Evidence-based guidelines for the management of lower urinary tract symptoms related to uncomplicated benign prostatic hyperplasia in Italy: updated summary

ABSTRACT

Background and scope: Despite the high prevalence and huge socio-economic impact of benign prostatic hyper­plasia (BPH) in Italy, no national guidelines have been produced so far. This is a summary of the first Italian guidelines on the diagnosis and treatment of lower urinary tract symptoms (LUTS) related to uncomplicated BPH, prepared by a multidisciplinary panel under the auspices of the Italian Association of Urologists and introduced in Italy in 2003. An update compiled by the authors is also included.

Methods: Relevant papers published from 1998 to 2003 (updated to 2006) were identified through a structured literature review and the quality of evidence presented therein was graded according to the Centre for the Evaluation of Effectiveness in Health Administration (CeVEAS) system. Recommendations were based on evidence from the literature, but also on feedback from practitioners and specialists.

Main findings/recommendations: Given the prevalence of BPH, all men aged ≥ 50 years of age should be asked about LUTS and informed about disease characteristics and therapeutic options, while sexual function should always be assessed in patients with severe and long-standing LUTS. Initial assessment should include medical history (including drug and co-morbidity history), digital rectal examination, urinalysis, International Prostate Symptom Score-Quality of Life (IPSS-QoL) and a voiding diary, while prostate-specific antigen (PSA) and measure­ment of prostate volume by suprapubic ultrasonography are indicated in fully informed patients with a life expectancy of ≥ 10 years in whom BPH progression could influence treatment choices. QoL considerations should dictate whether to start active treatment. When QoL is not affected by LUTS, watchful waiting is indicated if symptoms are mild, acceptable if they are moderate. When QoL is affected, medical therapy with α₁-blockers or 5α-reductase inhibitors (the latter indicated in patients with increased prostate volume) is appropriate. Combined therapy with α₁-blockers + 5α-reductase inhibitors should only be considered in patients at high risk for progression (prostate volume > 40?mL or PSA > 4?ng/mL), since the incremental cost of combination therapy vs. monotherapy with α₁?blockers or finasteride is prohibitive. Selection of the type of surgery should be based on the surgeon's experience, the presence of co-morbid conditions and the size of the prostate. Open prostatectomy and transurethral resection of the prostate (TURP) are recommended in patients with acute or chronic retention of urine, and acceptable in obstructed patients with moderate/severe symptoms and worsened QoL. Transurethral incision of the prostate (TUIP) is acceptable when prostate volume is ≤ 30?mL. Holmium laser enucleation of the prostate (HoLEP) may be proposed to motivated patients where expert surgeons are available. Transurethral microwave thermotherapy (TUMT) or transurethral needle ablation (TUNA) may be proposed to motivated patients who prefer to avoid surgery and/or do not respond to medical treatment. The possible effects of medical or surgical treatments on sexual function should always be discussed.

Conclusions: These guidelines are intended to provide a framework for health professionals involved in BPH management in order to facilitate decision-making in all areas and at all levels of healthcare.     

经尿道前列腺电汽化与经尿道前列腺电切对BPH的疗效比较

对２４０例有症状的前列腺增生症（ＢＰＨ）患者分别行经尿道前列腺电汽化术（ＴＶＰ）和经尿道前列腺电切术（ＴＵＲＰ）。结果显示：１２０例ＴＶＰ手术者，前列腺症状评分（ＩＰＳＳ）从术前的２０．９下降至术后３个月的５．１（Ｐ＜０．００１），最大尿流率由１０．６ｍｌ／ｓ上升至１９．２ｍｌ／ｓ（Ｐ＜０．０１）。ＴＵＲＰ组１２０例，ＩＰＳＳ从术前的２１．２下降至术后３个月的５．２（Ｐ＜０．００１），最大尿流率由１０．２ｍｌ／ｓ上升至１９．４ｍｌ／ｓ（Ｐ＜０．０１），两组比较无显著差异性（Ｐ＞０．０５）。平均留置导尿管时间：ＴＶＰ组２６．５小时，ＴＵＲＰ组５０．７小时，有显著性差异（Ｐ＜０．０１）。术后阳萎发生率：ＴＶＰ组２．４％，ＴＵＲＰ组１４．５％（Ｐ＜０．０５）。ＴＶＰ组术中无大出血及经尿道前列腺电切综合征（ＴＵＲＳ）发生，需输血者仅１例。ＴＵＲＰ组３例发生ＴＵＲＳ，输血１４例。比较结果：ＴＶＰ能达到与ＴＵＲＰ完全相同的治疗效果，且并发症少，价格相对较低，近期效果满意。     

