NCT06385977

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

8.5 years

First QC Date

April 24, 2024

Last Update Submit

June 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

case group

participates diagnosed with Chronic prostatitis/chronic pelvic pain syndrome

Behavioral: lifestyleBehavioral: sexual habitsDrug: medication

control group

participates without Chronic prostatitis/chronic pelvic pain syndrome

Behavioral: lifestyleBehavioral: sexual habitsDrug: medication

Interventions

lifestyleBEHAVIORAL

Life habits and personal preferences

case groupcontrol group
sexual habitsBEHAVIORAL

Sexual experience and activities

case groupcontrol group

use of medication

case groupcontrol group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients are from Urology Clinic, while all the controls are recruited from the physical examination center of our hospital.

You may qualify if:

  • 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.

You may not qualify if:

  • Prostate cancer;
  • Benign prostatic hyperplasia with a post-void residual urine volume of \>50 ml;
  • Acute urinary tract infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Prostatitis

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Chun Du, Professor

    Shaanxi Provincial People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Qian Deng, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2024

First Posted

April 26, 2024

Study Start

January 1, 2016

Primary Completion

June 30, 2024

Study Completion

July 1, 2024

Last Updated

July 3, 2024

Record last verified: 2024-06

Locations