CONDUCT study A step further in changing treatment paradigm in BPH
|
|
- Jeremy Jennings
- 6 years ago
- Views:
Transcription
1 CONDUCT study A step further in changing treatment paradigm in BPH CLUJ, , Adriana Stoica, Medical Advisor GSK Toate informa,ile con,nute in aceasta prezentare sunt conforme cu Rezumatul caracteris,cilor produsului Acest material promoţional este des,nat profesioniş,lor din domeniul sănătăţiii
2 CONDUCT study Published on line in January 2015 online free access - Roehrborn CG et al, BJUInt 2015 doi: /bju.13033
3 CONDUCT study geography 1,2 Investigators from which countries contributed to the study 8 countries contributed to the study: 742 patients randomised France, Germany, Greece, Italy, Netherlands, Romania, Spain, United Kingdom 1. Roehrborn CG et al, BJUInt 2015 doi: /bju.13033; 2. CONDUCT study NCT Protocol summary show/nct ?term=conduct+and+dutasteride&rank=1 (accessed )
4 CONDUCT study scheme 1,2 Fixed dose combination of dutasteride and tamsulosin + lifestyle advice Randomisation 1:1 Watchful Waiting with initiation of tamsulosin if symptoms did not improve from baseline (V2) + lifestyle advice V1 V2 (screening) (baseline) V3 (W4) V4 (W13) V9 (W78) V10 (W91) V11 (W104) IPSS, BII score, Patient Perception of Study Treatment measured at each visit If initiated, escalation to tamsulosin 0.4 mg once daily at any visit after Visit 2 would be continued for the remainder of the study unless the subject elected to withdraw prematurely 1. NCT Protocol summary: 2. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju
5 CONDUCT study endpoints 1,2 Primary Endpoint Secondary Endpoints l Change in International prostate symptom score from baseline to Month 24 l Change in BPH Impact Index score from baseline l Change in Question 8 IPSS from baseline l Time to/proportion of subjects with clinical BPH progression l Improvements/change in questions 1 and 2 of the Patient Perception of Study Treatment (PPST) Questionnaire l Safety and tolerability 1. NCT Protocol summary: 2. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju
6 CONDUCT study rationale: adds to existing evidence The CONDUCT study adds to the existing clinical information (CombAT study) on the prescription of combination treatment to patients with moderate BPH at risk of progression 1 CONDUCT 2,3 investigated several areas which benefited from further investigation: l Less symptomatic (moderate) patients l Treatment naive patients l Earlier (4 weeks) fixed dose combination of Dutasteride and Tamsulosin efficacy measurement l Comparison to Watchful Waiting with initiation of tamsulosin if symptoms did not improve 1. Roehrborn CG, Siami P, Barkin J, Damiăo R, Major-Walker K, Nandy I, et al. Eur Urol 2010 Jan;57(1):123-31; 2. NCT Protocol summary: 3. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju
7 Entry criteria (CONDUCT vs CombAT) CONDUCT Eligibility Criteria 1 CombAT Eligibility Criteria 2,3 Age (years) 50 years 50 Total IPSS Total prostate volume (ml) 30 (by TRUS) 30 Total serum PSA 4 (ng/ml) Current or prior treatment related to BPH No current or prior treatment related to BPH Previous 5-ARI use 6 m prior to entry; Previous α-blocker use 2 w prior to entry 1. NCT Protocol summary: 2. Roehrborn CG, Siami P, Barkin J, Damiăo R, Becher E, Miňana B et al. Eur Urol 2009 Feb;55(2):461-71; 3. Roehrborn CG, Siami P, Barkin J, Damiăo R, Major-Walker K, Nandy I, et al. Eur Urol 2010 Jan;57(1):
8 Escalation to tamsulosin in Watchful Waiting with initiation of tamsulosin* group 1 More than a half of patients in Watchful Waiting with initiation of tamsulosin* arm escalated to tamsulosin, with initiation occurring in >50% of cases within the first 6 months 100% Initiation of 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% % % % % % % % % Tamsulosin (if any IPSS measurement shown no improvement or worsening from baseline) No Initiation of Tamsulosin * if symptoms did not improve 1. Roehrborn CG, Warnack W, Perez IO, Roos E, Calomfirescu N, Brotherton B, et al. Eur Urol Suppl Apr 2014;13(1):LBA1, EAU Congress presentation.
9 Efficacy: mean IPSS at each visit Mean IPSS at visit (LOCF*) demonstrates the effect of study treatment arms** on the symptom category (moderate vs mild) throughout the study course 1,2 14 Mean IPSS Fixed dose combination of dutasteride and tamsulosin (n=369) Watchful Waiting with initiation of tamsulosin if symptoms did not improve (n=373) Moderate Mild Months from randomisation *Last observation carried forward **Both treatment arms included lifestyle advice administered 1. NCT Study results: 2. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju
10 Efficacy: mean IPSS at each visit Mean IPSS at visit (LOCF*) demonstrates the effect of study treatment arms** on the symptom category (moderate vs mild) throughout the study course 1,2 14 Mean IPSS Fixed dose combination of dutasteride and tamsulosin (n=369) Watchful Waiting with initiation of tamsulosin if symptoms did not improve (n=373) Moderate Mild Months from randomisation *Last observation carried forward **Both treatment arms included lifestyle advice administered 1. NCT Study results: 2. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju
11 Efficacy: mean IPSS at each visit Mean IPSS at visit (LOCF*) demonstrates the effect of study treatment arms** on the symptom category (moderate vs mild) throughout the study course 1,2 14 Mean IPSS Fixed dose combination of dutasteride and tamsulosin (n=369) Watchful Waiting with initiation of tamsulosin if symptoms did not improve (n=373) Moderate Mild Months from randomisation Combination therapy resulted in shifting of BPH *Last observation carried forward **Both treatment arms included lifestyle advice administered symptom score from moderate to mild category from month 9 onwards 1. NCT Study results: 2. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju
12 Study results: IPSS change Adjusted mean change from baseline in IPSS Fixed dose combination of dutasteride and tamsulosin (n=369)** Watchful Waiting with initiation of tamsulosin if symptoms did not improve (n=373)** 6 9 p< Months from randomisation Patient assessment of improvement thresholds *,3 Slight -1.9 Moderate -4.0 Marked -7.4 *Improvement thresholds were selected for the lower IPSS baseline score (8-19) **Both treatment arms included lifestyle advice administered 1. NCT Study results: 2. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju ; 3. Barry MJ, Williford WO, Chang Y, Machi M, Jones KM, Walker-Corkery E, et al. J Urol 1995 Nov;154(5):
