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Creative Commons licence CC-BY-NC 4.0. RESEARCH

Outcomes of outpatient ureteral stenting without


fluoroscopy at Groote Schuur Hospital, Cape Town,
South Africa
S Sinha,1 MBBS, MS, FRCS (Glasg), FC Urol (SA); S Z Jaumdally,2,3 PhD; F Cassim,1 MB ChB, MMed (Urol), FC Urol (SA);
J Wicht,1 MB ChB, MMed (Urol), FC Urol (SA); L Kaestner,1 MB ChB, MMed (Urol), FC Urol (SA); A Panackal,1 MD, FC Urol (SA);
C H Jehle,1 MB ChB, MRCS (Lond), MMed (Urol), FC Urol (SA); P Govender,1 MB ChB, MMed (Urol), FC Urol (SA);
S de Jager,1 MB ChB; E de Wet,1 MB ChB; M Dewar,1 MB ChB, MMed (Urol), FC Urol (SA); M E Kolia,1 MB ChB, FC Urol (SA);
S Salukazana,1 MB ChB; C Moolman,1 MB ChB, MMed (Urol), FCUrol (SA); A P van den Heever,1 MB ChB, FC Urol (SA);
B Kowlessur,1 MBBS, FC Urol (SA); G Pinto,1 MD, FC Urol (SA); J Lazarus,1 MB ChB, MMed (Urol), FC Urol (SA)

1
D
 ivision of Urology, Department of Surgery, Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital, Cape Town,
South Africa
2
D
 ivision of Immunology, Institute of Infectious Disease and Molecular Medicine, Faculty of Health Sciences, University of Cape Town,
South Africa
3
School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, South Africa

Corresponding author: S Sinha ([email protected])

Background. Ureteral stenting is generally a theatre-based procedure that requires a multidisciplinary team and on-table imaging. Limited
hospital bed numbers and theatre time in our centre in Cape Town, South Africa, have led us to explore an alternative approach.
Objectives. To see whether outpatient insertion of ureteric stents under local anaesthesia without fluoroscopy was a possible and acceptable
alternative to theatre-based ureteral stenting.
Methods. Ureteral stenting (double-J stents and ureteric catheters) was performed with flexible cystoscopy under local anaesthesia and
chemoprophylaxis, but without fluoroscopic guidance, in an outpatient setting. Every patient had an abdominal radiograph and an
ultrasound scan of the kidney after the procedure to confirm stent position.
Results. Three hundred and sixteen procedures (276 double-J stents and 40 ureteric catheters) were performed in 161 men and 155 women.
The overall success rate for the procedures was 85.4%, independent of gender (p=0.87), age (p=0.13), type of device inserted (p=0.81) or
unilateral/bilateral nature of the procedure (p=1.0). Procedures with a successful outcome were performed in a significantly (p<0.0001)
shorter median time (10 minutes (interquartile range (IQR) 5 - 15)) than failed procedures (20 minutes (IQR 10 - 30)). Patients with a
pain score of >5 experienced a significantly (p=0.02) greater proportion of failure (27.3%) than patients with a pain score of ≤5 (12.5%).
Difficulties were encountered in 23.7% of procedures, with a significantly higher proportion being registered in failed interventions
compared with successful ones (82.6% v. 13.7%; p<0.0001).
Conclusions. The procedure was easily mastered and technically simple, and represents savings in cost, time and human resources in our
setting.

