Ignite Creation Date:
2024-05-06 @ 9:31 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03008382
Status:
COMPLETED
Last Update Posted:
2023-02-13
First Post:
2016-12-28
Brief Title:
Interstitial Cystitis Examination of the Central Autonomic Network
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Interstitial Cystitis Examination of the Central Autonomic Network
Status:
COMPLETED
Status Verified Date:
2023-02
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:
ICECAN
Brief Summary:
Interstitial CystitisBladder Pain Syndrome ICBPS afflicts 3 to 8 million women in the US Symptoms of ICBPS reduce quality of life suppressing both social well-being and physical function The chronic pain voiding dysfunction sleep deprivation and associated co-morbid conditions interfere with relationships and employment with significant direct doctor visits medication surgery and indirect loss of productivity economic impact currently exceeding 100 million per yearThis proposal aims to move the science of chronic pelvic pain CPP from simple associations towards an investigation of cause and effect relationships The investigators will determine whether the striking changes in autonomic nervous system responsiveness ANS-R contribute meaningfully to the pathogenesis of ICBPS
Detailed Description:
This multi-site trial will recruit 3 groups of female subjects ages 18-80 years evenly distributed across decades 10 or 20 per decade as appropriate Interstitial CystitisBladder Pain Syndrome ICBPS Myofascial Pelvic Pain MPP and Healthy Controls HC
This proposal aims to move the science of chronic pelvic pain CPP from simple associations towards an investigation of cause and effect relationships We will determine whether the striking changes in ANS-R contribute meaningfully to the pathogenesis of Interstitial CystitisBladder Pain Syndrome ICBPS through 3 aims
1 Careful longitudinal repeated measures in individual subjects to determine if ANS-R changes precede clinical changes
2 Assessing the impact of an intervention designed to change ANS-R on the clinical course of ICBPS
3 Evaluating changes in brain connectivity between the prefrontal cortex PFC and the periaqueductal gray PAG associated with changes in ANS-R and improved disease status
Subjects will be pre-screened in person or on the phone An in-person pre-screen takes place in the MCW Neurology Research Rooms at Froedtert Hospital If the subject is able to participate subject will sign the informed consent form before completing a baseline evaluation The baseline evaluation occurs either following consent or at another date convenient for them Subjects must complete all baseline activities within 2 weeks or before their Week 4Visit 2 The baseline evaluation is comprised of a general examination a set of questionnaires background history documenting date of diagnosis medications tried duration of each treatment and dosing surgeries and therapeutic and exploratory procedures performed A pelvic examination will be performed with CPP subjects patients only Active Change in Posture ACP is administered to the subject Subjects will complete the uroflow urine measurement and Valsalva maneuver in the MCW Neurology Research Rooms with a member of the research team present
Observational Substudy
This substudy is identical to the above with the exception of not taking a beta-blocker or placebo and is only 12 weeks long instead of 24 This is strictly an observational study to monitor subjects who have been diagnosed with IC or MPP If the screening information shows that the subject meets the requirements then they will be able to start If the screening information shows that they cannot be in the research the research doctor will discuss other options with them andor refer them back to their regular doctor
If the subject is able to participate they will complete 3 regular on-site long-visits at weeks 0 4 and 12 The first long-visit baseline evaluation may occur either today following consent or at another date convenient for them The baseline evaluation comprises a general and pelvic examination no speculum psychological questionnaires and a background history questionnaire
Weekly Home Checks will occur for 24 weeks or 12 weeks if in observational sub-study following consent Once each a week subjects will complete a 24-hour heart rate HR recording and the ACP recording using the eMotion Faros 360 portable EKG device A member of the research team will contact the subject each week while they complete the weekly questionnaires and ACP recording This will ensure compliance and will give the subject the opportunity to ask any questionsThe researcher will remain on the phone or via Skype to monitor the subject while the ACP recording is completed from home just prior to the subjects bedtime The HR recording will be uploaded to MCWs secure server at the subjects next hospital visit Throughout the study subjects flare activity will be monitored via phone calls and recording flares in the EMA application on the smartphone This will be a Daily Flare Question in the EMA which is a set alarmed time to sound as a reminder for the duration of the subjects participation
The following weeks after each site visit and the night before visit 5 subjects will repeat complete the 24-hr HR recording to ensure comparability of the HRV recording at home to the one performed at the matching on-site visit Subjects will also complete the 24-h voiding diary a set of questions using the ICECAN mobile App installed on a pre-loaded smartphone and questionnaires Deidentified 24-hour HRV and ACP recordings will be sent to Ohio State University for analysis
Follow-up Visits Weeks 4 12 16 24 Visits 2-5 weeks 4 and 12 Visits 2 and 3 for the observational substudy Subjects will arrive to MCW Neurology Research Rooms to repeat the following review of comorbidities tender points exam questionnaires ACP and DNIC tests Subjects will complete the Valsalva maneuver in the MCW Neurology Research Rooms with a member of the research team present Chronic Pelvic Pain patients subjects will complete a repeat pelvic examination at Weeks 12 and 24
MPP and ICBPS patients subjects will be randomized to receive 8 weeks of either placebo a pill with no active agent or metoprolol a pill that reduces the impact of the brains fight or flight circuits Metoprolol is in the class of beta-blockers commonly used for mild blood pressure control and also commonly used for migraine Subjects will be administered 8 weeks of metoprolol or placebo starting at their Week 4 Visit Subjects will complete a 4-week washout period Week 12-16 and will be administered 8 weeks of crossover Weeks 16-24
