Status:
UNKNOWN
Multi-center Clinical Observation of a New Treatment Method Based on the Pathogenesis of Obstructive Prostatitis
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Sir Run Run Shaw Hospital
Xin Hua Hospital of Zhejiang Province
Conditions:
Chronic Prostatitis
Eligibility:
MALE
35-80 years
Phase:
NA
Brief Summary
Multi-center clinical observation of a new treatment method based on the pathogenesis of obstructive prostatitis
Detailed Description
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, co...
Eligibility Criteria
Inclusion
- older than 35 years old, urinary obstruction is clear;
- the total score of chronic prostatitis symptoms index (CPSI) is greater than 14 points, and the severity of symptoms is greater than 9 points;
- maximum urine flow rate is less than 15 ml/s;
- cystoscopy and pathological biopsy confirmed the presence of bladder neck fibrosis, bladder trabeculae formation;
- other conservative treatments are ineffective or ineffective, and drug treatment is not effective for more than 6 months;
- voluntarily participated in this clinical trial, complied with the requirements of this study and signed the informed consent form.
Exclusion
- urinary tract infection, urinary tumor, history of intestinal inflammatory disease;
- neurogenic bladder;
- history of pelvic radiation therapy or chemotherapy;
- PSA is abnormal;
- urethral stricture, history of bladder or prostate surgery;
- the investigator determined that it is not suitable for this clinical trial.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04128280
Start Date
January 1 2020
End Date
December 31 2021
Last Update
May 12 2020
Active Locations (1)
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1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009