Magnetic resonance (MR) is the best way to assess the new anatomy of the pelvis after male to female (MtF) sex reassignment surgery. The aim of the study was to evaluate the radiological appearance of the small pelvis after MtF surgery and to compare it with the normal women's anatomy. Fifteen patients who underwent MtF surgery were subjected to pelvic MR at least 6 months after surgery. The anthropometric parameters of the small pelvis were measured and compared with those of ten healthy women (control group). Our personal technique (creation of the mons Veneris under the pubic skin) was performed in all patients. In patients who underwent MtF surgery, the mean neovaginal depth was slightly superior than in women (P=0.009). The length of the inferior pelvic aperture and of the inlet of pelvis was higher in the control group (P<0.005). The inclination between the axis of the neovagina and the inferior pelvis aperture, the thickness of the mons Veneris and the thickness of the rectovaginal septum were comparable between the two study groups. MR consents a detailed assessment of the new pelvic anatomy after MtF surgery. The anthropometric parameters measured in our patients were comparable with those of women.
This is an open, multicentre, randomized, crossover study having the aim to evaluate the preference for sildenafil citrate or tadalafil in a population of Italian patients affected by ED, and to compare the efficacy and safety of these two drugs. Material and Methods. From October 2003 to November 2004, thirteen Italian centers enrolled ED patients (age >18) being in steady and naïve relation to ED treatment, both through PDE5 inhibitors and any other treatment option. These patients were randomized to sildenafil or tadalafil for 12 weeks, after which they were switched to the alternative treatment for a further 12 weeks. The preference was evaluated through the Treatment Preference Question (TPQ): “During this clinical trial you have taken tadalafil and sildenafil for the treatment of erectile dysfunction. Which medication do you prefer to take for the next 8 weeks of treatment?”. Moreover, patients were asked to express their preference as “strong” or “moderate” and to answer some questions to clarify the reasons behind their preference. SEP and IIEF-EF questionnaires were used for a comparison of efficacy. Results. 167 patients were enrolled, 144 of whom completed both treatment periods. On being asked the TPQ, 75% of patients (n=108) decided to continue treatment with tadalafil, in particular because it made it possible to have an erection many hours after taking the medication (first or second preference reason for 64.8% of patients), while 25% (n=36) preferred sildenafil (p=0.001). Both drugs improved the IIEF-EF and SEP scores compared to baseline, with a slightly but significantly greater improvement with tadalafil for both parameters. Conclusions. Tadalafil and sildenafil are both effective and well tolerated. Most of the patients prefer tadalafil thanks to the possibility of having sexual intercourse many hours after taking the medication.
Axel Heidenreich, Köln Markus Hohenfellner, Heidelberg Simon Horenblas, Amsterdam D. Jocham, Lübeck Hubert John, Zürich Klaus-Peter Jünemann, Kiel Kerstin Junker, Jena Ingo Kausch, Lübeck Ziya Kirkali, Izmir Theodor Klotz, Weiden Thomas Knoll, Mannheim Susanne Krege, Krefeld Markus Kuczyk, Hannover M. Pilar Laguna, Nijmegen Yeggapan Lakshmanan, Baltimore, Md. Elena Levtchenko, Leuven Bernhard Liedl, München Pedro Lopez Pereira, Madrid Jon Lovisolo, Varese Helmut Madersbacher, Innsbruck Stephan Madersbacher, Wien Andreas Manseck, Ingolstadt Antonio Martin Morales, Malaga Matthias Maruschke, Rostock Manuel Mas, Tenerife Axel S. Merseburger, Tübingen Eric J.M. Meuleman, Amsterdam Maurice Stephan Michel, Mannheim Sherif Mourad, Cairo R. Muschter, Rotenburg Vladimir Novotny, Dresden Carlos Nunez Mora, Madrid Sven Oehlschläger, Dresden Matthias Oelke, Amsterdam Miguel Arrabal Martin, Granada Anthony Atala, Winston-Salem, N.C. Rajinikanth Ayyathurai, Miami, Fla. Marko Babjuk, Prague Guido Barbagli, Arezzo Georg C. Bartsch, Ulm Guy Bogaert, Leuven Andreas Böhle, Bad Schwartau Christof Borgermann, Essen Noor Buchholz, London Fiona Burkhard, Bern Emmanuel Chartier-Kastler, Paris Myung-Soo Choo, Seoul Elisabetta Costantini, Perugia Francisco Cruz, Porto Zoran Culig, Innsbruck Jean J.M.C.H. de la Rosette, Amsterdam Dirk De Ridder, Leuven Christian Doehn, Lübeck Thomas Ebert, Fürth Mark Emberton, London Karel Everaert, Gent Margit Fisch, Hamburg Michael Froehner, Dresden Susanne Füssel, Dresden Michele Gallucci, Roma Petrisor Geavlete, Bucharest Fernando Gómez Sancha, Madrid Christian Gozzi, München Joachim Grosse, Aachen Axel Häcker, Mannheim Axel Haferkamp, Heidelberg C. Hampel, Mainz John Heesakkers, Nijmegen Internationalis Urologia
