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

Primary Purpose

Chronic Prostatitis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TUDP
TUIB
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Prostatitis focused on measuring Chronic Prostatitis

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test Group

Control Group

Arm Description

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.

Outcomes

Primary Outcome Measures

The score of CPSI
measure the chronic prostatitis symptom index (CPSI) by a questionnaire

Secondary Outcome Measures

Full Information

First Posted
October 14, 2019
Last Updated
May 9, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Sir Run Run Shaw Hospital, Xin Hua Hospital of Zhejiang Province, Huashan Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Changhai Hospital, Peking University First Hospital, The First Affiliated Hospital of Shanxi Medical University, The Affiliated Hospital of Qingdao University, First Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04128280
Brief Title
Multi-center Clinical Observation of a New Treatment Method Based on the Pathogenesis of Obstructive Prostatitis
Official Title
Multi-center Clinical Observation of a New Treatment Method Based on the Pathogenesis of Obstructive Prostatitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Sir Run Run Shaw Hospital, Xin Hua Hospital of Zhejiang Province, Huashan Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Changhai Hospital, Peking University First Hospital, The First Affiliated Hospital of Shanxi Medical University, The Affiliated Hospital of Qingdao University, First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Multi-center clinical observation of a new treatment method based on the pathogenesis of obstructive prostatitis
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Prostatitis
Keywords
Chronic Prostatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Experimental
Arm Description
Test group: Patients will receive a surgery: transurethral dilation of prostate with a columnar balloon
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Control group: Patients will receive a surgery: transurethral incision of bladder neck.
Intervention Type
Procedure
Intervention Name(s)
TUDP
Intervention Description
a surgery: transurethral dilation of prostate with a columnar balloon
Intervention Type
Procedure
Intervention Name(s)
TUIB
Intervention Description
a surgery: transurethral incision of bladder neck
Primary Outcome Measure Information:
Title
The score of CPSI
Description
measure the chronic prostatitis symptom index (CPSI) by a questionnaire
Time Frame
within 12 months after surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shigeng Zhang, Dr.
Phone
+86-571-87783550
Email
zsg710728@zju.edu.cn
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigeng Zhang, Dr.
Phone
+86-571-87783550
Email
zsg710728@zju.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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