Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain... | NCT00499317

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

NCT00499317

Sponsor

Boston Children's Hospital

Status

Recruiting

Last Update Posted

Jun 11, 2026Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
91208	Other Grant/Funding Number	Broad Institute

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2007Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Jul 9, 2007

First Submission Date that Met QC Criteria

Jul 9, 2007

First Posted Date

Jul 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2026

Last Update Posted Date

Jun 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participants With Candidate Disease-Causing Genetic Variant(s) Associated With CP/CPPS or IC/BPS	DNA from blood/saliva and, when available, bladder or skin tissue will be analyzed using linkage analysis, whole exome/genome sequencing, and candidate gene approaches to identify candidate disease-causing variants associated with CP/CPPS, IC/BPS, PBS, or BFS. The measure will be summarized as the number of participants with candidate disease-causing variant(s), and when applicable, co-segregation of variants with affected status or symptoms.	From enrollment until completion of genetic analysis for the participant or family, up to 22 years.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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, 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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elicia Estrella, MS, LCGC	Contact	617-919-4552		elicia.estrella@childrens.harvard.edu

Overall Officials

Name	Affiliation	Role
Catherine Brownstein, PhD	Boston Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boston Children's Hospital (BCH)	Recruiting	Boston	Massachusetts	02115	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12031372	Background	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.
26919663	Background

ID	Term
D018856	Cystitis, Interstitial
D017699	Pelvic Pain
D012735	Sexual Dysfunction, Physiological
D007172	Erectile Dysfunction
D004414	Dyspareunia

ID	Term
D003556	Cystitis
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases