Int Urol Nephrol
DOI 10.1007/s11255-015-0972-6
UROLOGY - ORIGINAL PAPER
Effects oforal testosterone undecanoate treatment forsevere
hypospadias
ChaoChen1 ChunxiuGong2 WeipingZhang1
Received: 13 February 2015 / Accepted: 31 March 2015
Springer Science+Business Media Dordrecht 2015
Abstract
Purpose We sought to evaluate the effects of oral tes-
tosterone undecanoate treatment based on the temporary
growth of penis and the complications of surgery in chil-
dren with microphallic hypospadias.
Materials and methods A total of 72 randomized consec-
utive children with microphallic hypospadias were included
in the study from March 2011 to September 2013. While
34 children were treated with oral testosterone undecanoate
treatment prior to surgery on time (group 1), 36 children
did not receive any treatment preoperatively (group 2). All
children underwent hypospadias repair using transverse
preputial island flap (Duckett technique) urethroplasty or
combination of Duckett and ThierschDuplay techniques.
Penile length, diameter, serum testosterone level, and sec-
ondary effects were recorded before and after therapy in
group 1. Postoperative complications were assessed with
respect to fistulas, urethral strictures, diverticula, meatal
stenosis, and glanular dehiscence in both groups.
Results Mean penile length and diameter increased signif-
icantly by 1.060.53cm (P<0.05) and 0.300.09cm deformities, but the precise etiology is still undefined. The
(P<0.05). Postoperative complications included urethrocu-
taneous fistulas in nine patients (25%) in group 2 com-
pared to two patients (5.9%) in group 1 (P<0.05). While
three patients (8.3%) in group 2 had urethral strictures,
no patient in the testosterone group had this complication
* Weiping Zhang
zhangwpp@163.com
1
Department ofPediatric Urology, Beijing Childrens
Hospital, Affiliated toCapital Medical University,
Beijing100045, China
2 hormonal stimulation before surgical intervention has been
Department ofEndocrinology, Beijing Childrens Hospital,
Affiliated toCapital Medical University, Beijing100045,
China
(P>0.05). There were three patients (8.3%) with diver-
ticula in group 2 and three patients (8.9%) with this com-
plication in group 1 (P>0.05). None of our patients had
signs or symptoms of meatal stenosis, glanular dehiscence,
or residual chordee in both groups. Finally, there was a sig-
nificant difference between the overall reoperation rates of
group 2 (14 patients, 38.9%) and group 1 (five patients,
14.7%, P<0.05).
Conclusions Pretreatment with oral testosterone unde-
canoate was effective in improving the temporary penile
growth and decreasing the surgical complications in chil-
dren with microphallic hypospadias.
Keywords Oral testosterone undecanoate treatment
Microphallic hypospadias Duckett technique
Introduction
Hypospadias is one of the most common male urogenital
incidence of hypospadias is reported to be one of three hun-
dred (only boys) and keeps increasing [1]. The prevalence
of hypospadias in China increased from 1996 to 2008, and
it has been speculated that environmental exposure and
maternal age might play critical roles in the development
of hypospadias [2]. Nordenvall [3] reported an increased
incidence of hypospadias in Sweden, including mild and
severe phenotypes. The repair for hypospadias, especially
for those proximal hypospadias and small-appearing penis,
remains challenging for pediatric urologist. To make cor-
rection surgery easier and improve success rates, the use of
accepted as a relatively common practice. Previous studies
have revealed temporary increases in penile length, glans
13

circumference, and tissue vascularity with the use of pre-
operative hormonal stimulation [4, 5]. However, there are
divergences about the hormone therapy of choice, time of
use, appropriate dose, and route of application. Snodgrass
etal. [6] reported that 63% of patients met the objective
criteria for preoperative parenteral testosterone stimulation
and that androgen resistance was found in patients with
proximal hypospadias. In a randomized controlled clini-
cal trial, Kaya etal. [7] emphasized the relevance of topi-
cal application of DHT, especially in terms of the improved
local conditions of skin and the consequent reduction in
postoperative complications. Achievement of a good surgi-
cal outcome is the main purpose of using preoperative hor-
mone stimulation; nevertheless, the outcome of the surgery
is still little reported. The objective of the present study was
to evaluate the efficacy of oral testosterone undecanoate
on the growth of penis and the surgical complications in
microphallic hypospadias, in which penile length is shorter
than the normal size by 2.5 standard deviations (SD) or
more.
Materials andmethods
Patients withmicrophallic hypospadias
A total of 72 consecutive children with primary micro-
phallic hypospadias were enrolled in this study from
March 2011 to September 2013. After informed parental
consent was obtained, the children were randomized into
two groups through the Research Randomizer (www.ran-
domizer.org). Group 1 comprised 36 children who were
treated with oral testosterone undecanoate preoperatively.
Group 2 comprised 36 children who did not receive any
preoperative hormonal treatment. Their penile length
ranged from 0.8 to 2.7cm (meanSD, 1.930.44cm) length of the neourethra. The rectangular flap was mobi-
and was 42.5 SD shorter than age-matched Chinese stand-
ards [8] (Table1). All patientss chromosome was 46,
XY, and all were positive for the sex-determining region
of the Y chromosome (SRY) gene. Children with any
Table1Normal penile length in China
Age (years) Penile length (CM)
~1 3.720.56
~2 3.750.52 a combination of the Duckett and ThierschDuplay tech-
~3 3.770.45
~4 4.020.58
~5 4.080.58
~6 4.100.53
~7 4.130.51
~8 4.200.27
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Int Urol Nephrol
endocrinological or clinical evidence of hypopituitarism or
a history of hypospadias surgery were excluded from the
study.
Oral testosterone undecanoate treatment protocol
A total of 36 patients with microphallic hypospadias in
group 1 were treated with oral testosterone undecanoate at
2mg/kg/day, the maximum dose being 120mg/day. Each
treatment period was 3 months, with the goal of enlarge-
ment is the patients penile length definitely above the min-
imum (mean 2.5 SD) of the age-matched Chinese stand-
ards. On failure to reach the target length, the treatment
period can be extended (one treatment period in 26 boys,
two treatment periods in eight boys). Surgery was sched-
uled within 36months after the final dose. A total of 36
children in group 2 did not receive any hormonal treatment
preoperatively.
Surgical technique
All patients from both groups underwent hypospadias repair
using transverse preputial island flap (Duckett technique)
urethroplasty with chordee correction by the same surgeon.
A circumferential incision was made proximal to the corona
and reached the depth of Bucks fascia. The dorsal skin was
degloved toward the proximal penis, and the fibrous scar tis-
sue around the corpus spongiosum was excised to release
the chordee. The urethral plate was transected to correct
the accompanying chordee in order to release the curvature
completely. An artificial erection was induced to identify the
correction of curvature. If the curvature was not completely
corrected, dorsal plication was used to correct the refractory
penile curvature. The distance between the retracted mea-
tus and the glans tip was measured to confirm the expected
lized at the inner aspect of the dorsal prepuce according to
the length of the defect. The mobilized foreskin was rolled
into a tube over a catheter and sutured with 60 polydiox-
anone sutures. The tubularized neourethra was transposed
ventrally and anastomosed obliquely with the native ure-
thra with mucosa-to-mucosa sutures. The glans channel was
incised adequately in size, the neourethra was placed, and
the new meatus was sutured on top of the glans.
If the rectangular flap was not long enough for defect,
niques was used to repair the hypospadias. Distal urethral
repair was managed by the Duckett procedure, the proxi-
mal urethra was repaired by the ThierschDuplay technique
through the base of the phallus, and proximal and distal
urethral anastomosis was made obliquely. The neourethra
was covered with the pedicle of the flap and supported with
adjacent tissues.
Int Urol Nephrol
Table2Effects of testosterone Observations Pretreatment
treatment in group 1
MeanSD
Penile length 1.930.44cm
Diameter 1.140.15cm
Serum testosterone 0.0320.012ng/ml
FSH 1.581.23IU/l
Measurement andfollowup
Penile length and glans diameter were measured by two
trained observers before and after testosterone treatment.
Observers performed measurement independently and took
the average of two measurements as the measured value.
Penile length was obtained with a ruler placed against the
dorsum of the stretched penis, and the distance between
the tip of the glans and the pubic symphysis was measured
while depressing the suprapubic fat pad as completely as
possible [9]. Glans diameter was obtained at the point of
maximum glans width. The penile lengths before and after
the final treatment are shown in Table2. The penile length
and diameter were also repeatedly measured during opera-
tion. The serum levels of testosterone, luteinizing hormone
(LH), follicle-stimulating hormone (FSH), and liver func-
tion were examined in group 1 before and after each treat-
ment period. Side effects such as the development of pubic
hair, axillary hair, and genital pigmentation were evalu-
ated. Bone age was also checked 1year after the therapy,
by evaluating the ossification centers of the hands and
wrists. Childrens operation time was recorded. All patients
attended outpatient assessments at 1, 3, 6, and 12month
postoperatively, and then, yearly follow-up visits were
planned. The appearance of micturition and uroflowme-
try was evaluated during the follow-up period. Postopera-
tive complications were analyzed with respect to fistulas,
glanular dehiscence, urethral strictures, residual chordee,
diverticula, and meatal stenosis according to the results of
the whole follow-up. The reoperation rates due to fistula,
diverticulum, stricture, stenosis, glanular dehiscence, and
residual chordee were also assessed.
Statistical analysis
Normality was analyzed using the ShapiroWilk test. In
group 1, differences in penile length, diameter, and serum
testosterone levels before and after the testosterone treat-
ment were analyzed by the Wilcoxon signed-ranks test and
paired samples test. Differences between the two groups
were analyzed using the Chi-squared test and t test. Data
are expressed as meanSD, with statistical significance
considered at P<0.05. SPSS for Windows 17.0 software
was used for all analyses.
Posttreatment t (Z) P
MeanSD
2.990.53cm 5.096 0.001
1.440.16cm 5.120 0.001
0.0560.022ng/ml 3.58 0.001
1.411.16IU/l 1.27 0.204
Results
Two patients in group 1 were excluded because they did
not take their medicine on time; thus, 34 patients in group
1 were evaluated. Their medication dosages ranged from
10 to 40mg/day. Their penile length increased by 0.20
2.70cm after the final treatment, with a mean increase of
1.060.53cm (P=0.001) (Table2). Only three children
did not achieve the clinical goal. Diameter increased sig-
nificantly by 0.300.09cm (P=0.001). The intraopera-
tive measurements were similar to these results. Only two
childrens penile length regressed slightly, 0.2 and 0.4cm,
respectively. Serum testosterone level after the treat-
ment was significantly higher than before (P =0.001),
but still remained within the normal range (00.20ng/ml
for patients age <8years in our hospitals clinical labora-
tory) (Table2). In contrast, the serum levels of FSH and
LH were not significantly different before and after tes-
tosterone treatment (P>0.05, each). The serum testoster-
one level returned to pretreatment level only 1month after
completion of the therapy. None of these patients experi-
enced other adverse events, such as gynecomastia, a delay
in bone age, and the appearance of pubic hair or axillary
hair, and genital pigmentation.
Mean age in patients receiving testosterone treatment
before hypospadias correction (21.614.3months, range
460) was similar to that in patients not receiving testoster-
one treatment (24.215.7months, range 1058, P>0.05).
Based on the location of the urethral meatus, in group 1,
10 were proximal penile type, 15 were penoscrotal, and
9 were perineal; in group 2, 10 were proximal penile, 19
were penoscrotal, and 7 were perineal. There was no sta-
tistically significant difference between children of group
1 and group 2 concerning urethral meatus type (P>0.05).
They had different degrees of ventral penile curvature: in
group 1, 4 in 2030, 24 in 3045, 6 above 45 and in
group 2, 3 in 2030, 28 in 3045, 5 above 45. Patients
characteristics for two groups are summarized in Table3.
A total of 70 patients in both groups underwent urethro-
plasty. Five patients in group 1 and three patients in group 2
underwent a combination of Duckett and ThierschDuplay
technique, and the others underwent the Duckett procedure.
