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Short Term Outcomes Of Bipolar Prostate Resection (BPR) Versus Diode Laser Ablation Versus Holmium Laser Enucleation Of Prostate Above 80 Grams With Minimum One Year Follow Up Duration.

ConditionBenign Prostatic Hyperplasia With Outflow Obstruction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age55-85
SponsorAin Shams University

About this trial

Randomized Controlled Study Comparing Safety, Efficacy and Short Term Outcomes Of Bipolar Prostate Resection (BPR) Versus Diode Laser Ablation Versus Holmium Laser Enucleation Of Prostate Above 80 Grams With Minimum One Year Follow Up Duration.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Refractory LUTS secondary to benign prostatic hyperplasia (BPH)

Acute retention secondary to BPH who failed medical treatment

Prostate size above 80 gm in Pelvi-Abdominal ultrasound or Trans-Rectal ultrasound

Disqualifiers

Suspected Neurogenic bladder.

Suspected Prostatic adenocarcinoma (either by digital rectal examination or high PSA level)

Urinary bladder carcinoma

urethral stricture. previous bladder, urethral or prostate surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • bipolar resection of the prostate

    Procedure/Surgery

    bipolar resection of the prostate

  • holimum laser enucleation of the prostate

    Procedure/Surgery

    holimum laser enucleation of the prostate

  • diode laser ablation of the prostate

    Procedure/Surgery

    diode laser ablation of the prostate

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: patient with prostate size above 80 grams for Bipolar resectionActive comparator 1 intervention
Group B: patient with prostate size above 80 grams for holmium laser enucleationActive comparator 1 intervention
Group C: patient with prostate size above 80 grams for Diode laser ablationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

time to catheter removal

number of days to catheter removal post-operatively

Time frame
within the first 1 week post-operatively

Secondary outcomes

1

removed prostatic tisuue

assessment of prostate size by Pelviabdominal ultrasound and wight of the removed prostatic tissues in grams

Time frame
within the first month postoperatively

Other outcomes

1

post voiding residual

post voiding urinary bladder volume by pelvic ultrasound in milliliters

Time frame
after the first month and 6th month postoperatively
2

maximum flow rate

doing uroflometry and measure the maximum flow rate milliliter/second

Time frame
within the first and 6th month postoperatively

Locations

This trial has no locations.

Sponsors and contacts

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

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: