Prostate Hypertrophy, Holmium Laser, Thulium Laser, Bipolar Diathermy, Prostate Enucleation
Conditions
Keywords
Holmium Laser, Thulium Laser, Bipolar diathermy, prostate enucleation
Brief summary
Because of the diversity of the studies and deficiency of those comparing various techniques of EEP for treatment of LUTs secondary to BPO in patients with large sized prostate, we aim in this study at testing the non-inferiority of PKEP and ThuLEP to HoLEP in relieving LUTs secondary to BPO in patients prostate size \>80ml. Our hypothesis is to present an evidence that enucleation is a technique rather than a power dependent procedure through a RCT.
Interventions
PROCEDUREHolmium Laser
Holmium laser enucleation of large sized prostate
PROCEDUREThulium Laser
Thulium laser enucleation of large sized prostate
PROCEDUREBipolar diathermy
Bipolar enucleation of large sized prostate
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients' age \>50 years * Lower urinary tract symptoms LUTS secondary benigh prostatic obstruction BPO who failed medical treatment * International prostate symptom scores (IPSS) \>15 and bother score quality of life (QOL) \> 3 (according to IPSS question 8) * Maximum urinary flow rate (Q max) \<15 ml/sec with at least 150 ml voided volume or cases with acute urine retention secondary to BPO who failed trial of voiding on medical treatment. * Transrectal ultrasound TRUS estimated total prostate size 80-250cc
Exclusion criteria
* Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease * Active urinary tract infection (positive urine culture) till treatment * Presence of bladder cancer (within the last 2 years) * Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| urinary functional outcomes using uroflowmetry | 2 years | assessed by maximum flow rate (Q-max) measured using uroflowmetry by ml/sec, better outcome above 15ml/sec |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patient symptoms | 2 years | assessed by international prostate symptoms score (IPSS) questionnaire, better outcome score below 9 |
| perioperative complications | 2 years | assessed by clavien dindo score |
Countries
Egypt
Outcome results
None listed