Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
International Urology and Nephrology
Published in: International Urology and Nephrology 5/2016

Open Access 01-05-2016 | Urology - Original Paper

Quality of life in patients with lower urinary tract symptoms associated with BPH: change over time in real-life practice according to treatment—the QUALIPROST study

Authors: Antonio Alcaraz, Joaquín Carballido-Rodríguez, Miguel Unda-Urzaiz, Rafael Medina-López, José L. Ruiz-Cerdá, Federico Rodríguez-Rubio, Darío García-Rojo, Francisco J. Brenes-Bermúdez, José M. Cózar-Olmo, Víctor Baena-González, José Manasanch

Published in: International Urology and Nephrology | Issue 5/2016

Login to get access

Abstract

Purpose

To evaluate change in quality of life (QoL) and symptoms in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH) in conditions of current clinical practice.

Methods

Prospective, longitudinal, multicenter open-label study was carried out in urology outpatient clinics. Patients were ≥40 years of age with an International Prostate Symptom Score (IPSS) score ≥8. QoL and symptoms were measured at baseline and 6 months using the Benign Prostatic Hyperplasia Impact Index (BII) and the IPSS.

Results

1713 patients were included for analysis. Mean (SD) IPSS and BII scores at baseline were 16.8 (5.4) and 6.8 (2.6), respectively. 8.9 % (n = 153) of study participants did not receive treatment (watchful waiting, WW), 70.3 % (n = 1204) were prescribed monotherapy (alpha-adrenergic blockers [AB]; phytotherapy [PT, of which 95.2 % was the hexanic extract of Serenoa repens, HESr]; or 5-alpha-reductase inhibitors [5ARI]), and 20.8 % (n = 356) received combined treatment (AB + 5ARI; AB + HESr; others). At 6 months, improvements in QoL were similar across the different medical treatment (MT) groups, both for monotherapy (AB: mean improvement [SD] of 2.4 points [2.4]; PT: 1.9 [2.4]; 5ARI: 2.5 [2.3]) and combined therapy (AB + 5ARI: 3.1 [2.9]; AB + PT: 3.1 [2.5]). There were no clinically significant differences between MT groups and all showed significant improvement over WW (p < 0.05). HESr showed similar efficacy to AB and 5ARI both as monotherapy and in combination with AB. Results on the IPSS were similar.

