Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Demographic requirements: Biological sex must be male, and actual age is strictly limited to between 18 years (inclusive) and 60 years (inclusive). 2. Core diagnosis and disease course baseline: The official diagnosis of CP/CPPS (i.e., type III prostatitis in the NIH classification) must be clearly issued by a physician at the attending level or above from the Second Hospital of Heilongjiang Province as the core diagnostic center, based on medical history and examinations, and the medical records must clearly confirm that the diagnosis has been established for at least 6 months. 3. Quantitative definition of 'refractory' clinical status: During the continuous 12 months before the study screening day, the patient must have at least 5 registered outpatient visits to the urology department of a tertiary public hospital, and the patient’s complaints or historical medical records must confirm that despite this period of frequent repeated visits and conventional drug treatment, the core clinical symptoms have not achieved any substantive improvement or relief. 4. Disease severity threshold: At the baseline (T0) assessment stage, the total score of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) completed by the subject must be greater than 15 points. 5. Informed consent: The patient must have full civil capacity, be able to fully understand the purpose, procedure, potential benefits, and possible costs of this study, and voluntarily sign the legally effective "Informed Consent Form of the Subject" to confirm consent.
Exclusion criteria
Exclusion criteria: 1. Potential serious organic lesions or red flag signs: Specifically including but not limited to: acute bacterial prostatitis (Type I, accompanied by high fever and chills), any type of genitourinary malignancy (such as prostate cancer, bladder carcinoma in situ, etc.), urinary system tuberculosis infection, severe urethral stricture causing significant urinary obstruction, etc. 2. Intervention crossover and compromise of scientific integrity: Patients are currently enrolled as subjects and actively participating in any other pharmacological clinical trials for prostatitis or pelvic pain (especially new drug Phase I-III trials under confidentiality) or device-related clinical trials. This exclusion is intended to absolutely prevent overlapping, interference, and potentially unresolvable data confounding effects between different trial interventions. 3. Severe psychiatric and cognitive communication disorders: Patients previously diagnosed with severe psychiatric disorders (e.g., acute phase of severe schizophrenia, bipolar disorder, depression with severe suicidal tendencies, etc.), or those with severe cognitive decline, language expression, or comprehension impairments due to sequelae of cerebrovascular accidents, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of outpatient visits to the urology department;NIH-CPSI score; | — |
Secondary
| Measure | Time frame |
|---|---|
| GAD-7 PHQ-9;QoL;CSQ-8 and NPS;Public and private medical expenditures, patient out-of-pocket expenses and transportation costs; | — |
Countries
China
Contacts
the 2nd Hospital of Heilongjiang Province