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The clinical trial protocol for the safety and effectiveness of the P100 pelvic shock wave therapy system in the treatment of prostate-pelvic syndrome

The safety and effectiveness of shock wave in the treatment of prostate-pelvic syndrome

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049603
Enrollment
Unknown
Registered
2021-08-06
Start date
2021-08-16
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Prostate-pelvic Syndrome

Interventions

Experimental group:Shock wave treatment

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Males aged 18-60 years; 2. Meet the diagnostic criteria for prostatic pelvic syndrome (chronic non-bacterial prostatitis); 3. No drugs and other treatments related to prostatic pelvic syndrome (chronic non-bacterial prostatitis) have been used in the past two weeks; 4. NIH-CPSI total score >=10 points; 5. Voluntarily participate in this clinical trial, abide by the requirements of this clinical trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who participated in other clinical trials three months before study enrollment; 2. Patients with severe organ insufficiency, abnormal coagulation function, and long-term oral anticoagulant drugs; 3. Patients with confirmed or suspected bladder and prostate cancer, patients undergoing surgery on the bladder, prostate, urethra and rectum; 4. Patients with unstable mental and psychological disorders, patients with cerebral and spinal injuries, patients with pelvic fractures and urethral injuries, and other patients with open trauma to the treatment site; 5. Patients with neurogenic cystitis, interstitial cystitis and glandular cystitis; 6. Blood routine indicates patients with acute and chronic blood system diseases and acute and chronic infections; 7. Urine routine prompts patients with acute and chronic urinary tract infection; 8. Diabetic patients; 9. The investigator determines that it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Treatment improvement rate;

Secondary

MeasureTime frame
Change in NIH-CPSI pain domain score from baseline;Change in NIH-CPSI voiding symptom score from baseline;The change value of the NIH-CPSI clinical symptom impact score on quality of life from baseline;Change in NIH-CPSI total score from baseline;Change in IPSS score from baseline;Change in PPS score from baseline;

Countries

China

Contacts

Public ContactLiang Chaozhao

Anhui Medical University First Affiliated Hospital

liang_chaozhao@163.com+86 13505604595

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026