13 Study results: IPSS change Adjusted mean change from baseline in IPSS Fixed dose combination of dutasteride and tamsulosin (n=369)** Watchful Waiting with initiation of tamsulosin if symptoms did not improve (n=373)** 6 9 p< Months from randomisation Patient assessment of improvement thresholds *,3 Slight -1.9 Moderate -4.0 Marked -7.4 Rapid *Improvement symptom thresholds were selected for the lower IPSS baseline score (8-19) improvement with **Both combination treatment therapy arms included lifestyle advice administered (measured at month 1) Superior symptom improvement with combination therapy at each post-baseline visit (p<0.001) vs. Watchful Waiting with initiation of tamsulosin if symptoms did Sustained superiority of fixed dose combination in symptom improvement over 2 years of treatment vs. Watchful Waiting with initiation of tamsulosin if symptoms did not improve 1. NCT Study results: 2. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju not ; improve 3. Barry MJ, Williford WO, Chang Y, Machi M, Jones KM, Walker-Corkery E, et al. J Urol 1995 Nov;154(5):
14 Efficacy: BPH clinical progression CONDUCT Clinical progression events were defined by 1 : A rise in IPSS of 3 points at any visit when compared to Visit 2 (baseline) AUR related to BPH Recurrent (more than one) UTI related to BPH Incontinence (overflow or urge) related to BPH Renal insufficiency related to BPH (a single 50% rise from baseline serum creatinine and a total value 1.5 mg/ dl) 1. NCT Protocol summary:
15 Efficacy: BPH clinical progression 1 Subjects with progression, % Fixed dose combination of dutasteride and tamsulosin** Watchful Waiting with initiation of tamsulosin if symptoms did not improve** Months from randomisation 29% 18% 43.1% relative risk reduction at year 2; (p<0.001) 11.3% absolute risk reduction (risk difference) Number needed to treat: 9 Cumulative number of events/subjects at risk Year 1 Year 2 Fixed dose combination of dutasteride and tamsulosin 48/369 17/276 Watchful Waiting with initiation of tamsulosin if symptoms did not improve 94/373 14/251 *Overall clinical progression events defined by a rise in IPSS of 3 points at any visit when compared to Visit 2 (baseline), AUR related to BPH, UTI related to BPH, Incontinence related to BPH, Renal insufficiency related to BPH. **Both treatment arms included lifestyle advice administered 1. Adapted from Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju
16 Efficacy: BPH clinical progression components 1-3 Fixed dose combination of dutasteride and tamsulosin** (n=369) Watchful Waiting with initiation of tamsulosin*, ** (n=373) Symptom progression (deterioration of IPSS 3) % of subjects with any occurrence (95% CI) 16 (12.5, 20.0) 27 (22.8, 31.9) BPH-related AUR <1 (0.0, 1.7) 3 (1.0, 4.3) BPH-related urinary incontinence 1 (0.0, 2.1) <1 (0.0, 1.7) BPH-related UTI <1 (0.0, 1.3) 2 (0.3, 2.9) BPH-related renal insufficiency 0 <1 (0.0, 0.8) * if symptoms did not improve **Both treatment arms included lifestyle advice administered 1. NCT Study results: 2. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju ; 3. Roehrborn CG, Warnack W, Perez IO, Roos E, Calomfirescu N, Brotherton B, et al. Eur Urol Suppl Apr 2014;13(1):LBA1, EAU Congress presentation.
17 Health outcomes results: BPH Impact Index BPH Impact Index (BII, bother score) decreased in both groups over time and the decrease was significantly greater (p<0.001) at all post-baseline visits in fixed dose combination of dutasteride and tamsulosin treatment arm 1,2,** Adjusted mean change from baseline (LOCF) Fixed dose combination of dutasteride and tamsulosin (n=369) Watchful Waiting with initiation of tamsulosin if symptoms did not improve (n=373) *Improvement thresholds were selected for the lower BII baseline scores (<5) **Both treatment arms included lifestyle advice administered Months from randomisation Patient assessment of improvement thresholds *,3 Moderate -0.7 Marked NCT Study results: 2. Adapted from Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju.13033; 3. Barry MJ, Williford WO, Chang Y, Machi M, Jones KM, Walker-Corkery E, et al. J Urol 1995 Nov;154(5):
18 Health outcomes results: BPH Impact Index BPH Impact Index (BII, bother score) decreased in both groups over time and the decrease was significantly greater (p<0.001) at all post-baseline visits in fixed dose combination of dutasteride and tamsulosin treatment arm 1,2,** Adjusted mean change from baseline (LOCF) Fixed dose combination of dutasteride and tamsulosin (n=369) Watchful Waiting with initiation of tamsulosin if symptoms did not improve (n=373) *Improvement thresholds were selected for the lower BII baseline scores (<5) **Both treatment arms included lifestyle advice administered Months from randomisation Patient assessment of improvement thresholds *,3 Moderate -0.7 Marked NCT Study results: 2. Adapted from Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju.13033; 3. Barry MJ, Williford WO, Chang Y, Machi M, Jones KM, Walker-Corkery E, et al. J Urol 1995 Nov;154(5):
19 Health outcomes results: BPH Impact Index BPH Impact Index (BII, bother score) decreased in both groups over time and the decrease was significantly greater (p<0.001) at all post-baseline visits in fixed dose combination of dutasteride and tamsulosin treatment arm 1,2,** Adjusted mean change from baseline (LOCF) Fixed dose combination of dutasteride and tamsulosin (n=369) Watchful Waiting with initiation of tamsulosin if symptoms did not improve (n=373) *Improvement thresholds were selected for the lower BII baseline scores (<5) **Both treatment arms included lifestyle advice administered Months from randomisation Patient assessment of improvement thresholds *,3 Moderate -0.7 Marked NCT Study results: 2. Adapted from Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju.13033; 3. Barry MJ, Williford WO, Chang Y, Machi M, Jones KM, Walker-Corkery E, et al. J Urol 1995 Nov;154(5):
20 Health outcomes results: BPH Impact Index BPH Impact Index (BII, bother score) decreased in both groups over time and the decrease was significantly greater (p<0.001) at all post-baseline visits in fixed dose combination of dutasteride and tamsulosin treatment arm 1,2,** Adjusted mean change from baseline (LOCF) Fixed dose combination of dutasteride and tamsulosin (n=369) Watchful Waiting with initiation of tamsulosin if symptoms did not improve (n=373) *Improvement thresholds were selected for the lower BII baseline scores (<5) **Both treatment arms included lifestyle advice administered Months from randomisation Patient assessment of improvement thresholds *,3 Moderate -0.7 Marked NCT Study results: 2. Adapted from Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju.13033; 3. Barry MJ, Williford WO, Chang Y, Machi M, Jones KM, Walker-Corkery E, et al. J Urol 1995 Nov;154(5):
