Ronas Med.
Medical Journal
Krajka K , Lauer W, Perkowski D, Markuszewski M, Matuszewski M Departament of Urology, Medical University in Gdan´sk, Poland Introduction: In last years we have been observing an increase of ... More 1. Introduction: The penile extender, a non-surgical device that employs progressive mechanical traction to the penis, has been claimed to produce significant improvement in penile length and circumference both in ... More
Journal
Penile extender
 Penile extender

1. Introduction:
The penile extender, a non-surgical device that employs
progressive mechanical traction to the penis, has been
claimed to produce significant improvement in penile length
and circumference both in the flaccid and the erect state. Little
scientific evidence, based to our knowledge exclusively on
abstracts presented to international conferences, supports the
potential clinical utility of the penile extender (Colpi GM, 2001;
Moncada I, 2005).
In the current study we
assessed a marketed brand
of penile extender, the
device, in a
phase II single arm study
that was powered to detect
significant changes in penile
size.
2. Material and methods:
2.1.- Patients eligibility:
Patients complaining of “small penis” and highly motivated to
receive effective treatment were considered eligible for the
study. Patients seeking exclusively a circumference augmentation
were excluded.
For study entry, a psychosexual counselling was required to select
those for whom the treatment was deemed beneficial from
the psychological point of view. Penile shortening following corporoplasty
for curvature of the shaft was an inclusion criteria
provided a minimum of 6 months from surgery had elapsed with
no residual curvature.
An hypoplastic penis was defined by any flaccid and stretched
length equal or below 4 and 7.5 cm respectively, the lower cutoff
of the normal reference value (Ponchietti et al, 2001). Any
size above constituted a penile dysmorphophobia, a condition
where a patient with a normal sized penis is dissatisfied with its
dimensions in the flaccid and/or the erect state (Austoni E,
2002). Patients complaining of shortening following penile surgery
were considered as a separate subgroup.
2.2.- Study endpoints:
Changes in flaccid and stretched penile length and circumference
over baseline after 6 months of treatment and durability
of the response at 1 year after treatment discontinuation were
considered the primary study end point. These were defined
also taking into account the “efficacy data” suggested by the
patient’s information sheet provided by the Company (Andromedical,
Madrid, Spain; Gomez EA, 2001).
Treatment tolerability, patient’s compliance and satisfaction as
well as changes in the IIEF erectile function domain (EF) scores
at last follow up over baseline constituted secondary end points
2.3.- Device description and treatment schedule:
Extender
device designed to exert a continuous and
gradually increasing traction force on the penis. The device
consists of a plastic ring, where the penis is introduced and
from where 2 dynamic metallic rods originate the traction. In
the superior part there is a plastic support where a silicone
band holds the glans in place. Detailed instructions on how to
increase the traction force from 600 gr during the 1st month,
900 gr during 2nd month, up to 1200 gr during 5th y 6th month
were provided following the manufacturer’s leaflet.
Patients were requested to wear the device preferably for 6
hours (and no less than 4 hours) daily and consecutively for an
optimal duration time of 6 months according to the
manufacturer suggestions.
3. Results:
From 2005 to 2007 50 patients with hypogonadism addressed
to the clinic for the penis enlargement. The causes of hypogonadism
were Kallmann syndrome, anorchism, cryptorchism,
previous traumas, inflammatory diseases of testicles in the
anamnesis and Kleinfelter syndrome.