RESUMO
Background: Premature ejaculation (PE) is a common sexual dysfunction that harms both sex partners. Aim: To evaluate the safety, efficacy and impact on sexual satisfaction scores of the combined use of tramadol HCl and sildenafil citrate for the treatment of PE. Methods: One hundred and sixty otherwise healthy males complaining of PE (primary/secondary) were enrolled in this randomized, double-blind, placebo-controlled study. Only 155 patients (age range 22-48 years) completed the study. Of them, 81 patients had primary PE, and 74 had secondary PE. The comparative groups included the placebo group (n = 34), sildenafil citrate 50 mg group (n = 39), tramadol HCl 100 mg group (n = 40), and the combination therapy group (n = 42). The treatment duration for all groups was 10 weeks. Outcomes: This combination is safe and effective. Results: Five patients discontinued the study, all from the placebo group, due to a lack of improvement over the treatment course. No significant differences were reported between groups before treatment as regards Intravaginal ejaculatory Latency Time (p = 0.8), satisfaction score (p = 0.7), age (p = 0.9), or duration of marriage (p = 0.9). There was a significant improvement in IELT after treatment with a placebo (p = 0.0001), associated with an insignificant improvement in satisfaction score (p = 1.0). In the other three groups, there was a significant improvement in IELT after treatment (p = 0.0001 for all), which coincided with a significant improvement in satisfaction scores in all three groups (p = 0.0001 for all). Clinical Implications: We recommend this combination in the treatment of premature ejaculation. Strengths: It is a prospective randomized double-blind placebo-controlled clinical trial. Limitations: Limited number of participants. Conclusion: Combined therapy of PE, whether primary or secondary, with sildenafil citrate 50 mg and tramadol HCl 100 mg is safe and effective; and its therapeutic effect is superior to the utilization of either agent alone.
RESUMO
PURPOSE: To compare the functional and cosmetic outcomes of two different frontalis sling techniques for correction of severe unilateral congenital ptosis: single triangle and Fox pentagon techniques using expanded polytetrafluoroethylene (ePTFE) suture. METHODS: This randomized controlled trial included 60 eyes of 60 patients with severe unilateral simple congenital ptosis and poor levator function (≤4 mm). Participants were randomly assigned for either single triangle or Fox pentagon frontalis suspension using ePTFE suture. Functional outcome measures were margin reflex distance (MRD1), palpebral fissure height (VFH), and lagophthalmos. Cosmetic outcome parameters (lid contour, lid crease, and height symmetry) were graded as 3 (excellent), 2 (good), or 1 (poor), with a minimum of 18 months' follow-up. RESULTS: At final follow-up, there was a significant improvement in the MRD1 and VFH in both groups, with no statistical difference (P = 0.9). Both groups showed comparative cosmetic results regarding lid height symmetry, crease, and contour. The patients in the single-triangle group showed more rapid recovery of postoperative edema and lagopthalmos with less visible forehead scarring. There were no serious ePTFE sling-related complications. CONCLUSIONS: In our study cohort, the single-triangle and Fox pentagon frontalis suspension techniques had similar outcomes with respect to MRD1 and VFH and comparable cosmetic results. However, the single-triangle technique avoids two forehead incisions and was associated with less postoperative edema, lagophthalmos, and scarring.
