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

NCT00499317 | Recruiting DMC

• 2 other identifiers: 04-11-160M91208
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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 or passed down (inherited) from one generation to the next. In this study, we are collecting genetic material and medical information to try to determine if genetic factors play a role in CP/CPPS. We will be collecting DNA (from Blood/Saliva sample) and urine from each participant. Bladder tissue from affected individuals will also be collected. 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.

Conditions

Chronic Prostatitis (CP); Chronic Pelvic Pain Syndrome (CPPS); Painful Bladder Syndrome (PBS); Benign Frequency Syndrome (BFS); Interstitial Cystitis

Keywords

Urgency; Frequency; Pelvic pain; Sexual dysfunction; Erectile dysfunction; Painful intercourse

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We are collecting individuals with a diagnoses of CP/CPPS and their family members (with or without symptoms) from North America (United States and Canada). Preference is given to families with multiple affected individuals (males or females with IC/BPS/CPPS).

You may qualify if:

• 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, Interstitial Cystitis (IC), Bladder Pain Syndrome BPS, or Bladder Fasciculation Syndrome (BFS)
• Be willing to provide a blood/saliva, bladder tissue (from previous biopsy) and urine sample
• Agree to complete several brief questionnaires
• Family member of someone with CP/CPPS, BPS, IC or BFS
• Live in the USA or Canada

You may not qualify if:

• Major structural/anatomical urinary tract abnormalities
• Underlying inborn or congenital conditions which affect the urinary tract
• Surgery/chemotherapy in the pelvic area
• Bacterial cause to CP/CPPS or recurrent Urinary tract infections (UTI)
• Traumatic cause to CP/CPPS

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital (BCH)

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (3)

• Propert KJ, Alexander RB, Nickel JC, Kusek JW, Litwin MS, Landis JR, Nyberg LM, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network. Design of a multicenter randomized clinical trial for chronic prostatitis/chronic pelvic pain syndrome. Urology. 2002 Jun;59(6):870-6. doi: 10.1016/s0090-4295(02)01601-1.

  PMID: 12031372 BACKGROUND

• Keay SK, Zhang CO. Abnormal Akt signalling in bladder epithelial cell explants from patients with interstitial cystitis/bladder pain syndrome can be induced by antiproliferative factor treatment of normal bladder cells. BJU Int. 2016 Jul;118(1):161-72. doi: 10.1111/bju.13457. Epub 2016 Mar 29.

  PMID: 26919663 BACKGROUND

• 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.

  PMID: 11489726 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

DNA sample via blood/saliva, bladder tissue and urine samples will be collected and stored.

MeSH Terms

Conditions

Cystitis, Interstitial; Pelvic Pain; Sexual Dysfunction, Physiological; Erectile Dysfunction; Dyspareunia

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases; Genital Diseases, Male; Sexual Dysfunctions, Psychological; Mental Disorders; Genital Diseases, Female

Study Officials

• Catherine Brownstein, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elicia Estrella, MS, LCGC

CONTACT

617-919-4552; elicia.estrella@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Professor of Genetics and Pediatrics, Harvard Medical School

Study Record Dates

• First Submitted: July 9, 2007
• First Posted: July 11, 2007
• Study Start: January 15, 2007
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: We will store study information and samples indefinitely and may share this information with future collaborators. All shared samples and data will be de-identified.
• Access Criteria: De-identified data may be shared with other CP/CPPS researchers or other BCH researchers

Locations

US (1)