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Piloting a supplemental care certification and referral pathway for refractory CP/CPPS: a hospital-based mixed-methods real-world study protocol

A pilot study on supplementary treatment accreditation and referral pathways for refractory chronic prostatitis/chronic pelvic pain syndrome

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123650
Enrollment
Unknown
Registered
2026-04-28
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Interventions

intervention group:Implement a system-level structural intervention, namely "Certified Referral Pathway (CRP)". Specifically, the multi-disciplinary expert team (MDT) of public tertiary hospitals cert

Sponsors

the 2nd Hospital of Heilongjiang Province
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

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

MeasureTime frame
Frequency of outpatient visits to the urology department;NIH-CPSI score;

Secondary

MeasureTime 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

Public ContactZhongliang Hu

the 2nd Hospital of Heilongjiang Province

525540860@qq.com+86 180 9463 7777

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026