Benign Prostatic HyperplasiaNCT05292235
Perioperative Parameter and Treatment Outcomes of Surgical Treatment for Benign Prostate Hyperplasia in Hong Kong
An observational study of Benign Prostatic Hyperplasia, run by Chinese University of Hong Kong at 3 sites in Hong Kong.
Trial summary
This is a prospective data registry to assess the treatment outcomes and complications of different treatment approaches in our hospital clusters. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- How many people
- 2,000 participants
- Where
- 3 sitesHong Kong
- Study dates
- 1 Apr 2022to 31 Jul 2032
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with BPH and planned for surgery (including all type of endoscopic procedures) in the hospitals will be identified and then enrolled to the study
Who may be able to join
- Patient at the age of 18 or above
Who cannot join
- Patient is unable to give consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong3 sites, 3 recruiting
- Recruiting
Alice Ho Miu Ling Nethersole Hospital
Hong Kong
Chi Fai NG, MD, 35052625, ngcf@surgery.cuhk.edu.hk
- Recruiting
North District Hospital
Hong Kong
Chi Fai NG, MD, 35052625, ngcf@surgery.cuhk.edu.hk
- Recruiting
Prince of Wales Hospital
Shatin
Chi Fai NG, MD, 3505 3953, ngcf@surgery.cuhk.edu.hk
About this study
Official title: A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Surgical Treatment for Benign Prostate Hyperplasia in Hong Kong
This is a prospective data registry to assess the treatment outcomes and complications of different treatment approaches in our hospital clusters.
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia
- Medical subject headings
- Prostatic Hyperplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (IPSS) questionnaire total Score
Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires
Measured: Baseline, 3 months after surgical treatment for BPH
Voiding function in uroflowmetry
Change in urodynamic function assessed by Uroflowmetry
Measured: Baseline, 3 months after after surgical treatment for BPH
Secondary outcomes (1)
Complication after surgical treatment
The 30-day complications will be graded according to the Clavien-Dindo classification
Measured: Post operation 30 days after surgical treatment for BPH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start1 Apr 2022
- Primary completion30 Apr 2032 (estimated)
- Study completion31 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NG Chi Fai, Chinese University of Hong Kong
- Investigators
- Chi Fai NG, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292235
- Sponsor's protocol ID
- CRE-2022.049
- Status last verified
- Oct 2026
- First submitted
- 15 Mar 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24445912Magistro 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.
PubMed 28734706Faber 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.
PubMed 25000418Dixon 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.
PubMed 25674555Siu BWH, Leung DKW, Wong RSK, Wong CHM, Liu AQ, Yee CH, Teoh JYC, Chiu PKF, Ng CF, Lo KL. Thulium fiber laser enucleation of the prostate with SOLTIVE SuperPulsed laser systems: a prospective evaluation of early outcomes in an Asian cohort. Front Urol. 2026 Mar 30;6:1753089. doi: 10.3389/fruro.2026.1753089. eCollection 2026.
PubMed 41983244