Introduction
LUTS in BPH has a complex pathogenesis, often linked to OAB. Alpha blockers, the first-line treatment, show limited efficacy in OAB cases. Previous studies suggest that Vesusten, a bioregulative peptide from cattle bladder, benefits OAB. This trial assessed whether combining Vesusten with alpha blockers is superior to monotherapy.
Materials & Methods
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An open-label, single-center, phase IV randomized study was conducted. Patients (aged 45–80) received either:
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Group 1 (Experimental): Vesusten 5 mg i.m. (10 doses) + alpha blocker.
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Group 2 (Control): Alpha blocker monotherapy.
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Follow-up lasted 60 days, evaluating IPSS, OAB-q, PPBC, uroflowmetry, TRUS, and adverse events (AE).
Results
Out of 100 enrolled patients (mean age 59.7), 93 completed the study. Both groups had comparable baseline characteristics.
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Symptom Improvement:
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IPSS: -2.43 (Group 1) vs -0.38 (Group 2), p<0.001
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OAB-q: -2.89 vs -0.12, p<0.001
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PPBC: -1.17 vs -0.06, p<0.01
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Urination Parameters:
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Urination rate (per 24 hrs): -3 vs -0.17, p<0.001
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Urination volume: +27.5 vs +5.2 ml, p<0.001
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PVR: -10.7 vs +2.9 ml, p=0.02
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Qmax/Qave: +1.7 vs +0.1 ml/s, +1.5 vs +0.1 ml/s, p<0.001
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No change in BPH volume.
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Safety: 17 mild AEs (pain/discomfort at injection site) were reported, resolving without intervention.
Conclusion
Adding Vesusten to alpha blockers significantly improved LUTS, uroflowmetry, and PVR, with mild, self-limiting AEs. This combination therapy could offer superior symptom relief without affecting BPH volume.
European Association of Urology, 21-24 March 2025, Madrid, Spain
