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Introduction There are only a few studies on the clinical utility of filler injections for penile augmentation (PA) in patients with small penis syndrome (SPS), which is a type of anxiety or body dysmorphic disorder, not a true micropenis. Aim To compare the clinical outcomes of hyaluronic acid (HA) with polylactic acid (PLA) filler injection for temporary PA in patients with SPS. Methods Our prospective, patient/evaluator-blind, comparative, randomized, non-inferiority trial consisted of a single filler injection and a 24-week post-injection period. Seventy-four men with SPS were included between November 2017 and February 2018. Patients were divided into those injected with HA (n = 39) and those injected with PLA filler (n = 35). Main Outcome Measure The psychological effects of PA, based on the Beliefs about Penis Size Scale, penile girth, and satisfaction, were assessed at baseline and at 4, 12, and 24 weeks post-injection. Results At 24 weeks, the mean penile girth increases were 2.1 ± 1.0 cm (P < .001) in the HA group and 1.6 ± 0.9 cm (P < .001) in the PLA group, with a mean difference of 0.5 ± 0.2 cm between groups (P = .031). In both groups, satisfaction levels significantly increased at 24 weeks, with 1.8 ± 1.7 and 1.6 ± 1.4 mean increases in the visual analog scale for penile appearance satisfaction in the HA and PLA groups, respectively (each P < .001), and 1.0 ± 1.1 and 0.7 ± 1.2 mean increases in the visual analog scale for sexual life satisfaction in the HA and PLA groups, respectively (each P < .001), with no significant differences between groups (P = .950 and P = .287). The mean Beliefs about Penis Size Scale scores significantly decreased at 24 weeks, with 7.8 ± 8.3 and 5.3 ± 7.2 mean decreases in the HA and PLA groups, respectively (each P < .001), and no significant difference between the groups (P = .920). There were no serious adverse events, but filler injection-related adverse events in the HA and the PLA groups were reported in 2 cases (5.13%) and 5 cases (14.29%), respectively (P = .245). Clinical Implications Our study provides an overview of clinical course after HA and PLA filler injections for PA and suggests that filler injections can be considered an alternative approach in patients with SPS. Strengths & Limitations Our study is the first to assess the psychological symptoms in patients with SPS who received the filler injection for PA; however, the follow-up duration was insufficient to prove the long-term outcomes of fillers. Conclusion Without serious adverse events, HA and PLA filler injections for PA significantly resulted in not only an augmentative effect but also improvement of psychological distress, and the clinical utility was comparable between the fillers.

Background Studies about the clinical utility of fillers on penile augmentation (PA) are lacking. Furthermore, no randomized study has compared the utilities of fillers. Aim To compare the efficacy and safety between hyaluronic acid (HA) and polylactic acid (PLA) filler injection for PA. Methods This prospective, randomized patient/evaluator-blind, comparative multicenter study consisted of an initial 2-week baseline period and 48-week patient/evaluator-blind post-injection period. 72 patients with small penis syndrome were enrolled from 3 institutions between March–July 2016. Patients were divided into 2 groups: the HA group, comprising 36 patients injected with HA, and the PLA group, comprising 36 patients injected with PLA. Main Outcome Measures Penile girth and satisfaction were assessed at baseline and at 4, 12, 24, and 48 weeks after injection. Results Penile girth increases adequately lasted ≤48 weeks in both groups (16.95 ± 10.53 and 13.49 ± 9.98 mm of mean increase in the HA and PLA groups, respectively; P < .001). The mean penile girth increase in the HA group was significantly greater than that in the PLA group at 4 weeks (P < .001). Subsequently, it gradually decreased and was no longer significantly different at 48 weeks (P = .075). Satisfaction levels increased after injection and were maintained ≤48 weeks. No significant differences were observed in the overall satisfaction level between the groups (P > .05). Filler injection–related adverse events were mild and transient and occurred in 1 and 3 patients in the HA and PLA groups, respectively. Clinical Implications This study provides an overview of the efficacy and safety of HA and PLA fillers, which are the most commonly used soft tissue fillers for PA. Strength and Limitations This study, to our knowledge, is the first to compare the efficacy and safety between different filler injections for human PA. However, it was impossible to perform a researcher-blinded trial because of the unique properties of fillers, and 31 patients (43.1%) were dropped during the study period. Conclusions Both HA and PLA filler injections for PA led to a significant augmentative effect without serious adverse events and had clinically comparable efficacy and safety.

Introduction There is partial evidence to support the use of phophodiesterase‐5 inhibitor (PDE5‐I) for the treatment of premature ejaculation (PE). Aim We compared on‐demand dosing of dapoxetine alone and combined with mirodenafil in subjects with lifelong PE and without erectile dysfunction (ED). Methods Our prospective, randomized, double‐blind, placebo‐controlled, multicenter trial enrolled 118 subjects with lifelong PE without ED. PE was diagnosed using D iagnostic and S tatistical M anual of M ental D isorders , fourth edition, text revision. Patients were divided into two groups: dapoxetine 30 mg plus placebo (group A, n = 56) and dapoxetine 30 mg plus mirodenafil 50 mg (group B, n = 62). Main Outcome Measures During 12 weeks, intravaginal ejaculatory latency time (IELT) and the time from foreplay to beginning intercourse (FTIT) with a stopwatch, and Premature Ejaculation Profile (PEP) were measured. Overall sexual act time (OSAT; sum of FTIT and IELT) was calculated. Any treatment‐emergent adverse events (TEAEs) were also recorded. Results Over 12 weeks, IELT, OSAT, and PEP index score significantly improved in group B compared with group A (increased geometric mean IELT in group A and B = 3.6 and 6.1 minutes, P = 0.026; increased geometric mean OSAT in group A and B = 5.5 and 9.9 minutes, P = 0.012; increased median PEP index score in group A and B = 1.0 and 1.3, P = 0.046). However, there was no significant difference between two groups with respect to improvement of FTIT ( P = 0.147). TEAEs did not differ between groups (all P > 0.05), and there was no serious adverse event in any subjects. Conclusions Low dose of dapoxetine combined with mirodenafil showed better results in terms of IELT, OSAT, and PEP index score, and similar TEAEs, compared with that of dapoxetine only. Our results support the suggestion that the PDE5‐Is have a potential role in the treatment of PE without ED. Lee WK, Lee SH, Cho ST, Lee YS, Oh CY, Yoo C, Cho JS, Lee SK, and Yang DY. Comparison between on‐demand dosing of dapoxetine alone and dapoxetine plus mirodenafil in patients with lifelong premature ejaculation: Prospective, randomized, double‐blind, placebo‐controlled, multicenter study. J Sex Med 2013;10:2832–2841.