S Afr Med J 2018;108(6):506-510. DOI:10.7196/SAMJ.2018.v108i6.12983

Ureteral stenting is a vital part of a urology service. Ureteral stenting for several years, resource limitations in the form of hospital bed
(double-J stents and ureteric catheters) is traditionally performed numbers for admission and theatre time having led us to seek a safe,
under general anaesthesia (GA) with fluoroscopic guidance. Some efficacious and well-tolerated alternative to the same procedure done
centres have reported on insertion of ureteric stents and catheters under general anesthesia and fluoroscopic guidance.
as an office-based procedure,[1-4] the reasons for performing
the intervention on an outpatient basis including: (i) avoiding Methods
unnecessary admission; (ii) saving cost and time; (iii) avoiding Patients and outcomes
the necessity of GA; (iv) patient tolerance of the procedure; and This study comprised a retrospective review of a series of patients
(v) minimal complications. Most of these centres have, however, undergoing ureteric stent or catheter insertion using flexible
performed the procedure using sedation as well as local anaesthesia, cystoscope guidance, performed on an outpatient basis at the
and under fluoroscopic guidance. Division of Urology, GSH, over the period July 2007 - June 2015.
A few centres, however, have reported using fluoroscopic guidance The main indication for ureteral stenting was obstruction due to
for the procedure in selected cases only, such as in pregnant women ureteric stone complicated by non-resolving pain, failure of medical
when a rigid cystoscope is used[5] and for exchange of double-J expulsive therapy, urinary tract infection or renal failure. We also
stents. [6] To our knowledge, flexible cystoscope-assisted ureteral did this procedure (ureteral catheterisation) before percutaneous
stenting on an outpatient basis without the use of fluoroscopy has not nephrolithotomy to save time in theatre or a retrograde pyelogram. In
yet been reported. This procedure has been performed at our centre, most cases such urgent procedures could not be undertaken because
Groote Schuur Hospital (GSH) in Cape Town, South Africa (SA), of overbooked emergency and elective operative lists.

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Ethical approval was obtained from the Human Research Ethics A B C

Committee at the University of Cape Town (ref. no. UCT 771/2015).


Patients included in the study were identified from the records list of
the Urology Clinic at GSH. A comprehensive database comprising
patient demographic characteristics (age, gender, hospital fee),
operative information (surgeon’s name, operative time, nature of the
procedure (stent or catheter), side (left, right or bilateral), outcome,
pain score and difficulties) and postoperative complications was set Ureteric stent
in position

up from data extracted from medical records. Guidewire

Procedure Ureteric
stent
The procedure was performed with written informed consent from Flexible
the patient and a single dose of prophylactic antibiotics (cefepime cystoscope

400 mg/ciprofloxacin 500 mg orally depending on availability). If


Pushing device
the patient was on a course of antibiotics for urosepsis, or a pre-
procedural urine culture was positive, culture-specific antibiotics
were given prior to the procedure. Anxious patients and those Fig. 1. Office-based stenting procedure. The appropriate ureteric orifice was
with complicated prior ureteric stent placement were taken to the identified. (A) A guidewire (red) was inserted via the cystoscope into the
main theatre for the stent to be placed under GA. The patient was appropriate ureteric orifice. The insertion was stopped when resistance to
positioned supine and anaesthetic gel (Remicaine Jelly 2%) was further advancement of the guidewire occurred. The cystoscope was removed
introduced per urethra after preparing and draping the patient. from the patient while leaving the guidewire in situ. The cystoscope was then
Flexible cystoscopy was performed as described in Fig. 1. Each reinserted per urethra alongside the guidewire, and the ureteric orifice was
patient was immediately asked to rate the level of pain using the ‘0 - again identified. (B) The ureteral stent or catheter (blue) was then advanced
10 Numeric Pain Rating Scale’ (0 being the lowest and 10 being the over the guidewire while visualising passage into the ureteric orifice using
highest).[7] The full procedure was performed without the assistance the cystoscope. (C) Once the desired depth was achieved (as noted by the
of fluoroscopic guidance or sedation. The patient was then allowed to markings on the ureteral stent), the guidewire was removed, allowing the
empty his/her bladder and sent for a confirmatory plain abdominal stent to curl in the bladder. A hydrophilic guidewire and multilength Fr 6
radiograph to assess for adequate positioning of the stent after its double-J stent was typically used, or an open-ended ureteric catheter.
position had been confirmed by ultrasonography at the bedside
(Fig. 2). In the event of failure, the patient was admitted and placed A B
on the emergency theatre list for the procedure to be attempted
under GA. If the reason for failure was thought to be an impacted
stone, a percutaneous nephrostomy was inserted (in the radiology
department) instead.

Learning curve
We sought to understand the learning curve of flexible cystoscopic
stent placement, using time to complete the procedure as a proxy
measure of mastery.
Fig. 2. Confirmatory plain abdominal radiograph (A) and ultrasound scan (B).
Statistical analysis
Explorative univariate statistical analysis of the data extracted ≤5 or >5, patients with a pain score of >5 experienced a significantly
was done. Unpaired non-parametric data were compared using (p=0.02) greater proportion of failure (27.3%) than patients reporting
the Mann-Whitney U-test. Statistical inferences on binary sets of a pain score of ≤5 (12.5%).
data were performed using Fisher’s exact test. Statistical analyses
were performed using GraphPad Prism version 5.0 for Windows Learning curve
(GraphPad Software, USA). All tests were two-tailed and p-values of The initial phase of the supervised learning curve consisted of the
<0.05 were considered significant. first 10 successful procedures, for which the median completion time
was 12 minutes (Fig. 3). There was a statistically significant improve­
Results ment in time to successful completion, halving from 12 minutes
A total of 316 procedures were included in this study, performed in at the start of the apprenticeship to 6 minutes following successful
161 men (median age 48 years (interquartile range (IQR) 38 - 57) completion of ≥30 interventions.
and 155 women (median age 45 years (IQR 38 - 59)). These involved
the insertion of 276 stents (250 (90.9%) being unilateral) and 40 Difficulty
catheters (all unilateral). The overall success rate for the procedures Overall, difficulties were encountered in 23.7% (75/316) of the
was 85.4% (270/316). As shown in Table 1, success was independent interventions. Difficulty encountered during intervention was the
of gender (p=0.87), age (p=0.13), type of device inserted (p=0.81) or main reason for failure, as is supported by the significantly different
unilateral/bilateral nature of the procedure (p=1.0). Procedures with proportion of difficulty in failures (82.6%, 38/46) compared with
a successful outcome were performed in a significantly (p<0.0001) successful procedures (13.7%, 37/270). It is of interest to note that
shorter median time (10 minutes (IQR 5 - 15)) than failed procedures difficulties did not necessarily lead to failure, as difficulties were
(20 minutes (IQR 10 - 30)). When stratified across a pain score of encountered in 37 procedures in the successful group. Almost half

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Table 1. Characteristics of participants and procedures, in relation to success or failure


Characteristics Success Failure p-value
N (% of total) 270 (85.4) 46 (14.6)
Gender, n (% of total)† 0.87
Male 137 (43.4) 24 (7.6)
Female 133 (42.1) 22 (6.9)
Age (yr), median (IQR)‡ 48 (38 - 58) 42 (34 - 57) 0.13
Procedure n (% relative to procedure classification)† 0.81
Stent 236 (85.5) 40 (14.5)
Catheter 34 (85.0) 6 (15.0)
Side, n (% relative to side classification)† 1.0
Unilateral 247 (85.4) 42 (14.6)
Bilateral 23 (85.1) 4 (14.9)
Pain score, n (% relative to pain classification)† 0.02*
≤5 238 (87.5) 34 (12.5)
>5 32 (72.7) 12 (27.3)
Time (min), median (IQR)‡ 10 (5 - 15) 20 (10 - 30) <0.0001*
IQR = interquartile range.
*Significant (p<0.05).

Fisher’s exact test used to compare groups.

Mann-Whitney U-test used to compare groups.

