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

Not Applicable

• Conditions: Benign Prostatic Hyperplasia

• Registration Number: NCT04912349
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-06-01
• Last Update Submitted: 2021-06-01
• Study First Posted: 2021-06-03
• Last Update Posted: 2021-06-03
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 150

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 α-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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
international prostate symptoms score（IPSS）	within 24 months after surgery	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)
maximum urinary flow rate（Qmax）	within 24 months after surgery	Measuring the maximum urinary flow rate by a urodynamic study

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China