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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06385977
Other study ID # ShaanxiPPH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2016
Est. completion date June 2024

Study information

Verified date August 2023
Source Shaanxi Provincial People's Hospital
Contact Qian Deng, Doctor
Phone 86-029-85251331
Email dengqian@xiyi.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date June 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - (1) discomfort or pain in the pelvic region or perineum; (2) symptoms lasting for at least 3 months; and (3) NIH-CPSI pain score of = 4. Controls are volunteers who do not present any prostatitis-related symptoms. Exclusion Criteria: - (1) prostate cancer; (2) benign prostatic hyperplasia with a post-void residual urine volume of >50 ml; (3) acute urinary tract infection.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
lifestyle
Life habits and personal preferences
sexual habits
Sexual experience and activities
Drug:
medication
use of medication

Locations

Country Name City State
China Shaanxi Provincial People's Hospital Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Shaanxi Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 baseline
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