Health TrialsbyHealthPanel

Feasibility and Safety of a Single Working Element for Bipolar and Laser Enucleation in Prostate Surgery: A Prospective Study

ConditionsProstateBPH (Benign Prostatic Hyperplasia)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age50+
SponsorMenoufia University

About this trial

A prospective feasibility study would be a practical first step, focusing on real-time assessment and ensuring the new working element's integration is safe and effective before broader clinical trials.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with benign prostatic hyperplasia (BPH) requiring surgical intervention.

Prostate volume ≥40 cc (as assessed by transrectal ultrasound).

No prior history of prostate cancer.

Disqualifiers

Patients with ongoing urinary tract infections.

Prior prostate surgeries.

Coagulation disorders or patients on long-term anticoagulation therapy.

Known urethral strictures or other anatomical abnormalities complicating endoscopic procedures.

Trial population

the study will include male patients aged ≥50 years who are diagnosed with benign prostatic hyperplasia (BPH) , prostate volume ≥40 cc without 4prior history of prostate cancer while patients with ongoing urinary tract infections, prior prostate surgeries, coagulopathy or urethral strictures were excluded.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • A single working element for bipolar enucleation

    Device

    Device: A single working element compatible with both bipolar and laser modalities. The bipolar energy will be used for cutting and coagulation during enucleation.

  • A single working element for laser enucleation

    Device

    Device: A single working element compatible with both bipolar and laser modalities. Thulium or Holmium laser will be employed for tissue dissection and hemostasis.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Bipolar Enucleation1 intervention
Group B: Laser Enucleation1 intervention

Trial outcomes

Primary outcomes

1

Feasibility

Successful completion of enucleation using the single working element. Time taken to switch between bipolar and laser modalities.

Time frame
the operative time
2

Safety

intraoperative complications (bleeding, urethral damage). Postoperative complications (infections, catheterization time, hospital stay).

Time frame
1 month

Secondary outcomes

1

Efficacy

Operative time. Enucleation efficiency (grams of tissue removed per minute). Postoperative symptom improvement measured using International Prostate Symptom Score (IPSS).

Time frame
1 month
2

Cost Analysis

Cost of using a single working element vs. standard separate tools for bipolar and laser.

Time frame
the operative time

Other outcomes

Sponsors and contacts

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

Menoufia University

Lead sponsor

Source ClinicalTrials.gov
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