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

Sponsor

Boston Children's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT00499317

Collaborator

(none)

500

Enrollment

Location

239.5

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Prostatitis (CP) Chronic Pelvic Pain Syndrome (CPPS) Painful Bladder Syndrome (PBS) Benign Frequency Syndrome (BFS) Interstitial Cystitis

Detailed Description

We would like to determine if chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has a genetic cause. We will be attempting to further describe the symptoms of CP/CPPS and to correlate them with changes in your genes. We will use several types of genetic testing; linkage analysis, whole exome sequencing and candidate gene studies. Each individual participant will be required to give a DNA sample (via Blood/Saliva), a urine sample and answer questionnaires. Affected participants will also be asked to provide a bladder sample from a clinical biopsy. All samples will be stored. Travel to Boston NOT required.

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Family-Based

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 15, 2007

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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, 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