Shinshu Med J, 65⑹：355～359, 2017

Safety and Pain-relief Efficacy of Urethral Catheter withLocal-anesthetic Injection PortTeppei Yamamoto＊, Masashi Shiozaki, Yuji Shimojima, Tomomi Haba
Tomohiko Oguchi, Kazuyoshi Iijima and Haruaki Kato
Department of Urology, Nagano Municipal HospitalObjectives : The NMOC 3-Way Catheter®(NMOC) functions as a conventional urethral catheter, but has alumen for injection of local anesthetics. Available in Japan, the NMOC is reported to alleviate catheterassociated postoperative discomfort and pain at the time of catheter withdrawal. We investigated the safety andefficacy of pain reduction of the NMOC compared with a conventional urinary catheter during high-dose-ratebrachytherapy (HDRB) of the prostate.
Methods : The NMOC (16 Fr, 10-ml cuff) was placed in 20 patients undergoing HDRB (NMOC group) ; 10 ml of
4% lidocaine was administered to the urethra through the injection port. A conventional catheter (16 Fr, 10-mlcuff) was placed in 10 additional HDRB patients (control group). Patients assessed their pain with a numericalrating scale (NRS) and face scale (FS). Higher scores indicated greater pain. The Mann-Whitney U test wasused for statistical analysis ; p<0.05 was considered statistically significant.
Results : There were no differences in patient background between the control and NMOC groups. Pain scores
were significantly lower in the NMOC group than in the control group both at the time of catheter exchange
and during catheter manipulation. The frequency of analgesia use through the following morning did notdecrease with NMOC use. However, the median time before first use of analgesics for catheter tractionassociated pain was about 2 hours longer with NMOC use than in the control group. Median pain scores at thetime of drug injection were 0 according to both NRS and FS. No complications occurred with NMOC use.
Conclusion : The NMOC was safely used in patients after HDRB of the prostate, and effectively reduced pain
during catheter exchange and catheter manipulation better than a conventional urethral catheter. Shinshu Med
J 65 : 355―359, 2017
(Received for publication June 22, 2017 ; accepted in revised form August 9, 2017)
Key words : urethral catheter, local anesthesia, 3-way catheter, urethral pain,
high-dose-rate brachytherapy
Abbreviations : Catheter, urethral catheter ; NMOC, NMOC 3-Way Catheter®; HDRB, high-dose-ratebrachytherapy ; NRS, Numerical Rating Scale ; FS, Face Scale
Ⅰ Introduction

reducing strategy for patients with catheters, except
for symptomatic therapy that depends on analgesics.

Indwelling urethral catheters are one of the mostIn Japan, a newly developed catheter with a lu-

frequently used medical devices in urology. Howev-men for injection of local anesthetic (NMOC 3-Wayer, catheter manipulation causes pain, especially inCatheter®) has been reported to be useful in alleviat-

males. To date there has been no effective pain-

ing postoperative catheter-related discomfort and＊Corresponding author : Teppei Yamamoto
Department of Urology, Nagano Municipal Hospital, 1333-1
Tomitake, Nagano, 381-8551, Japan
E-mail : t_yama9@yahoo.co.jp

No. 6, 2017

pain at the time of catheter withdrawal. However,
because the NMOC 3-Way Catheter®(NMOC) is notindicated for patients after urinary system surgeries,
it is not currently used in these patients. According355

Yamamoto・Shiozaki・Shimojima et al.

Fig. 1

Structure of NMOC 3-Way Catheter®(Modified from the package insert for NMOC)

Appendix 1

Questionnaire for evaluating pain during HDRB

※ Please include strong urinary sensation to pain
1. What degree of pain did you have before this treatment?
2. What degree of pain did you have during the afternoon irradiation?
3. What degree of pain did you have when exchanging the balloon catheter?
4. What degree of pain did you have during balloon catheter operation?
5. Did you feel pain until early morning after balloon catheter traction?
What time did you feel the pain most strongly?
What degree of pain did you have at that time?
Type of pain reliever, usage time : (nurse to fill in)
Thank you for your cooperation.