Conclusions

Improvements in QoL and symptoms were equivalent across the medical treatments most widely used in real-life practice to manage patients with moderate or severe LUTS. HESr showed an equivalent efficacy to AB and 5ARI with fewer side effects.
Appendix
Available only for authorised users
Literature
1.
Emberton M, Fitzpatrick JM, Garcia-Losa M, Qizilbash N, Djavan B (2008) Progression of benign prostatic hyperplasia: systematic review of the placebo arms of clinical trials. BJU Int 102:981–986CrossRefPubMed
2.
Welch G, Weinger K, Barry MJ (2002) Quality-of-life impact of lower urinary tract symptom severity: results from the Health Professionals Follow-up Study. Urology 59:245–250CrossRefPubMed
3.
Trueman P, Hood SC, Nayak US, Mrazek MF (1999) Prevalence of lower urinary tract symptoms and self-reported diagnosed ‘benign prostatic hyperplasia’, and their effect on quality of life in a community-based survey of men in the UK. BJU Int 83:410–415CrossRefPubMed
4.
Boyle P, Robertson C, Mazzetta C, Keech M, Hobbs R, Fourcade R et al (2003) The relationship between lower urinary tract symptoms and health status: the UREPIK study. BJU Int 92:575–580CrossRefPubMed
5.
Wu XJ, Zhi Y, Zheng J, He P, Zhou XZ, Li WB et al (2014) Dutasteride on benign prostatic hyperplasia: a meta-analysis on randomized clinical trials in 6460 patients. Urology 83:539–543CrossRefPubMed
6.
Rosen RC, Giuliano F, Carson CC (2005) Sexual dysfunction and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Eur Urol 47:824–837CrossRefPubMed
7.
8.
Batista JE, Palacio A, Torrubia R, Hernández C, Vicente J, Resel L et al (2002) Tamsulosin: effect on quality of life in 2740 patients with lower urinary tract symptoms managed in real-life practice in Spain. Arch Esp Urol 55:97–105PubMed
9.
Vallancien G, Emberton M, Alcaraz A, Matzkin H, van Moorselaar RJ, Hartung R et al (2008) Alfuzosin 10 mg once daily for treating benign prostatic hyperplasia: a 3-year experience in real-life practice. BJU Int 101:847–852CrossRefPubMed
10.
Mishra V, Emberton M (2006) To what extent do real life practice studies differ from randomized controlled trials in lower urinary tract symptoms/benign prostatic hyperplasia? Curr Opin Urol 16:1–4CrossRefPubMed
11.
Barry MJ, Fowler FJ Jr, Oleary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK (1995) Measuring disease-specific health status in men with benign prostatic hyperplasia. Measurement Committee of The American Urological Association. Med Care 33(4 Suppl):AS145–AS155PubMed
12.
Carballido Rodríguez J, Grunfeld Abellán A, Escudero Callen A, Bermejo GF, Regadera-Anechina L, Llach BX (2008) Validation of the Spanish version of the Benign Prostatic Hyperplasia Impact Index Questionnaire. “Validart Study”. Actas Urol Esp 32:230–239CrossRefPubMed
13.
Badía X, García-Losa M, Dal-Ré R, Carballido J, Serra M (1998) Validation of a harmonized Spanish version of the IPSS: evidence of equivalence with the original American scale. International Prostate Symptom Score. Urology 52:614–620CrossRefPubMed
14.
Barry MJ, Williford WO, Chang Y, Machi M, Jones KM, Walker-Corkery E et al (1995) Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients? J Urol 154:1770–1774CrossRefPubMed
15.
Haynes RB, Sackett DL, Gibson ES, Taylor DW, Hackett BC, Roberts RS et al (1976) Improvement of medication compliance in uncontrolled hypertension. Lancet 1:1265–1268CrossRefPubMed
16.
Lukacs B, Cornu JN, Aout M, Tessier N, Hodée C, Haab F et al (2013) Management of lower urinary tract symptoms related to benign prostatic hyperplasia in real-life practice in France: a comprehensive population study. Eur Urol 64:493–501CrossRefPubMed
17.
Cindolo L, Pirozzi L, Fanizza C, Romero M, Sountoulides P, Roehrborn CG et al (2014) Actual medical management of lower urinary tract symptoms related to benign prostatic hyperplasia: temporal trends of prescription and hospitalization rates over 5 years in a large population of Italian men. Int Urol Nephrol 46:695–701CrossRefPubMed
18.
Hutchison A, Farmer R, Verhamme K, Berges R, Navarrete RV (2007) The efficacy of drugs for the treatment of LUTS/BPH, a study in 6 European countries. Eur Urol 51:207–215CrossRefPubMed
19.
Desgrandchamps F, Droupy S, Irani J, Saussine C, Comenducci A (2006) Effect of dutasteride on the symptoms of benign prostatic hyperplasia, and patient quality of life and discomfort, in clinical practice. BJU Int 98:83–88CrossRefPubMed
20.