21 Health outcomes results: BPH Impact Index BPH Impact Index (BII, bother score) decreased in both groups over time and the decrease was significantly greater (p<0.001) at all post-baseline visits in fixed dose combination of dutasteride and tamsulosin treatment arm 1,2,** Adjusted mean change from baseline (LOCF) Fixed dose combination of dutasteride and tamsulosin (n=369) Watchful Waiting with initiation of tamsulosin if symptoms did not improve (n=373) *Improvement thresholds were selected for the lower BII baseline scores (<5) **Both treatment arms included lifestyle advice administered Months from randomisation Patient assessment of improvement thresholds *,3 Moderate -0.7 Marked NCT Study results: 2. Adapted from Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju.13033; 3. Barry MJ, Williford WO, Chang Y, Machi M, Jones KM, Walker-Corkery E, et al. J Urol 1995 Nov;154(5):
22 Health outcomes results: BPH Impact Index BPH Impact Index (BII, bother score) decreased in both groups over time and the decrease was significantly greater (p<0.001) at all post-baseline visits in fixed dose combination of dutasteride and tamsulosin treatment arm 1,2,** Adjusted mean change from baseline (LOCF) Fixed dose combination of dutasteride and tamsulosin (n=369) Watchful Waiting with initiation of tamsulosin if symptoms did not improve (n=373) *Improvement thresholds were selected for the lower BII baseline scores (<5) **Both treatment arms included lifestyle advice administered Months from randomisation Patient assessment of improvement thresholds *,3 Moderate -0.7 Marked NCT Study results: 2. Adapted from Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju.13033; 3. Barry MJ, Williford WO, Chang Y, Machi M, Jones KM, Walker-Corkery E, et al. J Urol 1995 Nov;154(5):
23 Health outcomes results: BPH Impact Index BPH Impact Index (BII, bother score) decreased in both groups over time and the decrease was significantly greater (p<0.001) at all post-baseline visits in fixed dose combination of dutasteride and tamsulosin treatment arm 1,2,** Adjusted mean change from baseline (LOCF) Fixed dose combination of dutasteride and tamsulosin (n=369) Watchful Waiting with initiation of tamsulosin if symptoms did not improve (n=373) *Improvement thresholds were selected for the lower BII baseline scores (<5) **Both treatment arms included lifestyle advice administered Months from randomisation Patient assessment of improvement thresholds *,3 Moderate -0.7 Marked NCT Study results: 2. Adapted from Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju.13033; 3. Barry MJ, Williford WO, Chang Y, Machi M, Jones KM, Walker-Corkery E, et al. J Urol 1995 Nov;154(5):
24 Health outcomes results: Question 8 of IPSS Question 8 of IPSS score decreased in both groups over time and the decrease was significantly greater (p<0.001) at all post-baseline visits in fixed dose combination of dutasteride and tamsulosin treatment arm 1,2 Adjusted mean change from baseline (LOCF) Fixed dose combination of dutasteride and tamsulosin (n=369)* Watchful Waiting with initiation of tamsulosin if symptoms did not improve (n=373)* Months from randomisation *Both treatment arms included lifestyle advice administered NCT Study results: 2. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju
25 Extent of exposure and summary of adverse events (AEs) after randomisation CONDUCT 1 Safety was monitored in all subjects Fixed dose combination of dutasteride and tamsulosin (n=369)** Watchful Waiting with initiation of tamsulosin (n=229)** Subjects, n (%) Years of subject exposure* Any AE 190 (51) 95 (41) Drug-related AE 87 (24) 23 (10) Any serious AE (SAE) 38 (10) 19 (8) AE leading to discontinuation of study drug AE leading to withdrawal from study 27 (7) 11 (5) 27 (7) 11 (5) Any fatal AE 0 2 (<1) * *Fatal SAEs were not related to treatment **Both treatment arms included lifestyle advice administered 1. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju
26 Drug-related AEs (in 2% subjects) CONDUCT 1 Fixed dose combination of dutasteride and tamsulosin (n=369)* Watchful Waiting with initiation of tamsulosin (n=229)* Subjects, n (%) Any drug-related AE 87 (24) 23 (10) Erectile dysfunction 29 (8) 0 Retrograde ejaculation 18 (5) 9 (4) Dizziness 9 (2) 4 (2) Decreased libido 9 (2) 0 Ejaculation disorder 6 (2) 0 Loss of libido 6 (2) 0 Vertigo 6 (2) 0 Drug-related AEs affecting sexual function were reported by subjects during the first 6 months of therapy then incidence of sexual adverse events diminished over the course of treatment. 1. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju *Both treatment arms included lifestyle advice administered
27 Non-fatal SAEs (reported in 2 subjects) CONDUCT 1 Fixed dose combination of dutasteride and tamsulosin (n=369)* Watchful Waiting with initiation of tamsulosin (n=229)* Subjects, n (%) Any non-fatal SAE 38 (10) 19 (8) Atrial fibrillation 4 (1) 2 (<1) Respiratory tract infection 1 (<1) 2 (<1) Cellulitis 2 (<1) 0 Diverticulitis 0 1 (<1) Inguinal hernia 2 (<1) 0 Presyncope 2 (<1) 0 Prostatitis 1 (<1) 1 (<1) Colon cancer 0 2 (<1) Prostate cancer 0 1 (<1) 1. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju *Both treatment arms included lifestyle advice administered
28 CONDUCT study: safety profile of Duodart was consistent with previous evidence 1,2 The safety profile of Duodart remained consistent with other studies and post-marketing experience. The most frequently reported AEs in both primary treatment groups were erectile dysfunction and retrograde ejaculation No subject in the DUODART group was diagnosed with prostate cancer No breast cancer cases were reported Cardiovascular events: The overall proportion of subjects with any cardiovascular AEs of special interest was similar between the DUODART and the Watchful Waiting with initiation of tamsulosin if symptoms did not improve groups (1.9% vs. 1.6%) No unexpected adverse events No fatal SAEs were reported in the DUODART group. Three subjects experienced fatal SAEs in the Watchful Waiting with initiation of tamsulosin if symptoms did not improve group* *Both treatment arms included lifestyle advice administered 1. NCT Study results: 2. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju
29 CONDUCT results: summary 1,2 Duodart is superior vs. Watchful Waiting with initiation of tamsulosin if symptoms did not improve* in symptom reduction Duodart resulted in greater (p<0.001) symptom improvement from 1st month out to 2 years in BPH patients with moderate symptoms and at risk of progression 1. NCT Study results: 2. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju *Both treatment arms included lifestyle advice administered 29
30 CONDUCT results: summary 1,2 Duodart is superior vs. Watchful Waiting with initiation of tamsulosin if symptoms did not improve* in improving QoL outcomes Duodart provided a superior improvement in QoL outcomes (BPH Impact Index and IPSS Q8) at all post-baseline visits (p<0.001) 1. NCT Study results: 2. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju *Both treatment arms included lifestyle advice administered
31 CONDUCT results: summary 1,2 Duodart is superior vs. Watchful Waiting with initiation of tamsulosin if symptoms did not improve* in reducing clinical progression Duodart significantly reduced the risk of BPH clinical progression over a 2-year period (p<0.001) 43.1% relative risk reduction 11.3% absolute risk reduction Number needed to treat: 9 1. NCT Study results: 2. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju *Both treatment arms included lifestyle advice administered
32 CONDUCT results: summary 1,2 CONDUCT Study Compliments CombAT data Evaluated BPH patients at risk of progression with only moderate symptoms and naïve to treatment 1. NCT Study results: 2. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju
33 CONDUCT results: summary 1,2 CONDUCT Study Consistent safety profile The safety profile of Duodart was consistent with other studies and post-marketing experience 1. NCT Study results: 2. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju
34 CONDUCT results: summary 1,2 CONDUCT Study Supports first line use CONDUCT data supports first line use of Duodart in BPH patients with moderate symptoms and at risk of progression 1. NCT Study results: 2. Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. BJU Int 2015 Jan doi: /bju
35 EAU LUTS Guidelines support first-line medical treatment decision based on patient s symptoms and risk of BPH progression Male LUTS (without indications for surgery) No Bothersome symptoms? Yes No Nocturnal polyuria predominant Yes No Storage symptoms predominant Yes No Prostate volume >40 ml? Yes Education + lifestyle advice with or without α 1 -blocker No Long-term treatment? Residual storage symptoms Yes Watchful waiting with or without education + lifestyle advice Add muscarnic receptor antagonist Education+ lifestyle advice with or without 5-ARI ± α 1 -blocker/ PDE5I Education + lifestyle advice with or without muscarinic antagonist Gravas et al. Guidelines on management of male LUTS, incl. BPO (2014). Guidelines_2014_30_April_2014.pdf (Accessed February 2015) Education + lifestyle advice with or without vasopressin analogue
36 CONDUCT study results: new evidence to support initial treatment with combination dutasteride and tamsulosin in patients with moderate BPH symptoms at risk of progression
37 Thank You
38 Informaţiile complete de prescriere a produselor GSK sunt disponibile la cerere. Produs eliberat pe bază de prescripţie medicala (P-RF) Evenimentele adverse trebuie raportate la biroul local GSK sau ANMDM. GlaxoSmithKline S.R.L. Opera Center One, str. Costache Negri nr. 1-5, et 5 şi 6 (zona 1), Cod , sector 5, Bucureşti, România Tel; , Fax: farmacovigilenta.romania@gsk.com; medical.ro@gsk.com
39 International prostate symptom score (IPSS) Patient assessment of improvement thresholds Clinical significance (patient global ratings of improvement) of changes in IPSS: Pt. Assessment of Improvement 0 35 Baseline Score Mean Absolute Change Scores ± SEM 8 19 (Moderate) Baseline Score Mean Absolute Change Scores ± SEM (Severe) Baseline Score Mean Absolute Change Scores ± SEM Marked -8.8 ± ± ± 0.76 Moderate -5.1 ± ± ± 0.62 Slight -3.0 ± ± ± 0.54 None -0.7 ± ± ± 0.62 Worse +2.7 ± ± ± 1.79 Thresholds relevant to CombAT study Adapted from Barry MJ et al. J Urol 1995;154(5): Thresholds relevant to CONDUCT study
The Evolution of Combination Therapy. US men eligible for BPH treatment * with projected population changes
The Management of BPH & The Impact of Combination Therapy Results Combination of Avodart and Tamsulosin (CombAT) Medical Therapy of Prostate Symptoms (MTOPS) Dr. Jack Barkin, md, fics, facs, dabu, Mcert
More informationIncreasing Awareness, Diagnosis, and Treatment of BPH, LUTS, and EP
Introduction to Enlarged Prostate E. David Crawford, MD Professor of Surgery (Urology) and Radiation Oncology Head, Urologic Oncology E. David Crawford Endowed Chair in Urologic Oncology University of
More informationBPH: a present and future perspective on health impact
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
More informationBenign Prostatic Hyperplasia (BPH) Important Papers / Landmark. Vijayan Manogran
Benign Prostatic Hyperplasia (BPH) Important Papers / Landmark Studies Vijayan Manogran MTOPS & CombAT PLESS SMART ALTESS ALF-ONE VA PREDICT EPICS Landmark Studies MTOPS Medical Therapy of Prostatic Symptoms
More informationLiterature Scan: Drugs for BPH
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationBenign Prostatic Hyperplasia. Jay Lee, MD, FRCSC Clinical Associate Professor University of Calgary
Benign Prostatic Hyperplasia Jay Lee, MD, FRCSC Clinical Associate Professor University of Calgary Copyright 2017 by Sea Courses Inc. All rights reserved. No part of this document may be reproduced, copied,
More informationOverview. Urology Dine and Learn: Erectile Dysfunction & Benign Prostatic Hyperplasia. Iain McAuley September 15, 2014
Urology Dine and Learn: Erectile Dysfunction & Benign Prostatic Hyperplasia Iain McAuley September 15, 2014 Overview Review of the most recent guidelines for ED and BPH ED Guidelines CUA 2006 AUA 2011
More informationThe Journal of International Medical Research 2012; 40:
The Journal of International Medical Research 2012; 40: 899 908 Comparison of α-blocker Monotherapy and α-blocker Plus 5α-Reductase Inhibitor Combination Therapy Based on Prostate Volume for Treatment
More informationAs man draws near the common goal Can anything be sadder Than he who, master of his soul Is servant to his bladder LUTS 2. Prevalence of BPH LUTS 5
BPH / LUTS Dr Jonny Coxon MA MD MRCS MRCGP DRCOG Beaconsfield Medical Practice, Brighton As man draws near the common goal Can anything be sadder Than he who, master of his soul Is servant to his bladder
More informationBPH / LUTS. Prevalence. Prevalence of BPH. It is abnormal NOT to have benign growth of the prostate with increasing age. Prevalence.
