NCT07718256

Brief Summary

Bipolar enucleation of the prostate (BEEP) was introduced to treat patients with large prostate. The study compared the functional outcomes and perioperative complications of bipolar TURP and bipolar enucleation of large prostates above 80 gm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

July 17, 2026

Last Update Submit

July 30, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • volume of residual prostatic adenoma

    measurement of volume of residual prostatic adenoma post bipolar TURP and BEEP was done by pelvi-abdominal ultrasound

    one month postoperative

  • change in international prostate symptoms score

    The international prostate symptoms score is a patient-completed questionnaire for standardized assessment of lower urinary tract symptoms (LUTS). It includes seven questions that evaluate the following urinary symptoms: * Weak urinary stream (0 : 5) * Incomplete bladder emptying (0 : 5) * Straining during urination (0 : 5) * Intermittent urine flow (0 : 5) * Increased urinary frequency (0 : 5) * Urgency (0 : 5) * Nocturia (0 : 5) Grade 1 (score = 0 - 7) : Mild LUTS Grade 2 (score = 8 - 19) : Moderate LUTS Grade 3 (score = 20 - 35) : Severe LUTS

    pre-operative, one, three, six and twelve months postoperative

  • change in maximum urine flow rate(Q max)

    Maximum urine flow rate was evaluated by Uroflowmetry

    pre-operative, 1, 3, 6 and 12 months postoperative

Secondary Outcomes (2)

  • change in post voiding residual urine

    pre-operative, 1, 3, 6 and 12 months postoperative

  • operation time

    during operation

Study Arms (2)

bipolar TURP

ACTIVE COMPARATOR

transurethral resection of the prostate by bipolar current

Procedure: bTURP

BEEP

ACTIVE COMPARATOR

endoscopic enucleation of the prostate by bipolar current

Procedure: BEEP

Interventions

bTURPPROCEDURE

transurethral resection of the prostate by bipolar current

Also known as: TURIS
bipolar TURP
BEEPPROCEDURE

endoscopic enucleation of the prostate by bipolar current

Also known as: TUEP
BEEP

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All male patients above the age of 40 years who presented to the urology clinic in Ain Shams university hospitals with BPH with prostate size 80 - 120 g and have any of the following criteria:
  • Voiding symptoms that are poorly responsive to medical treatment (IPSS more than 18 and Qmax less than 15 ml/sec)
  • Persistent or recurrent attacks of urine retention due to BPH.
  • Large bladder stones from BPH.
  • Recurrent UTI due to BPH.
  • Severe gross hematuria from BPH.

You may not qualify if:

  • Patients with untreated or active UTI.
  • Previous pelvic radiation or pelvicl trauma.
  • Patients with anesthesia contraindications such as uncontrolled diabetes mellitus, severe coagulation disorders and severe cardiac diseases.
  • Known or suspected neurogenic bladder.
  • Urethral stricture or urethral cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams university hospitals

Cairo, Cairo Governorate, 11566, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
A statistician randomized the eligible patients using block randomization with a block size of 8. Allocation concealment was achieved using sequentially numbered opaque sealed envelopes. The participants were blinded to the assigned type of intervention at the time of surgery. Outcome assessors also were blinded, whereas surgeons were not blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: one group had undergone bipolar TURP and the other group had undergone bipolar enucleation of the prostate
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 17, 2026

First Posted

July 21, 2026

Study Start

July 1, 2025

Primary Completion

June 30, 2026

Study Completion

July 14, 2026

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations