Dataset Information

Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study.

ABSTRACT: Evidence indicating Prostatic Urethral Lift (PUL) delivers significant improvement in symptomatic BPH with low morbidity is based on subjects with lateral lobe (LL) enlargement only. MedLift was an FDA IDE extension of the L.I.F.T. randomized study designed to examine safety and efficacy of PUL for treatment of obstructive middle lobes (OML). Inclusion criteria for this non-randomized cohort were identical to the L.I.F.T. randomized study, except for requiring an OML:???50 years of age, IPSS???13, and Qmax???12?ml/s. Primary endpoint analysis quantified improvement in IPSS over baseline and rate of post-procedure serious complications. Quantification of symptom relief, quality of life, flow rate, and sexual function occurred through 12 months. Outcomes were compared to historical L.I.F.T LL results and were combined to demonstrate the full effectiveness of PUL. Of the 71 screened subjects, 45 were enrolled. At 1, 3, 6, and 12 months, mean IPSS improved from baseline at least 13.5 points (p?60% and >70%, respectively at 3, 6, and 12 months, p?70% (range CI 63-81%) of subjects demonstrated???8 point improvement in IPSS through 12 months. Analysis of the combined dataset indicates???40% (CI 30-51%) of sexually active men improved the minimal clinically important difference in erectile function through 12 months. Prostates, including those with middle lobe obstruction, can be treated with the PUL procedure safely and effectively.

SUBMITTER: Rukstalis D

PROVIDER: S-EPMC6760566 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study.

Rukstalis Daniel D Grier Douglas D Stroup Sean P SP Tutrone Ronald R deSouza Euclid E Freedman Sheldon S David Richard R Kamientsky Jed J Eure Gregg G

Prostate cancer and prostatic diseases 20181212 3

Evidence indicating Prostatic Urethral Lift (PUL) delivers significant improvement in symptomatic BPH with low morbidity is based on subjects with lateral lobe (LL) enlargement only. MedLift was an FDA IDE extension of the L.I.F.T. randomized study designed to examine safety and efficacy of PUL for treatment of obstructive middle lobes (OML). Inclusion criteria for this non-randomized cohort were identical to the L.I.F.T. randomized study, except for requiring an OML: ≥ 50 years of age, IPSS ≥ 1 ...[more]

PMID: 30542055

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Project description:ContextRecently, prostatic urethral lift (PUL) is being used to treat lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Although preliminary clinical studies on PUL are increasing, the long-term efficacy and safety of this procedure are still not well evaluated.ObjectiveThe objective of our study is to synthesize the existing literature evidence, and make a comprehensive and long-term systematic review for the PUL procedure.Evidence acquisitionA systematic search was performed from the electronic databases including PubMed, Embase, and OVID. The search period was up to January 1, 2020. Comprehensive retrospective and prospective studies on PUL were collected in accordance with specific inclusion and exclusion criteria. Pooled prostatic symptom scores, sexual health scores, and functional outcomes were calculated by using a fixed or random-effect model.Evidence synthesisNineteen articles meet our determined inclusion and exclusion criteria, and 11 independent patient series were included in the final analysis. Meta-analysis results indicated improvement after the PUL procedure, including International Prostate Symptom Score improvement of 9.73-12.16 points, BPH Impact Index improvement of 3.74-4.50 points, maximum flow rate improvement of 3.44-4.26 ml/s, and quality of life improvement of 2.20-2.55 points. Postvoid residual volume at most of the intervals was not significantly variable. Data regarding sexual function remained stable or improved slightly during the 24-mo follow-up period. Pooled estimates were largely heterogeneous except for sexual function.ConclusionsPUL can continue to relieve prostatic symptoms for 24 mo without causing serious complications. The extremely important advantage of the PUL procedure is that it can preserve or slightly improve sexual function. Longer-term and more comprehensive clinical trials are still needed to further clarify the functional outcomes and cost effectiveness of PUL.Patient summaryProstatic urethral lift is an attractive option for selected patients who seek rapid and durable relief of lower urinary tract symptoms with complete preservation of sexual function.

Project description:ObjectivesTo investigate tooth wear in young adults, intraoral scanning was used for digital monitoring of the mandibular first molar over 12 months. A possible influence of aetiological factors obtained by a questionnaire on tooth wear was investigated.Materials and methodsA total of 109 participants (mean age at the start of the study: 21.0 ± 2.2 years) were included in this clinical study. At baseline (T0), an intraoral scan (Trios 3, 3Shape) of the study tooth (FDI # 36 or #46) was conducted. After a mean observation period of 373 ± 19 days, a second intraoral scan (T1, n = 94) of the same tooth as at T0 was performed and standard tessellation language datasets were superimposed with 3D analysis software (GOM Inspect). The occlusal surface of the study tooth was divided into 7 areas (5 cusps, 2 ridges) and maximum vertical substance loss was measured between T0 and T1 (n = 91). Three types of tooth wear were defined: cupping (C), facet (F) and combined cupping-facet (CF). Furthermore, a questionnaire on aetiological factors, such as dietary behaviour, was filled out at T0. Data were analysed with non-parametric tests (p < 0.05).ResultsOnly one study tooth exhibited no tooth wear at T0, whereas 3 teeth showed C, 47 teeth F and 40 teeth CF. A progression of vertical substance loss for all three types was shown. Most affected were the mesiobuccal cusps (43, 38/47 µm; median, 95%CI) followed by distobuccal (36, 33/39 µm), mesiolingual (35, 26/40 µm), distolingual (34, 27/36 µm) and distal (31, 25/34 µm). On mesial and distal ridges, only F was detected with the lowest vertical substance loss of all areas (mesial ridge: 0, 0/0 µm; distal ridge: 0, 0/0 µm). An association between aetiological factors and loss values could not be shown.ConclusionsAll study teeth showed clear signs of wear, and after only 1 year, further substance loss was detectable. This result is of significance for young adults.Clinical relevanceSince data of young adults regarding tooth wear are scarce, the results give a first idea of the amount of vertical loss per year and its relation to aetiological factors such as dietary behaviour. Therefore, further studies over a longer observation period are highly recommended.

Dataset Information

Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study.

Publications

Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study.

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