BPH / LUTS Dr Jonny Coxon MA MD MRCS MRCGP DRCOG FECSM Beaconsfield Medical Practice, Brighton & Brighton & Sussex Universities NHS Trust As man draws near the common goal Can anything be sadder Than he
More informationClinicalTrials.gov Identifier: sanofi-aventis. Sponsor/company:
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: sanofi-aventis ClinicalTrials.gov
More informationα-blocker Monotherapy and α-blocker Plus 5-Alpha-Reductase Inhibitor Combination Treatment in Benign Prostatic Hyperplasia; 10 Years Long-Term Results
www.kjurology.org http://dx.doi.org/10.4111/kju.2012.53.4.248 Voiding Dysfunction α-blocker Monotherapy and α-blocker Plus 5-Alpha-Reductase Inhibitor Combination Treatment in Benign Prostatic Hyperplasia;
More informationThe population of subjects which was statistically analyzed was the Intent-to-Treat population
Study No.: ARIB3003 (Year 1) Title: A Randomized, Double-Blind, Placebo-Controlled, Two-Year Parallel-Group Study of the Efficacy and Safety of GI198745 in the Treatment and Modification of Progression
More informationManagement of LUTS. Simon Woodhams February 2012
Management of LUTS Simon Woodhams February 2012 The management of lower urinary tract symptoms (LUTS) in men Implementing NICE guidance May 2010 NICE clinical guideline 97 Background Lower urinary tract
More informationGUIDELINES ON NON-NEUROGENIC MALE LUTS INCLUDING BENIGN PROSTATIC OBSTRUCTION (BPO)
GUIDELINES ON NON-NEUROGENIC MLE LUTS INCLUDING BENIGN PROSTTIC OBSTRUCTION (BPO) (Text update pril 2014) S. Gravas (chair),. Bachmann,. Descazeaud, M. Drake, C. Gratzke, S. Madersbacher, C. Mamoulakis,
More informationGUIDELINES ON NON-NEUROGENIC MALE LUTS INCLUDING BENIGN PROSTATIC OBSTRUCTION
GUIDELINES ON NON-NEUROGENIC MLE LUTS INCLUDING BENIGN PROSTTIC OBSTRUCTION (Text update March 2015) S. Gravas (Chair), T. Bach,. Bachmann, M. Drake, M. Gacci, C. Gratzke, S. Madersbacher, C. Mamoulakis,
More informationAlpha-BlockerTherapy Can Be Withdrawn in the Majority of Men Following Initial CombinationTherapy with the Dual 5a-Reductase Inhibitor Dutasteride
European Urology European Urology 44 (2003) 461 466 Alpha-BlockerTherapy Can Be Withdrawn in the Majority of Men Following Initial CombinationTherapy with the Dual 5a-Reductase Inhibitor Dutasteride J.
More informationLUTS after TURP: How come and how to manage? Matthias Oelke
LUTS after TURP: How come and how to manage? Matthias Oelke Department of Urology Global Congress on LUTD, Rome, 26 th June 2015 Disclosures Consultant, speaker, trial participant and/or research grants
More informationConclusion. Keywords. The Authors BJU Int 2015; 116:
Efficacy and safety of a fixed-dose combination of dutasteride and tamsulosin treatment (Duodart ) compared with watchful waiting with initiation of tamsulosin therapy if symptoms do not improve, both
More informationDiagnostic approach to LUTS in men. Prof Dato Dr. Zulkifli Md Zainuddin Consultant Urologist / Head Of Urology Unit UKM Medical Center
Diagnostic approach to LUTS in men Prof Dato Dr. Zulkifli Md Zainuddin Consultant Urologist / Head Of Urology Unit UKM Medical Center Classification of LUTS Storage symptoms Voiding symptoms Post micturition
More informationBenign Prostatic Hyperplasia (BPH):
Benign Prostatic Hyperplasia (BPH): Evidence Based Guidelines for Primary Care Providers Jeanne Martin, DNP, ANP-BC Objectives 1. Understand the pathophysiology and prevalence of BPH 2. Select the appropriate
More informationNational Institute for Health and Care Excellence. Lower Urinary Tract Symptoms Update Addendum Consultation Table 3 rd February 5 pm 3 rd March 2015
British Association of Urological Surgeons British Association of Urological Surgeons National Institute for Health and Care Excellence Lower Urinary Tract Symptoms Update Addendum Consultation Table 3
More informationTreating BPH: Comparing Rezum UroLift and HoLEP
Treating BPH: Comparing Rezum UroLift and HoLEP Scott M. Cheney MD Mayo Clinic Arizona 2018 MFMER slide-1 Welcome to AZ 2018 MFMER slide-2 Outline Background on BPH, Rezum, Urolift, HoLEP AUA Guideline
More informationEAU GUIDELINES ON NON- NEUROGENIC MALE LUTS INCLUDING BENIGN PROSTATIC OBSTRUCTION
EAU GUIDELINES ON NON- NEUROGENIC MALE LUTS INCLUDING BENIGN PROSTATIC OBSTRUCTION (Limited text update March 2016) S. Gravas (Chair), T. Bach, A. Bachmann, M. Drake, M. Gacci, C. Gratzke, S. Madersbacher,
More informationVOIDING DYSFUNCTION IN ELDERLY MALE CURRENT STATUS
VOIDING DYSFUNCTION IN ELDERLY MALE CURRENT STATUS DR. FRANCIS LEE Voiding dysfunction Storage Emptying Common voiding dysfunction in elderly male Emptying BPH Storage Incontinence Overactive bladder Post-prostatectomy
More informationTherapeutic Strategies for Managing BPH Progression
european urology supplements 5 (2006) 997 1003 available at www.sciencedirect.com journal homepage: www.europeanurology.com Therapeutic Strategies for Managing BPH Progression John M. Fitzpatrick a, *,
More informationEAU GUIDELINES ON NON- NEUROGENIC MALE LUTS INCLUDING BENIGN PROSTATIC OBSTRUCTION
EAU GUIDELINES ON NON- NEUROGENIC MALE LUTS INCLUDING BENIGN PROSTATIC OBSTRUCTION (Text update March 2017) S. Gravas (Chair), T. Bach, M. Drake, M. Gacci, C. Gratzke, T.R.W. Herrmann, S. Madersbacher,
More informationEuropean Healthcare Innovation Leadership Network
MAY 2008 The Value Proposition of Medicines to Treat Benign Prostatic Hyperplasia: Introduction The following case study examines the evolution of Avodart, a drug manufactured by GSK that is currently
More informationAlpha antagonists from initial concept to routine clinical practice
european urology 50 (2006) 635 642 available at www.sciencedirect.com journal homepage: www.europeanurology.com Editorial 50th Anniversary Alpha antagonists from initial concept to routine clinical practice
More informationThe Enlarged Prostate Symptoms, Diagnosis and Treatment
The Enlarged Prostate Symptoms, Diagnosis and Treatment MAC00031-01 Rev G Financial support for this seminar has been provided by NeoTract, Inc., the manufacturer of the UroLift System. 1 Today s Agenda
More informationLast Review Status/Date: December Summary
Section: Surgery Effective Date: January 15, 2016 Subject: Prostatic Urethral Lift Page: 1 of 9 Last Review Status/Date: December 2015 Summary Benign prostatic hyperplasia (BPH) is a common condition in
More informationEvaluation of Recent Trends in Treatment Patterns Among Men With Benign Prostatic Hyperplasia
469245JMHXXX10.1177/1557988312469245A merican Journal of Men s HealthKruep et al. Article Evaluation of Recent Trends in Treatment Patterns Among Men With Benign Prostatic Hyperplasia American Journal
More informationLower Urinary Tract Symptoms (LUTS) and Nurse-Led Clinics. Sean Diver Urology Advanced Nurse Practitioner candidate Letterkenny University Hospital
