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International Journal of Urology (2015)

doi: 10.1111/iju.12782

Original Article

Influence of patient education on morbidity caused by ureteral stents Dominik Abt,1 Elisabeth Warzinek,1 Hans-Peter Schmid,1 Sarah Roberta Haile2 and Daniel Stephan Engeler1 1

Department of Urology and 2Clinical Trials Unit, St. Gallen Cantonal Hospital, St. Gallen, Switzerland Abbreviations & Acronyms SDQ = self-developed questions (relating to quality of patient education) USSQ = Ureteral Stent Symptom Questionnaire

Correspondence: Dominik Abt M.D., Department of Urology, St. Gallen Cantonal Hospital, Rorschacherstrasse 95, 9007 St. Gallen, Switzerland. Email: [email protected] Received 20 January 2015; accepted 8 March 2015.

Objectives: To investigate the influence of patient education on symptoms and problems caused by ureteral stents. Methods: The German version of the Ureteral Stent Symptom Questionnaire was completed by 74 patients with unilateral inserted indwelling stents. Additionally, six selfdeveloped questions regarding type and quality of patient education on pain, urinary symptoms, hematuria, activities permitted, stent function and overall patient education were answered. Correlations between questionnaires, subscores and single items, and the influence on economic aspects were analyzed. Results: Adjusting for age, sex, intravesical stent length, stent indwelling time, use of analgesics and an alpha-blocker, the correlation between the Ureteral Stent Symptom Questionnaire and self-developed questions was –0.40 (95% CI –0.58, –0.19, P < 0.001). The following subscores and items showed a statistically significant correlation with quality of patient education after correction for multiple testing: Ureteral Stent Symptom Questionnaire total score, urinary symptoms subscore, U6, U10, G3, G4 and GQ. No relevant influence of patient education on economic aspects was found. Conclusion: High-quality patient education on ureteral stent-related symptoms is highly advisable, as it has the potential to reduce these symptoms. However, the influence of information on the incidence and extent of potential problems seems to be limited. A much better approach would be to develop better designed devices and more convenient stent-free procedures.

Key words:

morbidity, patient education, symptoms, ureteral catheterization, Ureteral Stent Symptom Questionnaire.

Introduction Temporary drainage of the upper urinary tract by internal ureteral stents is a common procedure to assure renal function and to treat pain caused by ureteral obstruction. Indications for double-J stents range from the treatment of ureteral and kidney stones to relief of ureteral obstruction and other clinical conditions, such as endopyelotomy. Although ureteral stents offer a simple and effective method of ureteral drainage and avoid external or visible devices, they are frequently associated with a clear side-effect profile. Joshi et al. reported irritative voiding symptoms in 78% of patients and stent-related pain affecting daily activities in more than 80% of patients.1 Irritation by a foreign body and the reflux generated result in especially high rates of lower urinary tract symptoms, flank pain and hematuria. Leibovici et al. reported an incidence of distinct dysuria as high as 40%, and urinary frequency and urgency as high as 50% and 55%, respectively. They also found an inverse correlation between patient age and dysuria, but no correlation between age and urgency, frequency or flank pain. Although flank pain during micturition was reported by one-third of patients, constant dull flank pain was seen in 15.6%, and 41.6% suffered from hematuria.2 Side-effects were predominantly reported to persist during the entire stent dwelling time.2 Furthermore, functional impairment in many aspects of everyday life has been reported. Joshi et al. described a variable degree of impact on all general health domains, with an overall 80% quality of life impairment and a 35% risk for sexual dysfunction.1 Anxiety and sleep disorders, and a negative effect on social life and vitality were also common.1,2 The high morbidity of ureteral stenting also seems to have a significant negative economic impact. Reduced work capacity was reported for 58% of patients, with further costs for medical consultations (37.5% of patients had to seek assistance from healthcare professionals) and hospitalizations (5% visited the hospital once).1 In addition, antibiotic intake is high as a result of symptoms of urinary tract infection: © 2015 The Japanese Urological Association

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D ABT ET AL.

