The patient, your co-pilot in assessing LUTS

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1 The patient, your co-pilot in assessing LUTS Frank Van der Aa Leuven, Belgium This symposium is supported by Astellas Pharma Europe Ltd., including speaker honoraria and production of materials the slides are the speakers own. VSO/14/0028/EUd

2 Disclosures Speaker for Astellas, Ipsen, Eli-Lilly and GSK Proctor for Medtronic and AMS

3 Our co-pilot with LUTS can have a variety of symptoms VOIDING SYMPTOMS Hesitancy Intermittency Slow stream Splitting / spraying Straining Terminal dribble STORAGE SYMPTOMS Altered bladder sensation Increased daytime frequency Nocturia Urgency Urinary incontinence POST-MICTURITION SYMPTOMS Feeling of incomplete bladder emptying Post micturition dribble LUTS: lower urinary tract symptoms Abrams P et al. Urology 2003; 61:37-49

4 % of men Coyne KS et al. BJU Int 2009;103 (Suppl 3):4-11; Sexton CC et al. BJU Int 2009;103 (Suppl 3):12-23 LUTS have an impact on QoL EpiLUTS: 14,139 men 40 years old; 71% reported LUTS feeling mostly dissatisfied, unhappy or terrible about their urinary condition 34 with clinical depression with clinical anxiety no LUTS V PM S V+PM S+PM V+S V+S+PM V: voiding; S: storage; PM: post micturition LUTS

5 Bother increases with severity of LUTS BACH survey: Random sample of 2,301 men, years old from the city of Boston 6 5 4,81 Increasing bother 4 3 P < AUA-SI <8 AUA-SI ,54 0 AUA-SI: American Urology Association Symptom Index Kupelian V et al. Arch Intern Med 2006;166:2381-7

6 Concerns of patients about their LUTS PROBE survey: 502 BPH patients indicated their principal concerns about their initial BPH symptoms Fear that it may be cancer Disturbed/interrupted sleep Discomfort Embarrassment of symptoms Frustration with symptoms Impact of symptoms on work/professional life Impact on social activities/life Severe concerns Moderate concerns Affecting relationships None/not relevant % % of patients 6 Adapted from Emberton M et al. Int J Clin Pract 2008;62:18-26

7 Daily management of male LUTS: patient-doctor miscommunication? Ultrasound Prostate Uroflowmetry I am always going to the toilet! Urinalysis X Miscommunication?

8 Patient reported outcomes (PROs) Reports coming directly from patients about how they feel or function in relation to a health condition and its therapy Patrick FL et al. The Cochrane Collaboration, (last accessed March 2014); FDA, 2009: Guidance for Industry: Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

9 PROs for patients with LUTS: numerous options

10 PROs for patients with LUTS: numerous options Quality of life due to urinary symptoms If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that? Delighted Terrible

11 PROs for patients with LUTS: numerous options

12 PROs for patients with LUTS: numerous options

13 PROs for patients with LUTS: numerous options

14 PROs for patients with LUTS: numerous options DAN-PSS UROLIFE MLUTS ContiLife KHQ OAB-q I-QOL LUTS tool and many others

15 Why are PROs important? The reason - the patient Improves care Enhances understanding Understand the effects of treatment on patients (people) From the perspective of patients (people) Improves clinical decision making Offers insight to providers Increases patient understanding of treatment Improves communication between providers and patients Enhances satisfaction with care Dissatisfaction - feedback Improves self-care - compliance

16 Which PRO should you choose? Assessment should be simple Low burden for patient to complete Questionnaire should be Reliable Valid Responsive Useful for communication Common language Interpretable About both symptoms (severity/frequency) and QoL

17 Value of PROs in initial assessment Some aspects of the patient s health can only be provided by the patient This information can improve the diagnostic process and guide towards the right treatment In the past month: 1. Incomplete emptying How often have you had the sensation of not emptying your bladder? 2. Frequency How often have you had to urinate less than every 2 hours? 3. Intermittency How often have you found you stopped and started again several times when you urinated? 4. Urgency How often have you found it difficult to postpone urination? 5. Weak stream How often have you had a weak urinary stream? 6. Straining How often have you had to strain to start urination? 7. Nocturia How many times did you typically get up at night to urinate? Not at all Less than 1 in 5 times Less than half the time About half the time More than half the time Almost always None 1 time 2 times 3 times 4 times 5 times Total IPSS Score 1-7: Mild 8-19: Moderate 20-35: Severe Available at (last accessed March 2014) Your score

18 Mean change in score from baseline to wk 12 Value of PROs during treatment follow up Change in urinary urgency No change Slight improvement (reduction > 0 to <2 episodes) Improvement (reduction 2 episodes) Symptom bother Symptom Bother Coping Concern Sleep Social interaction Coping Concern OAB-q subscales Sleep Social Interaction all comparisons significant at P<0.001 Adapted from Coyne KS et al. J Urol 2006;176:627-32

19 Conclusions LUTS can have a serious impact on QoL Patient reported outcomes (PROs) can help to gain insight in the health-related QoL of your patient are a comprehensive assessment to ensure all symptoms are noted can improve communication with patient enable patients to self-monitor can help to evaluate treatment response

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