BPH: a present and future perspective on health impact Burden of disease in men with moderate LUTS Dalibor Pacík This presentation is financially supported by GlaxoSmithKline. CZ/DUTT/0019/12
Men with moderate LUTS due to BPH may experience a substantial health burden Today Tomorrow Bother Interference with daily activities Sexual dysfunction Worry Impact on physical and mental health Impact on personal relationships Potential BPH progression raises the prospect of additional adverse impact on quality of life through worsening of symptoms, as well as AUR and the need for surgery 2
Pharmacotherapy of BPH does not save life but can increase its quality.
LUTS associated with BPH are reported to impact a patient s activities of daily living % of men reporting that urinary symptoms interfered with activities of daily living at least some of the time during the past month Garraway WM et al. Br J Gen Pract 1993;43:318 321 4
One of the most bothersome symptoms in men with LUTS suggesting BPH is nocturia Nocturia may have a considerable adverse influence on QoL through sleep fragmentation Nocturia is cited as the most frequent cause of disturbed sleep continuity in older men Impaired sleep can have profound adverse consequences for somatic and mental health Abrams P. Eur Urol Supp 2005;3:1 7 Bonnet M H, Arand DL. Sleep Med Rev 2003;7:297 310 5
Sleep fragmentation and deprivation associated with nocturia can have a serious impact on health in the short and the long term Short-term Long-term Increased daytime sleepiness/reduced daytime alertness Longer reaction time Reduced daytime energy Reduced psychomotor performance Reduced concentration Depression Increased susceptibility to somatic disease Increased risk of cardiovascular disease Increased risk of car accidents and/or falls with fractures Institutionalisation Death Abrams P. Eur Urol Supp 2005;3:1 7 Bonnet M H, Arand DL. Sleep Med Rev 2003;7:297 310 6
Impact of BPH on HRQoL reflects severity of symptoms Mild symptoms Bother of urinary symptoms Interference with daily activities Worry about urologic disease Moderate-to-severe symptoms Bother of urinary symptoms Interference with daily activities Worry about urologic disease 4 6-fold worsening 1 4 6-fold worsening 1 2-fold worsening 1 1. Girman C et al. Urology 1994;44:825 31 7
Health-Related QoL Score (Age-Adjusted Means)* Impact of BPH on HRQoL reflects severity of symptoms Impact of bother begins with moderate symptoms LUTS Impact of interference begins with moderate symptoms Scale: 0 1 (health status: 0=best; 1=worst) *Higher scores indicate worse health status for all measures Girman C et al. Urology 1998; 51: 428 36 8
Reduction in QoL is much greater in patients with moderate-to-severe LUTS than in those with mild Men with moderate-to-severe LUTS and Enlarged Prostate were significantly more likely than those with mild symptoms to consider their prostate condition to have reduced their QoL (p<0.05) Roehrborn CG et al. Prostate Cancer Prostatic Dis 2006;9:30 4 9
The presence and severity of LUTS are risk factors for sexual dysfunction
The presence and severity of LUTS are risk factors for sexual dysfunction Sexual activity is common in a majority of men aged 50 80 years and is an important component of quality of life Men with moderate-to-severe LUTS are at increased risk for Erectile dysfunction Ejaculatory dysfunction Hypoactive desire Rosen R et al. Eur Urol 2003;44:637 49 Rosen R et al. Eur Urol 2005;47:824 837 11
Incidence (%) Erection problems are strongly associated with LUTS severity Effect of LUTS severity Effect of LUTS severity Effect of LUTS severity Age effect Rosen R et al. Eur Urol 2003; 44(6):637-49 50 59 years 60 69 years 70 79 years Rosen R et al. Eur Urol 2003;44:637 49 12
Average number of sexual activities per month Reduced sexual activity is strongly associated with LUTS severity Effect of LUTS severity Effect of LUTS severity Effect of LUTS severity Age effect Rosen R et al. Eur Urol 2003; 44(6):637-49 50 59 years 60 69 years 70 79 years Rosen R et al. Eur Urol 2003;44:637 49 13
Impaired sexual function is associated with reduced quality of life Rosen et al Sexual activity is common in a majority of men over age 50 and is an important component of overall quality of life. Because the inability to function sexually can erode an individual s sense of self-esteem and lead to emotional and marital tension, it is not surprising to find that QOL is diminished in men with erectile dysfunction. Althof Fugl-Meyer et al Using factor analytic technique, satisfaction with sexual life was found to be a powerful predictor for satisfaction with life as a whole. Rosen R et al. Eur Urol 2003;44:637 49 Althof SE. Urology 2002;59(6):803 810 Fugl-Meyer AR et al. Int J Impotence Res 1997;9:141 148 14
Partners of men with LUTS due to BPH also experience significant morbidity due to their husband s condition
