NCT07115147

Brief Summary

This is a prospective data collection of subjects using blude diode laser for the treatment of BPH.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress49%
Jun 2025Mar 2027

First Submitted

Initial submission to the registry

June 24, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

June 26, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

1.5 years

First QC Date

June 24, 2025

Last Update Submit

August 4, 2025

Conditions

BPH

Outcome Measures

Primary Outcomes (2)

  • Urinary symptoms measured by International Prostate Symptom Score (IPSS) score

    Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires. The higher score, the more worse symptom

    Baseline, 1 month, 3 months, 6 months, 12 month

  • Change in urodynamic in uroflowmetry

    Change in urodynamic function assessed by uroflowmetry

    Baseline, 1 month, 3 months, 6 months, 12 month

Secondary Outcomes (12)

  • Operation Time

    Intra-operation

  • Need of post operative irrigation

    Peri-operative period

  • Catheter time

    1 month, 3 month, 6 month, 12 month

  • Hospital stay

    Peri-operative period

  • Transfusion rate

    1 month

  • +7 more secondary outcomes

Study Arms (1)

Blue light laser Arm

EXPERIMENTAL

450nm center wavelength blue diode 200W laser is employed for the surgical procedure

Device: Blue diode laser

Interventions

Blue diode laserDEVICE

All procedures would be performed under spinal or general anaesthesia. Blue diode laser vaporization would be performed according to the standard approach for the obstructing prostate

Blue light laser Arm

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male ≥ 50 years
  • Symptomatic BPH

You may not qualify if:

  • Additional procedure is needed e.g. cystolithotripsy, orchidectomy etc2. Known Ca prostate patients
  • Patients with history of TURP
  • Known Urethral stricture / Bladder stone / Hypercontractile bladder
  • Known neurological diseases which may affect bladder function (e.g. Parkinsonism, stroke) 6. Contraindicated to undergo TURP (e.g. not fit for GA/SA, active urinary tract infection, fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (4)

  • Yee CH, Li JK, Lam HC, Chan ES, Hou SS, Ng CF. The prevalence of lower urinary tract symptoms in a Chinese population, and the correlation with uroflowmetry and disease perception. Int Urol Nephrol. 2014 Apr;46(4):703-10. doi: 10.1007/s11255-013-0586-9. Epub 2013 Oct 18.

    PMID: 24136186BACKGROUND

  • Teoh JY, Kan CF, Tsui B, Chiu PK, Man CY, Hou SS, Ng CF. Ambulatory care program for patients presenting with acute urinary retention secondary to benign prostatic hyperplasia. Int Urol Nephrol. 2012 Dec;44(6):1593-9. doi: 10.1007/s11255-012-0266-1. Epub 2012 Aug 23.

    PMID: 22914880BACKGROUND

  • Wei JT, Calhoun E, Jacobsen SJ. Urologic diseases in america project: benign prostatic hyperplasia. J Urol. 2008 May;179(5 Suppl):S75-80. doi: 10.1016/j.juro.2008.03.141.

    PMID: 18405761BACKGROUND

  • Teng J, Zhang D, Li Y, Yin L, Wang K, Cui X, Xu D. Photoselective vaporization with the green light laser vs transurethral resection of the prostate for treating benign prostate hyperplasia: a systematic review and meta-analysis. BJU Int. 2013 Feb;111(2):312-23. doi: 10.1111/j.1464-410X.2012.11395.x. Epub 2012 Nov 13.

    PMID: 23145474BACKGROUND

Study Officials

  • Ka Fung Peter CHIU, MBChB PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ka Fung Peter CHIU, MBChB PhD

CONTACT

35052625peterchiu@surgery.cuhk.edu.hk

Ka Fung CHIU

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 24, 2025

First Posted

August 11, 2025

Study Start

June 26, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

August 11, 2025

Record last verified: 2025-08

Locations

HK(1)