Complications
0 p=0.0007 The overall complication rate reported for this procedure was very
low (3.8%, 12/316). Two cases of complication were encountered in
5 the failed set of interventions, as the stents were deployed distal to
the impacted stone. Of the complications in successful interventions,
Time (min)

10 seven were in patients with urinary tract infection/pyelonephritis and


the other three were linked to stent migration.
15
Discussion
20 The development of flexible cystoscopy started through the novel
use of the choledochoscope into the bladder (originally it was
25 only meant for use in the common bile duct).[8] This breakthrough
1 - 10 11 - 20 21 - 30 >30 revolutionised the use of endoscopy in urology. Since then, there
has been a paradigm shift in the use of endoscopy in urology from
Interventions purely diagnostic to therapeutic management, not only in the bladder
but also encompassing the upper urinary tract. With the advent
Fig. 3. Learning curve of clinicians in training. 1 - 10, 11 - 20, 21 - 30 of double-J stents, the extent of therapeutic management widened
and >30 represent the consecutive three sets of 10 interventions and more to incorporate the use of flexible ureteroendoscopy to disobstruct
than 30 interventions, respectively. + denotes the median completion time blocked ureters and alleviate obstructive uropathy.
and the whiskers represent the interquartile range for each set. The dotted Ureteric stents are one of the most common devices used by
line represents the learning curve for the combined set of clinicians. Non- urologists. At our institution, where resources in terms of both
parametric assessments of variation between groups were done using infrastructure and medical personnel are limited, an alternative
Kruskal-Wallis analysis of variance. form of management was necessary to circumvent the long wait for
theatre time. This study documents the convenience of an alternative
of the difficulties leading to failures were due to impacted stone, method. We were able to demonstrate an 85.4% success rate with
but not all procedures with impacted stone ended up as failures, flexible cystoscopic stent insertion without fluoroscopy. These
suggesting that careful perseverance resulted in success (Table 2). successful procedures could be performed in a median of 10 minutes.
Stent blockage (encrustations), difficult angle of the ureteric Sivalingam et al.[3] demonstrated that urgent ureteric stent placement
orifice, trabeculated bladder and patient difficulty (procedure for obstructing stones can be performed safely and effectively under
poorly tolerated by patient, language barrier and full bladder) local anaesthesia in the office.[3] The authors note that there is little in
represented 30.2% of the reported difficulties, but in most cases the literature on the use of ureteral stenting for renal colic under local
(83.4%) these were successfully dealt with during the procedure. anaesthesia. They used rigid as well as flexible cystoscopy under local
Poor vision accounted for a third of all difficulties, and these anaesthesia with the addition of fluoroscopy, and reported a failure
included haematuria, cloudy urine, snowstorm, oedema, technical rate of 9% compared with our 15% failure rate without fluoroscopy
issues, and ureteric orifice not seen due to an enlarged prostatic or rigid cystoscopy.
middle lobe. Encountering any form of difficulty led to a significant Instead of office-based fluoroscopy, we used a post-procedure
increase in the median time required for the successful completion abdominal radiograph to check stent/catheter position. Kose et al.[6]
of the intervention (20 minutes with difficulties v. 10 minutes described their technique for manual replacement of an (existing
without difficulties; p<0.0001) (Fig. 4). in situ) double-J stent without fluoroscopy in female patients. This

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Table 2. Difficulties encountered during procedure, in relation to success or failure


Difficulty Success (N=270) Failure (N=46) p-value
n/N (%) 37/270 (13.7) 38/46 (82.6) <0.0001*
Classification (% of N)
Stone blockage 3 (8.1) 17 (44.7) 0.0005*
Stent blockage 5 (13.5) 0 (0.0) 0.03*
Buckling 1 (2.7) 1 (2.6) 1.00
Difficult angle of UO 6 (16.2) 1 (2.6) 0.06
GW slipped 3 (8.1) 1 (2.6) 0.36
Patient difficulty 7 (18.9) 1 (2.6) 0.03*
Trabeculated bladder 1 (2.7) 2 (5.3) 1.00
Urethral stricture 1 (2.7) 0 (0.0) 0.49
Poor vision 10 (27.0) 15 (39.5) 0.33
UO = ureteric orifice; GW = guidewire.
*Significant (p<0.05).

