Linkage Analysis in Interstitial Cystitis (IC)

This study is currently recruiting participants.

Verified June 2011 by Beth Israel Deaconess Medical Center

Sponsor:

Collaborator:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Information provided by:

Beth Israel Deaconess Medical Center

ClinicalTrials.gov Identifier:

NCT00675298

First received: May 7, 2008

Last updated: June 23, 2011

Last verified: June 2011

History of Changes

Purpose

Urologic pelvic pain syndrome (UCPPS), variably termed painful bladder syndrome/interstitial cystitis (PBS/IC) in females and chronic prostatitis/chronic pelvic pain syndrome in men (CP/CPPS), is a chronic, debilitating clinical syndrome presenting as severe pelvic pain with extreme urinary urgency and frequency in the absence of any known cause. The etiologic mechanisms underlying UCPPS are unknown, but recurrence, risks to siblings of affected individuals, concordance among monozygotic twins, and our own preliminary studies indicate a strong genetic contribution to the cause of UCPPS. The overall goal of this proposal is use novel approaches to understand the basis of UCPPS, to identify candidate genes containing mutations that result in UCPPS and determine how the different encoded proteins of these genes interact with one another in a common biological pathway. Ultimately, understanding how mutations in at least five different genes yield the symptoms of UCPPS should lead to improved diagnosis and possible therapies.

Condition
Prostatitis Cystitis, Interstitial Urinary Bladder, Overactive Chronic Pelvic Pain Syndrome Painful Bladder Syndrome

Study Type:	Observational
Study Design:	Observational Model: Family-Based Time Perspective: Prospective
Official Title:	Genetic Studies of Urologic Chronic Pelvic Pain Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Interstitial Cystitis Pelvic Pain

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Biospecimen Retention: Samples With DNA

Saliva and urine

Estimated Enrollment:	300
Study Start Date:	January 2006
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Men with chronic prostatitis/chronic pelvic pain syndrome
2 Women with painful bladder syndrome/interstitial cystitis
3 Children with overactive bladder
4 Bulgarian cohort with chronic prostatitis/chronic pelvic pain syndrome, painful bladder syndrome/interstitial cystitis and children with overactive bladder
5 Asymptomatic healthy controls

Eligibility

Ages Eligible for Study:	3 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Self-referred patients and subjects from a Bulgarian high-prevalence CPPS population

Criteria

Inclusion Criteria:

Have symptoms for at least 3 months within the preceding 6 months:
Pain in the pelvic area
Urinary frequency and/or
Urinary urgency and/or
Sexual dysfunction (erectile dysfunction)
Have CP/CPPS, IC, PBS, or BFS
Be willing to provide a saliva and urine sample
Agree to complete several brief questionnaires
Family of someone with CP/CPPS, PBS, IC or BFS
Live in the USA or Canada

Exclusion Criteria:

Major structural/anatomical urinary tract abnormalities
Underlying inborn or congenital conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675298

Contacts

Contact: Jordan D Dimitrakoff, MD, PhD

6176672051

jdimitra@bidmc.harvard.edu

Locations

United States, Massachusetts
Jordan D Dimitrakoff	Recruiting
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Study Chair:

Jordan D Dimitrakoff, MD, PhD

Beth Israel Deaconess Medical Center

More Information

Publications:

Dimitrakov J, Joffe HV, Soldin SJ, Bolus R, Buffington CA, Nickel JC. Adrenocortical hormone abnormalities in men with chronic prostatitis/chronic pelvic pain syndrome. Urology. 2008 Feb;71(2):261-6.

Dimitrakov J, Kroenke K, Steers WD, Berde C, Zurakowski D, Freeman MR, Jackson JL. Pharmacologic management of painful bladder syndrome/interstitial cystitis: a systematic review. Arch Intern Med. 2007 Oct 8;167(18):1922-9. Review. Erratum in: Arch Intern Med. 2007 Dec 10-22;167(22):2452.

Dimitrakov JD, Kaplan SA, Kroenke K, Jackson JL, Freeman MR. Management of chronic prostatitis/chronic pelvic pain syndrome: an evidence-based approach. Urology. 2006 May;67(5):881-8. Review. No abstract available.

Dimitrakov JD. A case of familial clustering of interstitial cystitis and chronic pelvic pain syndrome. Urology. 2001 Aug;58(2):281.

Responsible Party:	Jordan Dimitrakoff, MD, PhD, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA
ClinicalTrials.gov Identifier:	NCT00675298 History of Changes
Other Study ID Numbers:	R01 DK081647, R01DK081647
Study First Received:	May 7, 2008
Last Updated:	June 23, 2011
Health Authority:	United States: Federal Government

Keywords provided by Beth Israel Deaconess Medical Center:

Prostatitis
Cystitis, Interstitial
Urinary Bladder, Overactive
Chronic pelvic pain syndrome

Painful bladder syndrome
Urgency
Frequency

Additional relevant MeSH terms:

Cystitis
Cystitis, Interstitial
Pain
Pelvic Pain
Prostatitis
Somatoform Disorders
Urinary Bladder, Overactive
Urinary Bladder Diseases

Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Mental Disorders
Urological Manifestations

ClinicalTrials.gov processed this record on May 23, 2013

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