Lower Urinary Tract Symptoms (LUTS) and Nurse-Led Clinics Sean Diver Urology Advanced Nurse Practitioner candidate Letterkenny University Hospital 01/02/2018 Lower Urinary Tract Symptoms LUTS - one of
More informationH6D-MC-LVHR Clinical Study Report Synopsis Page LVHR Synopsis (LY450190)
H6D-MC-LVHR Clinical Study Report Synopsis Page 1 2. LVHR Synopsis H6D-MC-LVHR Clinical Study Report Synopsis Page 2 Clinical Study Report Synopsis: Study H6D-MC-LVHR Title of Study: A Randomized, Double-Blind,
More informationVoiding Dysfunction. Hyo Serk Lee, Sae Woong Kim 1, Seung-June Oh 2, Myung-Soo Choo 3, Kyu-Sung Lee
www.kjurology.org http://dx.doi.org/10.4111/kju.2012.53.3.178 Voiding Dysfunction Efficacy and Safety of Tamsulosin for Treating Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia:
More informationBenign Prostatic Hyperplasia: Update on Innovative Current Treatments
Benign Prostatic Hyperplasia: Update on Innovative Current Treatments Michael Ferrandino, MD As.soc Professor Director of Minimally Invasive Urologic Surgery Division of Urologic Surgery Duke University
More informationMale Lower Urinary Tract Symptoms: Management in primary care and beyond. Daniel Cohen PhD FRCS(Urol) Consultant Urological Surgeon
Male Lower Urinary Tract Symptoms: Management in primary care and beyond Daniel Cohen PhD FRCS(Urol) Consultant Urological Surgeon 1 LUTS Very common: 1/3 men over age of 50 have moderate to severe LUTS
More informationSexual dysfunction in male LUTS. M. Gacci Department of Urology, University of Florence
Sexual dysfunction in male LUTS M. Gacci Department of Urology, University of Florence Roma, 25-26 June, 2015 Cross-sectional population-based study of 4800 men (40 79 yr of age) UK, Netherlands, France,
More informationEVALUATION OF THE EFFICACY OF TADALAFIL IN IMPROVING LOWER URINARY TRACT SYMPTOMS IN PATIENTS WITH SYMPTOMATIC BENIGN PROSTATIC ENLARGEMENT
Basrah Journal Of Surgery EVALUATION OF THE EFFICACY OF TADALAFIL IN IMPROVING LOWER URINARY TRACT SYMPTOMS IN PATIENTS WITH SYMPTOMATIC BENIGN PROSTATIC ENLARGEMENT MB, ChB, FIBMS, Assistant Professor
More informationRecommended drug treatment of BPH in primary care Claire Taylor MRCS, Charlotte Foley MRCS and Roger Kirby MA, MD, FRCS Urol
Drug review BPH Recommended drug treatment of BPH in primary care Claire Taylor MRCS, Charlotte Foley MRCS and Roger Kirby MA, MD, FRCS Urol Skyline Imaging Ltd The development of safe and effective drugs
More informationEvaluation of Sexual Dysfunction in Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia Patients
Original Article Print ISSN: 2321-6379 Online ISSN: 2321-595X DOI: 10.17354/ijss/2018/10 Evaluation of Sexual Dysfunction in Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia Patients N. Narayanamoorthy,
More informationIntroduction. Keywords Benign prostatic hyperplasia BPH Impact Index Dutasteride Lower urinary tract symptoms Tamsulosin Watchful waiting
DOI.7/s345-6-884-5 ORIGINAL ARTICLE Can we use baseline characteristics to assess which men with moderately symptomatic benign prostatic hyperplasia at risk of progression will benefit from? A post hoc
More informationj 727
Efficacy and Safety of the Coadministration of Tadalafil Once Daily with Finasteride for 6 Months in Men with Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia
More informationMMM. Topic The use of Tadalafil 5mg daily for the treatment of BPH-LUTS
Dr Tan & Partners MMM Vol. 1 No. 1 Morbidity & Mortality Meeting 14 th November 2014 Introduction Topic The use of Tadalafil 5mg daily for the treatment of BPH-LUTS Tadalafil 5mg daily is a well established
More informationISSN: (Print) (Online) Journal homepage:
Archives of Andrology Journal of Reproductive Systems ISSN: 0148-5016 (Print) (Online) Journal homepage: http://www.tandfonline.com/loi/iaan19 CHANGE IN INTERNATIONAL PROSTATE SYMPTOM SCORE AFTER TRANSURETHRAL
More informationCombination Drug Therapy for Benign Prostatic Hyperplasia (BPH)
The Annals of African Surgery www.sskenya.org Combination Drug Therapy for Benign Prostatic Hyperplasia (BPH) Author: Oliech J.S. FRCS, Affiliation: Department of Surgery, University of Nairobi. P.O. Box
More informationWhat can the primary care physician do? Brian W. Ellis
What can the primary care physician do? Brian W. Ellis Consultant Urological Surgeon at Ashford & St Peter s 1983-2007 Currently Consultant Urological Surgeon at Cobham Hospital Visiting Professor at Middlesex
More informationMonth/Year of Review: May 2014 Date of Last Review: November 2012 Source Document: OSU College of Pharmacy
Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35, Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119 Copyright 2012 Oregon State University. All Rights
More informationLUTS in the modern era. Dr Jon Rees Tyntesfield Medical Group
LUTS in the modern era Dr Jon Rees Tyntesfield Medical Group In the past! Man with urinary symptoms = PROSTATISM Prostatism = TURP TURP unsuccessful = REDO TURP Redo TURP unsuccessful = can t help you!
More informationMANAGING BENIGN PROSTATIC HYPERTROPHY IN PRIMARY CARE DR GEORGE G MATHEW CONSULTANT FAMILY PHYSICIAN FELLOW IN SEXUAL & REPRODUCTIVE HEALTH
MANAGING BENIGN PROSTATIC HYPERTROPHY IN PRIMARY CARE DR GEORGE G MATHEW CONSULTANT FAMILY PHYSICIAN FELLOW IN SEXUAL & REPRODUCTIVE HEALTH INTRODUCTION (1) Part of male sexual reproductive organ Size
More informationGuideline for the primary care management of male lower urinary tract symptoms
review Article GUIDELINES FOR LUTS M.J. SPEAKMAN et al. As my Comment in the first section of the journal suggested, the MTOPS results have offered the possibility to general practitioners of reducing
More informationOffice based non-oncology urology trials Richard W. Casey, MD, 1 Jack Barkin, MD 2
Office based non-oncology urology trials Richard W. Casey, MD, 1 Jack Barkin, MD 2 1 The Male Health Centre, Oakville, Ontario, Canada 2 Humber River Regional Hospital, University of Toronto, Toronto,
More informationManaging lower urinary tract symptoms in men
Managing lower urinary tract symptoms in men MacKenzie KR, Aning JJ. Managing lower urinary tract symptoms in men. Practitioner 6; 6(79):-6 Mr Kenneth R MacKenzie MBChB MRCS (Ed) Core Trainee in Urology
More informationCurrent drug management of BPH in primary care Claire Taylor MRCS, Charlotte Foley MRCS and Roger Kirby MA, MD, FRCS Urol
Drug review BPH Current drug management of BPH in primary care Claire Taylor MRCS, Charlotte Foley MRCS and Roger Kirby MA, MD, FRCS Urol Skyline Imaging Ltd The range of drug treatments for BPH, alone
More informationCorrespondence should be addressed to Yoshinori Tanaka;
Hindawi Advances in Urology Volume 2017, Article ID 4842025, 6 pages https://doi.org/10.1155/2017/4842025 Clinical Study The Persistence of Silodosin Monotherapy and the Reasons for Withdrawal from Treatment
More informationKey words: Lower Urinary Tract Symptoms (LUTS), Prostatic Hyperplasia, Alpha-1 Adrenoceptor Antagonists, Tamsulosin, Terazosin.
