Chronic Prostatitis With Chronic Pelvic Pain SyndromeNCT00672087
Diagnostic Challenges in IC (and Male CPPS)
An observational study of Chronic Prostatitis With Chronic Pelvic Pain Syndrome and Chronic Bacterial Prostatitis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The etiology and pathogenesis of interstitial cystitis (IC) and its related condition in men, chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has remained elusive. This has hampered development of mechanistic treatment strategies for these common, chronic and distressing medical conditions. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Chronic Bacterial Prostatitis, Asymptomatic Inflammatory Prostatitis
- What is being tested?
- Genomic and proteomic biomarker discovery
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Tertiary university medical centers and primary care clinic
Who may be able to join
- Participant has signed and dated the appropriate Informed Consent document.
- Participant must have had symptoms of discomfort or pain in the pelvic region for at least a three (3) month period within the last six (6) months.
Who cannot join
- Major structural/anatomical urinary tract abnormalities
- Underlying inborn conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The etiology and pathogenesis of interstitial cystitis (IC) and its related condition in men, chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has remained elusive. This has hampered development of mechanistic treatment strategies for these common, chronic and distressing medical conditions. We believe that IC and perhaps CP/CPPS are a spectrum of complex but inter-related genetic and acquired diseases resulting from the interaction of several genes regulating immune/inflammatory and neurogenic parameters and environmental factors/circumstances or exposure, culminating in the combination of pain, frequency, urgency and sexual specific symptoms. New research has delineated the dynamic and powerful association of the immune and neurogenic system in pain activation. An immune-modulated neurogenic model of IC illuminating the action of immune derived substances and pain related substances might be important in discovering the determinants of pain, voiding dysfunction and gender specific sexual problems. This inter-related dynamic model of IC disease pathogenesis could be explored for potential avenues leading to novel diagnostic and treatment strategies. We plan to identify and evaluate the sensitivity and specificity of several novel nerve and inflammation related markers in the diagnosis and follow up of IC (and CP/CPPS). By correlating the levels of urine immune and pain related substances to disease mechanisms, severity and progression, we may be able to create a human disease specific model for diagnosis and treatment.
- Conditions
- Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Chronic Bacterial Prostatitis, Asymptomatic Inflammatory Prostatitis, Painful Bladder Syndrome, Cystitis, Interstitial
- Being tested
- Genomic and proteomic biomarker discovery
- Keywords
- Chronic Prostatitis with Chronic Pelvic Pain Syndrome, Chronic Bacterial Prostatitis, Asymptomatic Inflammatory Prostatitis, Painful Bladder Syndrome, Cystitis, Interstitial
- Medical subject headings
- Prostatitis, Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genomic and proteomic biomarker discoveryGenetic
Discovery of novel biomarkers for CP/CPPS and PBS/IC using genomic and proteomic methods
| Study group | Role | What they receive |
|---|---|---|
| A | Chronic prostatitis/chronic pelvic pain syndrome patients Receives: Genetic: Genomic and proteomic biomarker discovery | |
| B | Painful bladder syndrome/interstitial cystitis patients Receives: Genetic: Genomic and proteomic biomarker discovery | |
| C | Asymptomatic controls Receives: Genetic: Genomic and proteomic biomarker discovery |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startSep 2003
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Prostatitis With Chronic Pelvic Pain SyndromeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jordan D Dimitrakoff, MD, PhD, Study chair, Harvard Medical School, Boston, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672087
- Sponsor's protocol ID
- 2010P000229
- Other IDs
- R01DK065990
- Status last verified
- Feb 2014
- First submitted
- 2 May 2008
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Dimitrakov J, Kroenke K, Steers WD, Berde C, Zurakowski D, Freeman MR, Jackson JL. Pharmacologic management of painful bladder syndrome/interstitial cystitis: a systematic review. Arch Intern Med. 2007 Oct 8;167(18):1922-9. doi: 10.1001/archinte.167.18.1922.
PubMed 17923590Dimitrakov JD, Kaplan SA, Kroenke K, Jackson JL, Freeman MR. Management of chronic prostatitis/chronic pelvic pain syndrome: an evidence-based approach. Urology. 2006 May;67(5):881-8. doi: 10.1016/j.urology.2005.12.015. No abstract available.
PubMed 16698346Allsop SA, Erstad DJ, Brook K, Bhai SF, Cohen JM, Dimitrakoff JD. The DABBEC phenotyping system: towards a mechanistic understanding of CP/CPPS. Nat Rev Urol. 2011 Feb;8(2):107-13. doi: 10.1038/nrurol.2010.227. Epub 2011 Jan 18.
PubMed 21243018Strauss AC, Dimitrakov JD. New treatments for chronic prostatitis/chronic pelvic pain syndrome. Nat Rev Urol. 2010 Mar;7(3):127-35. doi: 10.1038/nrurol.2010.4. Epub 2010 Feb 9.
