Long-Term Outcomes of Two Ipsilateral vs Single Double-J Stent After Laser Endoureterotomy for Bilharzial Ureteral Strictures

Abstract

Background:

Laser endoureterotomy became a preferable choice for managing benign ureteral strictures. Ureteral stricture caused by bilharzias is characterized by focal destruction of ureteral musculature, ending by fibrosis, making it poor responder to endoureterotomy. There is no consensus about the ideal ureteral stent size after endoureterotomy. However, many researches recommend larger stents caliber (12–14F). We assess long-term efficacy of insertion of two ipsilateral Double-J stents vs single Double-J stent after laser endoureterotomy for bilharzial ureteral stricture.

Materials and Methods:

Within 4 years, 70 patients underwent retrograde laser endoureterotomy for bilharzial ureteral stricture (diagnosed by positive history of bilharziasis, positive serology test, and/or bilharzial cystoscopic finding). Patients with history of stone, urologic or pelvic surgery were excluded. Patients were randomized into two groups: the first group (35 patients) received ipsilateral two Double-J (7F each) postendoureterotomy, whereas the second group (35 patients) received one Double-J (7F). Double-Js were removed after 8 weeks. Follow-up was done regularly by clinical interpretation and imaging studies. Patients' characteristics, operative data, and postoperative outcomes (subjectively and objectively) were compared in both groups.

Results:

Sixty-three patients completed follow-up >18 months, mean follow-up 30 ± 4 months [19–41], and mean stricture length 1.4 ± 0.6 cm [0.5–3.0], with no statistical significance between both groups. Success proved by relief of symptoms and radiographic resolution of obstruction. The overall success rate was significantly better in 2-Double-J group than in 1-Double-J group (83.9% vs 53.1%) p = 0.009, and also for stricture >1.5 cm (85.7% vs 38.5%) p = 0.018, respectively.

Conclusions:

Insertion of two ipsilateral Double-J, after laser endoureterotomy for bilharzial ureteral stricture associated with long-term success rate better than insertion of 1-Double-J, especially for stricture segment >1.5 cm.

Introduction

Urinary schistosomiasis is a chronic parasitic infection of the urinary tract caused by Schistosoma haematobium. The pathogenesis of this infection leads to bilharzial ureteral stricture as a result of focal destruction of ureteral musculature ending by fibrosis.¹ Davis et al. were the first to describe that the ureteral mucosa and musculature regenerates around the incised ureteral stricture replacing the scarred region and correcting the stricture.²

With the advancement of endourology equipment and the use of holmium laser as leading cutting modality, the ureteral stricture can be managed by minimally invasive technique with a success rate ranging from 55% to 85% for benign ureteral strictures.^3
–5 All authors recommend ureteral stent insertion postendoureterotomy. However, there is debate about the stent size used. If the urologist considers that the stent acts as a method of diversion (act as a scaffold) hence the size does not matter, whereas if it acts as a mold for the ureteral structures regeneration then the large caliber is better.^6,7

Owing to the wide varieties of cutting tools, the differences of etiologies of ureteral strictures, and its length and its locations, duration of follow-up, and size of stent and its duration made the comparisons between series is problematic.^8,9 Liu et al. and others recommend two ipsilateral ureteral stents in managing of malignant ureteral obstruction if one stent failed.^10
–12 Razdan et al. treat recurring and recalcitrant ureteral strictures in 10 cases by endoureterotomy and placing two ureteral stents vs single stent, they got a success rate 80% for long-term follow-up for the double stent group.¹³ Later two studies use two ipsilateral Double-J for benign ureteral stricture (5 cases in the first and 22 in the second) with success rate 60% and 78.7%, respectively.^14,15

Till now we considered this study is the first randomized clinical trial to compare the long-term efficacy of insertion of two ipsilateral Double-J stents vs one-Double-J postlaser endoureterotomy for management of bilharzial ureteral strictures.

Materials and Methods

This study was approved by our faculty ethical committee and all patients signed written informed consents. Seventy patients with ureteral stricture caused by bilharzial infestation (diagnosed by positive history of bilharziasis, Schistosoma haematobium eggs in their urinary tracts, positive serology test [Western blot], and/or bilharzial cystoscopic finding) were accepted to participate in this study. Exclusion criteria: history of stone, urologic or pelvic surgery or radiation, or presence of mass compressing on ureter, multiple stricture sites. Patients were prospectively enrolled and randomized between March 2014 and August 2018, into two equal groups, by simple randomization procedures, with a 1:1 allocation ratio to either 2-Double-J (7F, each) (35 patients) or 1-Double-J (7F) (35 patients). The patients were blinded for the stents number.

Preoperative work-up included clinical evaluation, and kidney function tests, urine analysis, urine culture and sensitivity, and radiology studies inform of ultrasonography, urinary tract-CT without contrast ± urography, or intravenous urography. Renal dynamic study (DTPA-radioisotope scan) was done to asses split renal function and to confirm the obstruction.

Procedure

All patients underwent formal cystoscopy, followed by retrograde to determine the ureteral stricture site, degree, and length. Proximal, mid, and distal ureteral strictures were defined as being above, overlying, and below the sacroiliac joint, respectively. After passage of a hydrophilic 0.038 IN guidewire till the kidney followed by another safety one (Teflon), ureteral stricture site was dilated by ureteral balloon dilator 6-cm long with a 6-mm diameter (filled by contrast) till the waist resolved or decreased. This facilitates the passage of semirigid ureteroscope (8F) through the stricture site. Then we start endoureterotomy under vision, using a holmium:yttrium-aluminum-garnet (YAG) laser (Lumenis), by 550 μ fiber with energy setting 1 to 1.2 J and pulse rate of 10 to 15 Hz through the working channel of the ureteroscope. A precise incision started (under vision) 3 mm above the stricture site to incise all ureteral thickness till the periureteral fat and contrast extravasation on fluoroscopic imaging, passing downward through the stricture till 3 mm below it in a linear manner, keeping in mind the orientation of blood vessels. The ureteral stricture was recalibrated by balloon dilator under fluoroscopic control to assess the adequacy of the incision and if it needs additional incisions.¹⁵

After this we inserted two ipsilateral double pigtail stents (Double-J, 7F/each) in first group, and single double pigtail stents (Double-J, 7F) in second group. All Double-Js made from Percuflex material of the same brand. The length of stent varies according to ureteral length according to the retrograde study. No intraoperative complications were noted needing further interventions.

We gave prophylactic antibiotic before the operation followed by quinolones tablet twice daily for 5 days. For Double-J-related lower urinary tract symptoms (LUTS) we give combination of alpha blocker (0.4 mg Tamsulosin) and anticholinergics (Tolterodine 4 mg) once daily from day 1 for all patients.¹⁶

Follow-up

After 8 weeks all patients underwent cystoscopy for removal of stents, followed by retrograde ureteropyelography to assess ureteral patency. One month later renal ultrasonography was done and repeated every 3 months. Contrast study±diuretic renal scan were done at 3-month poststent retrieval, and repeated if needed. Follow-up was done for >18 months. Patients were followed radiographically within the first 18 months, and afterward only if symptomatic.

Resolution of obstruction by radiographic (resolution of backpressure or improvement of hydroureteronephrosis degree) and diuretic studies (radiotracer washout after Lasix injection with a T1/2 < 10 minutes) considered objective success, whereas improvement of symptoms according to visual analogue scale (VAS) pain score (ranging from 0 to 10) with reduction of >30% in VAS pain score considered subjective success. We presented our results by the objective success.

Statistical analysis

Data were analyzed using the statistical package SPSS version 20. Variables were represented using number and percentage for qualitative variables, mean and standard deviation for quantitative normally distributed data, and median and interquartile range for not normally distributed variables. Comparison of qualitative variables between groups was done using the chi-square test and Fisher's exact test, comparison of quantitative variables was done using independent t-test for normally distributed variables, otherwise Mann–Whitney U test was used; p-value <0.05 was considered statistically significant.

Results

From March 2014 to August 2018, 70 patients underwent holmium:YAG laser endoureterotomy for managing ureteral strictures caused by bilharzial infestation. Seven patients (four patients from 2-Double-J group, and three from 1-Double-J group) did not complete the follow-up for the first 12 month, so they were excluded from the study. CONSORT flow diagrams for the study (Fig. 1). Therefore, there were 63 patients analyzed, the majority were men, 40 (63.5%). The mean age was 43.6 ± 13 years. The mean stricture length was 1.4 ± 0.6 cm, range [0.5–3 cm]. There were no significant statistical differences between both groups regarding all studied variables (Table 1). The mean operative time was 59 ± 6 minutes for the first group and 54 ± 6 minutes for the second group.

FIG. 1.

CONSORT flow diagrams for the study. Color images are available online.

Table 1.

Summarizes the Perioperative Characteristics for Both Groups

	Two-Double-J	One-Double-J	p
	31 patients	32 patients	p
Age, mean ± SD	44.5 ± 15	42.7 ± 12	0.609^a
Mean stricture length (cm), mean ± SD	1.48 ± 0.58	1.3 ± 0.6	0.227^a
Mean follow-up (month), mean ± SD	29.5 ± 4.6	30.9 ± 4.7	0.259^a
Serum creatinine mg/dL, median [range]	1 [0.7–3.7]	1 [0.7–3.8]	0.835^b
Gender, no. of patients (%)
Male	21 (67.7)	19 (59.4)	0.490^c
Female	10 (32.3)	13 (40.6)
Stricture site
Proximal	5 (16.1)	7 (21.9)
Middle	11 (35.5)	9 (28.1)	0.760^c
Lower	15 (48.4)	16 (50)
Kidney function
Normal (≤1.5)	25 (80.6)	25 (78.1)	0.805^c
Elevated (>1.5)	6 (19.4)	7 (21.9)
Stricture side
Rt	15 (48.4)	16 (50)	0.898^c
Lt	16 (51.6)	16 (50)
Stricture length grouping
≤1.5 cm	17 (54.8)	19 (59.4)	0.716^c
>1.5 cm	14(45.2)	13 (40.6)
Hydronephrosis
Mild	8 (25.8)	8 (25)
Moderate	13 (41.9)	13 (40.6)	0.984^c
Marked	10 (32.3)	11 (34.4)
LUTS
No	13 (41.9)	15 (46.9)
Mild	13 (41.9)	11(34.4)	0.825^c
Moderate	5 (16.1)	6 (18.8)

Data presented as mean ± SD, median [range], or number (%).

Independent t-test.

Mann–Whitney U test.

Chi-square test.

LUTS = lower urinary tract symptoms; SD = standard deviation.

The mean follow-up was 30.2 ± 4.7 months; range [19–41]. Forty-three patients showed resolution of obstruction by radiographic studies (objective success) and improvement of symptoms, with overall success rate of 68.3%, whereas 20 patients showed recurrence of their ureteral obstruction with a failure rate 31.7% for which they were scheduled for another trial of endoureterotomy or frequent Double-J exchanges. All failures appeared within the first year. The objective success rate was 83.9% (26 patients) and 53.1% (17 patients), whereas the failure rate was 16.1% and 46.9% in the 2-Double-J group and in the 1-Double-J group, respectively, with significant difference between both groups (p = 0.009) in favor of the 2-Double-J group (Table 2).

Table 2.

Comparison of Objective Success Rate in Relation to Number of Double-J

	Success (%)	Failed (%)	p
No. of Double-J
Two-Double-J (31 patients)	26 (83.9)	5 (16.1)	0.009^a
One-Double-J (32 patients)	17 (53.1)	15 (46.9)
Total patients (63)	43 (68.3)	20 (31.7)

Pearson chi-square test.

Significant.