The median operation time was 106.48.9min in group
1 and 124.87.4min in group 2 (P<0.05). The median
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 Int Urol Nephrol

Table3Basic characteristics of patients in the two groups by the American Academy of Pediatrics Section of Urol-
Observations Group 1 Group 2 2
t ( ) P ogy found that 78% respondents used testosterone preop-
MeanSD MeanSD eratively in North America, and it appears that the use of
testosterone is primarily limited to patients with proximal
Number of patient 34 36 hypospadias, small-appearing penis, reduced glans circum-
Age (months) 21.614.3 24.215.7 0.708 >0.05 ference, or reduced urethral plate [10]. Although testoster-
Chordee one use is well accepted by many pediatric urologists, the
Mild 4 3 clinical value of the preoperative use of testosterone for
Moderate 24 28 hypospadias remains unclear.
Severe 6 5 0.574 >0.05 Many studies have demonstrated that the effects of tes-
Hypospadias site tosterone on penile growth and the prepuce up to the day of
Proximal penile 10 10 surgery are significant in the correction of severe cases of
Penoscrotal 15 19 hypospadias, particularly in boys with micropenis [11, 12].
Perineal 9 7 0.664 >0.05 The present study indicates that treatment with oral testos-
terone undecanoate is an effective therapeutic method for
increasing the penile length and diameter in children with
Table4Comparison of surgical complications in two groups microphallic hypospadias. The increase in penile length
Observations Group 1 Group 2 2 P paralleled the increase in glans diameter. The mean incre-
ment of penile length in this study (1.060.53cm) was
Fistula 2 9 4.825 <0.05 similar to that reported by Ishii (1.010.50cm), in which
Stricture 0 3 1.277 >0.05 intramuscular injection was used [13]. In the present study,
Diverticulae 3 3 0.005 >0.05 the side effects were minimal. Serum testosterone level
Reoperation 5 14 5.171 <0.05 after the treatment was significantly higher than before
Operation time 106.48.9min 124.87.4min 9.448 <0.05 (P=0.001), but still remained within the normal range. In
addition, the serum levels of FSH and LH did not change
significantly, which indicated that testosterone treatment
postoperative follow-up duration in group 1 and group did not suppress the hypothalamicpituitarygonadal
2 was 21months (range 1242months) and 26months axis or normal testicular growth. Moreover, none of these
(range 1546months), respectively. During the follow-up patients had signs of sexual precocity and the delay of bone
period, two patients (5.9%) in group 1 and nine patients age.
(25%) in group 2 had urethrocutaneous fistulas (P<0.05). Compared with distal hypospadias, the proximal type
No patient in group 1 and three patients (8.3%) in group usually has a higher incidence of complications. The aim of
2 had urethral strictures (P>0.05), only one patient with proximal hypospadias repair surgery is to create a straight
stricture was cured by repeated dilations, and the other two penis without chordee, a meatus at the top of the glans,
required reoperation. Three patients (8.9%) in group 1 and and a neourethra of adequate caliber [14]. Various surgical
three patients (8.3%) in group 2 had diverticula (P>0.05), techniques have been used to repair proximal hypospadias,
and no patient in either group had signs or symptoms of including tubularized incised plate (TIP), onlay island flap
meatal stenosis, glanular dehiscence, or residual chordee. (OIF), two-stage techniques, and transverse preputial island
Five patients in group 1 and 14 patients in group 2 needed flap (Duckett technique) urethroplasty [1517]. A recent
reoperations (P<0.05). Analysis of the overall complica- trend in proximal hypospadias repair has been to preserve
tions revealed that fistulas, diverticula, and urethral stric- the urethral plate and use it for urethroplasty. Urethral
tures were found in 15.7, 8.6, and 4.3% of the patients, plate mobilization and midline dorsal plication have been
respectively (Table4). performed to correct the penile curvature of hypospadias
with chordee in order to preserve the urethral plate. How-
ever, simple midline dorsal plication was reported to be
Discussion associated with a recurrence rate of 37% compared with
no curvature recurrence after simultaneous dorsal plication
The effect of hypospadias repair is related not only to the and urethral plate transection in patients who had proximal
surgeons technique and choice of correction procedure, hypospadias with severe ventral curvature [18]. Transec-
but also to the quality of available penile tissue. There- tion of the urethral plate may reduce the recurrence rate of
fore, preoperative testosterone has been described and used chordee, especially in cases of proximal hypospadias with
as a method to increase the foreskin, penile length, glans severe chordee. Additionally, in these microphallic hypo-
circumference, and neovascularity of the tissues. A study spadias cases, who had short penile length short, midline

13
Int Urol Nephrol
dorsal plication could result in penile shortening. The tubu-
larized transverse preputial flap (Duckett technique) has
been used classically to repair proximal hypospadias with
severe chordee [19, 20]. The present study included a total
of 70 patients with microphallic hypospadias accompanied
by different degrees of ventral penile curvature, most of
whom were moderate and severe curvature according to
the American Academy of Pediatrics survey, which defines
mild curvature as less than 30, moderate curvature as
between 30 and 45, and severe curvature as greater than
45 [21]. Therefore, the Duckett technique was chosen as
the major procedure in this study. This technique can lead
to some later complications such as urethral stricture [19].
