Interstitial Cystitis/Painful Bladder SyndromeICEPACNCT01616992
Interstitial Cystitis: Elucidation of the Psychophysiologic and Autonomic Characteristics (ICEPAC) Study
An observational study of Interstitial Cystitis/Painful Bladder Syndrome and Myofascial Pelvic Pain, run by Case Western Reserve University at 2 sites in United States.
Trial summary
Interstitial cystitis/painful bladder syndrome (IC/PBS) causes severe bladder pain and extensive disability in a large group of women int he prime of their productive lives. Extensive study of the bladder itself has uncovered many abnormalities, but the investigators do not know if these are the cause or result of the… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Interstitial Cystitis/Painful Bladder Syndrome, Myofascial Pelvic Pain
- What is being tested?
- Bupivacaine
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patient population will be composed of four subject groups: Group I: This group will consist of female IC/PBS patients (n = 76) Group II: This group will consist of female siblings of patients (n = 38) Group III: This group will consist of female MPP patients (n = 76) Group IV: This group will consist of healthy female control subjects (n = 38) Female subjects ages 18-80 will be recruited.
Who may be able to join
None listed.
Who cannot join
- Pelvic surgery within the last 12 months
- Pelvic injection with the last 90 days
- Presence of IC/PBS by the current NIDDK criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Summa Health System
Akron, Ohio, 44304
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Interstitial Cystitis: Elucidation of the Psychophysiologic and Autonomic
Interstitial cystitis/painful bladder syndrome (IC/PBS) causes severe bladder pain and extensive disability in a large group of women int he prime of their productive lives. Extensive study of the bladder itself has uncovered many abnormalities, but the investigators do not know if these are the cause or result of the disorder. None of these has led to any real long-term progress in treatment, so far. The investigators have found that other autonomic disorders often occur in both the patients themselves and in the family members of patients with IC/PBS. The investigators therefore propose to determine whether the main abnormality in IC/PBS actually lies in the autonomic nervous system, rather than the bladder. The investigators will do this through careful measurements of autonomic function and sensation in patients who have IC/PBS, both at rest, and under controlled psychological stress. The investigators will compare their measurements to patients with myofascial pelvic pain, to know which abnormalities are truly linked to IC/PBS, and which simply reflect the presence of pelvic pain.
Read the detailed description
The investigators primary hypothesis is that IC/PBS is a member of a larger family of disorders sharing aberrant central autonomic and sensory response to stress, pain or threat. These disorders appear to share a common vulnerability that seems to be conferred during development, and symptoms of these disorders usually are first manifested in response to an environmental trigger. This proposal aims to compare the neural, psychological, and endocrine phenotypes that characterize patients with IC/PBS with those of patients suffering myofascial pelvic pain (MPP) syndrome, an chronic pelvic pain distinct from IC/PBS, age-matched, healthy controls, and first degree relatives. These studies are designed to identify which levels of the neuraxis are impaired, both in the basal state, and in response to a well-characterized psychosocial stressor.
Aim 1: To differentiate the specific baseline neurophysiological abnormalities that occur in IC/PBS from those present in patients with MPP and healthy subjects, specifically:
1a: Bladder and pelvic floor afferent and efferent urogynecological function: (1) voiding diaries (efferent) modified to include void-state related numeric rating scales for pain (afferent); Uroflow measurements (efferent), and a double-blind placebo-controlled evaluation of the diagnostic lidocaine instillation test (afferent) with impact on voiding function (efferent); (2) semi-quantitative evaluation of pelvic floor function and identification of myofascial trigger points (efferent), including inter-observer validation of a standardized semi-quantitative examination (afferent); (3) quantitative Q-tip test for vulvodynia (afferent) (4) evaluation of dysmenorrhea (afferent) and menstrual function (efferent).
1b: somatic afferent and autonomic efferent neural function, specifically: (1) global screen for autonomic and neurological abnormalities through the established Small Fiber Score Instrument (SFIBS) questionnaire and structured neurological examination (afferent and efferent); (2) specific evaluation of sacral and lumbar nerve root function through a focused neurological examination (afferent and efferent); (3) parasympathetic cardiac function through the cardiac response to deep breathing (efferent); (4) sympathetic cardiac and vasomotor functions through the cardiovascular responses to the Valsalva maneuver and to an upright tilt table test (efferent); (5) sudomotor sympathetic function through the quantitative sudomotor axon reflex test (QSART) that evaluates post-ganglionic function (specifically abnormal in autonomic neuropathies) and through a thermoregulatory sweat test (efferent).