3.3
80
No difficulties
p<0.0001 p=0.39 2.9
Difficulties
60 5
2.6
Time (min)

40 4
Cost (million ZAR)

20
3

0
2
Success Failure

1
Fig. 4. The cumulative operative time for each group of patients is depicted
by box-and-whisker plots, indicating the median (middle line), the 25th
0
(bottom line) and 75th percentiles (top line), and the range (whiskers).
Mann-Whitney U-tests were applied to compare operative time between the Day case 1 day 2 days 3 days
group with no difficulties and group with difficulties for successful and failed
interventions separately. Fig. 5. Cost benefit associated with the outpatient procedure.

method used cystoscopy to remove the stent and do a guidewire stent chance of failure with visual pain scores >5. Investigating this issue,
exchange, gently placing the end of the stent into the bladder without Hussein et al.[9] recommended self-watching of the procedure on the
a scope and positioning without fluoroscopy. video monitor together with a detailed explanation to reduce the
pain and anxiety associated with the procedure.[9] They randomised
Cost benefits patients to those allowed to and those prevented from viewing the
Gershman et al.[4] investigated how office-based placement of ureteric procedure. The latter group had statistically greater visual analogue
stents affects cost and hospital stay. They reported a three-fold pain scores.
reduction in total hospital time as a result of reduced preoperative
waiting times. This achieved a saving of USD1 551 per procedure. Learning curve
Fig. 5 provides a breakdown of cost-effectiveness associated with When we investigated the learning curve of this procedure, we found
our proposed procedure. For our outpatient-based procedure, the that operative time during the training of a set of registrars improved
patient would only be a day case, which is the reference situation significantly, being halved from a median of 12 minutes for the initial
used in a comparison of the 265 patients included in this study if set of 10 interventions to 6 minutes after successful completion of >30
they were to be admitted in hospital for a variable length of time (1, interventions. This highlights the fact that it is relatively easy to learn
2 or 3 days). After classifying patients based on their income bracket this procedure, and the continuous flow of patients requiring it in our
and calculating the incumbent cost of the procedure to the hospital facility (a stone clinic) provides the perfect setting for rapid training
after deduction of the patient’s payment, a total saving of between of surgeons in the mastery of the technique.
ZAR2.6 million (USD162 500) if a 1-day hospital stay was required,
and ZAR3.3 million (USD206 250) if a 3-day hospital stay was Difficulty
required, could be made. This represents a substantial saving in the We attempted to understand reasons for a failed procedure. Close to
current SA health system. half of the difficulty encountered in the failed interventions was due
to stone impaction. Pitfalls here include a deployed stent curling up
Tolerability below the impacted stone. Buckling of the guidewire in the bladder
Although explanation and informed consent are vital to success with is another pitfall that has a potential to delay the procedure, but
this procedure under local anaesthesia, we noted a statistically greater it can easily be avoided through the operator focusing carefully

