BPH With Urinary Obstruction, Male
Conditions
Keywords
BPH, enucleation, Prostate, LUTS, IPSS, quality of life, Large prostate
Brief summary
To compare bipolar plasmakinetic enucleation versus holmium laser enucleation for management of large BPH.
Detailed description
To compare safety and efficacy of bipolar plasmakinetic enucleation (BPEP) versus holmium laser enucleation (HoLEP) for management of large BPH (\>80gm).
Interventions
cystoscopic transurethral enucleation of the prostate using Holmium laser (Asclepion MultiPulse HoPlus 110W and Lumenis pulse 100W and 120W)
PROCEDUREBipolar plasma kinetic enucleation of the prostate
cystoscopic transurethral enucleation of the prostate using bipolar plasma kinetic energy (KLS Martin Maxium or Covidien Force Triad)
Sponsors
Theodor Bilharz Research Institute
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients suffering from LUTS secondary to infravesical obstruction from BPH * failed medical treatment * International Prostate Symptom Score (IPSS) \> 13 * a peak urinary flow rate (Qmax) \< 15 ml/sec * a prostate size ≥ 80 gm
Exclusion criteria
* presence of a urethral stricture * neurological disorder * bladder cancer * prostate cancer * previous history of bladder neck surgery or TURP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hemoglobin drop postoperatively (gm/dL) | Immediate postoperatively | difference in hemoglobin concentration postoperatively vs preoperatively |
| operative time | during surgery | operative time in minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| post-voiding residual urine | one year | postvoiding residual urine (ml) |
| complications (%) | one year | intraoperative and postoperative complications including blood transfusion, capsular perforation, irritative symptoms, SUI, urethral stricture, bladder neck contracture, urinary retention. |
| Quality of life (QoL) section of International prostate symptom score (IPSS) | one year | one question scored from 0 up to 6 (6 is worst) |
| International prostate symptom score (IPSS) | one year | an international commonly used score ranging from 0 - 35 (the worst is 35) evaluating voiding and storage urinary symptoms using 7 questions each one is scored from 0 to 5 according to severity of symptom |
| urine flow | one year | Qmax (ml/s), |
Countries
Egypt
Outcome results
None listed