Chronic Prostatitis (CP)CP/CPPSNCT00499317
Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
An observational study of Chronic Prostatitis (CP) and Chronic Pelvic Pain Syndrome (CPPS), run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Prostatitis (CP), Chronic Pelvic Pain Syndrome (CPPS), Painful Bladder Syndrome (PBS)
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2007to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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).
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital (BCH)
Boston, Massachusetts, 02115
Elicia Estrella, MS, LCGC, 617-919-4552, elicia.estrella@childrens.harvard.edu
Catherine Brownstein, PhD
About this study
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.
- 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
- Medical subject headings
- Cystitis, Interstitial, Pelvic Pain, Sexual Dysfunction, Physiological, Erectile Dysfunction, Dyspareunia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment until completion of genetic analysis for the participant or family, up to 22 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study start15 Jan 2007
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Prostatitis (CP)Studies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Brownstein, Boston Children's Hospital
- Investigators
- Catherine Brownstein, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499317
- Sponsor's protocol ID
- 04-11-160M
- Other IDs
- 91208
- Acronym
- CP/CPPS
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2007
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 12031372Keay 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 26919663Dimitrakov 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
- ClinicalTrials.gov ID
- NCT00499317
- Acronym / sponsor ID
- CP/CPPS / 04-11-160M
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 15 Jan 2007 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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).
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 12031372Propert 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.
- Background: PubMed 26919663Keay 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.
- Results publication: PubMed 11489726Dimitrakov 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catherine Brownstein, PhD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Prostatitis (CP) and Chronic Pelvic Pain Syndrome (CPPS), run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elicia Estrella, MS, LCGC (617-919-4552, elicia.estrella@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00499317, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.