Human acellular matrix graft of tunica albuginea for penile reconstruction.

INTRODUCTION: Penile curvature is one of the most common male conditions, affecting nearly 10% of men, and can impair sexual intercourse. Tunica albuginea (hTA) plays a key role in penile curvature, and reconstructive procedures may be necessary for its substitution. Although several grafts have been proposed for hTA repair, the ideal graft is not yet available. AIM: The aim of this article is to evaluate a new human tunica albuginea acellular matrix (hTAAM) as potential graft for penile reconstructive procedures. METHODS: Twelve penises were obtained during sex reassignment surgeries from male-to-female transsexual patients. After dissection, hTAs were assigned into two groups according to the decellularization methods: polyethylene glycol (PEG) 1000 method following ultraviolet-C radiation, and Triton X-100 modified method. MAIN OUTCOME MEASURES: Structural analyses were assessed by hematoxilin and eosin, Masson's trichrome, Weigert's, and picrosirius-polarization staining methods. Total protein, total glycosaminoglycan (GAG), and nucleic acid (DNA and RNA) concentrations were assessed by specific biochemical analyses. Uniaxial strength tests were performed to evaluate biomechanical properties. RESULTS: All hTAAMs presented no nuclear or cellular remnants. Total protein concentration was significantly higher in PEG 1000 hTAAM. Despite GAG concentration decreased significantly in hTAAM, Triton X-100 hTAAM retained the highest GAG concentration (1.0 ± 0.42 µg HexUr/mg dry tissue, P > 0.05). All decellularization methods were efficacious to remove nucleic acids. The maximal break point presented no difference between hTA and hTAAM groups (P > 0.05). CONCLUSIONS: PEG 1000 and Triton X-100 decellularization methods provide equally successful hTAAMs, preserving original structural and biochemical properties.

The management of erectile dysfunction with placebo only: does it work?

INTRODUCTION: Randomized clinical trials (RCT) remain the gold standard in providing scientific evidence in medical practice in spite of the significant placebo effect in the treatment of several disorders. Although the first-line therapy for erectile dysfunction (ED) is oral phosphodiesterase type-5 inhibitor (iPDE5), the placebo effect in RCT of iPDE5 for ED occurs at a rate as high as 50%. AIMS: To evaluate the role of therapeutic illusion in the oral treatment for ED. METHODS: A prospective, controlled, single-blind, parallel-group study was performed at single-center. One hundred and twenty-three patients with ED were randomly assigned into three groups and received different letters: Group 1 (G1) was informed to be receiving a substance for ED treatment; Group 2 (G2) was informed that they could be receiving an active drug or placebo; Group 3 (G3) was conscious to be using placebo. Starch capsules were dispensed to all patients. Median follow up was 12 weeks. MAIN OUTCOME MEASURES: ED improvement was assessed after 8 weeks of the intervention by the erectile function domain of the International Index of Erectile Function (IIEF) and the Quality of Erection Questionnaire. ED severity was classified by the IIEF erectile function (IIEF-EF) domain score into five categories: no ED (score of 26-30), mild (22-25), mild to moderate (17-21), moderate (11-16), and severe (6-10). Improvement in IIEF-EF domain was considered as a change in category of severity. RESULTS: ED severity improved in all three groups (G1 = 31.7%, P = 0.039; G2 = 36.8%, P = 0.028; G3 = 36.8%, P = 0.002) and no difference was found among groups (P = 0.857). Improvement of quality of erection score was only significant in G2 (P = 0.005) and G3 (P < 0.001). CONCLUSIONS: Written-suggested therapeutic illusion for patients with ED has no major influence in the outcomes. However, treatment of ED with oral placebo capsules demonstrates clinical effects, improving erectile function and quality of erection.