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

Chronic Prostatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04128280
• Other study ID #: 2019-307
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Shigeng Zhang, Dr.
• Phone: +86-571-87783550
• Email: zsg710728[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Prostatitis
• Prostatitis

Intervention

Procedure:
• TUDP
a surgery: transurethral dilation of prostate with a columnar balloon
• TUIB
a surgery: transurethral incision of bladder neck

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (10)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The score of CPSI	measure the chronic prostatitis symptom index (CPSI) by a questionnaire	within 12 months after surgery