 1; 3; 7; 4	—
SECONDARY O'Leary Sant Symptom Problem Index (OSPI)	26.4; 25.4; 18.9; 24.0; 16.1; 15.2	—
SECONDARY Visual Analog (VAS) Pain Scale	5.9; 5.7; 4.9; 4.6	—
SECONDARY Short Form Health Survey (SF-12)	39.0; 36.6; 47.0; 40.8; 46.5; 44.1	—
SECONDARY Female Sexual Function Index (FSFI)	2.9; 2.7; 3.5; 2.6; 2.6; 2.0	—
SECONDARY Pain Self-Efficacy Scale (PSEQ)	34.3; 30.8; 45.8; 33.5	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02457182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.