Blue Diode Laser Vaporization for BPH

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-26

Study Completion Date

2027-03-31

Brief Summary

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

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Detailed Description

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This is a prospective single-arm study evaluating the outcome of blue diode laser vaporization. The energy from a 450nm blue laser vaporization will be used for the treatment of BPH. The study period for each patient is 1 year. Recruited subjects will then be followed up at 3 months, 6 months and 12 months after operation. Blood tests, urine tests, ultrasound for prostate volume assessment, uroflowmetry and the same set of questionnaires will be performed again during follow-up for assessing the clinical progress. Any adverse event and unplanned admission will also be documented.

Conditions

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BPH

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Blue light laser Arm

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

Group Type EXPERIMENTAL

Blue diode laser

Intervention Type DEVICE

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

Interventions

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Blue diode laser

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male ≥ 50 years
* Symptomatic BPH

Exclusion Criteria

* 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)

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No