Dataset Information

Efficacy and safety of fexapotide triflutate in outpatient medical treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia.

ABSTRACT: Male lower urinary tract symptoms (LUTS) is an increasingly important problem for the majority of late middle aged and elderly men. Fexapotide triflutate (FT) is a first in-class compound given by local injection via the transrectal intraprostatic route under ultrasound guidance. Data from >1700 FT and control injections in prospective randomized blinded controlled multicenter trials are reviewed and discussed in relation to current developments in the field of treatments for LUTS associated with benign prostatic hyperplasia (BPH). Long-term studies of FT in the United States have shown statistically significant improvement in BPH symptoms and objective outcomes including significant reduction in both spontaneous acute urinary retention as well as the subsequent incidence of BPH surgery. FT has been shown to be well tolerated with an excellent safety profile, and is an efficacious clinic-based treatment for BPH involving an intraprostatic injection that requires only a few minutes to administer, with no catheter nor anesthesia requirements.

SUBMITTER: Shore N

PROVIDER: S-EPMC6348527 | biostudies-literature | 2019 Jan-Dec

REPOSITORIES: biostudies-literature

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Efficacy and safety of fexapotide triflutate in outpatient medical treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia.

Shore Neal N Tutrone Ronald R Roehrborn Claus G CG

Therapeutic advances in urology 20190114

Male lower urinary tract symptoms (LUTS) is an increasingly important problem for the majority of late middle aged and elderly men. Fexapotide triflutate (FT) is a first in-class compound given by local injection <i>via</i> the transrectal intraprostatic route under ultrasound guidance. Data from >1700 FT and control injections in prospective randomized blinded controlled multicenter trials are reviewed and discussed in relation to current developments in the field of treatments for LUTS associa ...[more]

PMID: 30719081

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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.

Dataset Information

Efficacy and safety of fexapotide triflutate in outpatient medical treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia.

Publications

Efficacy and safety of fexapotide triflutate in outpatient medical treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia.

Similar Datasets

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