Ten-Language Translation and
Harmonization of the International
Prostate Symptom Score:
Developing a Methodology for
Multinational Clinical Trials

Badı́a, Xavier; Garcı́a-Losa, Manuel; Dal‐Ré, Rafael

doi:10.1159/000474438

Cited by 190 publications

(101 citation statements)

References 15 publications

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“…The patient completed an anonymous questionnaire including sociodemographic data, time since the appearance of urinary problems, reasons for seeking medical advice, severity of LUTS as selfassessed using the IPSS questionnaire (culturally and linguistically validated versions [21,22]), impact of urinary symptoms on QoL (question 8 of the IPSS), knowledge of the disease, sexual function, and probable behaviour in case of treatment side-effects. The selected potential adverse events were those most frequently reported in the summary of product characteristics of the most widely used treatments for LUTS/BPH.…”

Section: Methodsmentioning

confidence: 99%

Profile and management of patients treated for the first time for lower urinary tract symptoms/benign prostatic hyperplasia in four European countries

Fourcade¹,

Théret²,

Taïeb³

2008

BJU International

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OBJECTIVETo describe the profile and management of patients medically treated for benign prostatic hyperplasia (BPH) in primary care in four European countries, as the diagnosis and management of BPH have developed dramatically in the last decade, and recent information from actual practice is insufficient.PATIENTS AND METHODSThis observational, cross‐sectional study was carried out by general practitioners in France (141 patients), Spain (127) and Portugal (50), and by office‐based urologists in Germany (162 patients) between July 2005 and June 2006. The physicians were unaware of the study sponsor. Patients aged ≥50 years were recruited if a decision for medical treatment of BPH was taken for the first time on that day. The patient and the investigator had to complete one questionnaire each.RESULTSThe physicians included 480 patients, with a mean (sd) age of 65.0 (7.8) years. The mean (sd) International Prostate Symptom Score (IPSS) was 16.0 (7.3). There were geographical differences in age (P = 0.009; patients in Germany being the youngest), IPSS (P = 0.017; patients in Spain having the highest score), quality of life (QoL; IPSS item 8, P < 0.001, the least altered being in Germany), and sexual activity (P = 0.010; the highest proportion of sexually active patients being in Portugal), but not for comorbidities and concomitant medication. The IPSS correlated poorly with age (r = 0.21) and moderately with QoL (r = 0.47). Severe symptoms (IPSS > 19) were not linked with sexual activity (age‐adjusted P = 0.378). Serum prostate specific antigen testing, although not recommended for BPH, was widely used (83.8% overall). All other examinations were carried out disparately depending on the country (P < 0.001 each). Digital rectal examination (DRE) and excluding urinary tract infection (urine culture) were used in ≈75% of study patients, but only half the patients in France had a urine culture, and 52% in Portugal had a DRE. A standardized assessment of symptoms and/or QoL was reported in 45% of study patients, with wide discrepancies among countries, i.e. 77.2% in Germany and 6.0% in Portugal. α‐blocker monotherapy was the most frequently prescribed treatment (62.5% overall, 87.1% in Germany, 46.1% in France), followed by phytotherapy (23.5%), and 5α‐reductase inhibitor monotherapy (3.75%); combinations were rare. Treatment varied according to the severity of the symptoms (P = 0.008), phytotherapy being given to patients with the lowest IPSS, and combinations to those with the highest IPSS.CONCLUSIONThere were geographical discrepancies that could be attributed to either different cultural habits or merely organisational differences, e.g. the presence of office urologists in Germany or diverse modes of access to phytotherapy (prescription vs ‘over the counter’) in the various countries.

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Section: Methodsmentioning

confidence: 99%

Profile and management of patients treated for the first time for lower urinary tract symptoms/benign prostatic hyperplasia in four European countries

Fourcade¹,

Théret²,

Taïeb³

2008

BJU International

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“…The validated Italian versions of the International Prostate Symptom Score (IPSS) [21] and International Index of Erectile Function (IIEF) [22] were administered to each patient, as it is routine in each urological institution. The questionnaire was offered to the patient on arrival at each center before the procedure and at the first follow-up visit after the procedure.…”

Section: Questionnairesmentioning

confidence: 99%

Antimicrobial prophylaxis for transrectal ultrasound-guided prostate biopsy: fosfomycin trometamol, an attractive alternative

Cai

Gallelli²,

Cocci

et al. 2016

World J Urol

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infections (UTIs) occurring within 1 month after TR-PB. The rate of symptomatic UTIs and the rate of ADRs were considered the main outcome measures. Results In the total study population, 72/1109 (6.5 %) patients experienced symptomatic UTIs and among these 11 (0.9 % of total) had urosepsis. Out of 72, 53 (73.6 %) symptomatic UTIs were caused by fluoroquinolone-resistant strains. Out of 632, 10 (1.6 %) patients in Group 1 and 62/477 (12.9 %) patients in Group 2 had symptomatic UTIs (p < 0.001); in particular, 2/632 (0.3 %) patients in Group 1 and 9/477 (1.8 %) patients in Group 2 had urosepsis (p < 0.001). No differences were reported in terms of adverse events (0.6 vs 0.4 %; p = 0.70). A Charlson comorbidity index ≤1 and type of antimicrobial prophylaxis (FT) were found to be associated with a lower probability of symptomatic UTIs in the multivariate model. Conclusions Antibiotic prophylaxis with FT for TR-PB had a lower rate of adverse events and a lower rate of symptomatic UTIs as compared with CIP. Fosfomycin trometamol appears as an attractive alternative prophylactic regimen in prostate biopsies.

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“…IPSS was assessed using a standard questionnaire form, composed with seven questions, each measured on a scale, to which patients respond on a scale of 0 (the best) to 5 (the worst) [29][30][31]. Decreases of MDA, plasma carbonyl groups (CG) and increase of CAT activity were secondary variables.…”

Section: Efficacy Variablesmentioning

confidence: 99%

Comparative Effects of Roystonea Regia (D-004) and Saw Palmetto Lipid Extracts On Blood Oxidative Variables in Men with Benign Prostate Hyperplasia (BPH)

Guzman¹

2013

iosrphr

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Ten-Language Translation and Harmonization of the International Prostate Symptom Score: Developing a Methodology for Multinational Clinical Trials

Cited by 190 publications

References 15 publications

Profile and management of patients treated for the first time for lower urinary tract symptoms/benign prostatic hyperplasia in four European countries

Profile and management of patients treated for the first time for lower urinary tract symptoms/benign prostatic hyperplasia in four European countries

Antimicrobial prophylaxis for transrectal ultrasound-guided prostate biopsy: fosfomycin trometamol, an attractive alternative

Comparative Effects of Roystonea Regia (D-004) and Saw Palmetto Lipid Extracts On Blood Oxidative Variables in Men with Benign Prostate Hyperplasia (BPH)

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