Perioperative Parameter and Treatment Outcomes of Surgical Treatment for Benign Prostate Hyperplasia in Hong Kong

Recruiting

• Conditions: Benign Prostatic Hyperplasia

• Registration Number: NCT05292235
• Lead Sponsor: Chinese University of Hong Kong

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 Timeline

• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-23
• Study Start: 2022-04-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05
• Primary Completion: 2032-04-30
• Study Completion: 2032-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 2000

Inclusion Criteria

• Patient at the age of 18 or above

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Exclusion Criteria

• Patient is unable to give consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (IPSS) questionnaire total Score	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	Baseline, 3 months after after surgical treatment for BPH	Change in urodynamic function assessed by Uroflowmetry

Secondary Outcome Measures

Name	Time	Method
Complication after surgical treatment	Post operation 30 days after surgical treatment for BPH	The 30-day complications will be graded according to the Clavien-Dindo classification

Trial Locations

Locations (3)

North District Hospital; 🇭🇰 Hong Kong, Hong Kong

Alice Ho Miu Ling Nethersole Hospital; 🇭🇰 Hong Kong, Hong Kong

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong