Evaluation of the Safety and Efficacy of Sildenafil Citrate for Erectile Dysfunction in Men With Multiple Sclerosis: A Double-Blind, Placebo Controlled, Randomized Study

Urology and Nephrology Research Center, Shahid Beheshti University, Tehran, Iran.
The Journal of urology (Impact Factor: 4.47). 12/2008; 181(1):252-8. DOI: 10.1016/j.juro.2008.09.003
Source: PubMed


We evaluated the safety and efficacy of sildenafil citrate for treating erectile dysfunction in patients with multiple sclerosis.
A total of 203 patients with multiple sclerosis (age range 18 to 50 years old) with erectile dysfunction were randomly assigned to receive 50 to 100 mg sildenafil (102 patients in group 1) or a similar regimen of placebo (101 patients in group 2) 45 minutes to 2 hours before sexual stimulation. Patients were asked to use at least 24 doses/attempts at home. Primary outcome measures consisted of responses to questions 3 and 4 from the International Index of Erectile Function questionnaires well as responses to Sexual Encounter Profile diary questions 2 and 3. We also assessed the number of attempts at sexual intercourse, the number of attempts that were successful and adverse drug effects.
Improved erections (positive response to the Global Assessment Questionnaire) were reported by 32.8% of patients receiving sildenafil and 17.6% of those receiving placebo (p = 0.04). For Sexual Encounter Profile question 2 (successful penetration) the increase from baseline in mean per patient percentage of yes responses was 29.4% after sildenafil vs 18.8% after placebo (p = 0.04). The proportion of successful sexual attempts ranged from 12% to 26% for sildenafil and from 9% to 21% for placebo, respectively (p = 0.044). Of patients taking sildenafil and placebo 24 (23.5%) and 9 (8.9%) experienced 81 and 31 adverse events, respectively (p = 0.01).
Compared with placebo, sildenafil has little effect on multiple sclerosis emergent erectile dysfunction and, therefore, cannot be recommended for the routine treatment of erectile dysfunction in patients with multiple sclerosis. This finding implies that there must be other mechanisms that are not affected by sildenafil or are resistant to the effects of sildenafil.

13 Reads
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Multiple sclerosis (MS) is a devastating neurologic disease that attacks young adults and affects all aspects of their lives. Genitourinary dysfunction in MS has a significant impact on quality of life with more than 80% of those with MS reporting genitourinary symptoms. Voiding dysfunction is a prominent problem affecting the majority of MS sufferers. Less commonly recognized, but of no less importance, is sexual dysfunction which affects both men and women with MS. At least 75% of men and 50% of women report sexual dysfunction and suspicions of under-reporting are strong. In this review, physiology of micturition, sexual functioning and disruptions in neural pathways occurring in MS that can result in the clinical syndromes of voiding dysfunction, sexual dysfunction and paraphilias will be discussed. Management of these disorders is also reviewed.
    Full-text · Article ·
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Descripción: El American College of Physicians desarrolló estas guías clínicas para presentar la evidencia disponible sobre la evaluación hormonal y el tratamiento farmacológico de la disfunción eréctil. Las terapéutica farmacológica actual incluye a los inhibidores de la 5-fosfodiesterasa (PDE-5) como el sildenafil, vardenafil, tadalafil, mirodenafil y udenafil, así como el tratamiento hormonal. Métodos: La literatura publicada sobre este tema fue identificada usando MEDLINE (1966 a mayo del 2007), EMBASE (1980 a la semana 22 del 2007), el Registro Central de Estudios Controlados Cochrane (segunda trimestre del 2007), PsycINFO (1985 a junio del 2007), AMED (1985 a junio del 2007), y SCOPUS (2006). La búsqueda bibligráfica fue actualizada buscando artículos en MEDLINE y EMBASE publicados entre mayo 2007 y abril 2009. Las búsquedas se limitaron a publicaciones en idioma inglés. Esta guía clínica establece el nivel de evidencia y el grado de recomendación utilizando el sistema de graduación de las guías clínicas del American College of Physicians.
    Preview · Article ·
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Pharmacotherapy of erectile dysfunction comprises oral and local application of drugs. Today, Yohimbin is the only drug listed for this indication. Yohimbin acts via central alpha-receptor blockade and showed a significant effect in a recent double blind study compared to placebo. The centrally acting substances Apomorphin and Trazodone were also tested for their potential use with Apomorphin showing promising results. The orally active phosphodiesterase-V inhibitor Sildenafil acts predominantly on the peripheral side; broad clinical studies demonstrated a significant effect of the drugs compared to placebo. For local use, intraurethral (MUSE) and intracavernous applications are available with PGE1 being the drug the most widely used for the moment. Since many different drugs with various modes of action and different modes of application are being developped at the moment, future pharmacological treatments will allow a more refined approach towards an individually adapted regimen.
    Preview · Article · Sep 1998 · Der Urologe
Show more