Randomized Clinical Trial Comparing
Effectiveness of Intracorpus Spongiosum
Block Versus Topical Anesthesia for
Performing Visual Internal Urethrotomy
for Urethral Stricture Disease
Bastab Ghosh, Lalgudi N. Dorairajan, Santosh Kumar, Ramanitharan Manikandan,
Kaliyaperumal Muruganandham, and Avijit Kumar
To compare the efficacy and safety of intracorpus spongiosum block (ICSB) over topical anes-
thesia for performing visual internal urethrotomy (VIU) in a randomized clinical trial.
VIU for urethral stricture can be performed under various types of anesthesia, including topical
anesthesia. Although recent studies have shown that ICSB and general anesthesia have
comparable efficacy for performing VIU, no studies have compared ICSB with topical anesthesia.
Forty consenting patients with single, short, passable anterior urethral stricture were randomized
into two groups. Group 1 patients received topical 2% lignocaine jelly and group 2 patients
received 1% lignocaine ICSB for undergoing VIU. Pain perception during and after the procedure
was assessed by visual analog scale (VAS). The changes in vital parameters during the procedure
and procedure-related complications were recorded. Statistical analysis was done using the
Mann-Whitney test or t test.
The mean ? standard deviation VAS scores intraoperatively (2.85 ? 1.34) and at 1-hour
postoperatively (1.17 ? 0.96) were significantly lower (P <.01) in group 2 patients than the
corresponding scores in group1(4.9 ?1.9and 2.35?1.34 respectively).The intraoperativerise in
and 11.3 ? 6.44 mm Hg) than in group 2 (8.05 ? 5.54/min and 6.35 ? 5.86 mm Hg).
ICSB is safe and more effective than topical anesthesia for providing pain relief during VIU.
This should become the local anesthesia technique of choice for performing VIU.
204e207, 2013. ? 2013 Elsevier Inc.
segment bulbar urethral strictures. Traditionally, VIU is
performed under general or regional anesthesia.2Several
under topical anesthesia to reduce the cost and hospital
stay.2-4In our institution, we have been performing VIU
under topical anesthesia, but some patients expressed
dissatisfaction with the anesthetic effect and reported
experiencing significant pain during the procedure.
A few studies have described the procedure under
intracorpus spongiosum block (ICSB), with fairly good
isual internal urethrotomy (VIU) is one of the
most commonly practiced treatments for urethral
stricture disease.1It is most useful for short-
analgesic effect.5,6This novel technique was described as
a simple, inexpensive, safe, and effective procedure with
efficacy comparable to general or spinal anesthesia in
a recent nonrandomized study.7One study recently
compared the efficacy of combined ICSB and topical
anesthesia with topical anesthesia alone and reported
significantly less pain in the combined anesthesia group.8
In the present study, we wished to find out if the tech-
nique of ICSB is safe and comparable or better than
topical anesthesia in a randomized clinical trial.
MATERIAL AND METHODS
After obtaining Institutional Review Board approval, we
approached and assessed patients who required VIU for the
treatment of urethral stricture disease as determined by the usual
policy of the department. All patients aged older than 18 years
with single passable anterior urethral stricture of 2 cm or less
were assessed. Detailed history and examination was obtained to
Financial Disclosure: The authors declare that they have no relevant financial interests.
From the Department of Urology, Jawaharlal Institute of Postgraduate Medical
Education and Research, Puducherry, India
Reprint requests: Lalgudi N. Dorairajan, M.Ch., Professor of Urology, JIPMER,
Puducherry 605006, India. E-mail: firstname.lastname@example.org
Submitted: August 5, 2012, accepted (with revisions): September 19, 2012
ª 2013 Elsevier Inc.
All Rights Reserved
ascertain stricture etiology and associated comorbidities. The
stricture length, location (proximal bulbar, midbulbar, and distal
bulbar/penobulbar), and passability were determined by retro-
grade urethrography (RGU). Sterile urine was mandatory before
surgical intervention. The study excluded patients with multiple
strictures, stricture of fossa navicularis, stricture length of more
than 2 cm, known allergy to lignocaine, associated urologic
comorbidities (eg, urethral or vesical calculus, benign prostatic
hyperplasia, and neurovesical dysfunction), and patients with
significant cardiovascular disease.
After patients provided written informed consent, they were
randomized into 1 of 2 groups. Group 1 patients received topical
anesthesia by instillation of 2% lignocaine jelly, and group 2
patients received ICSB with 1% lignocaine injection as an
anesthetic agent before VIU was performed. The sample size of
60 (30 in each group) was originally planned on the basis of
similar studies performed previously. However, the study was
terminated with a highly significant difference being noted on
interim analysis after 40 patients were recruited. The 40 patients
were prospectively randomized into 2 groups of 20 patients each,
based on computer-generated random numbers using block
randomization with block size of 10. Allocation concealment
was executed by using sealed envelopes that were opened in the
operating room by the surgeon performing the procedure after
the patient consented to participate in the study.
Detailed Technique of Anesthesia and Surgical
All the patients received an intravenous morphine injection
(0.1 mg/kg of body weight) 20 minutes before the procedure to
reduce anxiety. Pulse rate and blood pressure were monitored
before starting and throughout the procedure. Changes in vital
parameters were also recorded throughout the procedure. All
patients received preoperative antibiotics.
In group 1 patients, 2% lignocaine jelly (10 mL) was instilled
through the urethral meatus, and the meatus was kept clamped
for 10 minutes to allow the anesthetic agent to act. In group 2
patients, 1% lignocaine (3 mL) was injected using a 26-gauge
needle on the dorsal surface of the glans penis, slowly over
a period of 1 minute. The glans penis was compressed for
10 minutes for the bleeding to stop and to achieve the desired
anesthetic effect. In this group, water-soluble nonanesthetic
lubricant jelly was used for introduction of the VIU sheath.
All the procedures were done with the patient in the
lithotomy position. A standard Sachse urethrotomy knife was
used under guidance of a 0.035-inch guidewire. A single
12 o’clock incision was made. Complete incision of the stricture
was deemed achieved once the 21F sheath passed freely into the
bladder. The procedure was concluded and an 18F Foley
catheter was left for 5 days.
Parameters Studied and Statistical Analysis
All patients were assessed in the recovery room 1 hour after the
procedure for pain perception at that time and for pain
perceived during the procedure with the help of a visual analog
scale (VAS). The VAS consisted of scores 0 through 10, where
0 represents no pain and 10 reflects maximum pain. Assessment
of pain was done 1 hour after the procedure by a nurse in the
postoperative ward who was not involved in the surgical
procedure. The increase in pulse rate (preoperative vs maximum
perioperative pulse rate) and the change in systolic blood
pressure (SBP) during the procedure compared with the baseline
were recorded for each patient as an objective indicator of the
sympathetic response to pain.
Intraoperative complications, if any, of VIU and of the
anesthesia techniques were also recorded. Strictures were clas-
sified into 4 categories according to the etiology: traumatic,
inflammatory, iatrogenic, and idiopathic. The stricture location
was classified as proximal bulbar, midbulbar, and distal bulbar/
penobulbar stricture; however, this was not taken into consid-
eration before randomization.
Comparison of collected data between the 2 groups was done
using the Mann-Whitney test or t test as appropriate for
continuous variables. Statistical analysis of the VAS scores and
test. All statistical analyses were carried out at 5% level of
significance, and a P value <.05 was considered significant.
The study was conducted in a tertiary care institution.
From January 2010 to July 2011, 47 patients were
assessed. Three patients refused to participate in the
study. Four patients were excluded because they did not
meet eligibility criteria. The remaining 40 patients were
randomized into 2 groups of 20 patients each (Fig. 1).
The patients in both groups had matching baseline
variables, including mean age, preoperative blood pres-
sure and pulse rate, and length, location, and etiology of
the stricture (Table 1).
VIU was successfully completed in all patients in both
groups. The mean (?standard deviation) intraoperative
VAS score was 2.85 ? 1.34 in group 2, which was signif-
icantly less (P¼.0007)than the 4.9 ?1.9 score in group 1
(Fig. 2). The mean 1-hour postoperative VAS score was
also significantly lower (P ¼ .0067) in group 2 patients
(1.17 ? 0.96) than in group 1 patients (2.35 ? 1.34).
Figure 3 gives the 1-hour postoperative VAS score of each
Assessed for eligibility (n= 47)
Excluded (n= 7)
Not meeting inclusion criteria
Declined to participate (n=4)
Analyzed (n= 20)
Received allocated intervention
Allocated to intervention (n=20)
Received allocated intervention
Allocated to intervention (n= 20)
Randomized (n= 40)
Figure 1. Consolidated Standards of Reporting Trials
(CONSORT) flow diagram shows patient involvement and
exclusions in each group.
UROLOGY 81 (1), 2013
patient in the 2 groups. The change in pulse rate (preop-
erative vs maximum perioperative) was significantly
greater in group 1 (13 ? 5.1 beats/min) than in group 2
also significantly higher in group 1 (11.3 ? 6.44 mm Hg)
than in group 2 (6.35 ? 5.86 mm Hg, P ¼ .015).
All patients were discharged the next day, according to
institutional policy. The antibiotic was continued post-
operatively until the catheter was removed. The Foley
catheter was removed after 5 days in all patients except
for a patient in group 2 who developed urinary extrava-
sation (Clavien grade I). He was treated conservatively,
and the urethral catheter was removed after 7 days. All
anesthesia-related complications were noted.
After the introduction of VIU by Sachse, there was
a tremendous enthusiasm to establish this procedure as
a substitute of urethroplasty. The practice of VIU remains
widespread and popular among urologists because it is easy
procedure time and less morbidity.8Baring a few,
contemporary studies have shown good long-term
outcomes of VIU for short-segment strictures with super-
ficial spongiofibrosis.9-13When performed under local
anesthesia, it reduces time in the operating theater and the
risks and hazards associated with general or spinal anes-
thesia as well.4,7Furthermore, performing VIU under
general and regional anesthesia requires the presence of
a qualified anesthesiologist and also increases the overall
cost of the procedure substantially.
