Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Urinary Tract Infection (2120); Hematuria (2558); Sexual Dysfunction (4510); Skin Inflammation/ Irritation (4545); Insufficient Information (4580)
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Event Date 02/02/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: article publication date used.Initial reporter facility name: department of urology, school of medicine, university of st.Gallen.
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Event Description
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It was reported via a journal article that patient complications occurred.Abstract: background: prostatic artery embolisation (pae) for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction (luts/bpo) still remains under investigation.Objective: to compare the efficacy and safety of pae and transurethral resection of the prostate (turp) in the treatment of luts/bpo at 2 yr of follow-up.Design, setting, and participants: a randomised, open-label trial was conducted.There were 103 participants aged greater than or equal to 40 yr with refractory luts/bpo.Intervention: pae versus turp.Outcome measurements and statistical analysis: international prostate symptoms score (ipss) and other questionnaires, functional measures, prostate volume, and adverse events were evaluated.Changes from baseline to 2 yr were tested for differences between the two interventions with standard two-sided tests.Results and limitations: the mean reduction in ipss after 2 yr was 9.21 points after pae and 12.09 points after turp (difference of 2.88 [95% confidence interval 0.04 - 5.72]; p = 0.047).Superiority of turp was also found for most other patient-reported outcomes except for erectile function.Pae was less effective than turp regarding the improvement of maximum urinary flow rate (3.9 vs 10.23 ml/s, difference of -6.33 [-10.12 to -2.54]; p < 0.001), reduction of postvoid residual urine (62.1 vs 204.0 ml; 141.91 [43.31 - 240.51]; p = 0.005), and reduction of prostate volume (10.66 vs 30.20 ml; 19.54 [7.70 - 31.38]; p = 0.005).Adverse events were less frequent after pae than after turp (total occurrence n = 43 vs 78, p = 0.005), but the distribution among severity classes was similar.Ten patients (21%) who initially underwent pae required turp within 2 yr due to unsatisfying clinical outcomes, which prevented further assessment of their outcomes and therefore, represents a limitation of the study.Conclusions: inferior improvements in luts/bpo and a relevant re-treatment rate are found 2 yr after pae compared with turp.Pae is associated with fewer complications than turp.The disadvantages of pae regarding functional outcomes should be considered for patient selection and counselling.
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Manufacturer Narrative
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Correction - h6 updated to: skin inflammation/irritation and sexual dysfunction.B3 - date of event: article publication date used.E1 - initial reporter facility name: (b)(6).
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Event Description
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It was reported via a journal article that patient complications occurred.Abstract: background: prostatic artery embolisation (pae) for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction (luts/bpo) still remains under investigation.Objective: to compare the efficacy and safety of pae and transurethral resection of the prostate (turp) in the treatment of luts/bpo at 2 yr of follow-up.Design, setting, and participants: a randomised, open-label trial was conducted.There were 103 participants aged greater than or equal to 40 yr with refractory luts/bpo.Intervention: pae versus turp.Outcome measurements and statistical analysis: international prostate symptoms score (ipss) and other questionnaires, functional measures, prostate volume, and adverse events were evaluated.Changes from baseline to 2 yr were tested for differences between the two interventions with standard two-sided tests.Results and limitations: the mean reduction in ipss after 2 yr was 9.21 points after pae and 12.09 points after turp (difference of 2.88 [(b)(4) confidence interval 0.04 - 5.72]; p = 0.047).Superiority of turp was also found for most other patient-reported outcomes except for erectile function.Pae was less effective than turp regarding the improvement of maximum urinary flow rate (3.9 vs 10.23 ml/s, difference of -6.33 [-10.12 to -2.54]; p < 0.001), reduction of postvoid residual urine (62.1 vs 204.0 ml; 141.91 [43.31 - 240.51]; p = 0.005), and reduction of prostate volume (10.66 vs 30.20 ml; 19.54 [7.70 - 31.38]; p = 0.005).Adverse events were less frequent after pae than after turp (total occurrence n = 43 vs 78, p = 0.005), but the distribution among severity classes was similar.Ten patients ((b)(4)) who initially underwent pae required turp within 2 yr due to unsatisfying clinical outcomes, which prevented further assessment of their outcomes and therefore, represents a limitation of the study.Conclusions: inferior improvements in luts/bpo and a relevant re-treatment rate are found 2 yr after pae compared with turp.Pae is associated with fewer complications than turp.The disadvantages of pae regarding functional outcomes should be considered for patient selection and counselling.
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Search Alerts/Recalls
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