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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04128280
Enrollment
180
Registered
2019-10-16
Start date
2020-01-01
Completion date
2021-12-31
Last updated
2020-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Prostatitis

Keywords

Chronic Prostatitis

Brief summary

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

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.

Interventions

PROCEDURETUDP

a surgery: transurethral dilation of prostate with a columnar balloon

PROCEDURETUIB

a surgery: transurethral incision of bladder neck

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
35 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The score of CPSIwithin 12 months after surgerymeasure the chronic prostatitis symptom index (CPSI) by a questionnaire

Countries

China

Contacts

Primary ContactShigeng Zhang, Dr.
zsg710728@zju.edu.cn+86-571-87783550

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026