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Tadalafil versus tamsulosin as combination therapy with 5-alpha reductase inhibitors in benign prostatic hyperplasia, urinary and sexual outcomes

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Abstract

Purpose

To compare the urological and sexual outcomes of using either tamsulosin/finateride or tadalafil/finasteride as combination therapies in patients with large prostate.

Patients and methods

Selection criteria included prostate volume > 40 ml and IPSS > 7. Patients with severe erectile dysfunction (IIEF-erectile functions ≤ 10) were excluded. Patients were randomized into group I (tamsulosin/finasteride) and group II (tadalafil/finasteride). The primary endpoint was to define urinary and sexual function changes (IPSS, IPSS-quality of life, urinary flow rates and IIEF domains) within each group. The secondary endpoint was to compare the treatment induced changes between both groups.

Results

At 4th and 12th weeks, 131 and 127 patients were available in both groups, respectively. Both groups showed significant LUTS improvement (IPSS changes: − 4.9 ± 2.7 and − 4.3 ± 2.9 at 4th week and − 6.1 ± 3 and − 5.4 ± 2.8 points by the 12th week in both groups, respectively). Group I had better average flow rates at both follow-up visits. Meanwhile, maximum flow rates were comparable in both groups at 12th week (13.5 ± 3.9vs. 12.6 ± 3.7, p > 0.05). In group I, all IIEF domains were significantly lowered at both visits (p < 0.05). Group II showed significant increase in IIEF-erectile function scores (1.3 ± 1.1 and 1.8 ± 1.2 at the 4th and 12th weeks) with a transient significant reduction of IIEF-orgasm and sexual desire noted only by the 4th week (− 0.8 ± 0.4 and − 0.6 ± 0.4, respectively).

Conclusion

Within three months, both combinations are comparably effective in improving BPH related LUTS. Tamsulosin/finasteride provided significantly better Qmax only at 4th week. Tadalafil/finasteride had the advantage of improving sexual performance over the other combination.

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Data availability

All inclusion data are available upon contact with authors.

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Authors

Contributions

AMT contributed to protocol/project development and manuscript writing/editing. MA-E, MG, SS and AZ performed data collection or management. AE-A contributed to protocol/project development. IS performed data analysis and protocol/project development. AG performed manuscript writing/editing and protocol/project development.

Corresponding author

Correspondence to Ayman Ghoneim.

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Conflict of interest

None of the authors has any potential conflict of interest with any other person, institution or organization.

Research involving human participants and/or animals

Research was carried on human, approved by institutional ethical committees at Tanta university (36264PR164/2/23) and Ibn Sina national college of medical studies (IRRB-03-19032023).

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All participants were informed, discussed and asked to sign an informed written consent including all steps of the study including all possible side effects. Only those who signed the study were included.

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Tawfik, A., Abo-Elenen, M., Gaber, M. et al. Tadalafil versus tamsulosin as combination therapy with 5-alpha reductase inhibitors in benign prostatic hyperplasia, urinary and sexual outcomes. World J Urol 42, 70 (2024). https://doi.org/10.1007/s00345-023-04735-y

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