Linkage Analysis in Interstitial Cystitis

NCT ID: NCT00675298

Last Updated: 2017-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Men with chronic prostatitis/chronic pelvic pain syndrome

No interventions assigned to this group

2

Women with painful bladder syndrome/interstitial cystitis

No interventions assigned to this group

3

Children with overactive bladder

No interventions assigned to this group

4

Bulgarian cohort with chronic prostatitis/chronic pelvic pain syndrome, painful bladder syndrome/interstitial cystitis and children with overactive bladder

No interventions assigned to this group

5

Asymptomatic healthy controls

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA

Principal Investigators

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Jordan D Dimitrakoff, MD, PhD

Role: STUDY_CHAIR

Beth Israel Deaconess Medical Center

Locations

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Jordan D Dimitrakoff

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/j.urology.2007.09.025.

Reference Type BACKGROUND
PMID: 18308097 (View on PubMed)

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. doi: 10.1001/archinte.167.18.1922.

Reference Type BACKGROUND
PMID: 17923590 (View on PubMed)

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. doi: 10.1016/j.urology.2005.12.015. No abstract available.

Reference Type BACKGROUND
PMID: 16698346 (View on PubMed)

Dimitrakov JD. A case of familial clustering of interstitial cystitis and chronic pelvic pain syndrome. Urology. 2001 Aug;58(2):281. doi: 10.1016/s0090-4295(01)01138-4.

Reference Type BACKGROUND
PMID: 11489726 (View on PubMed)

Other Identifiers

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R01DK081647

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2010P000226

Identifier Type: -

Identifier Source: org_study_id

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