Chronic Prostatitis With Chronic Pelvic Pain SyndromeNCT06385977
Risk Factors for Chronic Prostatitis Patients in Northwest China
An observational study of Chronic Prostatitis With Chronic Pelvic Pain Syndrome, run by Shaanxi Provincial People's Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about the risk factors of lifestyle, medication and sexual habits in adult chronic prostatitis / chronic pelvic pain syndrome patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Prostatitis With Chronic Pelvic Pain Syndrome
- What is being tested?
- lifestyle, sexual habits and medication
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to 1 Jul 2024
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients are from Urology Clinic, while all the controls are recruited from the physical examination center of our hospital.
Who may be able to join
- Discomfort or pain in the pelvic region or perineum;
- Symptoms lasting for at least 3 months;
- NIH-CPSI pain score of ≥ 4;
- Controls are volunteers who do not present any prostatitis-related symptoms.
Who cannot join
- Prostate cancer;
- Benign prostatic hyperplasia with a post-void residual urine volume of >50 ml;
- Acute urinary tract infection.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710061
Qian Deng, Doctor, 86-029-85251331 ext. 2079, dengqian@xiyi.edu.cn
About this study
Official title: Risk Factors for Chronic Prostatitis/Chronic Pelvic Pain Syndrome Patients in Northwest China
The goal of this observational study is to learn about the risk factors of lifestyle, medication and sexual habits in adult chronic prostatitis / chronic pelvic pain syndrome patients. The main questions it aims to answer are:
- Is lifestyle, medication, and sexual habits related to chronic prostatitis / chronic pelvic pain syndrome
- Is there any medication available to protect men from chronic prostatitis / chronic pelvic pain syndrome.
Read more
Participants will:
- Independently receive a survey questionnaire on lifestyle, medication, and sexual habits.
- Symptomatic individuals will undergo additional prostate fluid examination for diagnosis.
Researchers will compare healthy adult males to see if there are differences on lifestyle, medication and sexual habits between the two groups.
Read the detailed description
All participants were asked to fill out a questionnaire which was modified based on Zhang Ran's research. The questionnaire contained the following parts: patient's general situation, dietary habits, disease status, medication, lifestyle, sexual habits and NIH-CPSI index (National Institutes of Health Chronic Prostatitis Symptom Index). Furthermore, the patients underwent digital rectal examination, expressed prostatic secretion microscopy and microbial culture, urinalysis, urine microbial culture and transrectal ultrasonography.
- Being tested
- lifestyle, sexual habits, medication
- Medical subject headings
- Prostatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyleBehavioural
Life habits and personal preferences
sexual habitsBehavioural
Sexual experience and activities
medicationDrug
use of medication
| Study group | Role | What they receive |
|---|---|---|
| case group | participates diagnosed with Chronic prostatitis/chronic pelvic pain syndrome Receives: Behavioral: lifestyle; Behavioral: sexual habits; Drug: medication | |
| control group | participates without Chronic prostatitis/chronic pelvic pain syndrome Receives: Behavioral: lifestyle; Behavioral: sexual habits; Drug: medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds Ratio
The ratio of exposed to unexposed individuals in the case group divided by the ratio of exposed to unexposed individuals in the control group
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study startJan 2016
- Primary completion30 Jun 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaanxi Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun Du, Professor, Study director, Shaanxi Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385977
- Sponsor's protocol ID
- ShaanxiPPH
- Status last verified
- Jun 2024
- First submitted
- 24 Apr 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Chronic Prostatitis/Chronic Pelvic Pain Syndrome Patients in Northwest China
- ClinicalTrials.gov ID
- NCT06385977
- Acronym / sponsor ID
- ShaanxiPPH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shaanxi Provincial People's HospitalUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 26 Apr 2024 (actual)
- 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 goal of this observational study is to learn about the risk factors of lifestyle, medication and sexual habits in adult chronic prostatitis / chronic pelvic pain syndrome patients. The main questions it aims to answer are:
- Is lifestyle, medication, and sexual habits related to chronic prostatitis / chronic pelvic pain syndrome
- Is there any medication available to protect men from chronic prostatitis / chronic pelvic pain syndrome.
Participants will:
- Independently receive a survey questionnaire on lifestyle, medication, and sexual habits.
- Symptomatic individuals will undergo additional prostate fluid examination for diagnosis.
Researchers will compare healthy adult males to see if there are differences on lifestyle, medication and sexual habits between the two groups.
Detailed description
All participants were asked to fill out a questionnaire which was modified based on Zhang Ran's research. The questionnaire contained the following parts: patient's general situation, dietary habits, disease status, medication, lifestyle, sexual habits and NIH-CPSI index (National Institutes of Health Chronic Prostatitis Symptom Index). Furthermore, the patients underwent digital rectal examination, expressed prostatic secretion microscopy and microbial culture, urinalysis, urine microbial culture and transrectal ultrasonography.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Behavioral: lifestyle, Behavioral: sexual habits, Drug: medicationparticipates diagnosed with Chronic prostatitis/chronic pelvic pain syndrome |
| control group | – | Behavioral: lifestyle, Behavioral: sexual habits, Drug: medicationparticipates without Chronic prostatitis/chronic pelvic pain syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients are from Urology Clinic, while all the controls are recruited from the physical examination center of our hospital.
Key inclusion criteria (4 listed)
- Discomfort or pain in the pelvic region or perineum;
- Symptoms lasting for at least 3 months;
- NIH-CPSI pain score of ≥ 4;
- Controls are volunteers who do not present any prostatitis-related symptoms.
Key exclusion criteria (3 listed)
- Prostate cancer;
- Benign prostatic hyperplasia with a post-void residual urine volume of >50 ml;
- Acute urinary tract infection.
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 |
|---|---|---|
| lifestyleLife habits and personal preferences | Behavioural | case group, control group |
| sexual habitsSexual experience and activities | Behavioural | case group, control group |
| medicationuse of medication | Drug | case group, control group |
Primary outcome
Odds Ratio
Time frame: baseline
The ratio of exposed to unexposed individuals in the case group divided by the ratio of exposed to unexposed individuals in the control group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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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.
Chun Du, Professor study director
Shaanxi Provincial People'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 With Chronic Pelvic Pain Syndrome, run by Shaanxi Provincial People's Hospital at 1 site in China.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Deng, Doctor (86-029-85251331 ext. 2079, dengqian@xiyi.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Odds Ratio (time frame: baseline). 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 3 Jul 2024.