Restricted accessResearch articleFirst published online 2026
Tadalafil and tamsulosin in the management of lower urinary tract symptoms due to benign prostatic hyperplasia: A prospective,randomized,open-label,comparative study
Benign prostatic hyperplasia (BPH) commonly presents with lower urinary tract symptoms (LUTS), which can significantly impair quality of life in aging men. Tamsulosin, a selective alpha-1 blocker, is widely used for symptom relief. Tadalafil, a phosphodiesterase-5 inhibitor, offers dual benefit for LUTS and erectile dysfunction (ED). However, limited comparative data exist from African populations.
Objective:
To compare the efficacy and safety of tadalafil and tamsulosin monotherapy in the management of LUTS due to BPH in men attending a tertiary hospital in Ghana.
Methods:
This prospective, randomized, open-label study was conducted over 12 weeks at the Korle-Bu Teaching Hospital. Eighty-two men aged ⩾40 years with moderate to severe LUTS due to BPH were randomized to receive either tadalafil 5 mg or tamsulosin 0.4 mg daily. Baseline, 4-week, and 12-week evaluations included International Prostate Symptom Score (IPSS), quality of life (QoL), peak urinary flow rate (Qmax), post-void residual urine (PVR), and International Index of Erectile Function (IIEF-5). Statistical analyses included t-tests and linear regression.
Results:
Both groups showed significant improvement in IPSS, QoL, Qmax, and PVR over time. At 12 weeks, Qmax was significantly higher in the tadalafil group compared to tamsulosin (18.7 ± 4.5 vs 16.9 ± 2.6 mL/s, p = 0.045). IPSS improvement was similar across both arms (Tadalafil: −9.3; Tamsulosin: −7.8). Tadalafil significantly improved IIEF-5 scores from 14.0 to 21.0 (p < 0.001), whereas tamsulosin showed minimal change. Subgroup analysis showed tadalafil’s erectile function benefit was consistent across demographic and clinical subgroups except in diabetics. Side effects were mild (5.1%) and equally distributed between groups.
Conclusion:
Tadalafil and tamsulosin are both effective in alleviating LUTS due to BPH. Tadalafil provides additional benefits in erectile function and superior improvement in urinary flow, making it a suitable first-line option, especially for patients with coexisting ED. These findings support individualized treatment decisions based on patient profile and symptom burden in resource-limited settings.
EganKB.The epidemiology of benign prostatic hyperplasia associated with lower urinary tract symptoms: prevalence and incident rates. Urologic Clinics of North America. W.B. Saunders, 2016. Vol. 43, pp.289–297.
2.
ChokkalingamAPYeboahEDDeMarzoA, et al. Prevalence of BPH and lower urinary tract symptoms in West Africans. Prostate Cancer Prostatic Dis2012; 15(2): 170–176.
3.
EmbertonMMartoranaG.BPH: social impact and patient’s perspective. Eur Urol Suppl2006; 5(20): 991–996.
4.
SpeakmanMKirbyRDoyleS, et al. Burden of male lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) - focus on the UK. BJU Int2015; 115(4): 508–519.
5.
GacciMEardleyIGiulianoF, et al. Critical analysis of the relationship between sexual dysfunctions and lower urinary tract symptoms due to benign prostatic hyperplasia. Eur Urol2011; 60: 809–825.
LeporH.Long-term evaluation of tamsulosin in benign prostatic hyperplasia: placebo-controlled, double-blind extension of phase III trial. Urology1998; 51(6): 901–906.
8.
HellstromWJSikkaSC.Effects of acute treatment with tamsulosin versus alfuzosin on ejaculatory function in normal volunteers. J Urol2006; 176(4 1): 1529–1533.
9.
AnderssonKEde GroatWCMcVaryKT, et al. Tadalafil for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia: Pathophysiology and mechanism(s) of action. Neurourol Urodyn2011; 30(3): 292–301.
10.
HatzimouratidisK.A review of the use of tadalafil in the treatment of benign prostatic hyperplasia in men with and without erectile dysfunction. Ther Adv Urol2014; 6(4): 135–147.
11.
CornuJGacciMHashimH, et al. EAU guidelines on non-neurogenic male lower urinary tract symptoms (LUTS). Eur Assoc Urol2023; 84(2): 207–222.
12.
LernerLBMcvaryKTBarryMJ, et al. Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA GUIDELINE PART I, initial work-up and medical management. J Urol2021; 206: 1339–1417.
13.
ManticaGAmbrosiniFDrocchiG, et al. Non-surgical management of BPH: an updated review of current literature and state of the art on natural compounds and medical therapy. Arch Ital Urol Androl2024; 96(4): 13098.
14.
BizzarriFPCampetellaMRagoneseM, et al. The role of alternative medicine and complimentary therapies in urologic disease: new horizons. Urologia2024; 91(4): 641–646.
15.
ParkMBHyunDSSongJM, et al. Association between the symptoms of benign prostatic hyperplasia and social disparities: does social capital promote prostate health?Andrologia2018; 50(10): e13125.
16.
BlankerMHBoschJLHRGroeneveldFPMJ, et al. Erectile and ejaculatory dysfunction in a community-based sample of men 50 to 78 years old: prevalence, concern, and relation to sexual activity. Urology2001; 57(4): 763–768.
17.
AlthubaitiA.Sample size determination: a practical guide for health researchers. J Gen Fam Med2023; 24: 72–78.
18.
SinghITkAGuptaS.Efficacy and safety of tadalafil vs tamsulosin in lower urinary tract symptoms (LUTS) as a result of benign prostate hyperplasia (BPH)-open label randomised controlled study. Int J Clin Pract2020; 74(8): e13530.
19.
SinghDVMeteUKMandalAK, et al. A comparative randomized prospective study to evaluate efficacy and safety of combination of tamsulosin and tadalafil vs. tamsulosin or tadalafil alone in patients with lower urinary tract symptoms due to benign prostatic hyperplasia. J Sex Med2014; 11(1): 187–196.
20.
GoyalNKGoelAYadavR.Re: Matthias Oelke, François Giuliano, Vincenzo Mirone, Lei Xu, David Cox, Lars Viktrup. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial. Eur Urol2012; 61:917-25. Eur Urol 2012; 62(2): e39.
21.
GuoBChenXWangM, et al. Comparative effectiveness of tadalafil versus tamsulosin in treating lower urinary tract symptoms suggestive of benign prostate hyperplasia: a meta-analysis of randomized controlled trials. Med Sci Monit2020; 26: e923179.
LokeshwarSDHarperBTWebbE, et al. Epidemiology and treatment modalities for the management of benign prostatic hyperplasia. Transl Androl Urol2019; 8(5): 529–539.
24.
OelkeMGiulianoFMironeV, et al. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial. Eur Urol2012; 61(5): 917–925.
25.
KimEHLarsonJAAndrioleGL.Management of benign prostatic hyperplasia. Annu Rev Med2016; 67: 137–151.
26.
DunnCJMathesonAFauldsDM.Tamsulosin: a review of its pharmacology and therapeutic efficacy in the management of lower urinary tract symptoms. Drugs Aging2002; 19(2): 135–161.
27.
DongYHaoLShiZ, et al. Efficacy and safety of tadalafil monotherapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia: A meta-analysis. Urol Int2013; 91(1): 10–18.
28.
BrockGBMcVaryKTRoehrbornCG, et al. Direct effects of Tada lafil on lower urinary tract symptoms versus indirect effects mediated through erectile dysfunction symptom improvement: integrated data analyses from 4 placebo controlled clinical studies. J Urol2014; 191(2): 405–411.
29.
DonatucciCFBrockGBGoldfischerER, et al. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a 1-year, open-label extension study. BJU Int2011; 107(7): 1110–1116.
30.
OelkeMGiulianoFMironeV, et al. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial. Eur Urol2012; 61(5): 917–925.
31.
GiulianoFOelkeMJungwirthA, et al. Tadalafil once daily improves ejaculatory function, erectile function, and sexual satisfaction in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia and erectile dysfunction: results from a randomized, placebo- and tamsulosin-controlled, 12-week double-blind study. J Sex Med2013; 10(3): 857–865.
32.
PogulaVRKadiyalaLSGouruVR, et al. Tadalafil vs. tamsulosin in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia: a prospective, randomized. Cent Eur J Urol2019; 72(1): 44–50.
33.
KhanSJKhastgirJ.Assessment of lower urinary tract symptoms. Surg2016; 34(7): 333–341.
34.
WangYBaoYLiuJ, et al. Tadalafil 5 mg once daily improves lower urinary tract symptoms and erectile dysfunction: a systematic review and meta-analysis. Lower Urinary Tract Symptoms2018; 10(1): 84–92.
35.
AnguloJCuevasPFernándezA, et al. Tadalafil enhances the inhibitory effects of tamsulosin on neurogenic contractions of human prostate and bladder neck. J Sex Med2012; 9(9): 2293–2306.
36.
DmochowskiRRoehrbornCKliseS, et al. Urodynamic effects of once daily tadalafil in men with lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia: a randomized, placebo controlled 12-week clinical trial. J Urol2013; 189(1): S135–S140.
OelkeMGiulianoFBayganiSK, et al. Treatment satisfaction with tadalafil or tamsulosin vs placebo in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH): results from a randomised, placebo-controlled study. BJU Int2014; 114(4): 568–575.
39.
KonstantinidisCZachariouAEvgeniE, et al. Recent advances in the diagnosis and management of retrograde ejaculation: a narrative review. Diagnostics2025; 15(6): 726.
40.
CouteauNDuquesneIFrédéricP, et al. Ejaculations and benign prostatic hyperplasia: an impossible compromise? A comprehensive review. J Clin Med2021; 10(24): 5788.
41.
FawziHAAkramSNTalibAF, et al. Comparing monotherapy with tadalafil or tamsulosin in men with benign prostatic hyperplasia: A case-control study. J Adv Pharm Technol Res2024; 15(3): 161–165.
42.
EltermanDAubé-PeterkinMEvansH, et al. UPDATE - Canadian Urological Association guideline: male lower urinary tract symptoms/benign prostatic hyperplasia. Can Urol Assoc J2022; 16(8): 245–256.
43.
ZabkowskiTSaracynM.Drug adherence and drug-related problems in pharmacotherapy for lower urinary tract symptoms related to benign prostatic hyperplasia. J Physiol Pharmacol2018; 69(4): 639.
44.
ZhouRCheXZhouZ, et al. A systematic review and meta-analysis of the efficacy and safety of tamsulosin plus tadalafil compared with tamsulosin alone in treating males with lower urinary tract symptoms secondary to benign prostrate hyperplasia. Am J Mens Health2023; 17(1): 15579883231155096.
45.
CuiJCaoDBaiY, et al. Efficacy and safety of 12-week monotherapy with once daily 5 mg tadalafil for lower urinary tract symptoms of benign prostatic hyperplasia: evidence-based analysis. Front Med2021; 8: 744012.