NRS (0-10)
NRS ( )NRS ( )NRS ( )NRS ( )
YES(aroundNRS ( )FS (0-10)
FS ( )FS ( )FS ( )FS ( )NO:)
FS ( )

HDRB, high-dose-rate brachytherapy ; NRS, numerical rating scale ; FS, face scale

ly, we investigated the safety and efficacy of pain re-added, the anesthesia wears off by the time of theduction of the NMOC compared with a conventional

second irradiation. After the second irradiation, theurinary catheter during high-dose-rate brachyther-catheter is exchanged for an 18 Fr 3-way catheter

apy (HDRB) of the prostate, which affects the urethra

for continuous bladder irrigation and to remove

and bladder and which can cause much pain during

coagula from the bladder, after which catheter

catheter manipulation.

traction is applied until the next morning. Thirty

Ⅱ Methods

patients underwent HDRB of the prostate fromApril to December 2016 at our hospital. Ten of theseIn addition to ordinary catheter function, the NMOC

patients underwent HDRB with a conventional 16 Fr

is equipped with a lumen for injection of local anes-silicone Foley catheter with a 10-ml cuff (controlthetics. Fig. 1 shows the external appearance of thegroup). Patients assessed their pain with a question-NMOC.

naire (Appendix 1). Pain at the time of removal ofNMOC is designed with three slits positioned

coagula from the bladder after catheter exchange

every 2 cm beginning at the distal end of the balloon.

and pain during catheter traction were regarded

The local anesthetic solution exits through theseas pain during catheter manipulation. HDRB wasthree slits when injected through the drug injection

performed in the remaining 20 patients with theport, making it possible to apply topical anesthesia

NMOC (silicone Foley catheter, 16 Fr, 10-ml cuff). 10

directly to the urethral mucosa.

ml of 4% lidocaine was injected through the NMOCHDRB is performed under lumbar spinal anesthe-port after completion of the second irradiation. The

sia at our hospital. The first irradiation is performed

same pain questionnaire survey was conducted inafter puncture of the prostate with an irradiationthese patients (NMOC group). An additional questionneedle and the second is performed 8 hours later.

on the pain felt at the time of drug injection wasBecause no additional lumbar spinal anesthesia is

included in the NMOC group. Patients who had356

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Safety and pain-relief efficacy of NMOC
Table 1

Questionnaire result
Control group
10 cases
NSR/FS (Median)

NMOC group16 cases
NSR/FS (Median)Age (years) (Median)
Pain before treatment
Pain during second irradiation
Pain during drug injection
Pain during catheter replacement55-80 (70)
0-1 (0)/0-1 (0)0-4 (0)/0-3 (1)－2-9.5 (7)/1-5 (4)62-80 (68.5)
0-0 (0)/0-0 (0)0-2 (0)/0-3 (0)0-1.5 (0)/0-1 (0)0-10 (1.5)/0-5 (1)0.77020.2059/0.1824
0.1001/0.0583－0.0055＊/0.0102＊

Pain during catheter operation

1-8.5 (6.5)/1-5 (4)0-8.5 (1.5)/0-4 (1)0.0064＊/0.0084＊

5/10 (50%)
0-2 (0.5)
1h20min

11/16 (68%)
0-5 (1.5)
3h30min

0.34850.2062-Postoperative analgesic use frequency
Number of postoperative analgesic uses
Time to mutual first postoperative analgesic use

P value(NSR/FS)＊P<0.05. NRS, numerical rating scale ; FS, face scale ; NMOC, The NMOC 3-Way Catheter＊difficulty completing the questionnaire as a result ofNMOC group, indicating significantly less pain in therestlessness after surgery and those who refused to

NMOC group than in the control group (NRS, p＝complete the questionnaire after surgery were0.0055 ; FS, p＝0.0102). The median pain scores at theexcluded. The safety and efficacy of the NMOC

time of catheter manipulation were 6.5 (NRS) and 4

was investigated in the remaining 16 patients. A(FS) in the control group and 1.5 (NRS) and 1 (FS) innumerical rating scale (NRS) and face scale (FS)the NMOC group, also indicating significantly lesswere used to assess pain. The Mann-Whitney U test

pain in the NMOC group than in the control group

was used for statistical analysis ; p<0.05 was consid-(NRS, p＝0.0064 ; FS, p＝0.0084). Postoperative anal-ered statistically significant. The safety of the NMOC

gesic use frequency in the control group was 50%

was also investigated. Approval was obtained fromand in the NMOC group it was 68%. The medianthe ethics committee of our hospital (Approval No.

number of postoperative analgesic uses in the control

27, City Hospital Ethics Committee No. 0204) before

group was 0.5 and in the NMOC group it was 1.5.

this study began. Furthermore, the intent of thisThe median time to mutual first postoperative anal-study was explained to the patients in writing andgesic use in the control group was 1 hour 20 min andtheir informed consent was obtained.

in the NMOC group it was 3 hours 20 min. Although

ⅢResults

use of the NMOC did not decrease the frequency ofpainkiller use through the following morning, theThe patients in the control group were 55 to 80

median time before the first use of analgesics foryears of age (median, 70 years) ; those in the NMOC

pain associated with catheter traction was about 2group were 62 to 80 years of age (median, 68.5 years).

hours longer in the NMOC group than in the control

The median pain scores before the start of treatmentgroup. The reported pain at the time of drug injec-

according to the NRS and FS were 0 and 0, respec-tion ranged from 0 to 1.5 (median value, 0) according

tively, in both the control and NMOC groups. Theto the NRS and from 0 to 1 (median value, 0) accord-

median pain scores during second irradiation were 0

ing to the FS (Table 1). Regarding complications,(NRS) and 1 (FS) in the control group and 0 (NRS)

there was one case of urinary retention in the controland 0 (FS) in the NMOC group. The above resultgroup and one case of postoperative restlessness inindicated no difference in patient background be-

the NMOC group.

tween the groups. The median pain scores at thetime of catheter exchange were 7 (NRS) and 4 (FS)in the control group and 1.5 (NRS) and 1 (FS) in theNo. 6, 2017

ⅣDiscussion

Indwelling urethral catheters are one of the most357

Yamamoto・Shiozaki・Shimojima et al.

frequently used medical devices in urology to drain

flexible cystoscopy, we decided to use 4% lidocaine inurine from the bladder. The pain and discomfort associ­this study.

ated with catheterization have been well described.

Concerning its pharmacological mechanism ofHowever, because of a lack of effective measures,

action, lidocaine blocks the sodium channel of nerve

only symptomatic therapy has been available tomembranes to reversibly inhibit the conduction oftreat this pain without taking aggressive measures.

action potentials in the nerve, blocking both sensory

Several reports in anesthesiology have confirmed theand motor nerves3）. Lidocaine does not effectively

usefulness of the NMOC, which has been newly

infiltrate tissues. Because the efferent nerves of thedeveloped in Japan. However, use of the NMOC is

urethra are located deep in the urethral wall4）, theyprohibited in patients after urinary system surgery

are unlikely to be affected by topical lidocaine in­and in those with a damaged urethra because it isjection into the urethra. Accordingly, lidocaine isassumed that these patients would suffer from side

considered an appropriate local anesthetic to block

effects caused by local anesthetic injection. There-

the submucosal afferent nerves. Furthermore, lido-fore, in this study we used the NMOC after HDRB,

caine causes little irritation either with topical use

which affects the urethra and bladder and which

or in infiltration anesthesia. Goldberd et al reported

can cause much pain during catheter manipulation.

