Health TrialsbyHealthPanel

Blue Diode Laser Vaporization for BPH

ConditionBPH
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorChinese University of Hong Kong

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male ≥ 50 years

Symptomatic BPH

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Blue diode laser

    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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Blue light laser ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline, 1 month, 3 months, 6 months, 12 month
2

Change in urodynamic in uroflowmetry

Change in urodynamic function assessed by uroflowmetry

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

Secondary outcomes

1

Operation Time

Duration of the operation

Time frame
Intra-operation
2

Need of post operative irrigation

Need of post operative irrigation

Time frame
Peri-operative period
3

Catheter time

Duration of catheter time in hour since completion of surgery

Time frame
1 month, 3 month, 6 month, 12 month
4

Hospital stay

Duration of hospital stay in hour since completion of surgery

Time frame
Peri-operative period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
Apply now