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while introducing the guidewire into the ureter. Other challenging high-volume areas as a screening tool to alleviate the emergency
scenarios include an oedematous and inflamed ureteric orifice, operative workload. This will be especially helpful in the developing
bleeding, clots in the bladder, murky/turbid urine due to sepsis, or a world, where the procedure can drastically reduce the waiting time
blocked double J during stent exchange. for patients requiring ureteric stenting/catheterisation. We propose
to evaluate this technique more vigorously through a randomised
Study limitations clinical trial.
This study has certain limitations. Notably, it suffers from being
an observational study. A randomised trial comparing equally Acknowledgements. This work was made possible through the valuable
skilled urological surgeons with a more comprehensive validated support of the nursing and administrative staff of the Division of Urology
questionnaire would probably be needed to support our assertions at GSH, specially Sr Millia Sojola, Sr Desire Abels, Sr Julia Jacabs,
about the safety, tolerability and efficacy of the procedure.
Sr Cecilia Wilson, Mr Phumlani Msi, Mrs Lesley Burke, Mrs Shene Isaacs,
One criticism of this work could be that some of these patients
Mrs Zubaida Viljoen and Mr Gasant Harris.
would have been better served by being taken to the main theatre
Author contributions. SS and SZJ did the data analysis and wrote up the
for ureteroscopy and definitive management of their stone. In our
setting, emergency theatre time is very limited and logistics therefore manuscript, to which they contributed equally. All the clinicians listed as
prevent this option. authors were involved in performing the procedure and generating the
data published. JL provided guidance for the draft manuscript.
Conclusion Funding. None.
The ever-growing demand of surgical time on emergency slates in Conflicts of interest. None.
busy hospitals has forced the conception of an alternative outpatient
procedure for the drainage of obstructed ureters by stenting. The 1. Adeyogu A, Collins G, Brooman P, et al. Outpatient flexible cystoscope-assisted insertion of
current reliance on fluoroscopy and use of general anaesthesia for ureteric catheters and ureteric stents. BJU Int 1999;83(7):748-750. https://doi.org/10.1046/j.1464-
410x.1999.00994.x
this procedure means that a significant number of patients do not 2. McFarlane JP, Cowan C, Holt SJ, et al. Outpatient ureteric procedures: A new method for retrograde
reach theatre timeously. In a retrospective series of over 300 cases of ureteropyelography and ureteric stent placement. BJU Int 2001;87(3):172-176. https://doi.org/10.1046/
j.1464-410x.2001.02039.x
flexible cystoscopic ureteral stenting without fluoroscopy, we believe 3. Sivalingam S, Tamm-Daniels I, Nakada SY. Office-based ureteral stent placement under local
anesthesia for obstructing stones is safe and efficacious. Urology 2013;81(3):498-502. https://doi.
that it is a safe, efficacious (85.4%) and well-tolerated procedure org/10.1016/j.urology.2012.10.021
to deal with cases of ureteric obstruction. With a high volume of 4. Gershman B, Eisner BH, Sheth S, et al. Ureteral stenting and retrograde pyelography in the office:
Clinical outcomes, cost effectiveness, and time savings. J Endourol 2013;27(5):662-666. https://doi.
patients requiring this intervention in our setting, and motivated org/10.1089/end.2012.0644
by the successful use of the office-based version of this procedure 5. Ngai H, Salih HQ, Albeer A, et al. Double-J ureteric stenting in pregnancy: A single-centre experience
from Iraq. Arab J Urol 2013;11(2):148-151. https://doi.org/10.1016/j.aju.2013.02.002
described in the literature, we introduced it for the first time in SA 6. Kose O, Gorgel SN, Ozbir S, et al. Manual replacement of double J stent without fluoroscopy (double
and were logically prompted to undertake a retrospective audit of J stent replacement). Int Surg 2015;100(2):381-385. https://doi.org/10.9738/INTSURG-D-13-00248.1
7. McCaffery M, Beebe A, Latham J. Pain: Clinical Manual for Nursing Practice. St Louis, Mo.: Mosby,
data from these interventions to assess its practicality. It is established 1994. https://doi.org/10.1016/0885-3924(90)90052-L
8. Wilbur H. The flexible choledochoscope: A welcome addition to the urologic armamentarium. J Urol
that stent insertions are done blindly without the need of fluoroscopy 1981;126(3):380-381. https://doi.org/10.1016/S0022-5347(17)54535-8
during laparoscopic pyeloplasty and ureteric reimplants,[10] and this 9. Hussein NS, Norazan MR. Impact of self-watching double J stent insertion on pain experience of
male patients: A randomized control study using visual analog scale. ISRN Urol 2013 (2013), article
encouraged us to translate this concept for our procedures. ID 523625. https://doi.org/10.1155/2013/523625
Considering the good success rate associated with our intervention 10. Chandrasekharam VVSS. Is retrograde stenting more reliable than antegrade stenting for pyeloplasty
in infants and children? Urology 2005;66(6):1301-1304. https://doi.org/10.1016/j.urology.2005.06.132
and challenges with regard to theatre time and availability of
fluoroscopy in outpatient settings in SA health centres, we propose
the roll-out of this alternative procedure in hospitals located in Accepted 15 December 2017.

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