ProstatitisNCT03027076
Microbiome of Urologic Chronic Pelvic Pain Syndrome
An observational study of Prostatitis and Chronic Prostatitis, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to learn more about the bacteria that live in the genito-urinary tract in subjects with urologic chronic pelvic pain syndrome (UCPPS). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prostatitis, Chronic Prostatitis, Interstitial Cystitis
- What is being tested?
- Genitourinary Specimen Collection and Collect midstream urine samples
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jan 2015
- How long will I take part?
- 6 Months
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community Sample
Who may be able to join
- Consent: Participant has signed and dated the Informed Consent document, approved by the Johns Hopkins Medical Institutions Institutional Review Board;
- Agreement: Participant agrees to participate in study procedures;
- Age: Participant is at least 18 years of age;
- Symptom Severity: Participant reports a response of at least 8 on the Pain Domain of the NIH-Chronic Prostatitis Symptom Index (CPSI) Questionnaire;
- Duration of Symptoms: Symptoms have been present for at least 3 months within the preceding 6 months.
Who cannot join
- Urethral conditions: Participant has an ongoing symptomatic urethral stricture;
- Bladder conditions: Participant has a history of cystitis caused by tuberculosis, radiation therapy or cytoxan/cyclophosphamide therapy, augmentation cystoplasty or cystectomy;
- Testicular conditions: Participant diagnosed with unilateral orchialgia, without pelvic symptoms;
- Prostate conditions or procedures: Participant has a history of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, prostate cryosurgery, or laser procedure;
- Neurological diseases or disorders affecting the bladder: Parkinson disease, multiple system atrophy, multiple sclerosis, spinal cord injury, cervical myelopathy, acute transverse myelitis, diabetic cystopathy, or dysfunctional voiding (non-neurogenic neurogenic bladder or Hinman syndrome);
- Psychiatric conditions: Participant has current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc.);
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- Malignancy: Participant has a history of cancer (with the exception of skin cancer).
- Control group exclusion criteria:
- In addition to the exclusion criteria listed above, additional criteria for control subjects are as follows:
- Chronic Pain: In the past year, symptoms of discomfort or pain in the pelvic region for a period longer than 3 months within the preceding year;
- Infection: Volunteers who have had a urinary tract infection with a urine culture value of >100,000 colony forming units/ml (CFU/ml) within the past three months.
- Intravesical Therapy: Volunteers treated with intravesical chemotherapy or Bacillus Calmette-Guerin (BCG) therapy;
- Gastrointestinal Conditions: Volunteers with inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microbiome Studies of Urologic Chronic Pelvic Pain Syndrome
This research is being done to learn more about the bacteria that live in the genito-urinary tract in subjects with urologic chronic pelvic pain syndrome (UCPPS).
Read the detailed description
This research is being done to learn more about the bacteria that live in the genito-urinary tract in subjects with urologic chronic pelvic pain syndrome (UCPPS).
A microbiome is defined as "the ecological community of commensal, symbiotic, and pathogenic microorganisms that literally share our body space." (Lederberg, 2001) The present study is designed to establish the prostate, urinary bladder and urethral microbiome in men with chronic prostatitis/chronic pelvic pain syndrome or the urinary bladder and urethral microbiome in women with interstitial cystitis/painful bladder syndrome.
The human urethra, bladder and prostate normally harbor microbial communities. The recent advent of large-scale "omics" technologies allows a detailed analysis of those communities. While current knowledge of the normal inhabitants of the human urogenital tract remains incomplete, more than 90% of patients with UCPPS report the onset of symptoms following a "urinary tract infection". The causative agents in most of those cases remain unknown, partly due to the limitations of older detection technologies that require the detection and isolation of a single microorganism for implicating it as a causative agent. Furthermore, many microbial species remain unculturable and therefore, are often undetectable using standard technology.
The current project will utilize state-of-the-art "omic" technology to detect and identify microbial species in the urethra and bladder of both men and women and the prostate of men. Additionally, the inflammatory response that accompanies those microbial communities will be characterized. Finally, the presence and number of microbial species will be correlated with the intensity of the inflammatory response and the severity of symptoms that patients with UCPPS experience.
- Conditions
- Prostatitis, Chronic Prostatitis, Interstitial Cystitis, Painful Bladder Syndrome, Bladder Pain Syndrome
- Being tested
- Genitourinary Specimen Collection, Collect midstream urine samples
- Keywords
- prostatitis, chronic prostatitis, chronic pelvic pain syndrome, interstitial cystitis, painful bladder syndrome, bladder pain syndrome, biomarkers, biological markers, bacteria, microbiome, inflammation
- Medical subject headings
- Prostatitis, Cystitis, Interstitial, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genitourinary Specimen CollectionProcedure or surgery
Collect urethral swab, urine before prostatic massage (pre-M), urine after prostatic massage (post-M) and Expressed Prostatic Secretion (EPS)
Collect midstream urine samplesProcedure or surgery
Collect midstream urine samples
| Study group | Role | What they receive |
|---|---|---|
| Men with UCPPS | Genitourinary Specimen Collection for microbiome evaluation Receives: Procedure: Genitourinary Specimen Collection | |
| Asymptomatic Men | Genitourinary Specimen Collection for microbiome evaluation Receives: Procedure: Genitourinary Specimen Collection | |
| Women with UCPPS | Collect midstream urine samples Receives: Procedure: Collect midstream urine samples | |
| Asymptomatic Women | Collect midstream urine samples Receives: Procedure: Collect midstream urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome
Evaluate the microbiome at baseline, one "good day" (minimal or no symptoms) and one "bad day" (worst symptoms) within a 6 month period
Measured: Within 6 month period from baseline evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startNov 2013
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Funding for project not secured
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstatitisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur L Burnett, MD, FACS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027076
- Sponsor's protocol ID
- NA_00089692
- Status last verified
- Aug 2017
- First submitted
- 18 Jan 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome Studies of Urologic Chronic Pelvic Pain Syndrome
- ClinicalTrials.gov ID
- NCT03027076
- Acronym / sponsor ID
- NA_00089692
- Conditions
- Prostatitis, Chronic Prostatitis, Interstitial Cystitis, Painful Bladder Syndrome, Bladder Pain Syndrome
- Keywords
- prostatitis, chronic prostatitis, chronic pelvic pain syndrome, interstitial cystitis, painful bladder syndrome, bladder pain syndrome, biomarkers, biological markers
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding for project not secured
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 20 Jan 2017 (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.
