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Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.

ABSTRACT: Item response theory (IRT) was used to characterize the time course of lower urinary tract symptoms due to benign prostatic hyperplasia (BPH-LUTS) measured by item-level International Prostate Symptom Scores (IPSS). The Fisher information content of IPSS items was determined and the power to detect a drug effect using the IRT approach was examined. Data from 403 patients with moderate-to-severe BPH-LUTS in a placebo-controlled phase II trial studying the effect of degarelix over 6 months were used for modeling. Three pharmacometric models were developed: a model for total IPSS, a unidimensional IRT model, and a bidimensional IRT model, the latter separating voiding and storage items. The population-level time course of BPH-LUTS in all models was described by initial improvement followed by worsening. In the unidimensional IRT model, the combined information content of IPSS voiding items represented 72% of the total information content, indicating that the voiding subscore may be more sensitive to changes in BPH-LUTS compared with the storage subscore. The pharmacometric models showed considerably higher power to detect a drug effect compared with a cross-sectional and while-on-treatment analysis of covariance, respectively. Compared with the sample size required to detect a drug effect at 80% power with the total IPSS model, a reduction of 5.9% and 11.7% was obtained with the unidimensional and bidimensional IPSS IRT model, respectively. Pharmacometric IRT analysis of the IPSS within BPH-LUTS may increase the precision and efficiency of treatment effect assessment, albeit to a more limited extent compared with applications in other therapeutic areas.

SUBMITTER: Lyauk YK

PROVIDER: S-EPMC7452927 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.

Lyauk Yassine Kamal YK Jonker Daniël M DM Lund Trine Meldgaard TM Hooker Andrew C AC Karlsson Mats O MO

The AAPS journal 20200827 5

Item response theory (IRT) was used to characterize the time course of lower urinary tract symptoms due to benign prostatic hyperplasia (BPH-LUTS) measured by item-level International Prostate Symptom Scores (IPSS). The Fisher information content of IPSS items was determined and the power to detect a drug effect using the IRT approach was examined. Data from 403 patients with moderate-to-severe BPH-LUTS in a placebo-controlled phase II trial studying the effect of degarelix over 6 months were us ...[more]

PMID: 32856168

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Project description:This study aimed to investigate perceived ejaculatory function/satisfaction before treatment for lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) and to identify associations between specific categories of ejaculatory dysfunctions (EjDs) and LUTS. A total of 1574 treatment-naïve men with LUTS/BPH were included in this study. All patients underwent routine evaluation for LUTS/BPH including the International Index of Erectile Function and a 5-item questionnaire developed to assess ejaculatory volume/force/pain/satisfaction/latency time. Patients who had sexual intercourse over the past 4 weeks were classified as sexually active group. A total of 783 patients were categorized as sexually active group. Decreased ejaculatory volume and force were reported by 53.4% and 55.7% of 783 sexually active men, respectively. There was a strong correlation between ejaculatory volume and force. Ejaculatory pain/discomfort, premature ejaculation (PE), and delayed ejaculation (DE) were reported in 41.0%, 16.3%, and 41.4% of the patients, respectively. Over 40.0% of men without decreased ejaculation volume/force were satisfied with ejaculatory function, whereas approximately 6.0% of men with decreased volume/force were satisfied with ejaculatory function. About 30.0% of men with decreased volume/force had orgasmic dysfunction, while approximately 10.0% of men without decreased volume/force did. Decreased ejaculatory volume or force was associated with LUTS severity after adjusting for other influential factors including testosterone level, erectile function, and prostate size on ultrasonography, but PE or DE or ejaculatory pain/discomfort was not. In conclusion, a considerable portion of men with LUTS/BPH appear to have a variety of EjDs. Ejaculatory volume/force and satisfaction/orgasm do not always appear to be concordant. Ejaculatory volume or force is independently associated with LUTS severity, whereas PE or DE or ejaculatory pain/discomfort is not.

Project description:ContextSeveral newer device-based procedures have recently become available for treating men with lower urinary tract symptoms attributed to benign prostatic hyperplasia, but their effectiveness remains uncertain.ObjectiveTo assess the longer-term comparative effectiveness (defined as >12 mo of follow-up) of the newer treatment modalities prostatic urethral lift (PUL), transurethral prostate convective radiofrequency water vapor (Rezūm), Aquablation, and prostatic arterial embolization (PAE).Evidence acquisitionOvid Medline, the Cochrane Central Register of Controlled Trials (CENTRAL), and the Agency for Healthcare Research and Quality databases were searched through September 30, 2019; hand searches of references of relevant studies were also performed. Eligible studies were randomized controlled trials (RCTs) published in English language. We excluded observational studies.Evidence synthesisOne RCT (n = 91) found that patients undergoing PUL may be less likely to respond (risk ratio [RR] 0.8; 95% confidence interval [CI] 0.7-1.0; low certainty of evidence [CoE]) and have a higher mean International Prostate Symptom Score (IPSS; mean difference 6.1; 95% CI 2.2-10.0; low CoE) than those undergoing transurethral resection of the prostate (TURP). Among patients undergoing PAE, one small RCT (n = 30) reported similar IPSS response rates (RR 0.9; 95% CI 0.7-1.1; low CoE) and one trial (n = 107) found similar mean IPSS (-0.7; 95% CI -1.3 to 2.7; moderate CoE) scores to those among patients undergoing TURP. A single study on Aquablation reported 12 mo of follow-up only, and a single 3-mo trial compared Rezūm with sham treatment.ConclusionsThe current best evidence underlying these newer therapies is limited to few trials (PUL and PAE), short-term follow-up of 12 mo (Aquablation and Rezūm), or sham comparison only (Rezūm).Patient summaryEvidence for four of the newer surgical treatments for men with an enlarged prostate is limited to few small trials with short-term follow-up; only one trial compared a new treatment modality with sham surgery.

Dataset Information

Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.

Publications

Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.

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