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

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

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

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

Conditions
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Chronic Prostatitis

Intervention / Treatment
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* Procedure: TUDP
* Procedure: TUIB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>Test group: Patients will receive a surgery: transurethral dilation of prostate with a columnar balloon | Procedure: TUDP<br>* a surgery: transurethral dilation of prostate with a columnar balloon<br>|
| Active Comparator: Control Group<br>Control group: Patients will receive a surgery: transurethral incision of bladder neck. | Procedure: TUIB<br>* a surgery: transurethral incision of bladder neck<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The score of CPSI | measure the chronic prostatitis symptom index (CPSI) by a questionnaire | within 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Prostatitis