The Professional Medical Journal DOI: 10.17957/TPMJ/17.4102 ORIGINAL PROF-4102 PROSTATIC HYPERPLASIA; COMPARISON BETWEEN TAMSULOSIN AND TERAZOSIN FOR EFFICACY IN MEDICAL MANAGEMENT OF LOWER URINARY TRACT
More informationBenign Prostatic Hypertrophy (BPH) is the most
Medical treatment of benign prostatic hypertrophy There is little doubt that medical therapy has transformed the treatment of benign prostatic hypertrophy (BPH). The medical treatment of BPH continues
More informationEjaculation. Emission. Ejection. Orgasm
Ejaculation Emission Ejection Orgasm Ejaculation sc T10-L2 S2-4 Emission: vas deferens, prostate, bladder neck Post. Urethra distention Ejection: Pelvic Floor / bulbocavernous muscle contraction Orgasm:
More informationResults. Conclusion. Keywords
A prospective randomised placebo-controlled study of the impact of dutasteride/tamsulosin combination therapy on sexual function domains in sexually active men with lower urinary tract symptoms (LUTS)
More informationThe Egyptian Journal of Hospital Medicine (January 2019) Vol. 74 (6), Page
The Egyptian Journal of Hospital Medicine (January 2019) Vol. 74 (6), Page 1377-1386 Evaluation of Silodosin in Comparison to Tamuslosin in Treatment of Benign Prostatic Hyperplasia with lower Urinary
More informationProstatic Urethral Lift
Protocol Prostatic Urethral Lift (701151) Medical Benefit Effective Date: 04/01/18 Next Review Date: 01/19 Preauthorization No Review Dates: 05/17, 01/18 Preauthorization is not required. The following
More informationNATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Centre for Clinical Practice Surveillance Programme
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Centre for Clinical Practice Surveillance Programme Clinical guideline CG97: The management of lower urinary tract symptoms in men Publication date May
More informationProstatic Urethral Lift. Summary
Section: Surgery Effective Date: January 15, 2017 Subject: Prostatic Urethral Lift Page: 1 of 10 Last Review Status/Date: December 2016 Prostatic Urethral Lift Summary Benign prostatic hyperplasia (BPH)
More informationManagement of Voiding Problems in Older Men. Dr. John Fenn Consultant, QEH 10 th October, 2005
Management of Voiding Problems in Older Men Dr. John Fenn Consultant, QEH 10 th October, 2005 Voiding Problems Poor stream Hesitancy Straining Incomplete emptying Intermittent micturition Terminal dribbling
More information50% of men. 90% of men PATIENT FACTSHEET: BPH CONDITION AND TREATMENTS. Want more information? What are the symptoms?
PATIENT FACTSHEET: BPH CONDITION AND TREATMENTS What is Benign Prostatic Hyperplasia (enlarged prostate)? Benign prostatic hyperplasia (BPH) is a noncancerous enlargement of the prostate, the gland that
More informationNOTE: This policy is not effective until April 1, Transurethral Water Vapor Thermal Therapy of the Prostate
NOTE: This policy is not effective until April 1, 2019. Medical Policy Manual Surgery, Policy No. 210 Transurethral Water Vapor Thermal Therapy of the Prostate Next Review: December 2019 Last Review: December
More informationConsensus Meeting for Asian-Pacific BPH Guideline
Consensus Meeting for Asian-Pacific BPH Guideline Byung Ha Chung Yonsei University Health System S a t e l l i t e S y m p o s i u m I Contents Diagnosis and Treatment Guidelines for BPH Prostate Volume
More informationIJBCP International Journal of Basic & Clinical Pharmacology
Print ISSN: 2319-2003 Online ISSN: 2279-0780 IJBCP International Journal of Basic & Clinical Pharmacology DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20172721 Original Research Article Patient-reported
More informationSystematic Review of Combination Drug Therapy for Non-neurogenic Male Lower Urinary Tract Symptoms
EUROPEAN UROLOGY 64 (2013) 228 243 available at www.sciencedirect.com journal homepage: www.europeanurology.com Platinum Priority Collaborative Review Benign Prostatic Hyperplasia Editorial by Herbert
More informationPROSTATIC EMBOLIZATION FOR BENIGN HYPERPLASIA
St. Louis Hospital PROSTATIC EMBOLIZATION FOR BENIGN HYPERPLASIA INITIAL CLINICAL RESULTS Faculty of Medical Sciences New University of Lisbon JOÃO PISCO LUÍS CAMPOS PINHEIRO TIAGO BILHIM HUGO RIO TINTO
More informationProstate Cancer Screening: Risks and Benefits across the Ages
Prostate Cancer Screening: Risks and Benefits across the Ages 7 th Annual Symposium on Men s Health Continuing Progress: New Gains, New Challenges June 10, 2009 Michael J. Barry, MD General Medicine Unit
More informationJMSCR Vol 05 Issue 07 Page July 2017
www.jmscr.igmpublication.org Impact Factor 5.84 Index Copernicus Value: 83.27 ISSN (e)-2347-176x ISSN (p) 2455-0450 DOI: https://dx.doi.org/10.18535/jmscr/v5i7.47 Original Research Article Tadalafil therapy
More informationL ower urinary tract symptoms (LUTS) are a major health problem and are prevalent in men aged.45 years1 3.
OPEN SUBJECT AREAS: UROGENITAL DISEASES DRUG DEVELOPMENT Received 23 October 2013 Accepted 15 January 2014 Published 4 February 2014 Correspondence and requests for materials should be addressed to P.H.
