Evaluation of Symptoms and Patients' Comfort for JJ-ureteral Stents With and Without Antireflux-membrane Valve

Technology and Engineering Evaluation of Symptoms and Patients’ Comfort for JJ-ureteral Stents With and Without Antireflux-membrane Valve Thorsten H. Ecke, Peter Bartel, Steffen Hallmann, and Jürgen Ruttloff OBJECTIVES METHODS

RESULTS

CONCLUSIONS

To evaluate safety and patients’ comfort by using the ureteral stent symptom questionnaire. Ureteral stents are used to provide upper urinary-tract drainage. A total of 133 JJ-ureteral stents with and without antireflux-membrane valve as consecutive referrals for therapy of hydronephrosis have been inserted. Four weeks after insertion of the ureteral stent, the patients were asked about pain while urination, flank pain due to reflux, and the comparison with former stents. Ultrasound of the kidney for hydronephrosis grade and creatinine value as follow-up have been documented. Statistical analysis included ␹2 test after Pearson correlation computed and performed by SPSS software. We found a high correlation between the JJ-ureteral stent used and the detection of a hydronephrosis (P ⫽ .004). More patients who had a JJ-ureteral stent without valve complained of flank pain (P ⬍.0005) and pain in the bladder (P ⬍.0005). Patients who had a ureteral stent before were asked to compare new stents with the former ones. No patients with a JJ-ureteral stent with valve found this one to be worse than what they had before. JJ-stent related symptoms are a major problem for these patients. New stent designs and materials will be developed in the future to reduce stent-related morbidity and improve patient comfort. JJ-ureteral stents with an antireflux-membrane valve have a lower complication rate and provide a higher patient comfort compared with stents without valve. UROLOGY 75: 212–216, 2010. © 2010 Published by Elsevier Inc.

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or many urological procedures ureteral stents are needed. The first description of an insertion of ureteral stents was made by Zimskind et al in 1967.1 Nowadays, it is one of the most frequent interventions in urology. Ureteral stents are commonly used to provide upper urinary tract drainage. Though stents ensure drainage after stone and reconstructive procedures, they are a significant cause of morbidity.2 The highest morbidity of ureteroscopic stone manipulation is associated with the stent that is left after surgery.2 Morbidity is mostly correlated with patients’ tolerance.3 Usually patients’ complaints include flank pain, particularly when bending, voiding or moving, and bladder symptoms such as frequency, urgency, dysuria, and hematuria.4,5 Bladder symptoms such as dysuria and frequency are theorized to be caused by local mucosal stent irritation of nerves located in the submucosa concentrated in the bladder trigone accentuated by patient movement.6,7 Flank pain is thought to be caused by reflux, especially during micturition, of urine from the bladder into the kidney, thus From the Department of Urology, HELIOS Hospital, Bad Saarow, Germany Reprint requests: Thorsten H. Ecke, M.D., Department of Urology, HELIOS Hospital, Pieskower Strasse 33, D-15526, Bad Saarow, Germany. E-mail: tho_ecke@ hotmail.com Submitted: May 11, 2009, accepted with (revision): July 28, 2009

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© 2010 Published by Elsevier Inc.

generating pressure.8,9 To have less of these irritative symptoms, the industry has modified the biomaterial and also established stents with antireflux-membrane valve. The mechanisms of stents with an antireflux-membrane valve are comparable to the Heimlich flutter valve that is used for drainage of pneumothorax.10 This Heimlich valve connects to chest tubing and allows fluid and air to pass in one direction only. After the same principle, the JJ-ureteral stents allows the pass of urine only in one direction. The antireflux-membrane valve at the vesical edge of the stent, automatically collapses as the bladder pressure increases, thus reducing the vesicoureteral reflux. Joshi et al11 examined the prevalence of symptoms associated with ureteral stents and their impact on health-related quality of life. They developed and validated a questionnaire of stent symptoms, the Ureteral stent symptom questionnaire (USSQ), based on a series of 85 patients.11-13 The questionnaire consists of 48 items and examines 6 criteria: pain, voiding symptoms, work performance, sexual health, overall general health, and additional problems. Their results demonstrated that 76% of patients had urinary symptoms, 70% had pain severe enough to require significant analgetics, 42% of patients had to reduce their activities by 50%, and patients felt less healthy in general. The USSQ is the first 0090-4295/10/$34.00 doi:10.1016/j.urology.2009.07.1258

