Clinical effectiveness of modified single pigtail fishtail stent on preoperative stenting and postoperative stenting during flexible ureteroscopic lithotripsy

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Clinical effectiveness of modified single pigtail fishtail stent on preoperative stenting and postoperative stenting during flexible ureteroscopic lithotripsy

https://doi.org/10.21203/rs.3.rs-2492162/v1

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In order to evaluated the clinical effectiveness of modified single pigtail fishtail stent(MSPF) on preoperative stenting and postoperative stenting during flexible ureteroscopic lithotripsy (FURS), a total of 160 patients who underwent ureteral stent placement before and after FURS for unilateral symptomatic ureteral or renal stones were randomized prospectively into two groups. There were 79 patients used modified single pigtail fishtail stent (MSPF group), and 81 patients used double pigtail ureteral stent (DPUS group) . The questionnaires were conducted on the day of 2 weeks after preoperative stenting（T1）and 2 weeks after postoperative stenting（T2）and 4 weeks after stent removal (T3). All 160 patients completed the study. Compared with the DPUS group, the urinary tract symptoms and somatic pain symptoms of the MSPF group were significantly lower than those of the DPUS group in T1 (25.0vs.31.1, P<0.001 and 16.7vs.17.8, P= 0.042) and T2(23.8vs.31.2, P<0.001 and 16.8vs.18.5, P<0.001). The results showed that, compared with conventional double pigtail ureteral stent, the using of MSPF during the stage of preoperative and postoperative stenting in URSL significantly reduced SRS, especially urinary tract symptoms and body pain, meanwhile showed a good safety profile.

Health sciences/Urology/Urogenital diseases/Urinary tract obstruction

Health sciences/Urology/Ureter

Ureteral stents are widely used in urological practice to alleviate or prevent ureteral obstruction. The necessity of routine preoperative stenting before flexible ureteroscopic lithotripsy is widely acknowledged by experts. However, Ureteral stent-related symptoms (SRS) are common complications after stent insertion, and their related symptoms, such as body pain, frequent urination, urgency, dysuria and hematuria are seriously affected patients’quality of life [1]. Joshi et al. reported that 78% of patients with double pigtail ureteral stent had SRS. The disturbing urinary symptoms including that more than 80% patients had pain affected their daily lives, 58% patients reduced work performance, and 32% patients merged sexual dysfunction[2]. Currently, pharmacological treatments (mainly includes alpha-blockers and anticholinergic drugs), engineering solutions (stent material, shape, design), and drug-eluting stent tubes are commonly used to relieve ureteral stent discomfort, but the overall results are unsatisfactory[3].

Studies have suggested that the distal end of ureteral stents is one of the main causes of stent-related urinary symptoms and pain, and the occurrence of ureteral stent-related symptoms can be significantly reduced if the ureteral stent does not cross the midline of the bladder[4]. Other studies have shown that fishtail stent can significantly reduce ureteral stent-related symptoms because they involve less intravesical material, and this may reduce bladder irritation, but there are expensive, poor practicality and other shortcomings[5]. Therefore, we designed a simple and practical ureteral stent improvement scheme, which was improved on the basis of the conventional double J stent and further approximates the shape of fishtail stent, hoping to reduce patients' symptoms related to ureteral stents and reduce related economic costs for patients.

The study was conducted to select 160 patients who underwent ureteral stent placement before and after URSL for unilateral symptomatic ureteral or renal stones in our hospital from december 2021 to december 2022. The effectiveness of the modified single pigtail fishtail stent on SRSs was studied by using a validated ureteral stent symptoms questionnaire (USSQ).

Patients. Between december 2021 to december 2022, we prospectively included 160 consecutive patients with unilateral ureteral or renal stone after acquiring informed consent form. All patients with symptomatic uni[1]lateral ureteral or renal stones with <20 mm diameter who underwent uncomplicated retrograde flexible ureteroscopic lithotripsy were randomly divided into two groups. There were 79 patients in the modified single pigtail fishtail stent(MSPF) group (38 males and 41 females) (mean age 43 years), who were placed the ureteral stent 2 weeks before and after FURS. In the MSPF group, left side were 43 cases, right side were 36 cases and there were 61 patients with renal calculi and 18 patients with upper ureteral calculi. The mean stone size was 11mm. The DPUS group also included 91 patients (43 males and 38 females) (mean age 43 years) in whom these stents were placed in a similar manner. In the DPUS group, left side were 39 cases, right side were 42 cases and there were 57 patients with renal calculi and 24 patients with upper ureteral calculi.The mean stone size was 11mm. This study has been approved by the Ethics Committee of Quzhou Hospital affiliated to Wenzhou Medical University(ethics approval number:2021-027). Written informed consent was obtained from all participants.

All the patients were placed the ureteral stent 2 weeks before the FURS. Then a new ureteral stent is replaced after FURS, and the ureteral stent were removed 2 weeks after FURS. Patients in both groups completed the ureteral stent symptom questionnaire (USSQ) 2 weeks after ureteral stent placement (the stage of preoperative stenting, T1), 2 weeks after FURS(the stage of postoperative stenting, T2) and 4 weeks after extubation(T3) respectively. There was no significant difference in gender, age, height and stone size between the two groups. All patients were treated with Bard's polyurethane ureteral stent (6 Fr, 26 cm).