This research is being done to learn more about the bacteria that live in the genito-urinary tract in subjects with urologic chronic pelvic pain syndrome (UCPPS).
Detailed description
This research is being done to learn more about the bacteria that live in the genito-urinary tract in subjects with urologic chronic pelvic pain syndrome (UCPPS).
A microbiome is defined as "the ecological community of commensal, symbiotic, and pathogenic microorganisms that literally share our body space." (Lederberg, 2001) The present study is designed to establish the prostate, urinary bladder and urethral microbiome in men with chronic prostatitis/chronic pelvic pain syndrome or the urinary bladder and urethral microbiome in women with interstitial cystitis/painful bladder syndrome.
The human urethra, bladder and prostate normally harbor microbial communities. The recent advent of large-scale "omics" technologies allows a detailed analysis of those communities. While current knowledge of the normal inhabitants of the human urogenital tract remains incomplete, more than 90% of patients with UCPPS report the onset of symptoms following a "urinary tract infection". The causative agents in most of those cases remain unknown, partly due to the limitations of older detection technologies that require the detection and isolation of a single microorganism for implicating it as a causative agent. Furthermore, many microbial species remain unculturable and therefore, are often undetectable using standard technology.
The current project will utilize state-of-the-art "omic" technology to detect and identify microbial species in the urethra and bladder of both men and women and the prostate of men. Additionally, the inflammatory response that accompanies those microbial communities will be characterized. Finally, the presence and number of microbial species will be correlated with the intensity of the inflammatory response and the severity of symptoms that patients with UCPPS experience.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Men with UCPPS | – | Procedure: Genitourinary Specimen CollectionGenitourinary Specimen Collection for microbiome evaluation |
| Asymptomatic Men | – | Procedure: Genitourinary Specimen CollectionGenitourinary Specimen Collection for microbiome evaluation |
| Women with UCPPS | – | Procedure: Collect midstream urine samplesCollect midstream urine samples |
| Asymptomatic Women | – | Procedure: Collect midstream urine samplesCollect midstream urine samples |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community Sample
Key inclusion criteria (5 listed)
- Consent: Participant has signed and dated the Informed Consent document, approved by the Johns Hopkins Medical Institutions Institutional Review Board;
- Agreement: Participant agrees to participate in study procedures;
- Age: Participant is at least 18 years of age;
- Symptom Severity: Participant reports a response of at least 8 on the Pain Domain of the NIH-Chronic Prostatitis Symptom Index (CPSI) Questionnaire;
- Duration of Symptoms: Symptoms have been present for at least 3 months within the preceding 6 months.
Key exclusion criteria (13 listed)
- Urethral conditions: Participant has an ongoing symptomatic urethral stricture;
- Bladder conditions: Participant has a history of cystitis caused by tuberculosis, radiation therapy or cytoxan/cyclophosphamide therapy, augmentation cystoplasty or cystectomy;
- Testicular conditions: Participant diagnosed with unilateral orchialgia, without pelvic symptoms;
- Prostate conditions or procedures: Participant has a history of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, prostate cryosurgery, or laser procedure;
- Neurological diseases or disorders affecting the bladder: Parkinson disease, multiple system atrophy, multiple sclerosis, spinal cord injury, cervical myelopathy, acute transverse myelitis, diabetic cystopathy, or dysfunctional voiding (non-neurogenic neurogenic bladder or Hinman syndrome);
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 |
|---|---|---|
| Genitourinary Specimen CollectionCollect urethral swab, urine before prostatic massage (pre-M), urine after prostatic massage (post-M) and Expressed Prostatic Secretion (EPS) | Procedure or surgery | Asymptomatic Men, Men with UCPPS |
| Collect midstream urine samplesCollect midstream urine samples | Procedure or surgery | Asymptomatic Women, Women with UCPPS |
Primary outcome
Microbiome
Time frame: Within 6 month period from baseline evaluation
Evaluate the microbiome at baseline, one "good day" (minimal or no symptoms) and one "bad day" (worst symptoms) within a 6 month period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
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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.
Arthur L Burnett, MD, FACS principal investigator
Johns Hopkins University
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 Prostatitis and Chronic Prostatitis, run by Johns Hopkins University 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 5 inclusion and 13 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: withdrawn, as of the sponsor's last update on 30 Aug 2017. 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 was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
Microbiome (time frame: Within 6 month period from baseline evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2017.