Objective: To evaluate variations in sexual and erectile function in subjects taking 1 mg of finasteride for androgenetic alopecia by administering the abridged 5-item version of the International Index of Erectile Function (IIEF-5) questionnaire before and during treatment.Design: In a multicenter study, 186 patients with androgenetic alopecia were asked to complete the IIEF-5 regarding the domain of erectile function before (at baseline) and 4 to 6 months after beginning finasteride treatment.The test was self-administered. Setting:The study was conducted in 7 institutional dermatology departments in Italy (Bologna, Rome, Genoa, Cagliari, Milan, Florence, and Bari).Patients: A total of 186 patients with androgenetic alopecia were evaluated before and 4 to 6 months after the initiation of finasteride therapy (1 mg).All patients (age range, 19-43 years; mean age, 28.3 years) were followed up as outpatients.Results: The score on each of the 5 domains of the IIEF-5 did not show any significant change after 4 to 6 months of treatment.Conclusions: Our results support the clinical impression that sexual side effects are actually much less common than reported in clinical trials.The sexual function of all patients remained stable during treatment with 1 mg of finasteride.
Background/Aim: Substances in the middle molecular weight range have been shown to play a significant pathogenetic role in as diverse disorders as end-stage renal disease and multiple organ failure. To overcome the limitations in the amount removed by hemofilters, new sorbents with a high biocompatibility are actively being developed. Furthermore, biocompatible sorbents by their nonspecific adsorptive behavior could have great impact on detoxification treatment in exogenous intoxications. We performed an in vitro evaluation of a newly developed highly biocompatible sorbent cartridge (Betasorb®), examining its adsorptive capacity concerning therapeutic drugs. Methods: Uremic blood spiked with a range of therapeutic drugs was recirculated for 2 h in an in vitro hemoperfusion circuit containing a Betasorb device for hemoperfusion. The drug concentrations before and after the passage of the cartridge were measured, and the total amount removed was calculated. Results: The sorbent showed effective removal of glycopeptide antibiotics, digoxin, theophylline, phenobarbital, phenytoin, carbamazepine, and valproic acid. Moderate removal could be demonstrated for tacrolimus and cyclosporine A; aminoglycosides were removed to a small extent only. Conclusions: Betasorb hemoperfusion shows a potent adsorptive capacity concerning therapeutic drugs (except aminoglycosides) and could be of major value in the treatment of intoxications. On the other hand, drug monitoring and possible adjustments are necessary during Betasorb hemoperfusion to maintain the therapeutic ranges of the drugs in blood.
Introduction: The chemical stability of prostaglandin E1 (PGE1) in physiological solution has been studied in different environmental conditions. However, very little data exist regarding the PGE1 stability and the consequent breakdown products in PGE1-based vasoactive cocktails under different environmental conditions. Objective: To evaluate the loss of the therapeutic efficacy of PGE1 either alone or in combination with other vasoactive substances under different storage conditions. Materials and Methods: Utilizing high performance liquid chromatography the PGE1 content was evaluated alone and in association with papaverine and papaverine plus phentolamine at temperatures of 2–8 and at 20°C, and after 15, 30, 60, 90 and 120 days of storage using multivariate statistical analysis of variance. Results: We found that the time of storage significantly affects PGE1 activity. Furthermore, both the storage temperature and cocktail composition had a significant effect on PGE1 stability. The chromatographic studies did not disclose the presence of the principal degradation products of PGE1 (PGA1, PGB1). The presence of papaverine and temperature of 20°C have the greatest effect on the degradation of PGE1 during the first 30 days of storage. Discussion: Temperature and time are prevalent factors determining the slow and progressive deterioration curve of PGE1 after 30 days of storage. None of the environmental conditions evaluated was so drastic to determine the presence of PGA1 and PGB1. Conclusion: For clinical use, one should note that PGE1 maintains 50–80% of its efficacy for about 1 month even if stored at room temperature (20°C) and/or combined with papaverine.
Background Our practical experience indicates that sexual side-effects in subjects taking finasteride 1 mg (Propecia(R)) for androgenetic alopecia are much less common than reported in the literature.Objective To evaluate the sexual function in subjects taking finasteride (1 mg) compared with age-matched controls using the International Index of Erectile Function (IIEF).Methods The IIEF, a brief, reliable questionnaire, was self-administered to 236 patients taking Propecia(R) and 236 age-matched males attending the Department of Dermatology of the University of Bologna.Results Statistical analysis showed no differences between scores obtained with the IIEF in subjects taking finasteride and controls.Conclusions The sexual and erectile function of subjects taking finasteride does not significantly differ from that of age-matched controls. This is consistent with the experience of many dermatologists who do not see sexual or erectile dysfunction in patients taking Propecia(R).
PURPOSE:Vasoactive cocktails are widely used in diagnosing and treating erectile dysfunction, especially in poor responders to prostaglandin E1 (PGE1). However, very little information as to their chemical interactions and stability is available, despite the huge amount of published work regarding their clinical efficacy. Obviously, medical and legal problems are involved.MATERIALS AND METHODS:We analyzed four kinds of vasoactive cocktails, composed of papaverine, phentolamine and PGE1 in different combinations, using High Performance Liquid Chromatography analysis after 5 to 60 days of storage at temperatures between 2 and 8C. SPSS MANOVA analysis and a t-test for paired samples were used for statistical purposes.RESULTS:Papaverine and phentolamine concentrations showed no significant variations during the 2 month study, ranging from a minimum of 96.75+/-1.20 to a maximum of 103.00+/-0.20% of the starting values. In the same period, PGE1 showed an accelerated degradation profile, reaching concentration values, after 60 days, of 76.00+/-2.28% and 70.20+/-2.02% when added to phentolamine or papaverine respectively and 70.00+/-2.40% with both.CONCLUSIONS:Papaverine and phentolamine are characterized by chemical stability when blended together or with PGE1. Papaverine and/or phentolamine increase the naturally occurring degradation of PGE1 in physiological solution. This effect is most evident in the first 10 days. Papaverine has the greatest deteriorating effect on PGE1. A safe and proper use of these cocktails should take into account the variations of PGE1 concentration.
The main aim of this double-blind randomized crossover study was to compare the efficacy and safety of alprostadil sterile powder (Caverject) (PGE1) in a new sterile powder formulation versus placebo in producing erection in patients with erectile dysfunction. Each patient was treated with 5 or 10 micrograms PGE1 and placebo in random order. If the results of the three injections were unsatisfactory, 20 micrograms PGE1 was administered in an open fashion. A total of 45 patients were recruited and evaluated; 31/45 patients (68.8%) responded to at least one injection of alprostadil. A dose-response relation was observed during the double-blind phase; the 10-micrograms dose was effective in 55.5% of patients. The acceptability and tolerability of the preparation, evaluated both clinically and by laboratory tests, was very good. In particular, only four drug-related side effects were observed, three (penile burning, penile pain and pain after injection) after 10 micrograms and one (hematoma) after 5 micrograms PGE.
The stability of prostaglandin E1(PGE1) in physiological solution for the treatment of erectile dysfunctions was investigated by liquid chromatography (HPLC). Two different HPLC procedures were used; the first included a pre-chromatographic derivatization of PGE1 with 2-bromoacetyl-6-methoxynaphthalene followed by fluorescence detection (λexc = 300 nm; λem = 460 nm), and the other was based on direct UV detection (205 nm) of the underivatized drug. The results showed that PGE1 physiological solutions can be conveniently stored at 2–8°C; under these conditions about 85% of the initial concentration remained at 90 days, while at ambient temperature rapid degradation of the drug was observed.