Plasmakinetic Enucleation of the Prostate to Treat Benign Prostatic Hypertrophy Patients With Large Prostate
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of Pasmakinetic Enucleation of the Prostate With Bipolar Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Hypertrophy Patients With Large Prostate|
- time of catheterization [ Designated as safety issue: No ]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.
- Operation time [ Designated as safety issue: Yes ]
- resected adenoma weight as a measure of treatment efficacy [ Designated as safety issue: No ]
- changes in serum haemoglobin as a measure of one of the complications [ Designated as safety issue: Yes ]
- postoperative International Prostate Symptom Score as a measure of treatment efficacy and durability [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- postoperative Qmax as a masure of treatment efficacy and durability [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- re-operation rate as a measure of durability [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2004|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
Active Comparator: PkEP
Patients in this group undergo PkEP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK).
Plasmakinetic enucleation of the prostate
Active Comparator: B-TURP
Patients in this group undergo B-TURP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK).
Bipolar transurethral resection of the prostate
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637701
|Fuzhou General Hospital|
|Fuzhou, Fujian, China|
|Study Director:||Jianming Tan, M.D. & Ph.D.||Fuzhou General Hospital|