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

Zhejiang University

Status: Unknown

Conditions: Chronic Prostatitis

Treatments: Procedure: TUIB; Procedure: TUDP

Study type: Interventional

Funder types: Other

Identifiers

NCT04128280

2019-307

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 estimated patients

Sex: Male

Ages: 35 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Test Group

Experimental group

Description:

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

Treatment:

Procedure: TUDP

Control Group

Active Comparator group

Description:

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

Treatment:

Procedure: TUIB