When evaluating the success rate and failure rate for both groups (2- and 1-Double-J) according to stricture length grouping (short segment ≤1.5 cm and long segment >1.5 cm), in this study 36 patients (57.1%) had stricture ≤1.5 cm and 27 patients (42.9%) had stricture >1.5 cm. For short segment group although the success rate in 2-Double-J group (82.4%) is more than in the 1-Double-J group (63.2%), it is not statistically significant (p = 0.199). Whereas for long segment the success rate in 2-Double-J group (85.7%) is more than in the 1-Double-J group (38.5%) with significant difference between both groups (p = 0.018), as 2-Double-J give better results for stricture >1.5 cm in patients who underwent laser endoureterotomy for their bilharzial ureteral stricture (Table 3).

Table 3.

The Objective Success Rate in Relation to Stricture Length Grouping, and the Number of Double-J

	Success (%)	Failed (%)	p
Stricture length ≤1.5 cm
2-Double-J (17 patients)	14 (82.4)	3 (17.6)	0.199
1-Double-J (19 patients)	12 (63.2)	7 (36.8)
Total (36 patients)	26 (72.7)	10 (27.8)
Stricture length >1.5 cm
2-Double-J (14 patients)	12 (85.7)	2 (14.3)	0.018^a
1-Double-J (13 patients)	5 (38.5)	8 (61.5)
Total (27 patients)	17 (62.9)	10 (37.1)

Fisher's exact test.

Significant.

In Table 4, we evaluate the different variables that may affect the outcome (e.g., age, stricture length, gender, and hydronephrosis) there was no statistical significances for these variables can affect the outcome (in Table 4).

Table 4.

Effect of Different Variables on the Objective Outcome in All Patients

	Success (43 patients)	Failed (20 patients)	p
Age (years), mean ± SD	43.3 ± 14	44.1 ± 12	0.834^a
Stricture length (cm) mean ± SD	1.35 ± 0.6	1.49 ± 0.6	0.342^a
Serum creatinine (mg/dL), median [range]	1 [0.7–3.7]	1 [0.8–3.8]	0.185^b
Gender, patients no. (%)
Male	28 (65.1)	12 (60)	0.695^c
Female	15 (34.9)	8 (40)
Stricture side, patients no. (%)
Rt	19 (44.2)	12 (60)	0.243^c
Lt	24 (55.8)	8 (40)
Length grouping, patients no. (%)
≤1.5 cm	26 (60.5)	10 (50)	0.435^c
>1.5 cm	17 (39.5)	10 (50)
Stricture site, patients no. (%)
Proximal	9 (20.9)	3 (15)
Middle	16 (37.2)	4 (20)	0.251^d
Lower	18 (41.9)	13 (65)
Serum creatinine grouping, patients no. (%)
Normal (≤1.5)	36 (83.7)	14 (70)	0.210^c
Elevated (>1.5)	7 (16.3)	6 (30)
Hydronephrosis, patients no. (%)
Mild	13(30.2)	3 (15)
Moderate	16 (37.2)	10 (50)	0.404^c
Marked	14 (32.6)	7 (35)

Independent t-test.

Mann–Whitney U test.

Chi-square test.

Fisher's exact test.

All patients had no intraoperative complications, whereas postoperative complications there were three patients in each group (two men and one woman in group 1, and one man and two women in group 2) suffering from acute pyelonephritis and they respond well to quinolones treatment. According to hematuria all of them respond well to conservative treatment without any intervention. In regard to stent-related LUTS (irritative bladder symptoms), all patients start to take combination of alpha blocker (0.4 mg Tamsulosin) and anticholinergics (Tolterodine 4 mg) once daily from day 1 and they instructed to void regularly without holding micturition, LUTS improved steadily by time.

Discussion

Ureteral stricture caused by chronic inflammation as schistosomiasis is common, and it is a sequel of ischemic changes ending by fibrosis and scar formation.¹⁷ This made it poor responder to endoureterotomy.^18,19 Technological advances changed dramatically ureteral stricture managements, as endoscopic laser ureterotomy become a preferable choice for minimally invasive techniques with minimal perioperative complication and success rates up to 89%.^5,13,20,21

Ureteral stenting after endoureterotomy is a crucial step; however, the size and number of stent is still a matter of controversial issues. Many urologists advice the use of large caliber, but this may induce ureteral fibrosis.^{7,8,11,12,15,18} The use of 2-Double-J become more popular after Liu and his colleague published their study.¹⁰ In the presence of Double-J the urine flows mainly around it rather than in its lumen. In the presence of 2-Double-J there is a potential space between them allowing sliding movement with the ureteral peristalsis this was proved by ultrasonography. This motion may lead to expansion of the incised segment, and this prevents ischemia or pressure necrosis of the ureter or synechiae formation.^22
–24

In this study, we evaluated the long-term efficacy of laser endoureterotomy as a precise cutting tool with good hemostasis effects, and limited damage to the surrounding tissue for managing ischemic stricture ureter caused by bilharziasis, when we use a large caliber stents (2-Double-J). As our philosophy in stenting it acts as mold for ureteral healing with wide lumen.^21,22

Most failures appear within the first year as reported in many series,^18,25 so seven patients were excluded from statistics, as they did not complete follow-up >1 year. Sixty-three patients completed follow-up >12 months, the overall success rate was 68.3%, and this within the range published for laser endoureterotomy.^9,21,25 The comparison between groups is problematic as there are multiple variables such as stricture type, and length, or stent size, or number, and the cutting modalities.^9,13 In regard to Double-J numbers the success rate when using 2-Double-J is significantly better than 1-Double-J (83.9% vs 53.1%, p = 0.009), and this rate is consistent with Rotariu and others,^11,12,24,26 when they use 2-Double-J, in treating difficult cases as, malignant ureter, or failed previous endoureterotomy.

When putting in mind the impact of the stricture length on the outcome, when the length ≤1.5 cm, the success rate is in favor for 2-Double-J group than 1-Double-J group (82.4% vs 63.2%); however, it was not statistically significant and this also presented in many studies showing that ureteral healing doing better in short segment regardless the stent size.^5,15,27 Although in long segment >1.5 cm the success rate is significantly better in 2-Double-J group than the 1-Double-J group (85.7% vs 38.5%, p = 0.018.), this supports the idea of stent act as mold allowing for wide regeneration and healing.

Lane et al.²⁵ use a large caliber stent in their study, endopyelotomy stent (14/7F or 10/7F) was placed with the wider portion set in the area of the stricture; our overall success rate for 2-Double-J is 83.9% and this is better than their success rate (68.4%) and this may be the effect of the movement of both Double-J. Ibrahim and others recommend the use of 2-Double-J in managing stricture in special circumstances, with success rate up to 90%.^{15,18,27
–29}

To our knowledge this is the first study that assessed the long-term efficacy of laser endoureterotomy for bilharzial ureteral stricture.

Conclusions

Holmium:YAG laser endoureterotomy provides favorable results with respect to long-term patency rate for managing bilharzial ureteral stricture. We presented that insertion of two ipsilateral Double-J after laser endoureterotomy for this type of stricture affords significant better long-term patency rate than insertion of single Double-J, especially for stricture >1.5 cm.

Footnotes

Authorship Confirmation Statement

All persons who meet authorship criteria are listed as authors, and all authors certify that they have participated sufficiently in the study to take public responsibility for the content, including participation in the concept, design, analysis, writing, or revision of the article. All authors certify that this article represents valid and original study. If requested I will provide raw data on which the article is based for examination by the editors and reviewers. Furthermore, each author certifies that this material or similar material has not been and will not be submitted to or published in any other publication before its appearance in Journal of Endourology.

Authors' Contributions

This paragraph delineates each specific contributions made by each author.

Category 1

Category 2

Category 3

We approve this version of the article to be published.

Author Disclosure Statement

No competing financial interests exist.

Funding Information

No funding was received for this article.

Abbreviations Used

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