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