37% took one, 10% took two and 2.5% took more than two courses of antibiotics other than those they received at the time of stent insertion, and more than 70% of patients took analgesics.1 Several studies have investigated the reasons for, and the treatment and prevention of morbidity caused by indwelling ureteral stents. Their results can be summarized as follows. Discomfort caused by ureteral stents can be partially reduced by oral administration of alpha-blockers3 and careful choice of the appropriate intravesical stent length.4,5 In contrast, the stent’s proximal end4 and diameter6–8 seem to have no influence. Despite many advances in stent composition, construction geometry and design, it seems that the ideal stent has yet to be designed.3,9 In consideration of the prevalence of ureteral stenting and subsequent symptoms, further clinical studies are required to investigate the prevention and treatment of stent-associated problems. An important step forward was made by Joshi et al. by developing and validating the USSQ, which analyzes various domains of health (six sections and 38 items) affected by stents, covering urinary symptoms, pain, general health, work performance, sexual matters and additional problems.10 Over the past 10 years, the USSQ has become a well-accepted standard in the examination of stent-associated symptoms, and has been translated into different languages. Validated versions in French,11 Italian,12 Korean13 and Spanish14 are available. A German version has been developed in a multistep process as recommended by Hutchinson e al.15 It is at present undergoing validation in a multicenter analysis in Regensburg and Sindelfingen-Böblingen in Germany, Salzburg in Austria, and in our own department (unpubl. data). Anxiety and discomfort might be reduced by thorough patient education. A well-informed patient could therefore enjoy better quality of life and incur fewer costs as a result of lost work, medical consultations and treatments. Joshi et al. also developed and validated a patient information booklet on ureteral stents.16 It is therefore surprising that they did not systematically investigate the influence of patient education on morbidity caused by ureteral stents. This was the aim of the present study.

Methods The study was approved by the local ethics committee (EKSG 13/096). Between July 2013 and June 2014, 74 patients with unilateral indwelling stents (Percuflex; Boston Scientific, Natick, MA, USA, 6-Fr, length 26–30 cm) were prospectively included in the present study based on questionnaires. They were asked to complete the German version of the USSQ on the day of stent removal, which allowed examination of the entire stent dwelling time. Additionally, six SDQ regarding type and quality of patient education before surgery and, as a minimum, before hospital discharge were added to the USSQ (Table 1), allowing participants to rate the information they received on pain, urinary symptoms, hematuria, activities permitted, function and benefit of the stent, and overall patient education on a scale of 1 (no information provided) to 6 (very good information provided). Patient education was therefore assessed using both specific topics and 2

Table 1 SDQ regarding type and quality of patient education (translated into English) SDQ 1

How well were you informed that the double-J catheter can cause pain? 2 How well were you informed that the double-J catheter can cause symptoms of bladder irritation (such as an urgent need to urinate and urinary incontinence)? 3 How well were you informed that the double-J catheter can cause blood in your urine? 4 How well were you informed about activities and everyday types of stress permitted with an indwelling double-J catheter? 5 How well were you informed about the function of the double-J catheter, i.e. that it ensures that urine can flow freely from the kidney into the bladder, or about preparation of the ureter for stone extraction? 6 Altogether, how do you rate the information you received about symptoms that can be caused by the double-J catheter? Possible answers for SDQs 1-5 Not at all ☐1 Badly ☐2 Inadequately ☐3 Satisfactorily ☐4 Well ☐5 Very well ☐6 Possible answers for SDQ 6 I was not given any information ☐1 I was informed badly ☐2 The information was inadequate ☐3 The information was adequate ☐4 I was given good information ☐5 I was given very good information ☐6

an overall score of between 6 to 36 points. Inclusion criteria were a unilateral ureteral stent, inserted for treatment of uretero- or nephrolithiasis and informed consent. Exclusion criteria were previous ureteral stenting, pregnancy, bilateral ureteral stenting, obstruction because of malignancy, additional procedures or operations carried out during stent indwelling time and debilitating disease. The influence of patient education (measured by SDQ score) on morbidity caused by ureteral stenting (measured by USSQ score) was defined as the primary end-point. The influence of patient education on USSQ subscores, single items and economic aspects measured by single items in the USSQ (reduction of work capacity, medical consultations, hospitalizations, need for medical treatment, accomplished antibiotic therapies) were analyzed as secondary end-points. According to power analysis, 68 patients would be required to detect a correlation greater than 0.3 between patient education and the morbidity score, with 80% power and a one-sided significance level of 0.05 using a one-sample z-test of the correlation coefficient. Categorical variables are reported as n (%) and were compared using Fisher’s exact test, whereas continuous variables are reported as median (range) and were compared using the Mann–Whitney U-test. Correlations between scores were estimated using the Pearson correlation (with the corresponding 95% confidence interval). Correlations adjusted for different factors were estimated using linear regression. A two-sided significance level of © 2015 The Japanese Urological Association

Patient education on ureteral stents

0.05 was used throughout. Holm’s method was used to control multiple testing.17 All analyses were carried out in the R programming language (version 3.1.0; R Core Team, 2013). As the total score on the questionnaire was the primary end-point, patients with incompletely answered questionnaires were excluded from the study.

