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Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

This study is currently recruiting participants.
Verified by Children's Hospital Boston, May 2008

Sponsored by: Children's Hospital Boston
Information provided by: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00499317
  Purpose

Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is a common condition with no known cure. It is estimated that every 15 seconds, a man in the USA is diagnosed with CP/CPPS. Studies have suggested that the condition may be genetic and passed down (or inherited) from one generation to the next.

In this study we are comparing different families' samples and medical information to determine which genetic factors may play a role in CP/CPPS. We will be collecting DNA and urine from each participant. Individuals and families with CP/CPPS will be enrolled. Family members are eligible with or without CP/CPPS symptoms


Condition
Chronic Prostatitis (CP)
Chronic Pelvic Pain Syndrome (CPPS)
Painful Bladder Syndrome (PBS)
Benign Frequency Syndrome (BFS)
Benign Daytime Frequency Syndrome (BDFS)

MedlinePlus related topics:   Pelvic Pain   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Family-Based, Prospective

Further study details as provided by Children's Hospital Boston:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

DNA sample via saliva and urine samples will be collected and stored.


Estimated Enrollment:   500
Study Start Date:   January 2007
Estimated Study Completion Date:   January 2011

Detailed Description:

To further describe the phenotype of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and to correlate the phenotypic information with the genotypic findings utilizing linkage analysis and candidate gene studies. A North American cohort and a Bulgarian cohort will be recruited. Each individual participant will be required to give a DNA sample (via Saliva) and a urine sample. All samples will be stored.

  Eligibility
Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Study Population

We are collecting individuals and families with symptoms and diagnoses of CP/CPPS and their family members (with or without symptoms) from North America (United States and Canada)


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 member 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 which affect the urinary tract
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499317

Contacts
Contact: Elicia Estrella, MS     617-919-4552     elicia.estrella@childrens.harvard.edu    
Contact: Stephanie J. Brewster, MS     617-919-4551     stephanie.brewster@childrens.harvard.edu    

Locations
United States, Massachusetts
Children's Hospital, Boston     Recruiting
      Boston, Massachusetts, United States, 02115
      Principal Investigator: Jordan Dimitrakov, MD, PhD            

Sponsors and Collaborators
Children's Hospital Boston

Investigators
Principal Investigator:     Jordan Dimitrakov, MD, PhD     Children's Hospital Boston    
  More Information


Publications of Results:

Other Publications:

Responsible Party:   Children's Hospital, Boston ( Jordan Dimitrakov, M.D., Ph.D. )
Study ID Numbers:   04-11-160M
First Received:   July 9, 2007
Last Updated:   May 22, 2008
ClinicalTrials.gov Identifier:   NCT00499317
Health Authority:   United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Urgency  
Frequency  
Pelvic pain  
Sexual dysfunction  
Erectile dysfunction  

Study placed in the following topic categories:
Prostatitis
Signs and Symptoms
Cystitis, Interstitial
Pelvic Pain
Urologic Diseases
Prostatic Diseases
Urinary Bladder Diseases
Cystitis
Chronic Disease
Pain
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on October 06, 2008




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