ClinicalTrials.gg
RecruitingNCT00499317CP/CPPSUpdated Jun 11, 2026

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

An observational study in Chronic Prostatitis (CP), Chronic Pelvic Pain Syndrome (CPPS) and Painful Bladder Syndrome (PBS), sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by Boston Children's Hospital · Observational

From the registry’s dates

  • Started Jan 2007; still recruiting 19 years 9 months later.
Study type
Observational
Model
Family-based
Time perspective
Prospective
Enrollment
500
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Cystitis, Interstitial

236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.

This study's planned enrollment of 500 is above the median of 100 across 63 observational studies indexed under Cystitis, Interstitial.

Browse Cystitis, Interstitial studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ) 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Family-based
Time perspective
Prospective
Enrollment
500 participants (estimated)
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment until completion of genetic analysis for the participant or family, up to 22 years.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 12031372 ↗
  • 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. PubMed 26919663 ↗
  • 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. PubMed 11489726 ↗

Individual participant data

Plan to share: Yes — Data from individual participants may be shared with other researchers. Other research studies will be approved by our internal review board and participants samples and data will be de-identified.

Supporting information: Statistical analysis plan, Informed consent form

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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00499317
Responsible party
Catherine Brownstein (Assoc. Professor of Genetics and Pediatrics, Harvard Medical School, Boston Children's Hospital) — Principal investigator
First posted
Jul 11, 2007
Start date
Jan 15, 2007
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jun 11, 2026

Study contacts

Elicia Estrella, MS, LCGC
Contact
elicia.estrella@childrens.harvard.edu
617-919-4552
Catherine Brownstein, PhD
principal investigator · Boston Children's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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