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

May 9, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Multi-center clinical observation of a new treatment method based on the pathogenesis of obstructive prostatitis

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • Second Affiliated Hospital, School of Medicine, Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Test Group
Test group: Patients will receive a surgery: transurethral dilation of prostate with a columnar balloon
Procedure: TUDP
a surgery: transurethral dilation of prostate with a columnar balloon
ACTIVE_COMPARATOR: Control Group
Control group: Patients will receive a surgery: transurethral incision of bladder neck.
Procedure: TUIB
a surgery: transurethral incision of bladder neck

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Peking University First Hospital
Changhai Hospital
First Affiliated Hospital, Sun Yat-Sen University
Huashan Hospital
The Affiliated Hospital of Qingdao University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sir Run Run Shaw Hospital
The First Affiliated Hospital of Shanxi Medical University
Xin Hua Hospital of Zhejiang Province

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

October 14, 2019

First Submitted That Met QC Criteria

October 14, 2019

First Posted (ACTUAL)

October 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 9, 2020

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-307

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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