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

This study is currently recruiting participants.
Verified July 2011 by Children's Hospital Boston
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00499317
First received: July 9, 2007
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  Purpose

Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is a condition with several causes of which some remain unknown. It is believed that some types of CP may be genetic and passed down (or inherited) from one generation to the next.

In this study, we are collecting genetic material and medical information to try to determine if there are genetic factors may play a role in CP/CPPS. We will be collecting DNA (from Saliva) and urine from each participant. Individuals and families with CP/CPPS will be enrolled. Family members of an individual with CP/CPPS are eligible whether or not they also experience 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)

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Pain
U.S. FDA Resources

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

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 500
Study Start Date: January 2007
Estimated Study Completion Date: June 2012
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

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
  • Surgery/chemotherapy in the pelvic area
  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: Louis M Kunkel, PhD            
Sponsors and Collaborators
Children's Hospital Boston
National Institutes of Health (NIH)
Investigators
Principal Investigator: Jordan Dimitrakov, MD, PhD Children's Hospital Boston
  More Information

Publications:

Responsible Party: Louis Kunkel, Ph.D., Children's Hospital, Boston
ClinicalTrials.gov Identifier: NCT00499317     History of Changes
Other Study ID Numbers: 04-11-160M
Study First Received: July 9, 2007
Last Updated: July 21, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Pain
Pelvic Pain
Prostatitis
Chronic Disease
Cystitis, Interstitial
Somatoform Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Prostatic Diseases
Genital Diseases, Male
Disease Attributes
Pathologic Processes
Cystitis
Urinary Bladder Diseases
Urologic Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013