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NCT04912349 Clinical Trial

Comparison of TUSP Versus TURP for Treatment of Benign Prostatic Hyperplasia in a Small Prostate Volume

Benign Prostatic Hyperplasia Clinical Trial

Official title:
Comparison of Transurethral Split of the Prostate Versus Transurethral Resection of the Prostate for Treatment of Benign Prostatic Hyperplasia in a Small Prostate Volume: A Prospective Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04912349
Other study ID # 2020-525
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date June 30, 2022

Study information
Verified date May 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Jiaming Wen, Dr.
Phone +86-571-87783550
Email wenjiaming@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparison of transurethral split of the prostate versus transurethral resection of the prostate for treatment of benign prostatic hyperplasia in a small prostate volume: A prospective controlled study

Description:

Transurethral resection of the prostate (TURP) was considered as the golden standard to treat benign prostatic hyperplasia (BPH) for decades. However, TURP was associated with low efficiency to alleviate the lower urinary tract symptoms and a significantly higher risk of bladder neck contracture (BNC) for patients with small-volume BPH. We aimed to compare the therapeutic effect of transurethral split of the prostate (TUSP) with TURP for patients with small-volume BPH (<30 ml). In this study, some selected small-volume BPH patients were randomly divided into two groups (TUSP and TURP group). The patient's baseline characteristics and perioperative outcomes were recorded. The follow-up was made at 6 months, 1 year and 2 years after surgical treatment.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender Male
Age group 35 Years to 80 Years
Eligibility Inclusion Criteria: - Benign prostatic hyperplasia patients with surgical indication - Maximum flow rate <12ml/s - Prostate volume <30ml - The international prostate symptoms score>21 - Medication of a-adrenergic blockers for at least 3 months Exclusion Criteria: - Acute prostatitis and urethritis - Neurogenic bladder - Abnormal prostate-specific antigen level - Urethral injury history

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• TUSP
Patients received the transurethral split of the prostate(TUSP) treatment.
• TURP
Patients received the transurethral resection of the prostate(TURP) treatment.

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

Sponsors (1)
Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary international prostate symptoms score(IPSS) Measuring the International Prostate Symptoms Score by a questionnaire (which minimum value is zero and the maximum value is 35; higher scores mean a worse outcome) within 24 months after surgery
Primary maximum urinary flow rate(Qmax) Measuring the maximum urinary flow rate by a urodynamic study within 24 months after surgery
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