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Clinical Trials/NCT05292235
NCT05292235RecruitingNot Applicable

A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Surgical Treatment for Benign Prostate Hyperplasia in Hong Kong

Chinese University of Hong Kong3 sites in 1 country2,000 target enrollmentStarted: April 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
2,000
Locations
3
Primary Endpoint
International Prostate Symptom Score (IPSS) questionnaire total Score

Study Overview

Brief Summary

This is a prospective data registry to assess the treatment outcomes and complications of different treatment approaches in our hospital clusters.

Detailed Description

Benign prostatic hyperplasia (BPH) is a very common disease affecting men. Patients with BPH may present with voiding symptoms including hesitancy, intermittence, slow stream and sensation of incomplete emptying, and storage symptoms including urinary frequency, urgency and nocturia. Patients may also suffer from complications including urinary retention, recurrent urinary tract infection, bladder stone formation and obstructive uropathy. For patients who have lower urinary tract symptoms refractory to medications, or those who suffer from complications of BPH, transurethral prostatectomy should be considered.

Surgical intervention options have evolved from electrosurgical resection to the use of lasers for enucleation and ablation [1]. Aquablation and Rezum system are new minimally invasive surgical technology for BPH management. [2,3,4]. Different treatment approaches will result in different treatment successful rate and also potential adverse effects to patients.

However, large-scale studies investigating the different modalities of surgical treatment of BPH are lacking. Therefore, a prospective data registry is created to assess the perioperative surgical outcomes for different surgical treatment of BPH.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patient at the age of 18 or above

Exclusion Criteria

  • Patient is unable to give consent

Outcomes

Primary Outcomes

International Prostate Symptom Score (IPSS) questionnaire total Score

Time Frame: Baseline, 3 months after surgical treatment for BPH

Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires

Voiding function in uroflowmetry

Time Frame: Baseline, 3 months after after surgical treatment for BPH

Change in urodynamic function assessed by Uroflowmetry

Secondary Outcomes

  • Complication after surgical treatment(Post operation 30 days after surgical treatment for BPH)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

NG Chi Fai

Professor

Chinese University of Hong Kong

Study Sites (3)

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