To overcome this problem, a variety of local analgesic
techniques have been applied.2-7,14Ye et al5showed the
feasibility of ICSB for performing VIU. Ather et al7
compared ICSB with general anesthesia for VIU and
showed this novel technique was equally effective and
beneficial. They found this technique to be safe and cost-
effective, too. Recently, Kumar et al8compared the
spongiosum block along with intraurethral lignocaine
vs intraurethral lignocaine alone. To date, however,
no study has directly compared ICSB with topical
Table 1. Patient characteristics in both groups
VariableGroup 1 Group 2
Stricture length, cm
Pulse rate, beats/min
SBP, mm Hg
40.95 ? 16.28
17.8 ? 22.1
1.28 ? 0.54
46.2 ? 15.03
36.5 ? 75.6
1.35 ? 0.51
75.15 ? 10.74
130.35 ? 10.12
72.45 ? 7.45
131.45 ? 9.97
SBP, systolic blood pressure.
Continuous data are shown as the mean ? standard deviation and discrete data as number.
Figure 2. Comparative intraoperative visual analog scale
(VAS) scores are shown for patients who received intracorpus
spongiosum block (ICSB) and topical anesthesia (Topical).
(Color version available online.)
Figure 3. The 1-hour postoperative pain scores on the visual
analog scale (VAS) are shown for 20 consecutive patients
who received intracorpus spongiosum block (ICSB) or topical
anesthesia (Topical). (Color version available online.)
UROLOGY 81 (1), 2013
Most of the strictures in both groups of our study Download full-text
population were pure bulbar strictures. Although there
was no restriction for selection, we did not find a suitable
pure penile urethral stricture. Etiologically, most of the
strictures were of idiopathic origin in both groups, with
traumatic and inflammatory strictures following thereafter
in the total number of cases.
In the present study, we could finish the procedure in
all patients, indicating the effectiveness of both tech-
niques, and the procedures were performed by various
surgeons, which reflects the easy applicability of both
techniques. However, the intraoperative VAS score was
significantly higher in the topical anesthesia group,
reflecting the superior analgesic effect of ICSB compared
with topical lignocaine anesthesia. The postoperative
VAS scores were also significantly higher in the topical
anesthesia group, representing the longer anesthetic effect
of ICSB. Along with the subjective evidence of superior
analgesic effect of ICSB, there were objective data too, as
evidenced by the significantly higher change in pulse rate
and SBP in the topical anesthesia group.
No complication attributable to the anesthetic tech-
nique was encountered. One patient in the ICSB group
developed urinary extravasation, which had no relation-
ship the anesthesia technique. Although Ather et al7and
Kumar et al8as well reported using a rubber tourniquet at
the base of the penis to prevent the rapid washout of
lignocaine to the venous blood, we did not find this was
necessary. Instead, we injected lignocaine (on the glans)
slowly over 10 minutes, which gave sufficient time for the
drug to fix to the tissue. As a result, there was no ligno-
caine toxicity despite achieving good analgesic effect. We
used a fixed dose of morphine in all patients as a depart-
mental protocol, which contributed to the analgesic
effect along with eliminating the anxiety. However, this
analgesic effect of morphine was applicable to patients in
both groups and is therefore unlikely to have had any
effect on the analysis.
We kept all patients admitted overnight due to hos-
pital policy based on logistic reasons; however, there was
no compelling reason to give any of the patients in-
hospital care. All of the patients were fit enough to be
discharged after 1 hour. Although the outcome of VIU
was not included in our study, only 2 patients, 1 from
each group, had recurrent stricture throughout the study
period of 1.5 years. All the patients were satisfied with the
anesthetic effect of ICSB and agreed to opt for similar
anesthesia if needed in future. However, documentation
of such data was beyond the scope of this study.
Being a surgical trial, it was not possible to blind the
surgeon or the patient. We did not think it ethical to
perform a sham injection in the topical group. However,
the nurses in the postoperative ward who obtained the
data on pain scores were not specifically informed about
the type of anesthesia applied, and thus we tried to limit
the bias. One limitation of our study is that we did not
separately document the pain perceived while injecting
on the glans for ICSB, which might have added some
discomfort and may have been reflected in the VAS
score. However, we believe that the pain due to the
injection should have been reflected in the overall
intraoperative and postoperative VAS scores. Yet, these
scores were significantly less in the ICSB group than in
the topical anesthesia group; therefore, the pain due to
the glans injection was likely not very significant.
The ICSB is a more effective technique than topical
anesthesia for providing pain relief during VIU and is also
a safe procedure. In view of its proven efficacy and safety,
ICSB should be the preferred technique of anesthesia for
VIU, particularly in patients at high risk for general
anesthesia, such as those with significant pulmonary
disease. However, this could also become the anesthesia
technique of choice for performing VIU of anterior
urethral strictures on an outpatient basis in general in
view of the cost advantages.
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