N/A
N=78
Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome
Chronic Interstitial Cystitis · Bladder Pain Syndrome · Cystitis, Interstitial · Painful Bladder Syndrome · Cystitis, Chronic Interstitial
Bottom Line
View on ClinicalTrials.gov: NCT04275297 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Change in the Genitourinary Pain Index (GUPI) 2 Months — 6.6; 4.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Psychosocial Treatment (Behavioral); Attention Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Genitourinary Pain Index (GUPI) 2 Months |
6.6; 4.8 | — |
| PRIMARY Change in the Genitourinary Pain Index (GUPI) 5 Months |
8.1; 6.6 | — |
| SECONDARY Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-8) |
0.9; 1.0; 0.8; 0.0 | — |
| SECONDARY The Widespread Pain Index (Derived From CHOIR Bodymap) |
0.6; 0.1; 0.9; 0.4 | — |
| SECONDARY Fibromyalgia Symptom Scale (FSS) |
0.4; 0.7; 0.8; 0.2 | — |
| SECONDARY Change in Posttraumatic Stress Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) With Criterion A |
-2.8; -1.3; 0.1; -3.5 | — |
| SECONDARY Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder (GAD-7) Questionnaire |
0.5; 0.6; 0.1; -0.1 | — |
| SECONDARY Difference in Response to Treatment/Perceived Improvement and Quality of Life Between Groups as Measured by the Patient Global Impression of Change Scale (PGIC) |
4.7; 2.8; 4.4; 3.1 | — |
| SECONDARY Quantitative Sensory Testing (Optional) - Threshold Average |
44.65; 40.76 | — |
| SECONDARY Quantitative Sensory Testing (Optional) - Tolerance Average |
47.89; 47.29 | — |
| SECONDARY Quantitative Sensory Testing - Temporal Summation (Slope) |
-.23; -.21 | — |
Summary
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. By creating and testing a psychosocial intervention specific to IC/BPS, we will learn if this intervention improves patient wellness, who the intervention works best for, and how the body's pain processing influences outcomes.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Diagnosis of IC/BPS as given by providers or indicated by assessments
Exclusion Criteria
- Comorbid neurological conditions including spinal cord injury or systematic neurologic illnesses, or central nervous system diseases such as brain tumor or stroke
- Current or history of diagnosis of primary psychotic or major thought disorder within the past five years
- Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, and/or PTSD (within the past 5 years)
- Psychiatric or behavioral conditions in which symptoms are unstable or severe (e.g. current delirium, mania, psychosis, suicidal ideation, homicidal ideation, substance abuse dependency) reported within the past six months
- Non-English speaking
- Presenting symptoms at time of screening that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking
- Difficulties or limitations communicating over the telephone
- Any planned life events that would interfere with participating in the key elements of the study
- Any major active medical issues that could preclude participation
- Currently being treated for cancer
- Cancer-related pain
- Currently engaged in individual counseling/psychotherapy or unwilling to pause this treatment for the trial duration
Data sourced from ClinicalTrials.gov (NCT04275297). 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.