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

NCT ID: NCT04912349

Last Updated: 2021-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test Group

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

Group Type EXPERIMENTAL

TUSP

Intervention Type PROCEDURE

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

Control Group

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

Group Type ACTIVE_COMPARATOR

TURP

Intervention Type PROCEDURE

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

Interventions

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TUSP

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

Intervention Type PROCEDURE

TURP

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jiaming Wen, Dr.

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiaming Wen, Dr.

Role: CONTACT

+86-571-87783550

Facility Contacts

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Jiaming Wen, Dr.

Role: primary

+86-571-87783550

Other Identifiers

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2020-525

Identifier Type: -

Identifier Source: org_study_id

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