Oral suspension versus tablet sildenafil for erectile dysfunction: a prospective multicenter comparative study on patient satisfaction
摘要
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.