Linkage Analysis in Interstitial Cystitis

Urinary Bladder, Overactive Clinical Trial

— IC  

Official title:

Genetic Studies of Urologic Chronic Pelvic Pain Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675298
• Other study ID #: 2010P000226
• Secondary ID: R01DK081647
• Status: Completed
• Phase: N/A
• First received: May 7, 2008
• Last updated: February 2, 2017
• Start date: January 2006
• Est. completion date: June 2011

Study information

• Verified date: February 2014
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Jordan D Dimitrakoff	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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