During the operation, the tubularized urethra anastomosed
obliquely with the native urethra with mucosa-to-mucosa
sutures in order to reduce urethral stricture. During the
follow-up period, none of the patients in either group had
symptoms of residual or recurrent chordee. Furthermore,
all of our patients parents were satisfied with the penile
length after chordee correction and urethroplasty, which is
consistent with the findings reported by Castagnetti [22].
The overall complications in both groups revealed that fis-
tulas, diverticula, and urethral strictures were found in 15.7,
8.6, and 4.3% of the patients, respectively. The Duckett
technique was appropriate for treatment of microphallic
hypospadias.
Some studies have shown that androgens had been iden-
tified as being repressors of cutaneous repair, retarding the
healing process and increasing inflammation [23, 24]. Stern
etal. [25] established a human skin transplant model and
found that treatment of the human foreskin with testoster-
one increased its vascularity and thus possibly increased
the risk of intraoperative bleeding. In the study by Gor-
duza [26], it was striking to see that those who had testos-
terone treatment less than 3months prior to surgery pre-
sented with a much higher rate of healing complications.
The hypospadias repair should be administrated under the
condition of testosterone level return to age-matched level.
In the present study, the patients serum testosterone levels
fluctuated slightly and returned to pretreatment levels, only
1month after completion of the therapy. Therefore, we
administrated the hypospadias surgery within 36months
after the final dose. It was difficult to compare the differ-
ence in intraoperative bleeding between the two groups
because of the small amount of bleeding, subjectively;
however, we did not find any distinction.
Koff and Jayanthi [27] reported that human chorionic
gonadotropin pretreatment in infancy advances the meatus
distally to decrease the severity of chordee and appears to
improve surgical results. Sakakibara etal. [28] reported a
66.7% overall success rate after primary repair after the
use of topical testosterone cream. However, their report on
postoperative effects was totally empiric, with no objective
data or control. Since hypospadias repair is complex and
involves several variables, such as anatomical variations,
surgical technique, tissue handling, suture material, and
stenting, it is difficult to compare surgical complication
rates. In the present series, a total of 70 patients underwent
the same procedure by the same surgeon. In the cases of
meatal locations, the total number of patients with chor-
dee and mean patient ages were similar in both groups, the
number of patients with urethrocutaneous fistula and, con-
sequently, the reoperation rates were significantly higher
in group 2 compared to group 1. Although not statistically
significant, the rate of urethral stricture was higher in chil-
dren who did not receive oral testosterone undecanoate
treatment. With respect to complications from all of these
consecutive patients, our results are consistent with other
studies in the literature [26]. At the same time, we found
that the penile tissue of the patients in group 1 was soft
and able to be easily separated and released during the
operation. The operation time was shorten. The preopera-
tive oral testosterone undecanoate therapy definitely made
the repair less difficult and decreased the risk of surgical
complications.
Conclusions
Based on our experience, it can be concluded that the oral
testosterone undecanoate therapy prior to hypospadias
repair is beneficial in children with microphallic hypospa-
dias. Significant penile growth was seen in the children
treated with testosterone. Side effects were minimal and
self-limiting. Moreover, pretreatment with oral testosterone
undecanoate is beneficial to decreasing the complication
and reoperation rates of hypospadias repair.
Acknowledgments This work was supported by grants from the
Specialized Research Fund for the Doctoral Program of Higher Edu-
cation (20111107110007).
Conflict of interest The authors declare that they have no conflict
of interest.
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