Study protocol and objectives
Medication-naive, cystolithiasis, prostate, hematuria, prostate or bladder cancer
RESPIRATORY DISORDERS, RECURRENT URINARY TRACT INFECTION, DIABETES MELLITUS, PROSTATE, HEMATURIA, CARDIAC DISEASE, PROSTATE, NEUROGENIC BLADDER
Details surrounding this study design have previously been reported.Subjects enrolled included: men ≥50 years, IPSS (International Prostate Symptoms Score) of ≥10, peak urinary flow rate of ≤12 mL/s with a 125 mL voided volume, prostate volume between 25 and 75 cc, and normal urinalysis, complete blood count, and biochemistry. Excluded patients had a postvoid residual volume (PVR) >250 mL, obstructive median lobe (OML) on ultrasound, prostate-specific antigen (PSA) >10 ng/mL or free PSA <25% without negative prostate biopsy, prostate or bladder cancer, previous prostate surgery, neurogenic bladder and/or sphincter abnormalities, recent hematuria or cystolithiasis, current urinary tract infection, decreased renal function, severe respiratory disorders, cardiac disease, immunosuppression, current antithrombotic and antiplatelet treatment, and uncontrolled diabetes mellitus. Cystoscopy was not mandatory during screening, but cystoscopy was used during placement of the device and an intraoperative exclusion criterion of OML existed.Baseline medical history, BPH-related medications, uroflowmetry, IPSS, PVR, and completion of questionnaires regarding QoL, ED, and EjD was collected at baseline, 6 weeks, 3 months, and 12 months postoperatively. All patients on BPH-related medications started a wash-out period before implantation: 1 month for alpha-blockers and 6 months for 5-ARIs. Medication-naive patients seeking treatment refused medication in preference for a MIST. Patients were unblinded at 3 months.