Recruiting

Genetic Study

Sponsor:

Boston Children's Hospital

Code:

NCT00499317

Conditions

Chronic Prostatitis (CP)

Chronic Pelvic Pain Syndrome (CPPS)

Painful Bladder Syndrome (PBS)

Benign Frequency Syndrome (BFS)

Interstitial Cystitis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT00499317

Start date

Jan 15, 2007

Status verified date

Jun, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Participants With Candidate Disease-Causing Genetic Variant(s) Associated With CP/CPPS or IC/BPS [ Time Frame: From enrollment until completion of genetic analysis for the participant or family, up to 22 years. ]

Central Contacts and Locations

Central contacts

Elicia Estrella, MS, LCGC

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

Locations

Boston Children's Hospital (BCH)

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Elicia Estrella, MS, LCGC

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

Principal Investigator:

Catherine Brownstein, PhD

More Information

Sponsor

Boston Children's Hospital

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-06-11.