PubMed 20142810Dimitrakov J, Joffe HV, Soldin SJ, Bolus R, Buffington CA, Nickel JC. Adrenocortical hormone abnormalities in men with chronic prostatitis/chronic pelvic pain syndrome. Urology. 2008 Feb;71(2):261-6. doi: 10.1016/j.urology.2007.09.025.
PubMed 18308097
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Challenges in IC (and Male CPPS)
- ClinicalTrials.gov ID
- NCT00672087
- Acronym / sponsor ID
- 2010P000229
- Conditions
- Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Chronic Bacterial Prostatitis, Asymptomatic Inflammatory Prostatitis, Painful Bladder Syndrome, Cystitis, Interstitial
- Keywords
- Chronic Prostatitis with Chronic Pelvic Pain Syndrome, Chronic Bacterial Prostatitis, Asymptomatic Inflammatory Prostatitis, Painful Bladder Syndrome, Cystitis, Interstitial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2003
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 May 2008 (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.
The etiology and pathogenesis of interstitial cystitis (IC) and its related condition in men, chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has remained elusive. This has hampered development of mechanistic treatment strategies for these common, chronic and distressing medical conditions. We believe that IC and perhaps CP/CPPS are a spectrum of complex but inter-related genetic and acquired diseases resulting from the interaction of several genes regulating immune/inflammatory and neurogenic parameters and environmental factors/circumstances or exposure, culminating in the combination of pain, frequency, urgency and sexual specific symptoms. New research has delineated the dynamic and powerful association of the immune and neurogenic system in pain activation. An immune-modulated neurogenic model of IC illuminating the action of immune derived substances and pain related substances might be important in discovering the determinants of pain, voiding dysfunction and gender specific sexual problems. This inter-related dynamic model of IC disease pathogenesis could be explored for potential avenues leading to novel diagnostic and treatment strategies. We plan to identify and evaluate the sensitivity and specificity of several novel nerve and inflammation related markers in the diagnosis and follow up of IC (and CP/CPPS). By correlating the levels of urine immune and pain related substances to disease mechanisms, severity and progression, we may be able to create a human disease specific model for diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | Genetic: Genomic and proteomic biomarker discoveryChronic prostatitis/chronic pelvic pain syndrome patients |
| B | – | Genetic: Genomic and proteomic biomarker discoveryPainful bladder syndrome/interstitial cystitis patients |
| C | – | Genetic: Genomic and proteomic biomarker discoveryAsymptomatic controls |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary university medical centers and primary care clinic
Key inclusion criteria (2 listed)
- Participant has signed and dated the appropriate Informed Consent document.
- Participant must have had symptoms of discomfort or pain in the pelvic region for at least a three (3) month period within the last six (6) months.
Key exclusion criteria (2 listed)
- Major structural/anatomical urinary tract abnormalities
- Underlying inborn conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genomic and proteomic biomarker discoveryDiscovery of novel biomarkers for CP/CPPS and PBS/IC using genomic and proteomic methods | Genetic | A, B, C |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Background: PubMed 17923590Dimitrakov J, Kroenke K, Steers WD, Berde C, Zurakowski D, Freeman MR, Jackson JL. Pharmacologic management of painful bladder syndrome/interstitial cystitis: a systematic review. Arch Intern Med. 2007 Oct 8;167(18):1922-9. doi: 10.1001/archinte.167.18.1922.
- Background: PubMed 16698346Dimitrakov JD, Kaplan SA, Kroenke K, Jackson JL, Freeman MR. Management of chronic prostatitis/chronic pelvic pain syndrome: an evidence-based approach. Urology. 2006 May;67(5):881-8. doi: 10.1016/j.urology.2005.12.015. No abstract available.
- Background: PubMed 21243018Allsop SA, Erstad DJ, Brook K, Bhai SF, Cohen JM, Dimitrakoff JD. The DABBEC phenotyping system: towards a mechanistic understanding of CP/CPPS. Nat Rev Urol. 2011 Feb;8(2):107-13. doi: 10.1038/nrurol.2010.227. Epub 2011 Jan 18.
- Background: PubMed 20142810Strauss AC, Dimitrakov JD. New treatments for chronic prostatitis/chronic pelvic pain syndrome. Nat Rev Urol. 2010 Mar;7(3):127-35. doi: 10.1038/nrurol.2010.4. Epub 2010 Feb 9.
- Results publication: PubMed 18308097Dimitrakov J, Joffe HV, Soldin SJ, Bolus R, Buffington CA, Nickel JC. Adrenocortical hormone abnormalities in men with chronic prostatitis/chronic pelvic pain syndrome. Urology. 2008 Feb;71(2):261-6. doi: 10.1016/j.urology.2007.09.025.
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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. This study is not recruiting at the moment.
Jordan D Dimitrakoff, MD, PhD study chair
Harvard Medical School, Boston, MA
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 With Chronic Pelvic Pain Syndrome and Chronic Bacterial Prostatitis, run by Beth Israel Deaconess Medical Center 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 4 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00672087, which also lists 5 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 4 Aug 2020.