Results Six of the 83 patients enrolled did not return the questionnaire, and three had to be excluded because of incompletely answered forms. None of the patients suffered from urinary tract infection at the time of stent insertion. Table 2 shows the demographics and clinical characteristics of the 74 remaining patients. Adjusting for age, sex, intravesical stent length and stent indwelling time, a significant correlation of –0.40 (95% CI –0.57, –0.18, P = 0.02) between USSQ and SDQ was shown after correction for multiple testing (Fig. 1). Adjusting also for type of analgesic and alpha-blocker, the correlation between USSQ and SDQ was –0.40 (95% CI –0.58, –0.19, P < 0.001). Using the same methods as for the primary end-point, correlations between USSQ subscores and SDQ, and USSQ single items and SDQ were explored, both unadjusted and adjusted. The following items still showed a statistically significant correlation with SDQ after correction for multiple testing using Holm’s method:17 urinary symptoms subscore, U6, U10, G3, G4 and GQ (Table 3). No differences relating to significance could be found between adjusted and unadjusted findings.

Table 2 Patient demographics and clinical characteristics n

%

Women Men Preparation for secondary ureterorenoscopy After primary ureterorenoscopy Preparation for shock wave lithotripsy Acute colic Mild symptoms only Asymptomatic patients None Non-steroidal antiinflammatory drug Paracetamol Metamizole Combination of two None Tamsulosin

17 57 71

23 77 95.9

2

2.7

1

1.4

42 22 10 10 4

56.8 29.7 13.5 13.5 5.4

16 7 37 60 14

21.6 9.5 50 81.1 18.9

Variable

Median

Minimum

Maximum

Age (years) Stent indwelling time (days)

53.0 30.0

20.5 8.0

80.1 94.0

Variable Sex Ureteral stent indication

Symptoms at the time of stent insertion Analgesics

Alpha-blocker

© 2015 The Japanese Urological Association

Fig. 1 Primary end-point. Correlation between ureteral stent symptoms (USSQ) and patient education (SDQ).

All other subscores (Table 3) and single items (data not shown) did not show a significant correlation with SDQ. As with the USSQ total score, most of the subscores and items had a negative correlation with SDQ. However, the following items showed a positive but not statistically significant correlation (either adjusted or unadjusted) with SDQ: U1, U2, P7 and A4 (all P = 1.0). No relevant influence of patient education on economic aspects could be found. After correction for multiple testing, SDQ had no effect on working capacity measured by the working performance subscore (P = 0.16) or single items W2 (P = 1.0), W3 (P = 1.0), W5 (P = 0.38), W6 (P = 0.27), W7 (P = 0.99), or on the number of medical consultations (A3; P = 0.70) or hospitalizations (A4; P = 1.0) (Table 3). Analyzing further factors that could have influenced the study’s outcome, we computed a sensitivity analysis by excluding the three patients not awaiting secondary URS, and adding symptoms at the time of stent insertion, stone size and stone location as adjusting factors. The result was similar for the primary end-point (–0.41; 95% CI –0.59, –0.19) as well as for secondary end-points (data not shown).

Discussion To the best of our knowledge, this is the first study to examine the correlation between patient education and problems caused by ureteral stents. We showed a significant correlation (–0.40; 95% CI –0.58, –0.19; P = 0.02) between high-quality patient education, and a lower incidence of typical complaints associated with indwelling ureteral stents. Overall, negative correlations could be found between patient education and symptoms, showing that better information is leading to lower morbidity. 3

D ABT ET AL.

Table 3 Primary and secondary end-points

USSQ (total score) USSQ subscores Urinary symptoms Body pain General health Work performance Sexual matters Additional problems USSQ single items with significant correlation with patient education (SDQ) U6 (How often do you feel that your bladder has not emptied properly after you have passed urine?) U10 (Overall, how much of a problem are your urinary symptoms to you?) G3 (Have you felt tired and worn out?) G4 (Have you felt calm and peaceful?) GQ (In the future, if you were advised to have another stent inserted, how would you feel about it?) Selected USSQ single items without significant correlation to patient education G5 (Have you enjoyed your social life [going out, meeting friends and so on]?) W2 (Following insertion of the stent, how many days did the symptoms associated with the stent keep you in bed all or most of the day?) W3 (Following insertion of the stent, for how many half days or more did you cut down your routine activities because of the symptoms associated with the stent?) W5 (Have you worked for short periods of time or taken frequent rests because of the symptoms associated with the stent?) W6 (Have you worked at your usual job, but with some changes because of the symptoms associated with the stent?) W7 (Have you worked your regular number of hours?) S2.ii (AND, why did this [sex life] stop?) A1 (How many times have you felt you may be suffering from a urinary tract infection e.g. running a temperature, feeling unwell and pain while passing urine?) A3 (Have you needed to seek help of a health professional [such as GP, nurse] due to any problem associated with the stent?) A4 (Have you needed to visit the hospital due to any problem associated with the stent?)

Correlation

95% CI

P-value

–0.40

–0.57, –0.18

Influence of patient education on morbidity caused by ureteral stents.

To investigate the influence of patient education on symptoms and problems caused by ureteral stents...
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