NCT04912349

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

June 3, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

May 28, 2021

Last Update Submit

June 1, 2021

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

  • 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)

    within 24 months after surgery

  • maximum urinary flow rate（Qmax）

    Measuring the maximum urinary flow rate by a urodynamic study

    within 24 months after surgery

Study Arms (2)

Test Group

EXPERIMENTAL

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

Procedure: TUSP

Control Group

ACTIVE COMPARATOR

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

Procedure: TURP

Interventions

TUSPPROCEDURE

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

Test Group
TURPPROCEDURE

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

Control Group

Eligibility Criteria

Age35 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Acute prostatitis and urethritis
  • Neurogenic bladder
  • Abnormal prostate-specific antigen level
  • Urethral injury history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Jiaming Wen, Dr.

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaming Wen, Dr.

CONTACT

+86-571-87783550wenjiaming@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2021

First Posted

June 3, 2021

Study Start

July 1, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

June 3, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)