Renal haemodynamic response to sodium-glucose cotransporter-2 inhibition does not depend on protein intake: An analysis of three randomized controlled trials

High protein intake may increase intraglomerular pressure through dilation of the afferent arteriole. Sodium-glucose cotransporter-2 (SGLT2) inhibitors may reduce intraglomerular pressure through activation of tubuloglomerular feedback. Given these opposing effects, we assessed whether the effect of dapagliflozin on glomerular filtration rate (GFR) and urinary albumin-to-creatinine ratio (UACR) was modified by estimated dietary protein intake using data from three separate randomized controlled trials (DELIGHT, IMPROVE and DIAMOND). The median protein intake was 58.4, 63.6 and 90.0 g/d, respectively. In the DELIGHT trial (n = 233), dapagliflozin compared to placebo caused an acute and reversible dip in GFR of 2.1 and 2.2 mL/min/1.73 m², and reduced UACR by 20.5% and 28.4% in participants with high and low protein intake, respectively. Similarly, in IMPROVE (n = 30) and DIAMOND (n = 53), the effect of dapagliflozin on GFR and UACR was comparable in participants with high and low protein intake (all P for interaction > 0.40). This post hoc, exploratory analysis of three clinical trials suggests that dietary protein intake does not modify the individual response of clinical kidney variables to dapagliflozin.     

Correlation of the International Prostate Symptom Score bother question with the Benign Prostatic Hyperplasia Impact Index in a clinical practice setting

OBJECTIVE

To evaluate the association between the International Prostate Symptom Score (IPSS) bother question (BQ) and a validated disease‐specific quality‐of‐life questionnaire, the Benign Prostatic Hyperplasia (BPH) Impact Index (BPH‐II), using the BPH Registry and Patient Survey database.

PATIENTS AND METHODS

The BPH Registry and Patient Survey is a multicentre, longitudinal, observational database of management practices and patient outcomes in a population of patients with BPH in the USA, managed with watchful waiting or pharmacotherapy. Men enrolled in the BPH Registry who completed the IPSS BQ and the four‐item BPH‐II at enrolment were identified. The association between the IPSS BQ score and the BPH Impact Index was assessed using Spearman rank correlation.

RESULTS

At baseline (enrolment visit), 6439 men (mean age 66 years) completed the IPSS BQ and the BPH‐II. The mean (sd ) score of the IPSS BQ was 2.5 (1.4) and of the BPH‐II was 2.8 (2.8). Based on responses to the BPH‐II, at least half the men reported that their urinary symptoms were associated with physical discomfort, worry about their health, and bothersomeness. The IPSS BQ score was significantly correlated (P < 0.001) with the BPH‐II (r = 0.68) and each of its four questions (physical discomfort, r = 0.52; worry about health, r = 0.53; bothersomeness of trouble with urination, r = 0.67; and time kept from usual activities, r = 0.44).

CONCLUSIONS

The IPSS BQ score has a strong and positive correlation with the BPH‐II among men enrolled in the BPH Registry. The IPSS BQ is a convenient tool for assessing disease‐specific quality of life when determining treatment strategies and evaluating treatment outcomes in men with BPH.     

The appropriateness of treatment of benign prostatic hyperplasia: a comparison of Dutch and multinational criteria

Over the last decade, a number of organisations have developed clinical guidelines, typically at a national level, in order to increase appropriate health care. This raises the question as to whether it is possible to develop guidelines, applicable on the national level, at an international level. In order to examine this, we compared the appropriateness criteria for the treatment of benign prostatic hyperplasia ratings developed by two panels, one a single-nationality (Dutch) panel, the other a multinational (European) panel. The panels, both consisting of experienced urologists, used a modified Delphi process to rate 1152 indications for the most common treatments (surgery, alpha-blocker, finasteride and watchful waiting) on a nine-point scale. This article describes the similarities and differences between the ratings produced by the panels. The appropriateness ratings were identical for 84% of the indications (kappa=0.76). The difference in the scores for individual indications was zero in 41% of indications and less than or equal to two in 99% of indications. This study provides strong evidence that a multinational panel can deliver essentially the same appropriateness ratings for BPH as a national panel. Developing appropriateness criteria on an international level may result in significant savings and may help contribute to the reduction of undesirable practice variation.