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Clinical Trials/NCT04912349
NCT04912349
Unknown
Not Applicable

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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country150 target enrollmentJuly 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Benign Prostatic Hyperplasia
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
150
Locations
1
Primary Endpoint
international prostate symptoms score(IPSS)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
June 30, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

international prostate symptoms score(IPSS)

Time Frame: 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)

Time Frame: within 24 months after surgery

Measuring the maximum urinary flow rate by a urodynamic study

Study Sites (1)

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