title: Evaluation of male sexual function in patients with Lower Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH) treated with a phytotherapeutic agent (Permixon), Tamsulosin or Finasteride.
abstract: OBJECTIVE
  Sexual function is one of the aspects in the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) that has gained increasing attention. We compared the influence on men's sexuality of Permixon, a lipido-sterolic extract of Serenoa Repens, with Tamsulosin and Finasteride using a specific validated questionnaire exploring patient's sexual functions.
  
  
  METHODS
  A database was created comprising patients from 3 main double-blind, randomized studies - Permixon vs. Finasteride, Permixon vs. Tamsulosin and Permixon 160 mg vs. 320 mg including a total of 2511 patients. Three hundred fifty four were on Tamsulosin, 545 on Finasteride and 1612 patients on Permixon. LUTS were assessed using the I-PSS questionnaire. Peak flow rates and prostate volume were recorded. The MSF-4 questionnaire, including 4 items that explore the patient's interest in sex, quality of erection, achievement of orgasm and ejaculation, was used across the studies. This questionnaire was demonstrated as highly reproducible and both psychometrically and clinically valid across different cultures. Correlation coefficients were given to assess the linear relationship between continuous variables.
  
  
  RESULTS
  At 3 months, there were no statistically significant differences between the three treatment groups in terms of I-PSS or Qmax evolutions (all p values > 0.05). At 6 months, as compared to pretreatment data, there was a slight increase in sexual disorders in Tamsulosin (+0.3) and Finasteride (+0.8) treated patients while it slightly improved with Permixon therapy (-0.2). Ejaculation disorders were the most frequently reported side effects after Tamsulosin or Finasteride (both +0.2 on the specific MSF-4 question 4). There was no correlation between the evolution of the MSF-4 scores and the evolution in I-PSS neither in patients treated with Permixon, Finasteride or Tamsulosin. However, there was a slight correlation between the MSF-4 score at baseline and the I-PSS at baseline (r2 = 0.032). Although there was a correlation between the MSF-4 and age at baseline (r2 = 0.1452), there was no correlation between the evolution in MSF-4 during therapy and the age of the patients.
  
  
  CONCLUSIONS
  The present study demonstrates that Permixon therapy has no negative impact on male sexual function. Both Finasteride and Tamsulosin had a slight impact on sexual function, especially on ejaculation, although these effects were rare and in line with previous reports about these two drugs.
authors.affiliation: Department of Urology, Erasme Hospital, University Clinics of Brussels, 808 route de Lennik, B-1070 Brussels, Belgium. azlotta@ulb.ac.be
authors.forename: Alexandre R
authors.initials: AR
authors.lastname: Zlotta
authors.forename: Pierre
authors.initials: P
authors.lastname: Teillac
authors.forename: Jean Pierre
authors.initials: JP
authors.lastname: Raynaud
authors.forename: Claude C
authors.initials: CC
authors.lastname: Schulman
mesh_terms: D000317:Adrenergic alpha-Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000726:Androgen Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D018120:Finasteride / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D028024:Serenoa / Q000009:adverse effects; D012725:Sexual Behavior / Q000187:drug effects*; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D000077409:Tamsulosin; D016896:Treatment Outcome; D014563:Urodynamics / Q000187:drug effects
chemical_list: D000317:Adrenergic alpha-Antagonists; D000726:Androgen Antagonists; D004791:Enzyme Inhibitors; D010936:Plant Extracts; D013449:Sulfonamides; D018120:Finasteride; D000077409:Tamsulosin; C040972:saw palmetto extract