BPH With Urinary Obstruction, Male
Conditions
Keywords
BPH, enucleation, Large Prostate, LUTS, IPSS, quality of life
Brief summary
To compare bipolar resection versus holmium laser enucleation for management of symptomatic large BPH (\> 80 gm)
Detailed description
To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of symptomatic large BPH (\> 80 gm)
Interventions
cystoscopic transurethral enucleation of the prostate using Holmium laser
PROCEDUREBipolar resection of the prostate
cystoscopic transurethral resection of the prostate using bipolar energy
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
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients suffering from LUTS secondary to infravesical obstruction from BPH with 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) | within two hours after surgery | change in hemoglobin concentration postoperatively vs preoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| operative duration in minutes | Time lapsed during surgery | operative duration |
| Hospital stay | From time of randomisation up to last day of admission in hospital (in days) up to 30 days | Hospitalisation starting from day of surgery till the day of discharge from Hospital in days |
| blood transfusion | during surgery and hospitalisation up to 10 days | rate of blood transfusion |
Other
| Measure | Time frame | Description |
|---|---|---|
| complications (percent) | Three years | All complications |
| International prostate symptom score (IPSS) | Three years | 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 |
| Quality of life (QoL) | Three years | section of International prostate symptom score (IPSS) one question scored from 0 up to 6 (6 is worst) |
| flowmetry | Three years | rate of flow (ml urine) per second |
Countries
Egypt
Outcome results
None listed