questionnaire regarding ureteral stents to be validated and is available on the Internet along with a patient information pamphlet on ureteral stents.13 Quantification of ureteral symptoms has become an important part of evaluating the subjective symptoms caused by ureteral stents and represents an important component of any clinical trial comparing the effect of newer stents or patient symptomatology. Therefore, we evaluated in this study the patients’ comfort of ureteral stents with and without antireflux-membrane valve by questionnaire.

MATERIAL AND METHODS Subjects In our study, 105 patients (56 men and 49 women, median age 65 years, range 18-94) were enrolled from July to September 2008 at the Department of Urology of HELIOS Hospital, Bad Saarow, Germany. Our study population consisted of consecutive referrals for therapy of hydronephrosis. Informed consent was obtained from all study participants.

Study Design We used in all cases JJ-ureteral stent sets, made of polyurethanes, latex-free, central open tip, hydrophilic, sterile, 28-cm length, for coaxial application. All stents were inserted retrogradely. The used JJ-valve ureteral stents are made of polyurethane with hydrogel coating, with JJ coupling, diaphragm valve and green marker at the vesical end, graduation in centimeters, and completely radio-opaque. An example for such a JJ-ureteral stent is shown in Figure 1. The diameter of the stent is only increased by 1F at the valve. All JJ-ureteral stents used in this study were produced by Teleflex Medical, GmbH, Kernen, Germany. Grading the hydronephrosis was defined as follow: grade 0 (normal), grade 1 (minimal dilatation of the calyces), grade 2 (visible papillae in a dilated system), grade 3 (moderate dilatation of the calyces), and grade 4 (severe dilatation of the calyces). One and 4 weeks after insertion of the ureteral stent the patients were asked the following questions: Question 1. Did you have pain while urination after the examination? Answer possibilities: no—sometimes—always Question 2. Did you feel pain in the kidney while urination (reflux)? Answer possibilities: no—sometimes—always Question 3. In case you had a ureteral stent before, was this ureteral stent better, same or worse than your stent before? Answer possibilities: better—same—worse The study was randomized and single-blinded. Statistical analysis was performed using the Spearman correlation coefficient for discrete variables and Pearson correlation coefficient for continuous values with SPSS software. Statistical analysis included ␹2 test after Pearson correlation computed and performed by the computer program SPSS version 12.0.1. UROLOGY 75 (1), 2010

Figure 1. JJ-ureteral stent with an antireflux valve.

RESULTS In total, 133 JJ-ureteral stents were inserted, 77 left and 56 right side. In 1 case we used a 6F JJ-ureteral stent, 7F in 57 cases, and 8F in 75 cases. We inserted 61 JJ-ureteral stents without antireflux-membrane valve, 72 patients received a JJ-ureteral stent with antireflux-membrane valve. The indwelling time was in median 65 days (range 2-188 days). Of the 105 patients, 25 were present more than once in this study. Eleven patients had JJ-ureteral stents on both sides, 12 other patients came twice, and 1 patient came thrice to our department during the study. One patient had JJ-ureteral stents on both sides and came twice to our department during the study time. In our results, we took every used JJ-ureteral stent as 1 case. All patients enrolled in this study completed the questionnaire. Important demographic factors such as age, sex, side, French of the inserted stent and indication are shown in Table 1. All calculated P values show that these factors are independent from the type of ureteral stents. There were no difficulties placing these stents with or without valve; all of them were placed through a cysto213

Table 1. JJ-ureteral stent and demographic factors

Age ⬍50 ⱖ50 Sex Female Male Side Left Right French 6 7 8 Indication Stone Tumor (ureter compression from outside) Stricture

JJ-Ureteral Stent Without Valve

JJ-Ureteral Stent With Valve

P

19 42

19 53

.545

26 35

39 33

.184

36 25

41 31

.809

0 29 32

1 28 43

.313 .349

39 12

30 16

.222

10

26

.208

Table 2. JJ-ureteral stents and results in detail JJ-Ureter JJ-Ureter Stent Stents Without Valve With Valve Creatinine increase Yes No Hydronephrosis (grade) 0 1 2 3 Reflux No Seldom Very often Pain No Seldom Very often Comparison with former stent Same Better Worse

P

7 51

9 42

.291

36 18 4 3

59 8 6 1

.001 .052 .237

29 20 12

63 8 1

⬍.0005 .133

20 31 10

53 17 2

⬍.0005 .212

4 16 11

13 39 0

.655 ⬍.0005

scope. Also, while removing the stents there were no difficulties. Parameters of creatinine increase, grade of hydronephrosis, flank pain due to reflux, pain in the bladder, and comparison with former ureteral stents are shown in detail in Table 2. Time of ultrasound examination was the time point just before stent removal. There was no difference in patients’ answers 1 and 4 weeks after insertion. It is noteworthy that 12 patients had the JJ-ureteral stent for less than 4 weeks because of complications or the end of the therapy. In all these cases, we used the 214

Figure 2. (A) Ultrasound of left kidney with hydronephrosis (JJ-ureteral stent without antireflux valve). (B) Ultrasound of left kidney without hydronephrosis (JJ-ureteral stent with antireflux valve).

answers of the last days before stents were removed or changed. An overview of the results in Table 2 shows that the creatinine level increase has not influenced the used JJ-ureteral stent with a calculated P value (P ⫽ .291). We could show a high correlation between the used JJ-ureter stent and the detection of a hydronephrosis (P ⫽ .004). In 7 cases, it was necessary to change from JJ-ureteral stent without antireflux-membrane valve to a stent with valve due to patients’ symptoms. As an example to show the difference of hydronephrosis with and without valve the results of ultrasound examination are visible in Figures 2A and B. The purpose of Figures. 2A and B is to show the difference of JJ-ureteral stent with and without antireflux-membrane valve in 1 patient. In this patient, the ureteral stent without valve had to be changed to a JJ-ureteral stent with valve because of pain and symptomatic hydronephrosis. More patients who had received a JJ-ureteral stent without valve complained of flank pain (P ⬍.0005) and pain in the bladder (P ⬍.0005) compared with patients with a valve stent. There were patients who had a ureteral stent before they were asked to compare with the former stents. None of the patients with a JJ-ureteral UROLOGY 75 (1), 2010

stent with valve found this one worse than the stent they had before. However, 11 patients with a JJ-ureteral stent without valve complained that this one was worse than the stent they had before. For this point of the study, Pearson’s significance with ␹2 test for the comparison to former stents was calculated with P ⬍.0005. Calculating the parameters of Table 2 for stone, tumor, and stricture patients separately, we found nearly the same statistical significance as in all patients together. Therefore, we conclude that the complications rates are independent of the indication of stent insertion. Comparing French size of the inserted stent with other parameters, we found no statistically significant correlation for flank pain due to reflux (P ⫽ .623) and pain in the bladder (P ⫽ .461). We could not find a higher rate of bladder discomfort in smaller patients concerning to the JJ-ureteral stent length. In our cohort, we did not have very tall or short individuals, so on average 28 cm is the best solution. In our study, 83 patients had ureteral stents before. In some cases, it was necessary to change the ureteral stents because of severe flank pain due to reflux or other pain. Four ureteral stents (3 without valve, and 1 with valve) had to be changed immediately. Pearson’s significance with ␹2 test between ureteral stents with or without valve and the need of change was calculated with P ⫽ .015. As a special case, we report about 1 patient who had JJ-ureteral stents on both sides. This patient reported about heavy flank pain in the kidney with JJ-ureteral stent without valve, and no flank pain at the other side with JJ-ureteral stent with valve. After changing to JJureteral stent with antireflux-membrane valve on both sides he reported no pain.

