Linkage Analysis in Interstitial Cystitis (IC)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00675298
First received: May 7, 2008
Last updated: February 5, 2014
Last verified: February 2014
  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:


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
Study Completion Date: June 2011
Primary Completion Date: June 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Jordan D Dimitrakoff
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Study Chair: Jordan D Dimitrakoff, MD, PhD Beth Israel Deaconess Medical Center
  More Information

Publications:
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: February 5, 2014
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
Pain
Pelvic Pain
Prostatitis
Cystitis, Interstitial
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 July 10, 2014