Dataset Information

Model-based meta-analysis of individual International Prostate Symptom Score trajectories in patients with benign prostatic hyperplasia with moderate or severe symptoms.

ABSTRACT: AIMS:International Prostate Symptom Score (IPSS) is a marker of lower urinary tract symptoms (LUTS) deterioration or improvement in benign prostate hyperplasia (BPH). Whereas changes in IPSS relative to baseline have been used as endpoints in clinical trials, little attention has been given to the time course of symptoms. The current investigation aimed to develop a drug-disease model to describe individual IPSS trajectories in moderate and severe BPH patients. METHODS:A model-based meta-analytical approach was used including data from 10 238 patients enrolled into Phase III and IV studies receiving placebo, tamsulosin, dutasteride or combination therapy over a period of up to 4 years. Model predictive performance was assessed using statistical and graphical criteria. Subsequently, simulations were performed to illustrate the implications of treatment with drugs showing symptomatic and disease-modifying properties in patients with varying disease progression rates. RESULTS:Improvement and worsening of IPSS could be characterized by a model including a sigmoid function which disentangles drug effects from placebo and varying disease progression rates on IPSS. Mean estimate (95% confidence intervals) for the disease progression rate was 0.319 (0.271-0.411) month-1 . Treatment effect on IPSS (DELTA) was found to be 0.0605, 0.0139 and 0.0310 month-1 for placebo, tamsulosin and combination therapy, respectively. In addition, it appears that individual trajectories can be clustered together into different phenotypes describing the underlying disease progression rate (i.e. slow, moderate and fast progressors). CONCLUSIONS:The availability of a drug-disease model enables the evaluation of interindividual differences in disease progression rate, deterioration of symptoms and treatment effects on LUTS/BPH.

SUBMITTER: D'Agate S

PROVIDER: S-EPMC7373698 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Model-based meta-analysis of individual International Prostate Symptom Score trajectories in patients with benign prostatic hyperplasia with moderate or severe symptoms.

D'Agate Salvatore S Wilson Timothy T Adalig Burkay B Manyak Michael M Palacios-Moreno Juan Manuel JM Chavan Chandrashekhar C Oelke Matthias M Roehrborn Claus C Della Pasqua Oscar O

British journal of clinical pharmacology 20200414 8

<h4>Aims</h4>International Prostate Symptom Score (IPSS) is a marker of lower urinary tract symptoms (LUTS) deterioration or improvement in benign prostate hyperplasia (BPH). Whereas changes in IPSS relative to baseline have been used as endpoints in clinical trials, little attention has been given to the time course of symptoms. The current investigation aimed to develop a drug-disease model to describe individual IPSS trajectories in moderate and severe BPH patients.<h4>Methods</h4>A model-bas ...[more]

PMID: 32144791

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Project description:PurposeWe aimed to determine the usefulness of the frequency-volume chart over the International Prostate Symptom Score in patients with benign prostatic hyperplasia. Furthermore, we investigated the clinical characteristics suggesting that patients could benefit from frequency-volume chart assessment in addition to International Prostate Symptom Score assessment.MethodsA total of 193 patients with benign prostatic hyperplasia were analyzed. The relationship between the information obtained from the frequency-volume chart and the International Prostate Symptom Score was assessed. Because the urine output per kilogram per hour was not associated with any question in the International Prostate Symptom Score questionnaire, patients were divided into 2 groups according to the presence of global polyuria, defined as urine output >40 mL·kg-1·h-1. Multivariable analysis was performed to determine the predictors of global polyuria, and the results were externally validated using 397 patients with benign prostatic hyperplasia.ResultsAlthough the other information obtained from the frequency-volume chart correlated with the International Prostate Symptom Score, the urine output was not associated with the International Prostate Symptom Score. Based on these results, patients were dichotomized into the global polyuria group (n = 19, 9.8%) and the non-global polyuria group. Although the patient characteristics did not differ between the 2 groups, the number of voids was higher in patients with global polyuria. Multivariable analysis showed that diabetes mellitus (odds ratio: 3.497, p = 0.039) and increased number of voids (odds ratio: 1.320, p < 0.001) were significant predictors of global polyuria. On external validation, the area under curve for the model was 0.723.ConclusionsGlobal polyuria cannot be suspected using the International Prostate Symptom Score, although it worsens the lower urinary tract symptoms of patients with benign prostatic hyperplasia. Assessment with the frequency-volume chart needs to be considered in diabetic patients with increased number of voids.

