Benign Prostate Hyperplasia Clinical Trial
Official title:
Comparison of Plasmakinetic Enucleation of the Prostate With Open Prostatectomy for the Treatment of Benign Prostatic Hypertrophy Patients With Large Prostate
The investigators hypothesize that Plasmakinetic Enucleation of the Prostate (PkEP) might
yield functional results comparable to OP but with lower perioperative morbidity, and have
equivalent long-term efficacy with OP for large prostates. The first objective was to
demonstrate the non-inferiority of PKEP compared to OP concerning Qmax at one year
postoperatively.
To explore the long-term efficacy, we compared the efficacy, safety, and morbidity of PkEP
with those of OP in BPH patients with prostate glands larger than 100 g over a follow-up
period of 6 years.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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