WebThe primary outcomes were International Prostate Symptom Score (IPSS) improvement in the PAE group at 12 months post-procedure, and complication data post-PAE. We also aimed to compare IPSS score improvements between the PAE and TURP groups, using non-inferiority analysis on propensity-score-matched patient pairs. WebA significant improvement in IPSS score (− 50.90% vs. − 33.50%, and − 53.90%, respectively), IIEF5 score (+ 39.28%, vs. + 45.96%, vs. 60.23%, respectively), and PVR (− …
NDA 21-319 Summary Review - Food and Drug Administration
WebJan 18, 2024 · The improvement in QoL, Qmax, and IPSS over baseline are significant and while data over 2 years is sparse the treatment has remained durable thus far. Complications Complication profiles are paramount for any new procedure in the BPH induced LUTS space, as TURP is an excellent surgical option in terms of clinical … WebFigure 2. Total IPSS improvement versus quality of life (QOL) improvement (r¼.282, p<.01). A change of 1 unit on the IPSS scale corresponded to an improvement of 0.282 units in the QOL score. Table 1. True-positive and false-positive percentages for a predicted postoperative IPSS improvement of at least 7 or at least 10 points % IPSS improvement raymond dratler
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WebFunctional outcomes assessed by patient administered questionnaire at a median follow-up of 26.2 months showed an improvement in median IPSS score from 8.0 preoperatively to … WebApr 1, 2024 · However, 38% (n = 40) of patients who presented with mild-to-moderate ED reported improvement in their erectile function 3 months following PAE. Overall, the changes in baseline SHIM score were relatively small; 82% (n = 137) of patients did not have more than 5 points of change in their SHIM scores at 3 months following PAE. When assessing MIT outcomes, we typically look at International Prostate Symptom Score (IPSS) and IPSS-QoL, patient-reported satisfaction, and preservation of sexual function. Both Rezūm and UroLift significantly improve IPSS at three months. Individuals enrolled in both studies had a baseline IPSS of about … See more Durability of treatment is also of importance for MITs, as freedom from retreatment is important to patients. Five-year follow-up clinical data from the pivotal studies showed that Rezūm had lower surgical and … See more Annual treatment costs for BPH were estimated to be $4 billion in 2006.1 As a result, cost effectiveness of treatments is an important consideration. An analysis performed by Ulchaker et al. evaluated the cost effectiveness of … See more Rezūm and UroLift have demonstrated comparable improvement in IPSS, IPSS-QoL and Qmax. Both treatments score high on patient … See more It is important to set patient expectations prior to Rezūm Therapy. Because of the effect that steam has on tissue, most patients may require post-procedure catheterization for … See more simplicity self storage