Project description:ObjectivesOveractive bladder (OAB) symptoms are often encountered in patients after transurethral resection of the prostate (TUR-P) or transurethral incision of the prostate (TUI-P) for benign prostatic obstruction (BPO). Either antimuscarinics or β-3 agonist has been found effective in relieving OAB symptoms. However, urologists usually do not prescribe such medication immediately after TUR-P or TUI-P to avoid an increase in postvoid residual and risk of urinary tract infection. If OAB medication can be used and adverse events (AEs) can be reduced to minimum, patients' quality of life after bladder outlet obstruction surgery could be improved. This study compared the safety and efficacy between solifenacin and mirabegron in men undergoing TUR-P or TUI-P.Materials and methodsThis prospective, randomized trial compared the safety and efficacy of OAB medication on the reduction in Urgency Severity Score (USS), OAB Symptoms Score (OABSS), International Prostate Symptom Score, and urgency urinary incontinence episodes in men with BPO undergoing surgical intervention. All patients could void smoothly after catheter removal and were randomly received daily solifenacin 5 mg, mirabegron 50 mg, or no interventions for 4 weeks. At 2 and 4 weeks postoperatively, participants' OAB symptoms and AEs were evaluated.ResultsA total of 57 men were enrolled in this study with a mean age of 70.8 ± 6.1 years. At 2 weeks postoperatively, USS (1.56 ± 1.72 vs. 2.39 ± 1.72 vs. 2.26 ± 1.73, P < 0.011) and OABSS (5.33 ± 3.65 vs. 7.67 ± 4.19 vs. 8.58 ± 4.31, P < 0.000) were significantly reduced in patients taking solifenacin, mirabegron, or control, respectively. Two patients in the solifenacin group developed urinary retention. However, the changes of variables at 4 weeks postoperatively were insignificant among the three groups.ConclusionSolifenacin and mirabegron are two different drug classes both equally effective in treating immediate OAB symptoms after TUR-P or TUI-P. However, OAB symptoms could be relieved at 4 weeks without any medication. Considering AEs, β-3 agonist has a more favorable safety profile than antimuscarinics.

Project description:Background and purposeBenign prostatic hyperplasia (BPH) is the most common urologic disorder affecting older men, necessitating medical or surgical intervention. Limited data exists regarding the effect these surgeries have on the endourologist's musculoskeletal system following the surgery because of the required difficult posture, prolonged procedures, repetitive movements, and the settings of an adjustable visual display terminal workstation. The aim of our study was to survey the prevalence and possible causes of musculoskeletal disorders among endourologists performing transurethral resection of the prostate (TURP) or laser prostatectomy using either holmium laser enucleation or thulium laser enucleation.Materials and methodsAn email inviting all members of the Endourological Society to participate in the survey was sent. The questionnaire included different demographic and practice characteristics, with concern regarding performing either TURP or laser prostatectomy and the incidence and type of musculoskeletal incidents following these surgeries. All responses were collected by a commercially available internet based survey host (www.surveymonkey.com) over a period of 6 weeks.ResultsOf the 121 complete responses, 84 (69%) of endourologists complained of a musculoskeletal disorder following TURP or laser prostatectomy. The most frequent complaint was for neck (64%), followed by back (57%), shoulder (48%), hand (40%), and elbow (18%). The average prostate volume turned out to be the most compelling predictor for musculoskeletal disorder occurrence with an average prostate volume of 76 g operated on by the complaining group compared with 59 g in the noncomplaining group. Those with more severe symptoms were linked to a mean prostate size of 80 g (60-146) and constantly complained of shoulder, neck, or back trouble compared with the less-severely complaining group.ConclusionsA high prevalence of musculoskeletal complaints among urologists performing endourologic prostatectomy was confirmed and was found to be proportionally related to the size of the prostate. The integration of an ergonomic specialist inside the operation room to watch and correct the surgeon's position during endourologic procedures may reduce the endourologist's exposure to these occupational hazards.

Dataset Information

Model-based meta-analysis of individual International Prostate Symptom Score trajectories in patients with benign prostatic hyperplasia with moderate or severe symptoms.

Publications

Model-based meta-analysis of individual International Prostate Symptom Score trajectories in patients with benign prostatic hyperplasia with moderate or severe symptoms.

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