---
title: Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy
nct_id: NCT05416606
overall_status: COMPLETED
phase: NA
sponsor: Helwan University
study_type: INTERVENTIONAL
primary_condition: Benign Prostatic Hyperplasia
countries: Egypt
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05416606.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05416606"
ct_last_update_post_date: 2022-06-13
last_seen_at: "2026-05-12T06:40:53.614Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy

**Official Title:** Transurethral Bipolar Enucleation and Resection of the Prostate Versus Open Prostatectomy for the Treatment of Benign Prostatic Hyperplasia

**NCT ID:** [NCT05416606](https://clinicaltrials.gov/study/NCT05416606)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 64
- **Lead Sponsor:** Helwan University
- **Conditions:** Benign Prostatic Hyperplasia
- **Start Date:** 2020-10-01
- **Completion Date:** 2022-06-01
- **CT.gov Last Update:** 2022-06-13

## Brief Summary

Benign prostatic hyperplasia (BPH) is a frequent disease in aging men accompanied by bladder outlet obstruction (BOO). Open prostatectomy (OP) is still considered the first-line treatment for more than 80 ml prostate size. In this study, a mixed technique called transurethral bipolar enucleation and resection of the prostate (TBERP) was compared to the standard open prostatectomy.

## Detailed Description

Benign prostatic hyperplasia (BPH) is a frequent disease in aging men accompanied by bladder outlet obstruction (BOO). Open prostatectomy (OP) is still considered the first-line treatment for more than 80 ml prostate size. In this study, a mixed technique called transurethral bipolar enucleation and resection of the prostate (TBERP) was compared to the standard open prostatectomy.

This is a Comparative, Prospective Study conducted on men over 50 years.The patients were randomly distributed into two groups treated by TBERP and OP. Patients were evaluated preoperatively and at 1-week post catheter removal and 1-3-months postoperatively in terms of blood loss, operation time, the weight of resected prostatic tissues, post-operative catheterisation period, hospital stay, IPSS, PVR, prostate volume, early complications (recatheterization, urine retention, UTI and irritative symptoms) and late complications (urinary incontinence, urethral stricture and bladder neck contracture).

## Eligibility

- **Minimum age:** 50 Years
- **Sex:** MALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Male patients
* Age more than 50 years
* Prostate size of more than 80 ml
* IPSS ≥ 8, and maximum urinary flow rate (Qmax) ≤ 15 mL/s
* Indications for surgery

  * Refractory retention (failed ≥1 trial of voiding).
  * Associated bladder Stones.
  * Associated recurrent gross Hematuria.
  * Associated with recurrent Infections.
  * Associated renal insufficiency.
  * Bother symptoms refractory to medical treatment.

Exclusion Criteria:

* Uncorrectable coagulopathy.
* Patient with active UTI.
* Prostate less than 80 ml.
* Severe associated comorbidities.
* Previous urethral, prostate, and bladder surgeries,
* Patients diagnosed with neurogenic bladder.
* Patients diagnosed with prostate cancer.
```

## Arms

- **transurethral bipolar enucleation and resection of the prostate** (ACTIVE_COMPARATOR) — transurethral bipolar enucleation and resection of the prostate
- **open prostatectomy** (ACTIVE_COMPARATOR) — open surgical transvesical prostatectomy

## Interventions

- **transurethral bipolar enucleation and resection of the prostate** (PROCEDURE) — transurethral bipolar enucleation and resection of the prostate
- **open surgical transvesical prostatectomy** (PROCEDURE) — open surgical transvesical prostatectomy

## Primary Outcomes

- **operative time** _(time frame: Three months)_ — To measure the difference between the two procedure regarding operative time measured in minutes.
- **recovery outcome** _(time frame: Three months)_ — To measure the difference between the two procedure regarding mean hospital stays measured in days and catheterization period measured in days

## Secondary Outcomes

- **peri-operative complication** _(time frame: Three months)_
- **weight of resected prostatic tissues** _(time frame: Three months)_
- **post-operative International Prostate Symptom Score (IPSS) score.** _(time frame: Three months)_

## Locations (1)

- Helwan university faculty of medicine, Helwan, Egypt

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.helwan university faculty of medicine|helwan||egypt` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05416606.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05416606*  
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