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

June 1, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group
Patients received the transurethral split of the prostate(TUSP) treatment.
Procedure: TUSP
Patients received the transurethral split of the prostate(TUSP) treatment.
Active Comparator: Control Group
Patients received the transurethral resection of the prostate(TURP) treatment.
Procedure: TURP
Patients received the transurethral resection of the prostate(TURP) treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
within 24 months after surgery
maximum urinary flow rate（Qmax）
Time Frame: within 24 months after surgery
Measuring the maximum urinary flow rate by a urodynamic study
within 24 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Jiaming Wen, Dr., Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

May 28, 2021

First Submitted That Met QC Criteria

June 1, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Actual)

June 3, 2021

Last Update Submitted That Met QC Criteria

June 1, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-525

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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