- c: gastrointestinal afferent and efferent function, specifically upper bowel motility with established methods: (1) early satiety \& gastric compliance by water load test (afferent). (2) gastric electrical activity through electrogastrography (efferent). Aim 2: To determine the specific developmental, psychiatric, pain, autonomic, and stress response characteristics common to IC/PBS and their family members, that differ from MPP and healthy subjects through:
- a: Stress and trauma history in early childhood and adulthood.
2b: Psychiatric screening and psychometric quantitation of psychological symptoms, pain and function.
2c: Quantitation of associated co-morbid autonomic disorders through the ODYSA questionnaire.
2d: Salivary cortisol levels immediately prior to autonomic testing (anticipatory stress) and after a period of relaxation once the test is finished, in conjunction with a stress self-assessment inventory.
2e: Performance of the Trier test on a subset of patients and controls, with measurement of autonomic cardiovascular parameters, body temperature, catecholamine concentrations (norepinephrine, epinephrine, dopamine) and endocrine parameters: ACTH and adrenocortical hormones.
- Being tested
- Bupivacaine
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
20 ML dose of 0.75% Bupivacaine Instillation (into bladder) 1 time during second study visit.
| Study group | Role | What they receive |
|---|---|---|
| Interstitial Cystitis | Not described Receives: Drug: Bupivacaine | |
| Myofascial Pelvic Pain | Not described Receives: Drug: Bupivacaine | |
| Healthy | Not described | |
| First Degree Relative | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interstitial Cystitis
Clinical Assessment
Measured: 1 month
Myofascial Pelvic Pain
Clinical Assessment
Measured: 1 Month
Secondary outcomes (2)
Depression Symptoms
Questionnaire Assessment of Symptoms
Measured: 1 Month
Stress Symptoms
Questionnaire Assessment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startSep 2009
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Cystitis/Painful Bladder SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Chelimsky, Case Western Reserve University
- Investigators
- Thomas C Chelimsky, MD, Principal investigator, Medical College of WisconsinJeffrey Janata, PhD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616992
- Sponsor's protocol ID
- R01DK083538
- Acronym
- ICEPAC
- Status last verified
- Feb 2015
- First submitted
- 8 Jun 2012
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Williams DP, Chelimsky G, McCabe NP, Koenig J, Singh P, Janata J, Thayer JF, Buffington CA, Chelimsky T. Effects of Chronic Pelvic Pain on Heart Rate Variability in Women. J Urol. 2015 Nov;194(5):1289-94. doi: 10.1016/j.juro.2015.04.101. Epub 2015 May 9.
PubMed 25963185
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial Cystitis: Elucidation of the Psychophysiologic and Autonomic
- ClinicalTrials.gov ID
- NCT01616992
- Acronym / sponsor ID
- ICEPAC / R01DK083538
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interstitial cystitis/painful bladder syndrome (IC/PBS) causes severe bladder pain and extensive disability in a large group of women int he prime of their productive lives. Extensive study of the bladder itself has uncovered many abnormalities, but the investigators do not know if these are the cause or result of the disorder. None of these has led to any real long-term progress in treatment, so far. The investigators have found that other autonomic disorders often occur in both the patients themselves and in the family members of patients with IC/PBS. The investigators therefore propose to determine whether the main abnormality in IC/PBS actually lies in the autonomic nervous system, rather than the bladder. The investigators will do this through careful measurements of autonomic function and sensation in patients who have IC/PBS, both at rest, and under controlled psychological stress. The investigators will compare their measurements to patients with myofascial pelvic pain, to know which abnormalities are truly linked to IC/PBS, and which simply reflect the presence of pelvic pain.
Detailed description
The investigators primary hypothesis is that IC/PBS is a member of a larger family of disorders sharing aberrant central autonomic and sensory response to stress, pain or threat. These disorders appear to share a common vulnerability that seems to be conferred during development, and symptoms of these disorders usually are first manifested in response to an environmental trigger. This proposal aims to compare the neural, psychological, and endocrine phenotypes that characterize patients with IC/PBS with those of patients suffering myofascial pelvic pain (MPP) syndrome, an chronic pelvic pain distinct from IC/PBS, age-matched, healthy controls, and first degree relatives. These studies are designed to identify which levels of the neuraxis are impaired, both in the basal state, and in response to a well-characterized psychosocial stressor.
