New formulations of sildenafil, such as oral suspension, may improve onset of action and patient acceptability. This prospective, non-randomized, multicenter observational study compared sildenafil oral suspension (SiSUS) and sildenafil tablets (SiTAB) in treatment-naïve men with erectile dysfunction (ED). Patients from four urology centers in Madrid selected either SiSUS (Bandol®, AspargoLabs Inc., NY, USA) or SiTAB after standardized counseling and received on-demand treatment for eight weeks. Primary outcome was patient satisfaction assessed by the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire; secondary outcomes included changes in the International Index of Erectile Function-Erectile Function (IIEF-15) scores, latency to erection, and adverse events. A total of 133 patients completed the study (SiSUS: 64; SiTAB: 69). Both groups showed significant improvement in IIEF-15 scores (mean ΔIIEF-15: 17.41 ± 12.46 vs. 17.33 ± 15.02; p = 0.977). Median EDITS score was similar for both groups (77.27 vs. 61.36; p = 0.1312), with significantly greater satisfaction for SiSUS in those men ≤65 (77.27 vs 52.27, p = 0.0486). Median and interquartile ranges (IQR) times for latency to erection were shorter in the SiSUS group: 30 (30-45) vs. 60 (50-60) min; p < 0.0001). Adverse events were comparable (26.6 vs. 21.7%; p = 0.6547), with headache being the most frequent for both groups (12.5, vs 10.14%, p = 0.3244). Limitations include the observational, non-randomized design, short follow-up, and baseline differences between groups. Sildenafil oral suspension offers similar efficacy and safety to tablets, with a faster onset and higher satisfaction in younger patients, supporting its role in individualized ED management.
International journal of impotence research. 2026 Apr 09 [Epub ahead of print]
Borja García-Gómez, Manuel Alonso-Isa, Esther García-Rojo, Celeste Manfredi, Javier Romero-Otero
Department of Urology, Hospital Universitario 12 de Octubre, Madrid, Spain., Department of Urology, HM Hospitals and ROC Clinic, Madrid, Spain., Unit of Urology, Department of Woman, Child and General and Specialized Surgery, University of Campania Luigi Vanvitelli, Naples, Italy., Department of Urology, HM Hospitals and ROC Clinic, Madrid, Spain. .