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

NCT04128280 | Unknown

• 1 other identifier: 2019-307
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Prostatitis

Keywords

Chronic Prostatitis

Outcome Measures

Primary Outcomes (1)

• The score of CPSI

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

  within 12 months after surgery

Study Arms (2)

Test Group

EXPERIMENTAL

Test group: Patients will receive a surgery: transurethral dilation of prostate with a columnar balloon

Procedure: TUDP

Control Group

ACTIVE COMPARATOR

Control group: Patients will receive a surgery: transurethral incision of bladder neck.

Procedure: TUIB

Interventions

TUDP PROCEDURE

a surgery: transurethral dilation of prostate with a columnar balloon

Test Group

TUIB PROCEDURE

a surgery: transurethral incision of bladder neck

Control Group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Interventions

tubercidin-5'-diphosphate

Central Study Contacts

Shigeng Zhang, Dr.

CONTACT

+86-571-87783550; zsg710728@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 12, 2020

Record last verified: 2019-10

Locations

CN (1)