PMID- 30323234
OWN - NLM
STAT- MEDLINE
DCOM- 20190701
LR  - 20190701
IS  - 1476-5489 (Electronic)
IS  - 0955-9930 (Linking)
VI  - 31
IP  - 2
DP  - 2019 Mar
TI  - The intra-meatal application of alprostadil cream (Vitaros(R)) improves drug 
      efficacy and patient's satisfaction: results from a randomized, 
      two-administration route, cross-over clinical trial.
PG  - 119-125
LID - 10.1038/s41443-018-0087-6 [doi]
AB  - To investigate the efficacy, tolerability, and patient's preference of 
      alprostadil cream for topical use administered within the urethral meatus versus 
      the standard administration route, in erectile dysfunction (ED) treatment. 
      Seventy-one patients (mean age 59.7 +/- 9.0 years) affected by ED were analyzed in 
      this multicenter, randomized, two-administration routes, cross-over trial. All 
      patients received a single dose of alprostadil cream applying the dispenser to 
      the tip of the penis (without contacting the urethral meatus) (Standard 
      administration route or ST.AR) alternating with a single dose of alprostadil 
      cream applying the dispenser within the urethral meatus (New administration route 
      or NEW.AR) separated by a one-week washout period, according to randomization. 
      The primary objective of the study was to evaluate the change in International 
      Index of Erectile Function (IIEF-5) total score from baseline to the control 
      visit by comparing the ST.AR and NEW.AR. Secondary objectives of the study were 
      to compare the different methods of administration by evaluating the change in 
      the Sexual Encounter Profile (SEP-2 and SEP-3) questionnaire score and the 
      Patient Reported Outcomes (PROs) by scoring the Patient Self-Assessment of 
      Erection (PSAE) questionnaire. The treatment safety profile was assessed by 
      analysis of adverse events (AEs). Based on the study findings it is evident that 
      the NEW.AR is more efficacious than the ST.AR in improving IIEF-5 and SEP scores 
      from baseline to control visit (IIEF-5: +3.8 vs +6.3; p < 0.001; positive 
      response to SEP-2: 10 vs 27; p = 0.002) and in terms of PSAE (a significant 
      improvement from the baseline in 31% of patients; p < 0.001). As regards the 
      safety profile, no difference in terms of local and systemic side effects was 
      found.
FAU - Cai, Tommaso
AU  - Cai T
AD  - Department of Urology, Santa Chiara Regional Hospital, Trento, Italy.
FAU - Palumbo, Fabrizio
AU  - Palumbo F
AD  - San Giacomo Hospital, Monopoli, BA, Italy.
FAU - Liguori, Giovanni
AU  - Liguori G
AD  - Department of Urology, University of Trieste, Trieste, Italy.
FAU - Mondaini, Nicola
AU  - Mondaini N
AD  - Urology Unit, Nuovo San Giovanni di Dio Hospital, Florence, Italy.
FAU - Scroppo, Fabrizio Idelfonso
AU  - Scroppo FI
AD  - Urology Unit, Ospedale di Circolo di Varese, Varese, Italy.
FAU - Di Trapani, Danilo
AU  - Di Trapani D
AD  - Urology Unit, Buccheri La Ferla Fatebenefratelli Hospital, Palermo, Italy.
FAU - Cocci, Andrea
AU  - Cocci A
AD  - Department of Urology, University of Florence, Florence, Italy.
FAU - Zucchi, Alessandro
AU  - Zucchi A
AD  - Department of Urology, University of Perugia, Perugia, Italy.
FAU - Verze, Paolo
AU  - Verze P
AD  - Department of Neurosciences, Reproductive Sciences, Odontostomatology - Urology 
      Unit, University of Naples "Federico II", Naples, Italy. pverze@gmail.com.
FAU - Salonia, Andrea
AU  - Salonia A
AD  - Department of Urology, University Vita e Salute, San Raffaele, Milan, Italy.
FAU - Palmieri, Alessandro
AU  - Palmieri A
AD  - Department of Neurosciences, Reproductive Sciences, Odontostomatology - Urology 
      Unit, University of Naples "Federico II", Naples, Italy.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20181015
PL  - England
TA  - Int J Impot Res
JT  - International journal of impotence research
JID - 9007383
RN  - 0 (Ointments)
RN  - 0 (Vasodilator Agents)
RN  - F5TD010360 (Alprostadil)
SB  - IM
MH  - Administration, Topical
MH  - Aged
MH  - Alprostadil/*administration & dosage
MH  - Cross-Over Studies
MH  - Erectile Dysfunction/*drug therapy
MH  - Humans
MH  - Italy
MH  - Male
MH  - Middle Aged
MH  - Ointments
MH  - Patient Reported Outcome Measures
MH  - Penile Erection/*drug effects
MH  - Penis/drug effects
MH  - Sexual Behavior
MH  - Vasodilator Agents/*administration & dosage
EDAT- 2018/10/17 06:00
MHDA- 2019/07/02 06:00
CRDT- 2018/10/17 06:00
PHST- 2018/06/08 00:00 [received]
PHST- 2018/09/20 00:00 [accepted]
PHST- 2018/08/28 00:00 [revised]
PHST- 2018/10/17 06:00 [pubmed]
PHST- 2019/07/02 06:00 [medline]
PHST- 2018/10/17 06:00 [entrez]
AID - 10.1038/s41443-018-0087-6 [pii]
AID - 10.1038/s41443-018-0087-6 [doi]
PST - ppublish
SO  - Int J Impot Res. 2019 Mar;31(2):119-125. doi: 10.1038/s41443-018-0087-6. Epub 
      2018 Oct 15.