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 large BPH.
Detailed description
To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of large BPH (\> 75 gm).
Interventions
cystoscopic transurethral enucleation of the prostate using Holmium laser (Versa pulse 100W; Lumenis; Germany)
PROCEDUREBipolar resection of the prostate
cystoscopic transurethral resection of the prostate using bipolar energy
Sponsors
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 * failed medical treatment * International Prostate Symptom Score (IPSS) \> 13 * a peak urinary flow rate (Qmax) \< 15 ml/sec * a prostate size ≥ 75 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 duration in minutes | during surgery | operative duration |
| Hospital stay in days | immediately after surgery | Hospital stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International prostate symptom score (IPSS) | Two 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 |
| complications (%) | Two years | intraoperative and postoperative complications including blood transfusion, capsular perforation, irritative symptoms, SUI, urethral stricture, bladder neck contracture, urinary retention. |
| Catheter duration | immediate postoperatively | Catheter duration in hours |
| Quality of life (QoL) | Two years | section of International prostate symptom score (IPSS) one question scored from 0 up to 6 (6 is worst) |
| urine flow | Two years | Qmax (ml/s), |
| post-voiding residual urine | Two years | postvoiding residual urine (ml) |
Countries
Egypt
Outcome results
None listed