Back to results

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

Primary Purpose

Benign Prostatic Hyperplasia

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

TUSP

TURP

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test Group

Control Group

Arm Description

Patients received the transurethral split of the prostate(TUSP) treatment.

Patients received the transurethral resection of the prostate(TURP) treatment.

Outcomes

Primary Outcome Measures

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)

maximum urinary flow rate（Qmax）

Measuring the maximum urinary flow rate by a urodynamic study

Secondary Outcome Measures

Full Information

NCT ID

NCT04912349

First Posted

May 28, 2021

Last Updated

June 1, 2021

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT04912349

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2020 (Actual)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Test Group

Arm Type

Experimental

Arm Description

Patients received the transurethral split of the prostate(TUSP) treatment.

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Patients received the transurethral resection of the prostate(TURP) treatment.

Intervention Type

Procedure

Intervention Name(s)

TUSP

Intervention Description

Patients received the transurethral split of the prostate(TUSP) treatment.

Intervention Type

Procedure

Intervention Name(s)

TURP

Intervention Description

Patients received the transurethral resection of the prostate(TURP) treatment.

Primary Outcome Measure Information:

Title

international prostate symptoms score（IPSS）

Description

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)

Time Frame

within 24 months after surgery

Title

maximum urinary flow rate（Qmax）

Description

Measuring the maximum urinary flow rate by a urodynamic study

Time Frame

within 24 months after surgery

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiaming Wen, Dr.

Phone

+86-571-87783550

wenjiaming@zju.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiaming Wen, Dr.

Organizational Affiliation

Second Affiliated Hospital, School of Medicine, Zhejiang University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Second Affiliated Hospital, School of Medicine, Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jiaming Wen, Dr.

Phone

+86-571-87783550

wenjiaming@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs