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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05292235
• Other study ID #: CRE-2022.049
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: July 31, 2032

Study information

• Verified date: January 2024
• Source: Chinese University of Hong Kong
• Contact: Chi Fai NG, MD
• Phone: 35052625
• Email: ngcf[@]surgeryh.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: July 31, 2032
• Est. primary completion date: April 30, 2032
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient at the age of 18 or above

Exclusion Criteria:

• Patient is unable to give consent

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Locations

Country	Name	City	State
Hong Kong	Alice Ho Miu Ling Nethersole Hospital	Hong Kong
Hong Kong	North District Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (4)

Dixon CM, Rijo Cedano E, Mynderse LA, Larson TR. Transurethral convective water vapor as a treatment for lower urinary tract symptomatology due to benign prostatic hyperplasia using the Rezum((R)) system: evaluation of acute ablative capabilities in the human prostate. Res Rep Urol. 2015 Jan 30;7:13-8. doi: 10.2147/RRU.S74040. eCollection 2015. — View Citation

Faber K, de Abreu AL, Ramos P, Aljuri N, Mantri S, Gill I, Ukimura O, Desai M. Image-guided robot-assisted prostate ablation using water jet-hydrodissection: initial study of a novel technology for benign prostatic hyperplasia. J Endourol. 2015 Jan;29(1):63-9. doi: 10.1089/end.2014.0304. — View Citation

Kahokehr A, Gilling PJ. Landmarks in BPH--from aetiology to medical and surgical management. Nat Rev Urol. 2014 Feb;11(2):118-22. doi: 10.1038/nrurol.2013.318. Epub 2014 Jan 21. — View Citation

Magistro G, Chapple CR, Elhilali M, Gilling P, McVary KT, Roehrborn CG, Stief CG, Woo HH, Gratzke C. Emerging Minimally Invasive Treatment Options for Male Lower Urinary Tract Symptoms. Eur Urol. 2017 Dec;72(6):986-997. doi: 10.1016/j.eururo.2017.07.005. Epub 2017 Jul 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Prostate Symptom Score (IPSS) questionnaire total Score	Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires	Baseline, 3 months after surgical treatment for BPH
Primary	Voiding function in uroflowmetry	Change in urodynamic function assessed by Uroflowmetry	Baseline, 3 months after after surgical treatment for BPH
Secondary	Complication after surgical treatment	The 30-day complications will be graded according to the Clavien-Dindo classification	Post operation 30 days after surgical treatment for BPH