Benign Prostate Hypertrophy(BPH)
Conditions
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.
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.
Interventions
PROCEDUREbTURP
transurethral resection of the prostate by bipolar current
PROCEDUREBEEP
endoscopic enucleation of the prostate by bipolar current
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
one group had undergone bipolar TURP and the other group had undergone bipolar enucleation of the prostate
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| volume of residual prostatic adenoma | one month postoperative | measurement of volume of residual prostatic adenoma post bipolar TURP and BEEP was done by pelvi-abdominal ultrasound |
| change in international prostate symptoms score | 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: * 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 |
| change in maximum urine flow rate(Q max) | pre-operative, 1, 3, 6 and 12 months postoperative | Maximum urine flow rate was evaluated by Uroflowmetry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in post voiding residual urine | pre-operative, 1, 3, 6 and 12 months postoperative | post voiding residual urine in bladder was evaluated by Trans-abdominal ultrasound |
| operation time | during operation | Operation time was calculated from insertion of the cystoscope/resectoscope into the urethra to final removal of the scope |
Countries
Egypt
Outcome results
None listed