Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299683
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-02-29
Brief Title:
Pain Type and Interstitial CystitisBladder Pain Syndrome Treatment
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Mechanistic-Based Treatment of Interstitial CystitisBladder Pain Syndrome
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Interstitial cystitisbladder pain syndrome ICBPS is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work Emotional suffering is common in ICBPS and known to make physical symptoms worse and studies show patient sub-groups respond differently to treatment Individuals with ICBPS have distinct subgroups or phenotypes largely characterized by the distribution of pain throughout the body Supported by our preliminary evidence the overall goal of this project is to assess how ICBPS phenotype may affect response to two different therapies often given without regard to patient phenotype pelvic floor physical therapy PT and cognitive-behavioral therapy CBT for ICBPS
Detailed Description:
Interstitial cystitisbladder pain syndrome ICBPS is a debilitating incurable and costly pain condition affecting approximately 3-8 million individuals in the United States and is extremely challenging to treat Treatment advances in ICBPS have stalled due to a lack of clear understanding of the condition as symptoms and presentations vary widely For these reasons national organizations have prioritized the need to improve both treatment options and understanding of ICBPS Leading multi-institutional research networks have now identified that individuals with ICBPS have distinct subgroups or phenotypes largely characterized by the distribution of pain throughout the body At the same time the chronic pain field is adopting a new approach driven by mechanisms of illness and treatment Growing evidence suggests that different phenotypes of patients with ICBPS respond differently to medical intervention The overall goal of this project is to assess how ICBPS phenotype may affect response to two different therapies often given without regard to patient phenotype pelvic floor physical therapy PT and cognitive-behavioral therapy CBT for ICBPS The investigator is proposing a randomized mechanistic trial to evaluate which participants may benefit from each treatment Aim 1 and evaluate whether neurobiological mechanisms may moderate outcomes and change with treatment Aim 2 The investigator hypothesizes that a prediction of which participants will respond preferentially to either form of treatment based on reported bodily pain distribution pelvic pain primarily pain outside of the pelvis This project has great potential to tailor treatment and improve future ICBPS precision-medicine care efforts
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DK133415-01A1 | NIH | None | httpsreporternihgovquickSearch1R01DK133415-01A1 |