Lukacs B, Grange JC, Comet D (2000) One-year follow-up of 2829 patients with moderate to severe lower urinary tract symptoms treated with alfuzosin in general practice according to IPSS and a health-related quality-of-life questionnaire. BPM Group in General Practice. Urology 55:540–546CrossRefPubMed
21.
Vallancien G, Pariente P (2001) Treatment of lower urinary tract symptoms suggestive of benign prostatic obstruction in real life practice in France. Prostate Cancer Prostatic Dis 4:124–131CrossRefPubMed
22.
Barkin J, Roehrborn CG, Siami P, Haillot O, Morrill B, Black L et al (2009) Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 2-year data from the CombAT trial. BJU Int 103:919–926CrossRefPubMed
23.
Debruyne F, Koch G, Boyle P, Da Silva FC, Gillenwater JG, Hamdy FC et al (2002) Comparison of a phytotherapeutic agent (Permixon) with an alpha-blocker (Tamsulosin) in the treatment of benign prostatic hyperplasia: a 1-year randomized international study. Eur Urol 41:497–506CrossRefPubMed
24.
Debruyne F, Boyle P, Calais da Silva F, Gillenwater JG, Hamdy FC, Perrin P et al (2004) Evaluation of the clinical benefit of Permixon and tamsulosin in severe BPH patients—PERMAL study subset analysis. Eur Urol 45:773–779CrossRefPubMed
25.
Carraro JC, Raynaud JP, Koch G, Chisholm GD, Di Silverio F, Teillac P et al (1996) Comparison of phytotherapy (Permixon) with finasteride in the treatment of benign prostate hyperplasia: a randomized international study of 1,098 patients. Prostate 29:231–240CrossRefPubMed
26.
Al-Shukri SH, Deschaseaux P, Kuzmin IV, Amdiy RR (2000) Early urodynamic effects of the lipido-sterolic extract of Serenoa repens (Permixon(R)) in patients with lower urinary tract symptoms due to benign prostatic hyperplasia. Prostate Cancer Prostatic Dis 3:195–199CrossRefPubMed
27.
Boyle P, Robertson C, Lowe F, Roehrborn C (2004) Updated meta-analysis of clinical trials of Serenoa repens extract in the treatment of symptomatic benign prostatic hyperplasia. BJU Int 93:751–756CrossRefPubMed
28.
Bent S, Kane C, Shinohara K, Neuhaus J, Hudes ES, Goldberg H et al (2006) Saw palmetto for benign prostatic hyperplasia. NEJM 354:557–566CrossRefPubMed
29.
Barry MJ, Meleth S, Lee JY, Kreder KJ, Avins AL, Nickel JC et al (2011) Effect of increasing doses of Saw palmetto extract on lower urinary tract symptoms. JAMA 306:1344–1351CrossRefPubMedPubMedCentral
30.
MacDonald R, Tacklind JW, Rutks I, Wilt TJ (2012) Serenoa repens monotherapy for benign prostatic hyperplasia (BPH): an updated Cochrane systematic review. BJU Int 109:1756–1761CrossRefPubMedPubMedCentral
31.
32.
Bayne CW, Donnelly F, Ross M, Habib FK (1999) Serenoa repens (Permixon): a 5alpha-reductase types I and II inhibitor-new evidence in a coculture model of BPH. Prostate 40:232–241CrossRefPubMed
33.
Di Silverio F, Monti S, Sciarra A, Varasano PA, Martini C, Lanzara S et al (1998) Effects of long-term treatment with Serenoa repens (Permixon) on the concentrations and regional distribution of androgens and epidermal growth factor in benign prostatic hyperplasia. Prostate 37:77–83CrossRefPubMed
34.
Sirab N, Robert G, Fasolo V, Descazeaud A, Vacherot F, de la Taille A et al (2013) Lipidosterolic extract of Serenoa repens modulates the expression of inflammation related-genes in benign prostatic hyperplasia epithelial and stromal cells. Int J Mol Sci 14:14301–14320CrossRefPubMedPubMedCentral
35.
Latil A, Libon C, Templier M, Junquero D, Lantoine-Adam F, Nguyen T (2012) Hexanic lipidosterolic extract of Serenoa repens inhibits the expression of two key inflammatory mediators, MCP-1/CCL2 and VCAM-1, in vitro. BJU Int 110:E301–E307CrossRefPubMed
36.
37.
Scaglione F, Lucini V, Pannacci M, Dugnani S, Leone C (2012) Comparison of the potency of 10 different brands of Serenoa repens extracts. Eur Rev Med Pharmacol Sci 16:569–574PubMed
38.
Habib FK, Wyllie MG (2004) Not all brands are created equal: a comparison of selected components of different brands of Serenoa repens extract. Prostate Cancer Prostatic Dis 7:195–200CrossRefPubMed
39.
Scaglione F, Lucini V, Pannacci M, Caronno A, Leone C (2008) Comparison of the potency of different brands of Serenoa repens extract on 5alpha-reductase types I and II in prostatic co-cultured epithelial and fibroblast cells. Pharmacology 82:270–275CrossRefPubMed
40.
Giuliano F (2008) Medical treatments for benign prostatic hyperplasia and sexual function. BJU Int 102(Suppl 2):8–12CrossRefPubMed
41.
Dutkiewics S (2001) Efficacy and tolerability of drugs for treatment of benign prostatic hyperplasia. Int Urol Nephrol 32:423–432CrossRefPubMed