The inclusion criteria were the following: (1) Patient aged between 18-80 years, with unilateral upper ureteral calculi or renal calculi complicated with hydronephrosis confirmed by imaging examination, the maximum diameter of calculi<2cm; (2) The body tolerated the operation without cardiopulmonary dysfunction, abnormal coagulation function, uncontrolled infection and other surgical contraindications; (3) All patients had unilateral indwelling double pigtail ureteral stents, and no double pigtail ureteral stents had been indwelled in the past. (5) Abdominal plain films were taken 2 weeks after surgery to confirm the normal position of the double J stent tubes and exclude large residual stones. (6) All patients signed informed consent.

The exclusion criteria were the following: (1) Fever (body temperature>38℃), renal failure, pregnancy and lactation, urinary system tumors; (2) Patients with severe urinary tract infection or hydronephrosis, severe hepatic or renal insufficiency before surgery, and postoperative X-ray films showing residual ureteral or bladder stones; (3) Preoperative examination found obvious ureteral stricture and urethral stricture could not be passed by endoscopy; (5) Bilateral calculi, contralateral calculi should be treated at the same time; (6) The affected kidney had a history of ureteroscopy; (7) Severe lower urinary tract symptoms existed before treatment, history of OAB, bladder outlet obstruction, urinary retention, neurogenic urination dysfunction, stress urinary incontinence, severe gynecological infection and gynecological tumors.

The ureteral stent improvement scheme(MSPF). The bottom of the conventional double pigtail ureteral stent(Bard,6 Fr, 26 cm, Germany) was vertically sectioned about 2 to 4 cm, which depends on patient's height. In order to reduce irritation of distal ureter and bladder, sectioned edge was tied by two threads of non-absorbable silicone sutures made of polyester. Furthermore, sutures were elongated and knotted in bladder for convenience of stent removal as well as preventing stent remote migration. (Fig. 1). This adjustable replacement of distal loop might be a more appropriate manner to reduce the irritation and vesicoureteral reflux, and potentially to decrease SRS.

Surgical procedure and study design. Patients in both groups were operated by the same senior physician and anesthetized by intravenous inhalation general anesthesia. All patients were received a single dose antibiotic prophylaxis with a negative preoperative urine culture. We approached the calculi by using a guide wire and the 6/7.5-F semirigid ureteroscope (Olympus, Japan). Then we placed a ureteral access sheath (Cook, USA) under fluoroscopic guidance and fragmented the calculi with a 30 W (5-10 Hz and 0.5-1.0J) Holmium-YAG laser(Lumenis, USA). The stones were disintegrated by a Flex-X2 fiber-optic flexible ureterorenoscope(Karl Storz, Germany). All the patients received preinstalled ureteral stents for 2 weeks before surgery, followed by flexible ureteroscopic lithotripsy. Plain radiographs of urinary system were performed after ureteral stent placement in all patients(Fig. 2). The image after the MSPF positioning showed that the end of the ureteral stent was completely inside the ureter(Fig. 3A). The ureteral stents were replaced after surgery, and the stent tubes were removed 2 weeks after surgery. By reducing the irritation of the bladder segment, the follicular hyperplasia around the ureteral orifice was significantly reduced under cystoscopy 2 weeks after MSPF placement(Fig. 3 B,D). what’s more, because of the wire knot at the tail end, the stent extubation was relatively easy(Fig. 3 C).

All patients had completed the ureteral stent symptoms questionnaire (USSQ) at different stage. A single physician conducted and assessed all the questionnaires, and he was not participated in any of these surgeries. What’s more, both physician and patients were ignorant of the distribution of patients. The questionnaires were conducted on the day of 2 weeks after presetting stent(T1) and 2 weeks after FURS(T2) and 4 weeks after removal(T3). The questionnaire including lower urinary tract symptoms (Urgent urination, frequent urination, and endless urination), body pain symptoms (the location of pain, degree of pain and its influence on daily activities and sleep), general health index (whether physical activity is limited or the normal social life is interfered), the ability to work (such as bed rest time, reduce working hours), sex index (sexual satisfaction), Quality of life and others ( the number of urinary tract infections, the number of to the hospital due to stent discomfort). The baseline assessment was 6 weeks after surgery (4 weeks after extubation ,T3), and the primary endpoint was the urinary symptom index score (U1-U11) in the stage of 2 weeks after preset tube (T1) and the stage of 2 weeks after URSL (before extubation ,T2) in the MSPF group and DPUS group. Secondary endpoints included physical pain symptom score (P3-P9), physical general health index (G1-G6), work ability (W5-W7), and sexual life index (S3-S4). The related postoperative complications including severe postoperative hematuria, fever (Body temperature>38.5℃), stent displacement and urinary sepsis were compared between the two groups.

Statistical Analysis. The data were analyzed using IBM SPSS Statistics for Windows, Version 26.0. Data are expressed as n (%) or mean±standard deviation. Continuous data were compared with independent sample t test when normally distributed or Mann-Whitney U test when not normally distributed. Categorical data were compared with chi-square test. Significance of the statistical tests was set at P value <0.05.

Compliance with ethical standards. All procedures performed in studies involving human participants were in accordance with the ethical standards of the Ethics Committee of Quzhou Hospital affiliated to Wenzhou Medical University and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent. Informed consent was obtained from all individual participants included in the study.

Patient/Stone Demographics. Totally 160 patients were included in the study (81 men and 79 women, 79 in the MSPF group and 81 in the DPUS group), All patients were followed up. The baseline patient characteristics are listed in Table 1. