1 INTRODUCTION
Over the last few decades, ureteral stents have been widely used as temporary or permanent drainage measures for intrinsic or extrinsic occlusions of the upper urinary tract. They are an essential tool in contemporary urological practice with numerous indications for use[
1].
The double‐J ureteral stent has been proven to be an effective and simple method of draining urine. It is used to prevent and/or relieve obstructions in the path of urine from the kidney to the bladder. It can be used in situations such as ureteral manipulation, performance of anastomoses on the ureter, occurrence of high obstructions, incomplete lithiasis treatment, reduction of post‐surgical complications, and management of difficult‐to‐drain infections, and so forth[
2].
Although its use is extremely widespread in urology, it can cause some complications[
2–
4]. Among the most common are urinary symptoms and the consequent impact on the quality of life[
2,
4].
Aware of the importance of the double‐J ureteral stent in urological practice and its impact on quality of life, the aim of this study is to analyze the symptoms and assess the level of satisfaction of patients who used this stent and consulted at the urology postoperative clinic at the Paraíba Valley Regional Hospital (Taubaté, São Paulo) between January and March 2020.
The general of this study is to analyze the frequency of symptoms and the level of satisfaction of patients using the double‐J ureteral stent. And the specific objective is to recognize the epidemiological and clinical profile of patients who used the double‐J ureteral stent, identify their level of satisfaction, and establish a relationship between the groups subdivided in this study and the frequency of symptoms associated with its use.
2 MATERIALS AND METHODS
This was a cross‐sectional study carried out at the Hospital Regional do Vale do Paraíba, Taubaté, São Paulo, between January and March 2020. This study consisted of 40 patients who underwent a urological procedure that required the use of a double‐J ureteral stent, pigtail type (4.7 Fr × 26 cm), hydrophilic, marketed by Indovasive. All the patients were informed of the study's objectives and signed an informed consent form. The study did not influence the post‐operative schedule of the patients involved.
Data were collected by applying a questionnaire created by the authors (Appendix 1). The questionnaire used is an adaptation of the Ureteral Stent Symptom Questionnaire (USSQ)[
5], administered during the post‐operative consultation and supplemented with information from the electronic medical record software MV 2000 version 4.8.0 J152. The data were then compiled and organized in electronic spreadsheets using Excel software from the Microsoft Office 2016 Home & Student 64 Bits EDS package. After collecting and analyzing the data, tables and graphs were created showing the epidemiological profile of the sample studied.
Different segmentations were established for comparisons:
• Nylon extractor wire: presence versus absence.
• Biological sex: male versus female.
• Age: up to 40 years old versus 41 years old or more.
• Time of use of the double‐J ureteral stent: up to 7 days versus over 7 days.
The “chi‐square test” and “Fischer's exact test” were used for the comparative analysis, with an alpha error of 5%.
3 RESULTS
3.1 Results in the general sample
The average age of the patients was 43 years old, with a range between 21 and 73 years old, with 75% female and 80% self‐declared white. Comorbidities were reported by 42.5% of users, with systemic arterial hypertension being the most prevalent (37.5%), followed by diabetes mellitus (12.5%) and hypothyroidism (7.5%). No patients reported any known urinary malformations. Regarding habits, 12.5% were smokers, 12.5% were alcoholics, 2.5% reported using illicit drugs (marijuana), and 55% were sedentary (Table 1).
Regarding the history of the current disease, 82.5% of the patients already knew about the diagnosis of urolithiasis and 20% of them had used the double‐J ureteral stent at least once. The presence of renal pain while using the double‐J ureteral stent was denied by 72.5% of the patients. When the etiology was analyzed, 15% of the patients had a diagnosis of obstructive pyelonephritis visualized during surgery by ureteroscopy, and 85% had isolated ureterolithiasis. Interventions on the left side of the urinary tract were more prevalent and carried out in 55% of cases.
The types of procedures the patients underwent included ureteroscopy, pyelolithotomy with pyeloplasty, ureterolithotomy, and ureterolithotripsy (Figure 1), with the latter being the most common (80%). Almost half of these procedures (52.5%) were carried out in the emergency department.
The double‐J ureteral stent with nylon thread was used in 29 patients (72.5%), with an average use time of 6 days, ranging from a minimum of 2 days to a maximum of 12 days. The loss of the double‐J ureteral stent was observed in two female patients, both of whom were unable to report when and why this had happened. Of the 11 patients (27.5%) who used the wireless model, only two had removed the double‐J ureteral stent by the end of the data collection period, while the others were waiting for the surgical procedure to be scheduled for removal or were continuing to use it by urological indication. Up until the final date of the survey, the average days of use of the wireless double‐J ureteral stent was 62 days, with a minimum of 42 days and a maximum of 83 days.
In an overall analysis of the urinary symptoms during the use of the double‐J ureteral stent (Figure 2), 95% of the patients had some complaints. Hematuria was the most frequent complaint, presented in 65% of cases, followed by dysuria in 62.5%, urgency in 52.5%, bladder fullness in 47.5%, and incontinence, the least reported complaint, in 32.5% of cases. Ureteral colic pain or discomfort was presented in 77.5% of users, and the average intensity of this symptom was 6.61 points on the numerical pain scale, with eight being the most cited intensity among patients. The fact that the patients underwent different procedures had no influence since they all shared a similar operative technique.
In the question about the level of satisfaction with the use of the stent, “satisfied” was the option most chosen by patients (35%). The least chosen option was “unhappy” with 5%. When analyzed in blocks, 55% of patients were “very satisfied,” “satisfied,” or “satisfied most of the time,” 22.5% had “mixed feelings” and 22.5% were “dissatisfied most of the time,” “unhappy” or “bad” (Figure 3).
When we correlated the level of satisfaction with the average number of urinary symptoms reported (a total of five symptoms), we found that the patients who chose the “satisfied most of the time” option had an average of one symptom and the “unhappy” option had an average of four symptoms. These were the options with the lowest average number of symptoms and the highest average number of symptoms, respectively (Figure 4).
3.2 Results according to the presence or absence of the nylon extractor thread
In the group that used the double‐J ureteral stent with the wire, the most prevalent urinary symptom was hematuria (69%), followed by dysuria (66%). Pain was present in 72% of this group, and the average pain score was 6 points on the numerical scale of symptom intensity, with 7 being the most cited score among the patients. 62% required analgesia for control. In contrast, in the group that used the double‐J ureteral stent without the wire, dysuria and urgency were the most commonly reported symptoms, both with 64% of cases, followed by hematuria with 55% (Figure 5). Pain was present in 91% of patients, and the average score for this symptom was 7.2 points on the numerical pain scale, with the most frequently cited score being 8 points. Around 73% of this group used analgesics.
When asked about their level of satisfaction with using the double‐J ureteral stent, the group that used the device with nylon thread chose the “satisfied” option in 44.8% of cases. The group that used the double‐J ureteral stent without the thread answered “mixed feelings” in 27.3% of cases (Figure 6).
3.3 Results according to the patient's biological sex
Dysuria and hematuria were the most common urinary symptoms among female patients, both accounting for 70% of cases (Figure 5). The women experienced pain in 80% of the cases, with the average score for this symptom being 6 points, 8 being the most chosen score, and 70% of them used analgesics for pain relief. In males, the most prevalent urinary symptoms were incontinence (50%) and hematuria (50%). Pain was present in 70% of cases, with an average of 6 points on the pain scale, 8 being the most reported intensity, and only 20% used analgesia.
When assessing the level of satisfaction with the use of the double‐J ureteral stent in the female group, 36.6% answered “satisfied,” 16.6% answered “mixed feelings,” and around 30% had some degree of dissatisfaction. In 40% of cases, the men responded that they had “mixed feelings” about using the double‐J ureteral stent, and 60% were “very satisfied,” “satisfied,” or “satisfied most of the time.” In the male gender, no patient chose the answers “dissatisfied most of the time,” “unhappy,” or “bad” (Figure 6).
3.4 Results according to patients' age (up to 40 years or >40 years)
In the group of patients aged up to 40, the most frequently reported symptom was dysuria, present in 76.5% of cases. In the over 40‐year‐old group, hematuria was the most frequently reported symptom (60.9%). Pain had a prevalence of 76.5% in the patients up to 40 years old and 78.3% of those over 40 years old (Figure 5). The level of satisfaction for both groups was predominantly “satisfied,” representing 41.2% in the younger group and 30.4% in patients over 40 (Figure 6).
3.5 Results according to length of time using the double‐J ureteral Stent
The patients who used the double‐J ureteral stent for up to 1 week had the most common urinary complaint: hematuria, which was present in 80% of these patients, followed by dysuria, with 73.3%. In the case of patients who used the double‐J ureteral stent for more than 1 week, the two most common complaints were also hematuria and dysuria, but both accounted for 56.5% of cases. Regarding pain, 66.7% of patients who used the double‐J ureteral stent for a maximum of 7 days had this symptom, while 82.6% of those who used it for more than 7 days reported pain (Figure 5).
Regarding the level of satisfaction of these patients, we noted that 53.3% of users who had used the stent for up to one week chose the “satisfied” option. While in the group that used the stent for more than one week, the most common answer was “mixed feelings” (30.4%) (Figure 6).
Table 2 shows a comparative analysis of the relationship between urinary symptoms and the above‐mentioned groups.
4 DISCUSSION
4.1 Discussion of methodology
It is undeniable that ureteral stents have revolutionized the field of urology. However, several studies have shown that their use is not without complications[
2–
4]. Among the most common complications are calcification of the stent (when the recommended time of use is exceeded), urinary infections (mainly caused by
Escherichia coli,
Enterococcus spp., and
Staphylococcus spp.), increased risk of vesico‐ureteral reflux, and a large number of symptoms (pain, hematuria, urgency, etc.), with the latter being the most common[
2,
4]. More rarely, cases of ureter perforation, stent migration, and forgotten stents had been observed[
3].
The pathophysiology of these symptoms is still unclear due to the complexity of the physiology of the organs involved. Currently, the most accepted hypotheses associate the symptoms with irritation of the bladder trigone, spasm of the smooth muscle in the ureter and bladder, urine reflux into the kidney during urination causing an increase in pressure, or a combination of these factors[
6,
7].
Aware of the importance of the subject, and aiming for a comprehensive analysis of patients using the double‐J ureteral stent, the authors of this study created their own questionnaire. This questionnaire aims to conduct an epidemiological and clinical assessment of patients, prioritizing questions about urinary complaints, pain, and the level of satisfaction with the use of the double‐J ureteral stent.
It is already known that Joshi et al., due to the high frequency of complaints associated with the use of the double‐J ureteral stent, developed a specific questionnaire to assess the symptoms and quality of life of patients using this stent, the Ureteral Stent Symptoms Questionnaire (USSQ)[
5]. This questionnaire covers six areas that affect the quality of life of patients using the stent: urinary symptoms, pain, general health, productivity at work, sexual activity, and additional problems[
5]. From the sum of the points relating to the patient's answers, the impact of the use of the double‐J ureteral stent on their quality of life is assessed[
7]. It is worth noting that questions about pain and urinary symptoms make up 50% of the questionnaire, while the rest address their impact on the most important areas of the individual's life.
The USSQ is a questionnaire that has been validated in several languages, used by various authors worldwide, and has provided important information to help manage patients with double‐J ureteral stents[
8–
12]. However, despite its undeniable importance, in the authors' experience is that it is a very long and complex questionnaire, requiring a considerable amount of time and often a mediator to complete. These factors made it impossible to use the USSQ questionnaire in this study due to the outpatient routine of the service where the work was carried out.
In addition to a general analysis of the epidemiological and clinical profile of the patients, the incidence of urinary symptoms, and the level of satisfaction with the use of the double‐J ureteral stent, this study also sought to compare the incidence of urinary symptoms in the following categories: female and male, the presence or absence of a nylon extractor wire in the double‐J ureteral stent, the patient's age, and the length of time the stent had been in place.
With regard to the age, the patients were divided into two groups: those aged up to 40 years old and those over 40 years old. This cut‐off was chosen due to the higher prevalence of urinary symptoms related to diseases causing LUTS (Lower Urinary Tract Symptoms) in both sexes from the 4th and 5th decades of life[
13]. It was expected that the older group would present more urinary symptoms, as they are already potential carriers of other diseases that cause the same symptoms as those related to the use of the double‐J ureteral stent.
Regarding the duration of use of the double‐J ureteral stent, the patients were also divided into two groups: up to one week and more than one week. This cut‐off was chosen due to the workflow of the service where the work was carried out. Patients using the double‐J ureteral stent with a nylon extractor wire, who had no complications, used the stent for a maximum of 7 days. Patients who used the wireless stent and/or had more complex clinical histories generally used the stent for longer.
4.2 Discussion of results
Initially, it is worth noting that all the patients assessed in this study used a double‐J ureteral stent as part of the interventional treatment for urolithiasis. It is estimated that between 5% and 15% of the world's population is affected by some form of renal lithiasis during their lifetime[
14], making it the third most common urological condition, second only to urinary tract infections and prostate diseases[
15].
The average age of the individuals was 43 years old, which is a common age indicated by several studies for this type of disease[
16,
17]. The age ranged from 21 to 73 years old, and 55% of the patients were in the 4th and 5th decades of life. This is in agreement with the study by Knoll et al., which noted a trend over the last 20 years of more common involvement in individuals aged between 40 and 49 in both sexes[
16].
Furthermore, 75% of the sample was made up of females, which is in line with an epidemiological study carried out in the Paraíba Valley region (where the Paraíba Valley Regional Hospital is located), which identified a higher incidence of urolithiasis in women[
18]. However, this is not the most widely reported fact in the literature, which indicates that the incidence of urolithiasis is two to three times higher in men[
19], despite recognition by the Brazilian Society of Urology (SBU) of a considerable increase in this ratio in women[
14].
In 20% of the sample, there was a report of previous use, at least once, of the double‐J ureteral stent in relation to previous treatment for renal lithiasis. According to the European Association of Urology (EAU) Urolithiasis Guideline, approximately 50% of patients with renal lithiasis experience a recurrence during their lifetime. Highly recurrent disease is seen in just over 10% of patients. According to the EAU, the main determinants of urolithiasis recurrence are the type of stone and the severity of the disease[
19].
The presence of at least one symptom related to the use of the double‐J ureteral stent was present in 95% of patients. Pain was the most frequent complaint, reported by 77.5% of ureteral stent users. Among urinary symptoms, hematuria was the most common complaint in 65% of cases, followed by dysuria in 62.5% and urgency in 52.5%. Similarly, Vega et al. found that 60% of the patients interviewed with USSQ had symptoms that impacted their quality of life[
20]. Joshi et al. described an 80% incidence of urinary symptoms, with hematuria being the most common, followed by dysuria, urgency, and urinary incontinence, as well as 78% of pain in patients using the stent[
21,
22]. In 2015, Cadena, studied a population of children and adolescents using the double‐J stent and concluded that around 94% of patients had pain, 94% had dysuria, and 88% had urgency. Approximately 82% of patients had some complication from using the double‐J ureteral stent, with bleeding (41.2%) and infection (29.4%) being the most common in this age group (10). In the present study, no case series of these complications with the use of the double‐J ureteral stent were obtained during the studied period.
In their study, Leibovici et al. concluded that the symptoms caused by the double‐J ureteral stent disappeared soon after the device was removed, regardless of the underlying disease[
23]. Although there were no questions on this issue in the questionnaire developed by the authors, relief was subjectively observed in patients after removal of the ureteral stent in the outpatient clinic.
Regarding the level of satisfaction with the use of the double‐J ureteral stent, 55% of the patients showed some degree of satisfaction, 22.5% reported mixed feelings, and 22.5% expressed different levels of dissatisfaction. The low rate of dissatisfaction observed is at odds with the literature analyzed. In their study, Vega et al. reported a dissatisfaction rate of around 60% of cases[
20]. Joshi et al. interviewed patients who had already used the stent and asked them how they would feel if they had to use it again, observing that 50% of those interviewed would not want to have this experience again[
22].
Analysis of the incidence of symptoms by biological sex showed that women presented more symptoms in percentage terms, with hematuria (70%) and dysuria (70%) being the most frequently cited, while in men it was hematuria (50%) and incontinence (50%). In addition, women had a higher percentage of pain than men (80% vs. 70%). None of these comparisons were statistically significant (
p > 0.05), a result similar to that found in Cadena's study, where no correlation was identified between patients' overall quality of life and biological sex[
10].
When analyzing the patients by the presence or absence of a nylon extractor wire, it was observed that 72.5% of the patients used the ureteral stent with a wire, and in these patients, dysuria and hematuria were the most frequently reported symptoms. On the other hand, in the group that used this device without the wire, dysuria and urgency were the most prevalent. In this comparison, no significant relationship was found between the frequency of urinary symptoms in the evaluated groups (
p > 0.05). Auge et al. also found no relationship between urinary symptom scores and the presence or absence of the extractor wire[
24].
The patients were also divided into two age groups. It was observed that the younger group had a higher incidence of urinary symptoms, with the exception of incontinence, which was present in only 23.5% of this group and 39.1% of the group over 40 years old. Regarding pain, there was a difference of only 2%. The relationship between these results was also not statistically significant (
p > 0.05). Similarly, Cadena also found no differences in quality of life when comparing ages[
10].
In the comparative analysis of the duration of stent use, no significant relationship was found between the duration of double‐J ureteral stent use and the incidence of any urinary symptoms or pain (
p > 0.05). Cadena also found no relationship between the user's quality of life and the duration of double‐J ureteral stent use[
10].
The present study also observed that the most common period of use was 5 days, with the shortest period being 2 days and the longest being 83 days. In this sense, Canepa et al. observed in their study that double‐J ureteral stents should be removed between 3 and 7 days[
25]. In their study, Shiguemura et al. noted that the use of the stent for more than 15 days significantly increased the incidence of adverse events such as fever, low back pain, and the need for antibiotic therapy. Moreover, earlier removal of the double‐J ureteral stent would improve hematuria, cause less pyuria, and therefore suggest a lower impact on patients' quality of life[
26]. However, the EAU pointed out in its guideline that the ideal duration for double‐J ureteral stent use is not yet known[
19].
It is worth noting that although some of the authors cited in this study[
8–
12] assessed quality of life and not specifically the symptoms associated with the double‐J ureteral stent, it was possible to compare their work with the present study because the impact of stent use on quality of life is inferred through the impact of urinary symptoms and pain on various areas of the patient's life.
The inability to apply the USSQ questionnaire in full, due to the lack of time for return visits, is a limitation of this study. However, it was possible to highlight important characteristics of the clinical picture associated with the use of the double‐J ureteral stent and the repercussions of satisfaction with its use.
Given the significant impact that the double‐J ureteral stent has on the lives of its users, as demonstrated by this study and several other authors[
10,
20–
22], further studies are needed to intervene in this scenario.
Currently, there are a variety of drugs on the market that act by blocking receptors involved in the pathophysiology of symptoms related to the double‐J ureteral stent. These drugs are used in the treatment of other diseases. However, some studies have shown efficacy in controlling symptoms related to the ureteral stent[
7,
27–
30].
The most recent meta‐analysis by He et al., including 16 studies with a total of 1489 patients, showed that alpha‐blockers provided significant relief in stent‐related symptoms in all analyzed USSQ categories[
29]. In addition, the largest meta‐analysis on the subject demonstrated that solifenacin monotherapy showed a significant reduction in the total USSQ questionnaire score and hematuria score[
30].
In light of this, future studies that intervene directly in symptoms will be of great value in improving the symptoms associated with the double‐J ureteral stent and, consequently, the quality of life of patients using this stent.
5 CONCLUSION
The epidemiological pattern of the patients who used the double‐J ureteral stent was of individuals with urolithiasis between the 4th and 5th decade of life, with the majority being female.
There was a high incidence of complaints associated with the stent (95% of patients), with pain being the most common complaint, reported by 77.5% of the sample, and among urinary symptoms, hematuria was the most frequent complaint (65%).
No relationship was identified between the symptoms (pain and urinary symptoms) caused by the use of the double‐J ureteral stent and age, gender, length of time the stent had been used and the presence or absence of the nylon thread in the population studied.
It was also observed that the majority of patients (55%) reported some degree of satisfaction if they needed to use the double‐J ureteral stent again.
Despite the unfeasibility of applying the USSQ, this study was able to highlight important features of the symptomatology of patients using the double‐J ureteral stent and the repercussions on satisfaction with its use.
Finally, we recommend studies on drug interventions for symptoms related to the use of the double‐J ureteral stent in order to improve the quality of life of its users.
1. In the future, if were advised to have another stent implanted, how would you feel?
2024 The Author(s). UroPrecision published by John Wiley & Sons Australia, Ltd on behalf of Higher Education Press.