N/A
Completed N=20
Mindfulness-Based Therapy for Interstitial Cystitis/Bladder Pain Syndrome
Interstitial Cystitis · Mindfulness · Complementary Medicine · Painful Bladder Syndrome
Source: ClinicalTrials.gov NCT02457182 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Global Response Assessment (GRA) — 2; 0; 1; 3 participants
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.
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 | — |
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
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. Informational only — not medical advice.