ObjectiveTo compare prostatic artery embolisation (PAE) with transurethral resection of the prostate (TURP) in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia in terms of patient reported and functional outcomes.DesignRandomised, open label, non-inferiority trial.SettingUrology and radiology departments of a Swiss tertiary care centre.Participants103 patients aged ≥40 years with refractory lower urinary tract symptoms secondary to benign prostatic hyperplasia were randomised between 11 February 2014 and 24 May 2017; 48 and 51 patients reached the primary endpoint 12 weeks after PAE and TURP, respectively.InterventionsPAE performed with 250-400 μm microspheres under local anaesthesia versus monopolar TURP performed under spinal or general anaesthesia.Main outcomes and measuresPrimary outcome was change in international prostate symptoms score (IPSS) from baseline to 12 weeks after surgery; a difference of less than 3 points between treatments was defined as non-inferiority for PAE and tested with a one sided t test. Secondary outcomes included further questionnaires, functional measures, magnetic resonance imaging findings, and adverse events; changes from baseline to 12 weeks were compared between treatments with two sided tests for superiority.ResultsMean reduction in IPSS from baseline to 12 weeks was −9.23 points after PAE and −10.77 points after TURP. Although the difference was less than 3 points (1.54 points in favour of TURP (95% confidence interval −1.45 to 4.52)), non-inferiority of PAE could not be shown (P=0.17). None of the patient reported secondary outcomes differed significantly between treatments when tested for superiority; IPSS also did not differ significantly (P=0.31). At 12 weeks, PAE was less effective than TURP regarding changes in maximum rate of urinary flow (5.19 v 15.34 mL/s; difference 10.15 (95% confidence interval −14.67 to −5.63); P<0.001), postvoid residual urine (−86.36 v −199.98 mL; 113.62 (39.25 to 187.98); P=0.003), prostate volume (−12.17 v −30.27 mL; 18.11 (10.11 to 26.10); P<0.001), and desobstructive effectiveness according to pressure flow studies (56% v 93% shift towards less obstructive category; P=0.003). Fewer adverse events occurred after PAE than after TURP (36 v 70 events; P=0.003).ConclusionsThe improvement in lower urinary tract symptoms secondary to benign prostatic hyperplasia seen 12 weeks after PAE is close to that after TURP. PAE is associated with fewer complications than TURP but has disadvantages regarding functional outcomes, which should be considered when selecting patients. Further comparative study findings, including longer follow-up, should be evaluated before PAE can be considered as a routine treatment.Trial registrationClinicaltrials.gov NCT02054013.
ObjectiveTo assess the efficacy and safety of sono-electro-magnetic therapy compared to placebo in men with refractory CPPS.Patients and MethodsIn a randomized, placebo-controlled, double-blind single center trial, we assessed the effect of sono-electro-magnetic therapy in men with treatment refractory CPPS. Sixty male patients were randomly assigned to treatment with either sono-electro-magnetic (n = 30) or placebo therapy (n = 30) for 12 weeks. The primary outcome was a change in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) from baseline to 12 weeks.ResultsThe 12-week difference between sono-electro-magnetic and placebo therapy in changes of the NIH-CPSI total score was −3.1 points (95% CI −6.8 to 0.6, p = 0.11). In secondary comparisons of NIH-CPSI sub-scores, we found differences between groups most pronounced for the quality-of-life sub-score (difference at 12 weeks −1.6, 95% CI −2.8 to −0.4, p = 0.015). In stratified analyses, the benefit of sono-electro-magnetic therapy appeared more pronounced among patients who had a symptom duration of 12 months or less (difference in NIH-CPSI total score −8.3, 95% CI −14.5 to 2.6) than in patients with a longer symptom duration (−0.8, 95% CI −4.6 to 3.1; p for interaction = 0.023).ConclusionsSono-electro-magnetic therapy did not result in a significant improvement of symptoms in the overall cohort of treatment refractory CPPS patients compared to placebo treatment. Subgroup analysis indicates, however, that patients with a symptom-duration of 12 months or less may benefit from sono-electro-magnetic therapy, warranting larger randomized controlled trials in this subpopulation.Trial RegistrationClinicalTrials.gov NCT00688506
Both cell separators showed safe collections of up to 4 PLT units per donation with adequate CCI. T produced a higher PLT yield despite shorter apheresis duration, but with slightly higher residual WBC counts and a trend to a higher side-effect frequency.
Context: Prostatic artery embolization (PAE) has been introduced into clinical practice for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH-LUTS) despite a lack of high-level evidence. Objective: To perform a systematic review and meta-analysis of clinical trials comparing efficacy and safety of PAE versus established surgical therapies. Evidence acquisition: Medline, Embase, and York CRD were searched up to June 23, 2018. Only comparative studies were included. The risk of bias was assessed by the Cochrane Collaboration tool. Meta-analyses were performed using RevMan 5.3. Evidence synthesis: Five studies including 708 patients met the selection criteria. Risk of bias was rated high for most of the studies. Mean reduction in the International Prostate Symptom Score was lower after PAE compared with standard surgical therapies (mean difference 3.80 points [95% confidence interval: 2.77-4.83]; p < 0.001). PAE was less efficient regarding improvements in all functional parameters assessed including maximum urinary flow, post void residual, and reduction of prostate volume.In contrast, patient-reported erectile function (International Index of Erectile Function 5) was better after PAE and significantly fewer adverse events occurred after PAE. Conclusions: Moderately strong evidence confirms efficacy and safety of PAE in the treatment of BPH-LUTS in the short term. Significant advantages regarding safety and sexual function, but clear disadvantages regarding all other patient-reported and functional outcomes were found for PAE. Large-scale randomized controlled trials including longer follow-up periods are mandatory before PAE can be considered as a standard therapy and to define the ideal indication for PAE in the management of BPH-LUTS. Patient summary: We reviewed the role of prostatic artery embolization (PAE) in the treatment of symptoms associated with benign overgrowth of the prostate. The results suggest that PAE is not as effective as established surgical therapies but has fewer side y These authors contributed equally. * Corresponding author. Kantonsspital St. Gallen,
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