- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07718256
Bipolar Enucleation of the Prostate Versus Bipolar TURP (TURP)
A Comparative Study Of Clinical Outcomes Of Bipolar Enucleation Of The Prostate Versus Bipolar TURP In Management Of Benign Prostatic Hyperplasia : A Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Recent literature suggests that enucleation techniques may provide superior functional results, reduced bleeding, and lower retreatment rates. Nevertheless, there remains limited high-quality randomized controlled data directly comparing bipolar TURP and bipolar enucleation of prostate as a head to head comparison regarding functional outcomes and peri-operative complications.
In this study, a randomized controlled trial was performed to compare bipolar enucleation of the prostate versus bipolar transurethral resection of the prostate in BPH regarding symptoms relief, residual adenoma, urine flow rate and post-operative morbidity.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt, 11566
- Ain Shams University Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: bipolar TURP
transurethral resection of the prostate by bipolar current
|
transurethral resection of the prostate by bipolar current
Other Names:
|
|
Active Comparator: BEEP
endoscopic enucleation of the prostate by bipolar current
|
endoscopic enucleation of the prostate by bipolar current
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
volume of residual prostatic adenoma
Time Frame: one month postoperative
|
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
Time Frame: pre-operative, one, three, six and twelve months postoperative
|
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:
|
pre-operative, one, three, six and twelve months postoperative
|
|
improvement in maximum urine flow rate(Q max)
Time Frame: pre-operative, 1, 3, 6 and 12 months postoperative
|
Maximum urine flow rate was evaluated by Uroflowmetry
|
pre-operative, 1, 3, 6 and 12 months postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
reduction in post voiding residual urine
Time Frame: pre-operative, 1, 3, 6 and 12 months postoperative
|
post voiding residual urine in bladder was evaluated by Trans-abdominal ultrasound
|
pre-operative, 1, 3, 6 and 12 months postoperative
|
|
operation time
Time Frame: during operation
|
Operation time was calculated from insertion of the cystoscope/resectoscope into the urethra to final removal of the scope
|
during operation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU MS 56/2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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