AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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

Other trials in United States

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).

  1. 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:
  2. 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 groups in NCT01616992
Study groupRoleWhat they receive
Interstitial CystitisNot described
Receives: Drug: Bupivacaine
Myofascial Pelvic PainNot described
Receives: Drug: Bupivacaine
HealthyNot described
First Degree RelativeNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Interstitial Cystitis

    Clinical Assessment

    Measured: 1 month

  2. Myofascial Pelvic Pain

    Clinical Assessment

    Measured: 1 Month

Secondary outcomes (2)
  1. Depression Symptoms

    Questionnaire Assessment of Symptoms

    Measured: 1 Month

  2. 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.

  1. First posted12 Jun 2012 (estimated)
  2. Study startSep 2009
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in