More informationProstate Cancer and BPH Management Revolutionised. Marc Laniado MD FEBU FRCS(Urol)! Consultant Urologist
Prostate Cancer and BPH Management Revolutionised Marc Laniado MD FEBU FRCS(Urol)! Consultant Urologist Prostate cancer is common and causes death worldwide Prostate Cancer BPH incidence by Age 2 Conventional
More informationLONG-TERM SAFETY AND EFFICACY OF TAMSULOSIN FOR THE TREATMENT OF LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA
0022-5347/03/1702-0498/0 Vol. 170, 498 502, August 2003 THE JOURNAL OF UROLOGY Printed in U.S.A. Copyright 2003 by AMERICAN UROLOGICAL ASSOCIATION DOI: 10.1097/01.ju.0000076140.68657.fd LONG-TERM SAFETY
More informationMedical Coverage Policy Prostatic Urethral Lifts
Medical Coverage Policy Prostatic Urethral Lifts EFFECTIVE DATE:12 01 2018 POLICY LAST UPDATED: 10 03 2017 OVERVIEW Benign prostatic hyperplasia is a common condition in older men that can lead to increased
More informationIntroduction. Original Article: Clinical Investigation
International Journal of Urology (2015) 22, 582--587 doi: 10.1111/iju.12741 Original Article: Clinical Investigation Treatment satisfaction and clinically meaningful symptom improvement in men with lower
More informationEAU meeting report March 2016 Munich, Germany
EAU meeting report 11-15 March 2016 Munich, Germany 2 EAU meeting report 11-15 March 2016 Munich, Germany At this year s European Association of Urology (EAU) in Munich there were around 13,000 participants
More informationDifferences make a Difference
Differences make a Difference The European Mens Health Forum: Overview European Mens Health: An oxymoron? Mens use of services: Self-care & navigation Good practice: Wot does work? A Storm is coming: Man
More informationCase studies: LUTS. Case 1 history. Case 1 - questions. Case 1 - outcome. Case 2 - history. Case 1 learning point 14/07/2015 DR JON REES
Case 1 history Case studies: LUTS DR JON REES A 49 year old male comes to see you he has had gradual deterioration of his flow over the last few years- he saw a colleague of yours 6 weeks ago who recorded
More informationLower Urinary Tract Symptoms
Advances in the management of BPH/LUTS Greetings from the Executive and Members of the European Association of Urology Christopher Chapple Professor of Urology Sheffield Hallam University Consultant Urological
More informationFEP Medical Policy Manual
FEP Medical Policy Manual Effective Date: January 15, 2019 Related Policies: None Prostatic Urethral Lift Description Benign prostatic hyperplasia (BPH) is a common condition in older individuals that
More informationMedical Therapy for Benign Prostatic Hyperplasia Present and Future Impact
REPORTS Medical Therapy for Benign Prostatic Hyperplasia Present and Future Impact Muta M. Issa, MD, MBA; Timothy S. Regan, BPharm, RPh, CPh Abstract The purpose of this manuscript is to provide clinicians,
More informationThe Royal Marsden. Prostate case study. Presented by Mr Alan Thompson Consultant Urological Surgeon
Prostate case study Presented by Mr Alan Thompson Consultant Urological Surgeon 2 Part one Initial presentation A 62 year old male solicitor attends your GP surgery. He has rarely seen you over the last
More informationFEP Medical Policy Manual
FEP Medical Policy Manual Effective Date: April 15, 2018 Related Policies: None Prostatic Urethral Lift Description Benign prostatic hyperplasia (BPH) is a common condition in older individuals that can
More informationStudy No Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable(s):
Studies listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationElements for a Public Summary
VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Benign prostatic hyperplasia (BPH), also called benign prostatic hypertrophy or benign prostatic obstruction, is a condition in
More informationDesign: Randomized controlled trial using a waiting list design.
Study on the effectiveness of a test-dependent osteopathic treatment for women with persistent post partum back pain. A randomized controlled trial Recknagel C. 1, Roß J. 2, Recknagel A. 1, Ruetz M. 3,
More informationChapter 3: Results of the Treatment Outcomes Analyses
Chapter 3: Results of the Treatment Outcomes Analyses Introduction To determine the appropriateness of individual therapies, as well as to develop practice recommendations, the American Urological Association
More informationHow Do New Data from Clinical Trials Allow Us to Optimise the Assessment and Treatment of Patients with Benign Prostatic Hyperplasia?
available at www.sciencedirect.com journal homepage: www.europeanurology.com How Do New Data from Clinical Trials Allow Us to Optimise the Assessment and Treatment of Patients with Benign Prostatic Hyperplasia?
More informationSingle Technology Appraisal (STA) Tadalafil for the treatment of symptoms associated with benign prostatic hyperplasia
Comment 1: the draft remit Appendix D - NICE s response to consultee and commentator comments on the draft scope and provisional matrix National Institute for Health and Clinical Excellence Single Technology
More informationProstate Disease. Chad Baxter, MD
Prostate Disease Chad Baxter, MD Managing BPH and LUTS Chad Baxter, MD Department of Urology cbaxter@mednet.ucla.edu 33 nd Annual UCLA Intensive Course in Geriatric Medicine & Board Review Prevalence of
More informationNATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE INTERVENTIONAL PROCEDURES PROGRAMME Interventional procedure overview of insertion of prostatic urethral lift implants to treat lower urinary tract symptoms
More informationWill Medical Management of Benign Prostatic Hyperplasia Result in Better or Worse Sexual Function in Men?
Urol Sci 2011;22(1):14 18 MINI REVIEW Will Medical Management of Benign Prostatic Hyperplasia Result in Better or Worse Sexual Function in Men? Thomas I.S. Hwang 1,2,3 * 1 Shin Kong WHS Hospital, Taipei,
More informationChapter 3: Results of the Treatment Outcomes Analyses
Chapter 3: Results of the Treatment Outcomes Analyses TABLE OF CONTENTS INTRODUCTION... 3 WATCHFUL WAITING... 11 STUDY OUTCOMES... 11 MEDICAL THERAPIES... 13 ALPHA-ADRENERGIC ANTAGONISTS (ALPHA-BLOCKERS)...
More informationStudy synopsis of the global non-interventional study SWITCH-RA
Study synopsis of the global non-interventional study SWITCH-RA Protocol number: MA22401 Title of Study: A global multi-centre observational study in RA patients who are non-responders or intolerant to
More informationREPORTS. Clinical and Economic Outcomes in Patients Treated for Enlarged Prostate
Clinical and Economic Outcomes in Patients Treated for Enlarged Prostate Michael James Naslund, MD, MBA; Muta M. Issa, MD, MBA; Amy L. Grogg, PharmD; Michael T. Eaddy, PharmD, PhD; and Libby Black, PharmD
More informationDesign and Analysis of a Cancer Prevention Trial: Plans and Results. Matthew Somerville 09 November 2009
Design and Analysis of a Cancer Prevention Trial: Plans and Results Matthew Somerville 09 November 2009 Overview Objective: Review the planned analyses for a large prostate cancer prevention study and
More informationManaging urinary morbidity after brachytherapy. Kieran O Flynn Department of Urology, Salford Royal Foundation Trust, Manchester
Managing urinary morbidity after brachytherapy Kieran O Flynn Department of Urology, Salford Royal Foundation Trust, Manchester Themes Can we predict urinary morbidity? Prevention of urinary morbidity
More information