Blood will be drawn 50 mL a little more than 3 tablespoons at each in-person visit at weeks 0 4 12 16 and 24 for chronic pelvic pain subjects healthy control only at Baseline and Final visits 2 draws total A portion of the blood plasmaserum will be sent to the University of Pittsburgh for additional related analysis The sample will be labeled by a number and will not contain any information that can be used to directly identify subject This portion of the study is critical to gather new information about pelvic pain which is very poorly understood and we highly encourage subjects to participate in this portion of the study however it is optional
Healthy Controls
60 healthy control subjects will also complete this study in 24 weeks that include 4 long site visits and 6 weekly home check visits During this first long visit they will complete a general exam and physician evaluation DNIC ACP Valsalva maneuver and questionnaires Subjects will complete a 24-hour HR recording from home once a week for 6 weeks total
This proposal aims to move the science of chronic pelvic pain CPP from simple associations towards an investigation of cause and effect relationships We will determine whether the striking changes in ANS-R contribute meaningfully to the pathogenesis of Interstitial CystitisBladder Pain Syndrome ICBPS through 3 aims
1 Careful longitudinal repeated measures in individual subjects to determine if ANS-R changes precede clinical changes
2 Assessing the impact of an intervention designed to change ANS-R on the clinical course of ICBPS
3 Evaluating changes in brain connectivity between the prefrontal cortex PFC and the periaqueductal gray PAG associated with changes in ANS-R and improved disease status
Subjects will be pre-screened in person or on the phone An in-person pre-screen takes place in the MCW Neurology Research Rooms at Froedtert Hospital If the subject is able to participate subject will sign the informed consent form before completing a baseline evaluation The baseline evaluation occurs either following consent or at another date convenient for them Subjects must complete all baseline activities within 2 weeks or before their Week 4Visit 2 The baseline evaluation is comprised of a general examination a set of questionnaires background history documenting date of diagnosis medications tried duration of each treatment and dosing surgeries and therapeutic and exploratory procedures performed A pelvic examination will be performed with CPP subjects patients only Active Change in Posture ACP is administered to the subject Subjects will complete the uroflow urine measurement and Valsalva maneuver in the MCW Neurology Research Rooms with a member of the research team present
Observational Substudy
This substudy is identical to the above with the exception of not taking a beta-blocker or placebo and is only 12 weeks long instead of 24 This is strictly an observational study to monitor subjects who have been diagnosed with IC or MPP If the screening information shows that the subject meets the requirements then they will be able to start If the screening information shows that they cannot be in the research the research doctor will discuss other options with them andor refer them back to their regular doctor
If the subject is able to participate they will complete 3 regular on-site long-visits at weeks 0 4 and 12 The first long-visit baseline evaluation may occur either today following consent or at another date convenient for them The baseline evaluation comprises a general and pelvic examination no speculum psychological questionnaires and a background history questionnaire
Weekly Home Checks will occur for 24 weeks or 12 weeks if in observational sub-study following consent Once each a week subjects will complete a 24-hour heart rate HR recording and the ACP recording using the eMotion Faros 360 portable EKG device A member of the research team will contact the subject each week while they complete the weekly questionnaires and ACP recording This will ensure compliance and will give the subject the opportunity to ask any questionsThe researcher will remain on the phone or via Skype to monitor the subject while the ACP recording is completed from home just prior to the subjects bedtime The HR recording will be uploaded to MCWs secure server at the subjects next hospital visit Throughout the study subjects flare activity will be monitored via phone calls and recording flares in the EMA application on the smartphone This will be a Daily Flare Question in the EMA which is a set alarmed time to sound as a reminder for the duration of the subjects participation
The following weeks after each site visit and the night before visit 5 subjects will repeat complete the 24-hr HR recording to ensure comparability of the HRV recording at home to the one performed at the matching on-site visit Subjects will also complete the 24-h voiding diary a set of questions using the ICECAN mobile App installed on a pre-loaded smartphone and questionnaires Deidentified 24-hour HRV and ACP recordings will be sent to Ohio State University for analysis
Follow-up Visits Weeks 4 12 16 24 Visits 2-5 weeks 4 and 12 Visits 2 and 3 for the observational substudy Subjects will arrive to MCW Neurology Research Rooms to repeat the following review of comorbidities tender points exam questionnaires ACP and DNIC tests Subjects will complete the Valsalva maneuver in the MCW Neurology Research Rooms with a member of the research team present Chronic Pelvic Pain patients subjects will complete a repeat pelvic examination at Weeks 12 and 24
MPP and ICBPS patients subjects will be randomized to receive 8 weeks of either placebo a pill with no active agent or metoprolol a pill that reduces the impact of the brains fight or flight circuits Metoprolol is in the class of beta-blockers commonly used for mild blood pressure control and also commonly used for migraine Subjects will be administered 8 weeks of metoprolol or placebo starting at their Week 4 Visit Subjects will complete a 4-week washout period Week 12-16 and will be administered 8 weeks of crossover Weeks 16-24
Blood will be drawn 50 mL a little more than 3 tablespoons at each in-person visit at weeks 0 4 12 16 and 24 for chronic pelvic pain subjects healthy control only at Baseline and Final visits 2 draws total A portion of the blood plasmaserum will be sent to the University of Pittsburgh for additional related analysis The sample will be labeled by a number and will not contain any information that can be used to directly identify subject This portion of the study is critical to gather new information about pelvic pain which is very poorly understood and we highly encourage subjects to participate in this portion of the study however it is optional
Healthy Controls
60 healthy control subjects will also complete this study in 24 weeks that include 4 long site visits and 6 weekly home check visits During this first long visit they will complete a general exam and physician evaluation DNIC ACP Valsalva maneuver and questionnaires Subjects will complete a 24-hour HR recording from home once a week for 6 weeks total
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None