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Bipolar TURP Versus Bipolar Enucleation for BPH Management

ConditionBenign Prostatic Hyperplasia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age45-80
SponsorKasr El Aini Hospital

About this trial

To compare the surgical outcomes at 12 months post-surgery between Bipolar TURP and BipoLEP in men with BPH and prostate volumes between 30-80 grams.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male patients aged 45-80 years diagnosed with symptomatic BPH.

Prostate volume between 30-80 grams as determined by transrectal ultrasound (TRUS) performed within 4 weeks before randomization.

Moderate to severe LUTS with an IPSS of ≥ 8.

Failure of medical management.

Disqualifiers

History of prostate cancer.

History of previous prostate surgery (including any procedure for BPH or prostate cancer).

History of urethral stricture or bladder neck contracture.

Neurogenic bladder dysfunction.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prostate surgery

    Procedure/Surgery

    Prostate removal

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Bipolar enucleationActive comparator 1 intervention
Group B: Bipolar resectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

International Prostate Symptom Score (IPSS)

Time frame
12 months
2

Qmax

Time frame
12 months

Secondary outcomes

1

PVR

Time frame
12 months
2

Complications

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Kasr El Aini Hospital

Lead sponsor

Source ClinicalTrials.gov

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