BPH With Large Prostate
Conditions
Keywords
benign prostatic hypertrophy, bipolar transurethral resection of the prostate, plasmakinetic enucleation of the prostate
Brief summary
The goal of this study is to compare the perioperative and postoperative characters of plasmakinetic enucleation of the prostate(PkEP) with bipolar TURP(B-TURP) for BPH patients with large prostate.
Detailed description
Despite the availability of numerous minimally invasive alternatives, monopolar transurethral resection of the prostate (TURP) remains the most frequently performed operation for benign prostatic hypertrophy (BPH) with small to moderate size prostates. Nevertheless, TURP for large prostates is associated with various complications and unsatisfactory long-term results. B-TURP and PkEP have both been proved to have more favorable postoperative outcomes than monopolar TURP. But whether B-TURP or PkEP is better remain controversial. We aim to compare the perioperative and postoperative characters of PkEP with B-TURP for BPH patients with large prostate. Moreover, we evaluate the long-term results of both approaches.
Interventions
PROCEDUREPkEP
Plasmakinetic enucleation of the prostate
PROCEDUREB-TURP
Bipolar transurethral resection of the prostate
Sponsors
Fuzhou General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Qmax \< 10 mL/s, IPSS \>19 * Age between 50 and 70 years * Prostate volume between 70 and 200 mL, as determined by TRUS, and medical therapy failure.
Exclusion criteria
* Patients with neurogenic bladder * Urethral stricture * Bladder tumor * Prostate cancer and previous prostate bladder neck * Urethral surgery * PSA\>4ng/ml, or receiving prostate biopsy within 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time of catheterization | — | At the end of both procedures, a 22F three-way Folley catheter was inserted and continuous bladder irrigation was performed. Irrigation was discontinued when the catheter drainage became clear, and the catheter was removed 6 h later.Two experienced urologists who were unaware of the surgical modality used decided bladder irrigation and catheter removal for all cases. |
Secondary
| Measure | Time frame |
|---|---|
| resected adenoma weight as a measure of treatment efficacy | — |
| changes in serum haemoglobin as a measure of one of the complications | — |
| Operation time | — |
| postoperative Qmax as a masure of treatment efficacy and durability | 5 years |
| re-operation rate as a measure of durability | 5 years |
| postoperative International Prostate Symptom Score as a measure of treatment efficacy and durability | 5 years |
Countries
China
Outcome results
None listed