no irritation reactions after application of 8% lido-

No adverse events clearly attributable to use of thecaine solution to the cornea of rabbits, which are

NMOC were observed, including allergic reactions tomore sensitive to the effects of lidocaine than humans5）.

the local anesthetic. Thus, our findings suggest that

The pain score at the time of injection of 4% lido-NMOC can be safely used in patients after urologicalcaine in the present study was 0 to 1.5 (mediansurgery as well. As to the efficacy of the NMOC,value, 0) according to the NRS and 0 to 1 (medianpain was significantly alleviated both at the time ofvalue, 0) according to the FS, indicating negligible orcatheter exchange and during catheter manipulation

no pain associated with lidocaine administration. As

compared with a conventional urinary catheter. Into the volume, injections of 5 ml and 10 ml have been

the field of anesthesiology, the NMOC had beenreported. Because the usage method clearly states

reported to be effective in alleviating the discomfort

that it is necessary to ensure that the local anestheticof balloon catheter after surgery and reducing theflows from the catheter side of the external urethralpain at the time of balloon removal after surgery.

orifice when injected through the NMOC, the larger

This study produced the same results, so, we consider

volume of 10 ml was used in this study to ensure

the NMOC to be useful for relieving pain comparedoutflow. However, further investigation is necessary

with a conventional urinary catheter.

to evaluate the best type, concentration and volume

However, the type, concentration and amount ofof local anesthetic to use with the NMOC.

local anesthetic to administer via the NMOC have

The pudendal nerve is an afferent nerve of the

not been established and no studies have reported

somatic system involved in the pain experienced atclinical experience with the device. According to

the time of catheter exchange and manipulation.

reports presented at the Association of Anesthesiol-The urethral mucosa and pudendal nerve at theogy, many clinicians have used 10 ml of 2% lidocaine

urethral sphincter and the afferent branches of theor 5 ml of 4% lidocaine with the NMOC. Lidocaine

pelvic visceral nerves are related to the vesical reflex.

was used as the local anesthetic in this study based

Barrington et al reported that urinary flow underon reports of its use on the urethral mucosa during

application of a catheter or mechanical stimulation offlexible cystoscopy. Goldfischer et al and Holmes etthe urethra excited the afferent nerves and promot-

al reported that lidocaine gel effectively alleviateded the vesical contraction reflex in anesthetized1）
2）. Because 4% lidocainecats6）7）. A subsequent study by Jung et al supported

is currently used at our hospital during outpatient

the findings of Barrington et al8）. These reports

pain during flexible cystoscopy

358

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Safety and pain-relief efficacy of NMOC

strongly suggest that the urethral afferent nerves

Ⅴplay an important role in the micturition reflex. ItConclusion

may therefore be possible not only to suppress

Although further investigation is necessary, oururethral pain and urethral sphincter pain but also tofindings indicate that the NMOC can be safely usedinhibit the vesical reflex, thereby improving tenesmus,

in patients after surgery of the urinary system andby injecting lidocaine into the urethra through theis effective in reducing the pain associated with

NMOC. In the present study, the time until use ofurethral catheter exchange and urethral catheter

additional painkiller was longer by about 2 hours

manipulation compared with a conventional urinary

when the NMOC was used. The effective duration ofcatheter. The effective duration of lidocaine is about

local anesthesia is about 2 hours. Therefore, we2 hours, and we suggest that repeated administra-assume that both local pain and also the vesicaltion of local anesthetic via the NMOC at the onset ofreflex were suppressed during these 2 hours. The

pain can inhibit the vesical reflex, help control theresults of this study suggest that repeated adminis-

discomfort of postoperative catheterization andtration of local anesthetic via the NMOC at the onset

reduce the amount of postoperative analgesics needed.

of pain can inhibit the vesical reflex, help control thediscomfort of postoperative catheterization and

COI : The authors declare no conflict of interest.

reduce the amount of postoperative analgesics
needed.

Acknowledgments : We would like to thank theparticipants in the study.
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