COMMENT In our prospective randomized study, we evaluated the safety, morbidity, and complication rate for JJ-ureteral stent with and without antireflux-membrane valve. Patients with stent-related problems are common in any busy urological practice. In this study, 133 JJ-ureteral stents were inserted, 61 without antireflux-membrane valve, and 72 patients received a JJ-ureteral stent with antireflux-membrane valve. Questionnaire parameters, increase in creatinine level, grade of hydronephrosis, flank pain due to reflux, pain in the bladder, and comparison with former ureteral stents were documented. Questions were asked to the patients 1 and 4 weeks after insertion as follow-up. There were no differences in the patients’ answers. This is in consensus with the results of Joshi et al.13 It seems that the JJ-ureteral stent used has no influence on the increase in creatinine level with a calculated P value (P ⫽ .291). This might be without correlation because of the short time of the indwelling stent. On the other hand, it is known that in most cases there is no increase in creatinine level in patients with another normal kidney. These are the 2 reasons why no correlaUROLOGY 75 (1), 2010

tion and even seldom an increase in the creatinine level were found. But this study shows a high correlation between the use of JJ-ureteral stent without a valve and the detection of a hydronephrosis compared with patients with valve stents (P ⫽ .004). In Figures 2A and B, ultrasound examination reveals that the same patient had hydronephrosis and flank pain with an JJ-ureteral stent without valve and after changing the stents, exhibited no symptoms and no hydronephrosis with an JJ-ureteral stent with valve. Patients who had a JJ-ureteral stent without valve complained more of flank pain due to reflux symptoms (P ⬍.0005) and pain in the bladder (P ⬍.0005) in comparison with patients with valve stents. The lower rate of bladder discomfort in patients with an antireflux-membrane valve could be caused by the fact that the valve is less irritating than a JJ-ureteral stent without valve. Pain in the kidney region while voiding, which appeared to be a symptom peculiar to the stents, may indicate reflux, as observed in other studies.14,15 Concerning these aspects our study shows that JJ-ureteral stents with antirefluxmembrane valve cause lower rates of hydronephrosis and reflux. Lasaponara et al16 could show that a JJ-ureteral stent with antireflux-membrane valve reduces almost completely the risk of vesicoureteral reflux. Also, the question about comparison with a former inserted ureter stent described higher rates of complaining in the group of patients without valve stent (P ⬍.0005). In an 18-month study, Richter et al17 prospectively examined 110 stented renal units in 90 patients and outlined the morbidity and complications of indwelling ureteral stents. In their series, 72 stents were inserted retrogradely, whereas antegrade insertion was established in the remainder. In 88 patients, the stent was inserted to relieve obstruction caused by urolithiasis, and in 22 patients the reason was extraluminal obstruction. The complication rate was high: 103 patients (94%) had stentrelated complications such as infection (38%), flank pain on voiding presumably from urinary reflux by the stent (15%), stent migration, and stent fragmentation (10%). Moreover, the authors found that hydronephrosis was not improved in 21 patients (19%) after stenting and, in fact, even worsened in 6 (5.5%) patients. Stent-related symptoms and complications are common among stented patients. In 2003, Joshi et al13 established the first USSQ as a psychometrical measure to evaluate the ureteral stentrelated symptoms and their effect on quality of life. Though this is a good instrument to describe nearly all aspects of symptoms and general health problems concerning the use of ureteral stents, we decided to shorten this questionnaire to only 3 questions. Additionally, we examined the grade of hydronephrosis and increase in creatinine level as objectives. The USSQ has been the model, but our results show that these 3 short questions have been sufficient to differ between JJ-ureteral stents 215

with and without antireflux-membrane valve. Though it is known that our questionnaire is not validated like the USSQ, we used it in this study for a better usefulness. The results of our study indicated higher rates of discomfort without antireflux-membrane valve. Also, the rate of patients who need an additional operation because of a necessary change in the stent is considerably higher in this group. The additional expense to replace a JJureteral stent by another is approximately €1100.18,19 The prices of JJ-ureteral stents with or without antireflux valve are equal (approximately €20). The use of JJ-ureteral stents with antireflux-membrane valve has a lower complication rate, is cost-effective, and less painful for patients. It has been shown that the side effects of stents have a negative impact on physical and psychosocial health, which was worse than symptoms and quality of life in patients with lower urinary tract symptoms or urinary calculi without stents.11

