Editing Functional: Pharmacological Management of LUTS (section)

=== Alpha-blockers and 5-ARIs ===
* '''<span style="color:#ff00ff">MTOPS</span>'''§
** '''Population: 3047 men age ≥ 50 with IPSS 8-30, PSA ≤ 10 ng/mL, Qmax ≥4 but ≤15 ml/s with minimum voided volume ≥125 ml'''
*** '''Mean prostate volume: 36mL'''
*** '''Mean PSA: 2.4ng/mL'''
** '''Randomized to placebo, doxazosin, finasteride, or combination therapy'''
** '''Primary outcome: overall clinical progression, defined as the first occurrence of:'''
**# '''≥ 4 points increase from baseline AUA symptom score'''
**# '''Acute urinary retention'''
**# '''Renal insufficiency'''
**# '''Recurrent UTI'''
**# '''Urinary incontinence'''
** Secondary outcomes: changes over time in the AUA symptom score and the maximal urinary flow rate
** '''Results:'''
*** '''Mean follow-up: 4.5 years'''
*** '''Rate of overall clinical progression:'''
**** Placebo 4.5 per 100 person-years
**** '''Doxazosin''': 2.7 per 100 person-years '''(P<0.001)'''
**** '''Finasteride''': 2.9 per 100 person-years '''(P=0.002)'''
**** '''No difference between doxazosin alone vs. finasteride alone'''
**** '''Combination therapy: 1.5 per 100 person-years (P<0.001), a significantly greater reduction than doxazosin alone (P<0.001) or finasteride alone (P<0.001)'''
* '''<span style="color:#ff00ff">CombAT</span>'''§
** '''Population: 4844 men age ≥ 50''' with a clinical diagnosis of BPH, '''IPSS ≥ 12,''' '''prostate volume ≥ 30g''', PSA 1.5-10 ng/ml, Qmax >5 but ≤15 ml/s with minimum voided volume ≥125 ml
*** '''Mean prostate volume: 55mL (larger than MTOPS)'''
*** '''Mean PSA: 4.0ng/mL (higher than MTOPS)'''
** '''Randomized to daily tamsulosin, dutasteride, or a combination of both (no placebo)'''
** '''Primary end point: time to first AUR or BPH-related surgery'''
** Secondary end points included BPH clinical progression, symptoms, Q(max), prostate volume, safety, and tolerability
*** BPH clinical progression defined as one of the following: symptom deterioration by International Prostate Symptom Score ≥4 points on two consecutive visits; BPH-related AUR; BPH-related urinary incontinence; recurrent BPH-related urinary tract infection or urosepsis; BPH-related renal insufficiency
** '''Results''':
*** '''Combination therapy was significantly better than tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery'''
*** '''Combination therapy was significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression'''
*** '''Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr.'''
* '''Summary of evidence for combination alpha-blockers and 5-ARIs from these trials:'''
** '''Combination better reduces risk of clinical progression and symptoms benefit at 4 years'''
** '''Monotherapy with 5-ARI and alpha-blockers are equally effective in risk of overall clinical progression'''
** '''5-ARI reduces risk of AUR or BPH-related surgery, addition of tamsulosin does not increase benefit'''