Bipolar Transurethral Enucleation Versus Resection in the Treatment of Benign Prostatic Hyperplasia: a Comparative Study

NCT06294366 | Completed DMC

• 1 other identifier: MenoufiaU2022
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

Benign prostatic hyperplasia (BPH) is a common chronic progressive disease resulting in the enlargement of the prostate gland and bladder outlet obstruction in aging men . Because of the increasing aged population and advancements in diagnostic tools, the incidence and importance of BPH have increased . BPH can be treated either with watchful waiting, drug therapy, or surgery being the most effective treatment option for BPH . Transurethral resection of the prostate (TURP) has been recognized as the standard treatment for BPH with morbidity rate varies from 18% and 26% Until now, only open prostatectomy and transurethral Holmium laser enucleation of the prostate (HoLEP) have shown an equal efficacy and durability compared to TURP

Conditions

Prostatic Hyperplasia; Prostate Enucleation

Outcome Measures

Primary Outcomes (1)

• Assessing and comparing the safety, the surgical efficacy and peri-operative morbidity of bipolar enucleation of the prostate and bipolar transurethral resection of the prostate for the treatment of patients with symptomatizing prostates.

  Preoperative evaluation will include detailed medical history, thorough clinical examination, international prostate symptom score (IPSS), digital rectal examination (DRE), prostate specific antigen \[Prostatic specific antigen (free/total)\], maximum flow rate (Qmax), and pelvi-abdominal ultrasound to assess prostate size and post-voiding residual urinary volume (PVR). Intraoperative evaluation will include operative time, irrigating fluid volume, the volume of removed prostate tissue, and intraoperative complications. Postoperative evaluation will include the mean haemoglobin difference, hematocrit level, catheterization period, hospital stay, medications, analgesics, and follow up maximum flow rate (Qmax).

  one year

Study Arms (2)

Bipolar enucleation

ACTIVE COMPARATOR

Bipolar enucleation of the prostate larger than 60 gm

Device: Bipolar Bowa device

Bipolar TURP

ACTIVE COMPARATOR

Bipolar transurethral resection of the prostate larger than 60 gm

Device: Bipolar Bowa device

Interventions

Bipolar Bowa device DEVICE

Bipolar Bowa device used in prostatic resection and enucleation

Bipolar TURP; Bipolar enucleation

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients with symptomatizing BPH who have a prostate volume \> 60 gm and indicated for surgical treatment.

You may not qualify if:

• patients with small fibrotic prostates, high PSA (not co-inciding with BPH), neurogenic bladder.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Faculty of medicine

Shibīn al Kawm, Menoufia, 32866, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer, Urology department, Faculty of Medicine, Menoufia University

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: March 5, 2024
• Study Start: June 12, 2022
• Primary Completion: July 1, 2024
• Study Completion: October 30, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

EG (1)