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 - Beyond the Abstract

Benign prostatic hyperplasia (BPH) is a common condition that can often result in lower urinary tract symptoms (LUTS) leading to a significant deterioration in patients’ quality of life (QoL).

A range of treatment alternatives are available for patients with LUTS/BPH, however relatively few studies have compared the effect on QoL and symptoms of the most widely used therapeutic strategies for LUTS/BPH in real-world conditions. This was the aim of the QUALIPROST (Quality of Life in Benign Prostatic Hyperplasia) study, a large-scale observational study carried out in Spain . Patients included were ≥40 years of age with moderate-to-severe symptoms of LUTS/BPH and assigned to a treatment regimen based on their clinician’s judgement. Patients with complicating factors, such as other urological disorders, surgery, or recent treatment with a medication having a known effect on the urinary system were excluded from the study.

The primary outcomes were changes in QoL and urinary symptoms, which were evaluated at baseline and after six months of treatment using the Benign Prostatic Hyperplasia Impact Index (BII) and the International Prostate Symptom Score (IPSS), respectively. At baseline, mean (SD) IPSS of the participants was 16.8 (5.4) and mean BII was 6.8 (2.6).

A total of 119 urologists participated in the study and 1888 patients were initially recruited, with data available from 1713 patients for intention to treat analysis. 70% of patients were assigned to monotherapy, 21% to combination therapy, and 9% to watchful waiting (WW). Monotherapy was with alpha-blockers (AB, with tamsulosin being the most frequently used at close to 89%), 5-¬alpha reductase inhibitors (5¬ARIs), or phytotherapy (95.2% of which was accounted for by the hexanic extract of Serenoa repens [HESr, Permixon®] and 4.8% by the extract of Pygeum africanum). The most common combination treatments were AB plus 5ARI (representing 5.4% of the overall sample) and AB plus HESr (12.8%).

After 6 months of follow-up, QoL and symptoms had improved substantially in all groups receiving medical treatment, while the improvement in patients assigned to WW was quite limited. In LUTS/BPH patients treated with monotherapy, alpha-blockers, 5ARIs, and the hexanic extract of S. repens led to similar levels of improvements in QoL and symptom relief. When combination treatment was used, AB plus 5ARI and AB plus HESr showed similar improvements in BII and IPSS scores. All medical treatments exceeded thresholds for clinically meaningful improvements on the outcomes measures. Patients with more severe baseline symptoms showed larger improvements, as observed in previous articles.

In terms of adverse effects, more than 10% of patients receiving AB and/or 5¬ARIs reported problems with sexual functioning, including ejaculatory dysfunction. No sexual adverse effects were reported for the hexanic extract of S. repens. Treatment adherence was high for all treatments.

These results underline the importance of focusing on specific extracts of S. repens when studying efficacy. A previous systematic review suggested that extracts of S. repens appeared to be no more effective than placebo in treating urinary symptoms associated with BPH. However, the QUALIPROST study has provided further evidence that, in the medium term, the hexanic extract of S. repens is as effective as alpha-blockers and 5ARIs in these patients, whilst being better tolerated.

As noted in the article, some of the earlier reviews2 did not distinguish between different extracts of S. repens, despite evidence of composition and wide variability in potency. , A recent European Medicines Agency (EMA) report concluded that only the hexanic extract of S. repens has sufficient evidence to support its use as a well-established medicinal product with recognized efficacy and safety. The results observed here with the hexanic extract of S. repens may therefore not be generalizable to other extracts of S. repens.

As it was an observational study, patients were not randomized or blinded to treatment and there was no placebo arm. On the other hand, the size of the improvement observed in the medical treatment groups was similar to that seen in earlier randomised clinical trials.

In conclusion, the study suggests that the medical treatments most widely used in real-life practice to manage moderate to severe LUTS/BPH produce similar levels of improvement in QoL and symptoms. The results provide additional evidence on current therapeutic options for managing LUTS/BPH and should help to further inform decision-making regarding treatment strategies in this patient population.

Written By:

Michael Herdman, Insight Consulting & Research and José Manasanch, Pierre Fabre Ibérica,

Reference:

Alcaraz A, Carballido-Rodríguez J, Unda-Urzaiz M, Medina-López R, Ruiz-Cerdá JL, Rodríguez-Rubio F, García-Rojo D, Brenes-Bermúdez FJ, Cózar-Olmo JM, Baena-González V, Manasanch J. 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. Int Urol Nephrol 2016. DOI 10.1007/s11255-015-1206-7

MacDonald R, Tacklind JW, Rutks I, Wilt TJ. Serenoa repens monotherapy for benign prostatic hyperplasia (BPH): an updated Cochrane systematic review. BJU Int 2012;109(12):1756-61.

 

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