Multi-center Clinical Observation of a New Treatment Method Based on the Pathogenesis of Obstructive Prostatitis

Multi-center Clinical Observation of a New Treatment Method Based on the Pathogenesis of Obstructive Prostatitis

Multi-center clinical observation of a new treatment method based on the pathogenesis of obstructive prostatitis

1. Study purpose: To investigate the therapeutic effect of transurethral dilation of prostate with a columnar balloon on patients with chronic obstructive prostatitis
2. Study design: A randomized, controlled, multi-center clinical trial
3. Study subjects: Patients with chronic obstructive prostatitis
4. Number of subjects: 180
5. Surgery treatments:

Test group: Patients will receive a surgery: transurethral dilation of prostate with a columnar balloon.

Control group: Patients will receive a surgery: transurethral incision of bladder neck.

Inclusion Criteria:

1. older than 35 years old, urinary obstruction is clear;
2. the total score of chronic prostatitis symptoms index (CPSI) is greater than 14 points, and the severity of symptoms is greater than 9 points;
3. maximum urine flow rate is less than 15 ml/s;
4. cystoscopy and pathological biopsy confirmed the presence of bladder neck fibrosis, bladder trabeculae formation;
5. other conservative treatments are ineffective or ineffective, and drug treatment is not effective for more than 6 months;
6. voluntarily participated in this clinical trial, complied with the requirements of this study and signed the informed consent form.

Exclusion Criteria:

1. urinary tract infection, urinary tumor, history of intestinal inflammatory disease;
2. neurogenic bladder;
3. history of pelvic radiation therapy or chemotherapy;
4. PSA is abnormal;
5. urethral stricture, history of bladder or prostate surgery;
6. the investigator determined that it is not suitable for this clinical trial.