Aim 1: To differentiate the specific baseline neurophysiological abnormalities that occur in IC/PBS from those present in patients with MPP and healthy subjects, specifically:
1a: Bladder and pelvic floor afferent and efferent urogynecological function: (1) voiding diaries (efferent) modified to include void-state related numeric rating scales for pain (afferent); Uroflow measurements (efferent), and a double-blind placebo-controlled evaluation of the diagnostic lidocaine instillation test (afferent) with impact on voiding function (efferent); (2) semi-quantitative evaluation of pelvic floor function and identification of myofascial trigger points (efferent), including inter-observer validation of a standardized semi-quantitative examination (afferent); (3) quantitative Q-tip test for vulvodynia (afferent) (4) evaluation of dysmenorrhea (afferent) and menstrual function (efferent).
1b: somatic afferent and autonomic efferent neural function, specifically: (1) global screen for autonomic and neurological abnormalities through the established Small Fiber Score Instrument (SFIBS) questionnaire and structured neurological examination (afferent and efferent); (2) specific evaluation of sacral and lumbar nerve root function through a focused neurological examination (afferent and efferent); (3) parasympathetic cardiac function through the cardiac response to deep breathing (efferent); (4) sympathetic cardiac and vasomotor functions through the cardiovascular responses to the Valsalva maneuver and to an upright tilt table test (efferent); (5) sudomotor sympathetic function through the quantitative sudomotor axon reflex test (QSART) that evaluates post-ganglionic function (specifically abnormal in autonomic neuropathies) and through a thermoregulatory sweat test (efferent).
- c: gastrointestinal afferent and efferent function, specifically upper bowel motility with established methods: (1) early satiety \& gastric compliance by water load test (afferent). (2) gastric electrical activity through electrogastrography (efferent). Aim 2: To determine the specific developmental, psychiatric, pain, autonomic, and stress response characteristics common to IC/PBS and their family members, that differ from MPP and healthy subjects through:
- a: Stress and trauma history in early childhood and adulthood.
2b: Psychiatric screening and psychometric quantitation of psychological symptoms, pain and function.
2c: Quantitation of associated co-morbid autonomic disorders through the ODYSA questionnaire.
2d: Salivary cortisol levels immediately prior to autonomic testing (anticipatory stress) and after a period of relaxation once the test is finished, in conjunction with a stress self-assessment inventory.
2e: Performance of the Trier test on a subset of patients and controls, with measurement of autonomic cardiovascular parameters, body temperature, catecholamine concentrations (norepinephrine, epinephrine, dopamine) and endocrine parameters: ACTH and adrenocortical hormones.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Interstitial Cystitis | – | Drug: Bupivacaine |
| Myofascial Pelvic Pain | – | Drug: Bupivacaine |
| Healthy | – | – |
| First Degree Relative | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population will be composed of four subject groups: Group I: This group will consist of female IC/PBS patients (n = 76) Group II: This group will consist of female siblings of patients (n = 38) Group III: This group will consist of female MPP patients (n = 76) Group IV: This group will consist of healthy female control subjects (n = 38) Female subjects ages 18-80 will be recruited.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Pelvic surgery within the last 12 months
- Pelvic injection with the last 90 days
- Presence of IC/PBS by the current NIDDK criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine20 ML dose of 0.75% Bupivacaine Instillation (into bladder) 1 time during second study visit. | Drug | Interstitial Cystitis, Myofascial Pelvic Pain |
Primary outcome
Interstitial Cystitis
Time frame: 1 month
Clinical Assessment
Myofascial Pelvic Pain
Time frame: 1 Month
Clinical Assessment
2 secondary outcomes
Depression Symptoms
Time frame: 1 Month
Stress Symptoms
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
- Derived from this study: PubMed 25963185Williams DP, Chelimsky G, McCabe NP, Koenig J, Singh P, Janata J, Thayer JF, Buffington CA, Chelimsky T. Effects of Chronic Pelvic Pain on Heart Rate Variability in Women. J Urol. 2015 Nov;194(5):1289-94. doi: 10.1016/j.juro.2015.04.101. Epub 2015 May 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas C Chelimsky, MD principal investigator
Medical College of Wisconsin
Jeffrey Janata, PhD principal investigator
University Hospitals Cleveland Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Cystitis/Painful Bladder Syndrome and Myofascial Pelvic Pain, run by Case Western Reserve University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interstitial Cystitis (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01616992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.