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

Not Applicable

• Conditions: Chronic Prostatitis
• Interventions: Procedure: TUDP; Procedure: TUIB

• Registration Number: NCT04128280
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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, 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.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Study Start: 2020-01-01
• Last Update Submitted: 2020-05-09
• Last Update Posted: 2020-05-12
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Group	TUDP	Test group: Patients will receive a surgery: transurethral dilation of prostate with a columnar balloon
Control Group	TUIB	Control group: Patients will receive a surgery: transurethral incision of bladder neck.

Primary Outcome Measures

Name	Time	Method
The score of CPSI	within 12 months after surgery	measure the chronic prostatitis symptom index (CPSI) by a questionnaire

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China