Purpose: To compare the efficacy and safety of plasma kinetic enucleation of the prostate (PKEP) with holmium laser enucleation of the prostate (HoLEP) for treatment of benign prostatic hyperplasia (BPH). Methods: A total of 160 patients with indications for the surgical treatment of BPH were randomly assigned to receive either PKEP or HoLEP prospectively. Baseline characteristics, perioperative data, and postoperative outcomes of the patients were recorded. One hundred twenty-six (78.75%) patients (PKEP 64 vs HoLEP 62) completed the 3-year follow-up assessment. Results: Patients in both groups had similar baseline characteristics. Compared with PKEP, HoLEP was associated with shorter operative time as well as take-out time, lower perioperative hemoglobin decrease, and shorter bladder irrigation time, catheterization time, and hospital stay time. PKEP was superior to HoLEP in terms of the noise of the machine and hospitalization expenses. There were no significant differences in enucleating time, resected weight, and serum sodium levels. Both groups achieved satisfactory results and maintained improvement from baseline in terms of maximum urinary flow rate (Qmax), International Prostatic Symptomatic Score, quality of life, and postvoid residual at 3-year follow-up, with no significant differences between the two procedures. Except for re-catheterization rate, postoperative data such as transrectal ultrasound volume, International Index of Erectile Function-5, and follow-up scores of the flexible cystourethroscopy results, as well as the acute and mid-to long-term complications after surgery, were statistically similar. Conclusion: The 3-year follow-up data of this randomized trial confirmed that both PKEP and HoLEP were effective and safe surgical procedures for the transurethral management of BPH. HoLEP presented certain advantages compared to PKEP, such as reduced operative duration, decreased risk of blood loss, and less bladder irrigation, hospital stay time, and re-catheterization rate, whereas PKEP had lower noise and no additional laser cost. Chinese Clinical Trial Registry (ChiCTR-TRC-13004468).
RCT Entities:
Purpose: To compare the efficacy and safety of plasma kinetic enucleation of the prostate (PKEP) with holmium laser enucleation of the prostate (HoLEP) for treatment of benign prostatic hyperplasia (BPH). Methods: A total of 160 patients with indications for the surgical treatment of BPH were randomly assigned to receive either PKEP or HoLEP prospectively. Baseline characteristics, perioperative data, and postoperative outcomes of the patients were recorded. One hundred twenty-six (78.75%) patients (PKEP 64 vs HoLEP 62) completed the 3-year follow-up assessment. Results:Patients in both groups had similar baseline characteristics. Compared with PKEP, HoLEP was associated with shorter operative time as well as take-out time, lower perioperative hemoglobin decrease, and shorter bladder irrigation time, catheterization time, and hospital stay time. PKEP was superior to HoLEP in terms of the noise of the machine and hospitalization expenses. There were no significant differences in enucleating time, resected weight, and serum sodium levels. Both groups achieved satisfactory results and maintained improvement from baseline in terms of maximum urinary flow rate (Qmax), International Prostatic Symptomatic Score, quality of life, and postvoid residual at 3-year follow-up, with no significant differences between the two procedures. Except for re-catheterization rate, postoperative data such as transrectal ultrasound volume, International Index of Erectile Function-5, and follow-up scores of the flexible cystourethroscopy results, as well as the acute and mid-to long-term complications after surgery, were statistically similar. Conclusion: The 3-year follow-up data of this randomized trial confirmed that both PKEP and HoLEP were effective and safe surgical procedures for the transurethral management of BPH. HoLEP presented certain advantages compared to PKEP, such as reduced operative duration, decreased risk of blood loss, and less bladder irrigation, hospital stay time, and re-catheterization rate, whereas PKEP had lower noise and no additional laser cost. Chinese Clinical Trial Registry (ChiCTR-TRC-13004468).