Partners of men with LUTS due to BPH also experience significant morbidity due to their husband s condition Factors mainly affecting partner s QoL Psychological burden Inadequate sex life Sleep disturbance Disruption in social life* Inability to take care of essential tasks inside and outside the house Fear of prostater cancer Fear of surgery *Significantly correlated with partner s IPSS Mitropoulos D et al. Eur Urol 2002;41:240 45 16
The severity of LUTS can adversely impact important areas of personal relationships Men Spouses with moderate-to-severe of men with enlarged symptoms prostate were also more more likely likely than than those their with husband mild to report symptoms specific to report relationship problems concerns in their as marriage a result of their husband s condition Roehrborn CG et al. Prostate Cancer Prostatic Dis 2006;9:30 4 17
BPH: the future perspective on health impact
Cumulative incidence of progression (%) 4-year cumulative incidence of clinical progression: MTOPS population 25 20 4-year cumulative incidence of clinical progression* = 17% 15 10 5 Disease course in placebo arm of MTOPS** highlights progressive nature of BPH 0 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 Years from randomisation *Clinical progression defined as an increase above base line of 4 points in the AUA symptom score, acute urinary retention, urinary incontinence, renal insufficiency, or recurrent urinary tract infection **MTOPS = Medical Therapy of Prostatic Symptoms study McConnell JD et al. NEJM 2003;349:2387 98 19
Deterioration in symptoms is the most common manifestation of BPH progression 4.5 years mean follow up in MTOPS (Medical Therapy of Prostatic Symptoms study) McConnell JD et al. N Engl J Med 2003;349:2387 98 20
Most men with BPH worry about the potential long-term consequences of their disease Patient concerns with risk for AUR and need for surgery Emberton M et al. Int J Clin Pract 2008; 62: 18 26 21
Men with moderate/severe symptoms have greater risk of AUR - Olmsted County Study Relative risk of AUR (unadjusted) 3.2 relative risk of AUR for men with moderate/severe symptoms compared to 1.0 for those with mild symptoms 40 49 50 59 60 69 70 79 0 7 8+ >12 12 30 >30 Retrospective review of occurence in the subsequent 4 y Age (yrs) AUA-SI Qmax (ml/s) Prostate volume (ml) Jacobsen SJ et al. J Urol 1997;158:481 487 22
The impact of AUR highlights the benefit of reducing the risk of the event occurring Acute urinary retention Pain Pain Short term Financial cost Recurrent hospitalization Likelihood of subsequent surgery Long term Increased risk of complications versus elective procedures Risk for recurrent retention Thomas K et al. BJU Int 2005; 95: 72 761; Roehrborn C. Rev Urol 2005;7(suppl4):S31 S41; Choong S, Emberton M. BJU Int 2000;85:186 201 23
Potential for occurrence of adverse events as outcomes of surgical therapies Median frequency (%) AUA Practice Guidelines Committee. J Urol 2003;170:530 47 24
Summary Initially, the burden of disease in a man with BPH largely reflects the severity of his symptoms Men with moderate LUTS due to BPH may experience a substantial reduction in their quality of life across multiple dimensions In many men the progressive course of BPH raises the prospect of worsening symptoms, as well as AUR and the need for surgery AUR and the need for surgery are of concern to the majority of men with BPH In the short term AUR may result in pain and the need for hospitalization A significant proportion of men presenting with AUR will ultimately require surgery, and the risk of poor outcomes is increased versus elective procedures BPH-related surgery is associated with risk for adverse events 25
Burden of disease in men with moderate LUTS Burden of BPH TODAY TOMORROW Reflects symptom severity and HRQoL impact Reflects disease progression 26
What is the prevalence of BPH in men s fifth decade? 1. 20% 2. 40% 3. 60% CZ/DUTT/0019a/12
Case Report
White male 68 ys old Admitted to Internal Disease Dpt Flatness, fatigue, nausea, sickness, dyspnoea gradually progressing during last several months No serious LUTS, last weeks frequency and sometimes incontinence History uneventful, Surgery for right inguinal hernia 5 ys ago Clinical status signs of pulmonary edema Laboratory findings: kreatinin 582, urea 22,8, K 6,1, mild anemia
Because of elevated kreatinin and K provided dialysis Consequently urological consultation US bilateral hydronephrosis, full bladder with large prostate TRUS prostate 150 ml PSA 9,8 ng/ml F/T 44%
Introduced urinary catheter, residual urine 800 ml, hydronephrosis disappeared Normalization urea, kreatinin Surgery open transvesical prostatectomy 4 weeks later. Pathology report: BPH
BPH several acute indications for surgery, rare cases jeopardizing life This case yes (renal insufficiency, cardiac complications, sepsis ) Prevention: periodic follow up, medication when symptoms, signs of progression, prevention of progression
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