CONCLUSIONS Currently, there is no perfect stent material or design architecture. Stent symptoms exist in most stented patients. New stent designs and materials will be developed in the future to reduce stent-related morbidity and improve patient comfort. JJ-ureteral stents with an antireflux-membrane valve have lower complication rate and a higher acceptance for patients. Acknowledgments. We thank all the involved patients for their participation, and the staff of the Department of Urology at HELIOS Hospital Bad Saarow for their excellent assistance. References 1. Zimskind PD, Fetter TR, Wilkerson JL. Clinical use of long-term indwelling silicone rubber ureteral splints inserted cystoscopically. J Urol. 1967;97:840-844. 2. Chew BH, Knudsen BE, Nott L, et al. Pilot study of ureteral movement in stented Patients: first step in understanding dynamic ureteral anatomy to improve stent comfort. J Endourol. 2007; 21:1069-1075.

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3. Chambade D, Thibault F, Niang L, et al. Etude de tolerance des endoprothèses urétérales de type double. J Prog Urol. 2006;16:445449. 4. Joshi HB, Okeke A, Newns N, et al. Characterization of urinary symptoms in patients with ureteral stents. Urology. 2002;59:511516. 5. Damiano R, Oliva A, Esposito C, et al. Early and late complications of double pigtail ureteral stent. Urol Int. 2002;69:136-140. 6. Chew BH, Knudsen BE, Denstedt JD. The use of stents in contemporary urology. Curr Opin Urol. 2004;14:111-115. 7. Pidsudko Z. Distribution and chemical coding of neurons in intramural ganglia of the porcine urinary bladder trigone. Folia Histochem Cytobiol. 2004;42:3-11. 8. Mosli HA, Farsi HM, Al-Zimaity MF, et al. Vesicoureteral reflux in patients with double pigtail stents. J Urol. 1991;146:966-969. 9. Ramsay JW, Payne SR, Gosling PT, et al. The effects of double J stenting on unobstructed ureters. An experimental and clinical study. Br J Urol. 1985;57:630-634. 10. Heimlich HJ. Heimlich’s valve for chest drainage. Med Instrum. 1983;17:19-31. 11. Joshi HB, Stainthorpe A, MacDonagh RP, et al. Indwelling ureteral stents: evaluation of symptoms, quality of life and utility. J Urol. 2003;169:1065-1069. 12. Joshi HB, Newns N, Stainthorpe A, et al. The development and validation of a patient-information booklet on ureteric stents. BJU Int. 2001;88:329-334. 13. Joshi HB, Newns N, Stainthorpe A, et al. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003;169:1060-1064. 14. Irani J, Siquier J, Pirès C, et al. Symptom characteristics and the development of tolerance with time in patients indwelling doublepigtail ureteric stents. BJU Int. 1999;84:276-279. 15. Candela JV, Bellman GC. Ureteral stents: impact of diameter and composition on patient symptoms. J Endourol. 1997;11:45-47. 16. Lasaponara F, Catti M, Morabito F, et al. Use of small caliber JJ ureteral stent with antireflux valve in ureterovesical anastomosis during renal transplantation. Minerva Urol Nefrol. 2000;52:195199. 17. Richter S, Ringel A, Shalev M, et al. The indwelling ureteric stent: a “friendly” procedure with unfriendly high morbidity. BJU Int. 2000;85:408-411. 18. Byrne RR, Auge BK, Kourambas J, et al. Routine ureteral stenting is not necessary after ureteroscopy and ureteropyloscopy: a randomized trial. J Endourol. 2002;16:9-13. 19. Haleblian G, Kijvikai K, de la Rosette J, et al. Ureteral stenting and urinary stone management. A systematic review. J Urol. 2008;179: 424-430.

UROLOGY 75 (1), 2010