Multi-center Clinical Observation of a New Treatment Method Based on the Pathogenesis of Obstructive Prostatitis
NCT ID: NCT04128280
Last Updated: 2020-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2020-01-01
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Test Group
Test group: Patients will receive a surgery: transurethral dilation of prostate with a columnar balloon
TUDP
a surgery: transurethral dilation of prostate with a columnar balloon
Control Group
Control group: Patients will receive a surgery: transurethral incision of bladder neck.
TUIB
a surgery: transurethral incision of bladder neck
Interventions
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TUDP
a surgery: transurethral dilation of prostate with a columnar balloon
TUIB
a surgery: transurethral incision of bladder neck
Eligibility Criteria
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Inclusion Criteria
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
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.
35 Years
80 Years
MALE
No
Sponsors
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Sir Run Run Shaw Hospital
OTHER
Xin Hua Hospital of Zhejiang Province
OTHER
Huashan Hospital
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Changhai Hospital
OTHER
Peking University First Hospital
OTHER
The First Affiliated Hospital of Shanxi Medical University
OTHER
The Affiliated Hospital of Qingdao University
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Locations
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-307
Identifier Type: -
Identifier Source: org_study_id
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