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Have you read ? Best of the Best: Clinical
A brief summary of the best papers and abstracts published in the main journals
related to Sexual Medicine
by Nicola Mondaini
dr. nicola Mondaini
Associate Editor
Department of Urology
Ospedale Santa Maria Annunziata
(Ponte a Niccheri)
Via dell’Antella, 58 – Bagno a Ripoli
Florence, Italy
Erectile Function
Montorsi F et alt:
Effects of Tadalafil Treat-
ment on Erectile Function Recovery Follow-
ing Bilateral Nerve-sparing Radical Prosta-
tectomy: A randomised placebo-controlled
study (REACTT).
Eur Urol. 2013 Oct 13.
The potential rehabilitative and protective effect
of phosphodiesterase type 5 inhibitors (PDE5-Is)
on penile function after nerve-sparing radical
prostatectomy (NSRP) remains unclear. The
primary objective was to compare the efficacy
of tadalafil 5mg once daily and tadalafil 20mg
on demand versus placebo taken over 9 mo in
improving unassisted erectile function (EF) fol-
lowing NSRP, as measured by the proportion of
patients achieving an International Index of Erec-
tile Function-Erectile Function domain (IIEF-EF)
score
≥
22 after 6-wk drug-free washout (DFW).
Secondary measures included IIEF-EF, Sexual
Encounter Profile question 3 (SEP-3), and pe-
nile length. Randomised, double-blind, double-
dummy, placebo-controlled trial in men
≤
68 yr of
age with adenocarcinoma of the prostate (Glea-
son
≤
7) and normal preoperative EF who under-
went NSRP at 50 centres from nine European
countries and Canada.1:1:1 randomisation to 9
mo of treatment with tadalafil 5mg once daily,
tadalafil 20mg on demand, or placebo followed
by a 6-wk DFW and 3-mo open-label tadalafil
once daily (all patients). Logistic regression,
mixed-effects model for repeated measures, and
analysis of covariance, adjusting for treatment,
age, and country, were applied to IIEF-EF scores
≥
22, SEP-3, and penile length. Four hundred
twenty-three patients were randomised to tada-
lafil once daily (n=139), on demand (n=143),
and placebo (n=141). The mean age was 57.9
yr of age (standard deviation: 5.58 yr); 20.9%,
16.9%, and 19.1% of patients in the tadalafil
once daily, on demand, and placebo groups,
respectively, achieved IIEF EF scores
≥
22 after
DFW; odds ratios for tadalafil once daily and on
demand versus placebo were 1.1 (95% confi-
dence interval [CI], 0.6-2.1; p=0.675) and 0.9
(95% CI, 0.5-1.7; p=0.704).
At the end of double-blind treatment (EDT), least
squares (LS) mean IIEF-EF score improvement
significantly exceeded the minimally clinically
important difference (MCID:
Δ
IIEF-EF
≥
4) in both
tadalafil groups; for SEP-3 (MCID
≥
23%), this
was the case for tadalafil once daily only. Treat-
ment effects versus placebo were significant
for tadalafil once daily only (IIEF-EF: p=0.016;
SEP-3: p=0.019). In all groups, IIEF-EF and
SEP-3 decreased during DFW but continued to
improve during open-label treatment. At month
9 (EDT), penile length loss was significantly re-
duced versus placebo in the tadalafil once daily
group only (LS mean difference 4.1mm; 95%
CI, 0.4-7.8; p=0.032). Tadalafil once daily was
most effective on drug-assisted EF in men with
erectile dysfunction following NSRP, and data
suggest a potential role for tadalafil once daily
provided early after surgery in contributing to the
recovery of EF after prostatectomy and possibly
protecting from penile structural changes. Unas-
sisted EF was not improved after cessation of
active therapy for 9 months.
Shim YS:
Effects of daily low-dose treatment
with phosphodiesterase type 5 inhibitor on
cognition, depression, somatization and
erectile function in patients with erectile dys-
function: A double-blind, placebo-controlled
study.
Int J Impot Res. 2013 Nov 28.
Phosphodiesterase type 5 (PDE5) inhibitors
have recently been shown to have cognitive-
enhancing effects in animal models and in our
previous pilot study. To investigate the efficacy
of daily low-dose treatment with a PDE5 inhibitor
on cognitive function, depression and somatiza-
tion in patients with erectile dysfunction (ED),
8-week, double-blind, placebo-controlled study
enrolled 60 male patients with ED for
≥
3 months
without cognitive impairment. Forty-nine patients
completed the study. Patients were randomized
to receive either daily low-dose udenafil 50mg
or placebo for 2 months. The International In-
dex of Erectile Function-5 (IIEF-5), the Korean
version of the Mini-Mental State Examination
(K-MMSE) for general cognitive function and the
Seoul Neuropsychological Screening Battery for
comprehensive neuropsychological examination,
the Physical Health Questionnaire-9 (PHQ-9)
for depression and the Physical Health Ques-
tionnaire-15 (PHQ-15) for somatization were
administered at baseline and at 2 months. The
change in the mean IIEF-5 was significantly
higher in the udenafil group than the placebo
group (6.08±4.72 vs 2.20±3.50, P=0.008).
The changes in the PHQ-9 and PHQ-15 were
-2.04±3.14 and -2.17±2.87 in the udenafil
group, and 1.20±1.63 and 0.56±2.48 in the
placebo group (both P<0.001). The changes
in the K-MMSE and Digit Span Forward were
1.25±1.26 and 0.92±1.02 in the udenafil
group, and -0.52±1.19 and -0.24±1.13 in the
placebo group (both P<0.001). However, there
were no differences in the other neuropsycho-
logical tests. Daily dosing with a PDE5 inhibitor
seems to improve cognitive function, depression
and somatization, as well as erectile function, in
patients with ED.
Fertility
Lotti F et alt:
Seminal, clinical and colour-Dop-
pler ultrasound correlations of prostatitis-
like symptoms in males of infertile couples.
Andrology. 2013 Nov 28.
‘Prostatitis-like symptoms’ (PLS) are a cluster of
bothersome conditions defined as ‘perineal and/
or ejaculatory pain or discomfort and National
Institutes of Health-Chronic Prostatitis Symp-
tom Index (NIH-CPSI) pain subdomain score
≥
4’ (Nickel’s criteria). PLS may originate from
the prostate or from other portions of the male
genital tract. Although PLS could be associated
with ‘prostatitis’, they should not be confused.