42.
Novara G, Chapple CR, Montorsi F (2015) Individual patient data from registrational trials of silodosin in the treatment of non-neurogenic male lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH): subgroup analyses of efficacy and safety data. BJU Int 115:802–814CrossRefPubMed
43.
Gacci M, Ficarra V, Sebastianelli A, Corona G, Serni S, Shariat SF et al (2014) Impact of medical treatments for male lower urinary tract symptoms due to benign prostatic hyperplasia on ejaculatory function: a systematic review and meta-analysis. J Sex Med 11:1554–1566CrossRefPubMed
44.
Fourcade RO, Lacoin F, Rouprêt M, Slama A, Le Fur C, Michel E et al (2012) Outcomes and general health-related quality of life among patients medically treated in general daily practice for lower urinary tract symptoms due to benign prostatic hyperplasia. World J Urol 30:419–426CrossRefPubMedPubMedCentral
45.
Hizli F, Uygur MC (2007) A prospective study of the efficacy of Serenoa repens, tamsulosin, and Serenoa repens plus tamsulosin treatment for patients with benign prostate hyperplasia. Int Urol Nephrol 39:879–886CrossRefPubMed
46.
Ryu YW, Lim SW, Kim JH, Ahn SH, Choi JD (2015) Comparison of tamsulosin plus Serenoa repens with tamsulosin in the treatment of benign prostatic hyperplasia in Korean men: 1-year randomized open label study. Urol Int 94:187–193CrossRefPubMed
47.
McConnell JD, Roehrborn CG, Bautista OM, Andriole GL Jr, Dixon CM, Kusek JW et al (2003) The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med 349:2387–2398CrossRefPubMed
48.
Roehrborn CG, Siami P, Barkin J, Damião R, Major-Walker K, Nandy I et al (2010) The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur Urol 57:123–131CrossRefPubMed
49.
Cindolo L, Pirozzi L, Fanizza C, Romero M, Tubaro A, Autorino R, De Nunzio C, Schips L (2015) Drug adherence and clinical outcomes for patients under pharmacological therapy for lower urinary tract symptoms related to benign prostatic hyperplasia: population-based cohort study. Eur Urol 68(3):418–425CrossRefPubMed
50.
Kawabe K, Yoshida M, Homma Y, Silodosin Clinical Study Group (2006) Silodosin, a new alpha1A-adrenoceptor-selective antagonist for treating benign prostatic hyperplasia: results of a phase III randomized, placebo-controlled, double-blind study in Japanese men. BJU Int 98:1019–1024CrossRefPubMed
51.
Porst H, Kim ED, Casabé AR, Mirone V, Secrest RJ, Xu L et al (2011) Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results of an international randomized, double-blind, placebo-controlled trial. Eur Urol 60:1105–1113CrossRefPubMed
Metadata
Title
Quality of life in patients with lower urinary tract symptoms associated with BPH: change over time in real-life practice according to treatment—the QUALIPROST study
Authors
Antonio Alcaraz
Joaquín Carballido-Rodríguez
Miguel Unda-Urzaiz
Rafael Medina-López
José L. Ruiz-Cerdá
Federico Rodríguez-Rubio
Darío García-Rojo
Francisco J. Brenes-Bermúdez
José M. Cózar-Olmo
Víctor Baena-González
José Manasanch
Publication date
01-05-2016
Publisher
Springer Netherlands
Published in
International Urology and Nephrology / Issue 5/2016
Print ISSN: 0301-1623
Electronic ISSN: 1573-2584
DOI
https://doi.org/10.1007/s11255-015-1206-7

Other articles of this Issue 5/2016

International Urology and Nephrology 5/2016 Go to the issue

Nephrology - Original Paper

Uremia-caused changes of ghrelin system in hippocampus may be associated with impaired cognitive function of hippocampus

Nephrology - Original Paper

Functional deficiency of vitamin K in hemodialysis patients in Upper Silesia in Poland

Nephrology - Original Paper

The effect of calcineurin inhibitors in the induction and maintenance treatment of lupus nephritis: a systematic review and meta-analysis

Urology - Review

Does solitary- and organ-confined metastasectomy really improve survival in advanced urologic malignancies?

Nephrology - Original Paper

Effects of various stages of nephropathy on wound healing in patients with diabetes: an observational cohort study encompassing 731 diabetics

Nephrology - Letter to the editor

Eculizumab for the treatment of atypical hemolytic uremic syndrome recurrence after kidney transplantation associated with complement factor H mutations: a case report with a 5-year follow-up
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Reserve your place

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

Read more

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine
Image Credits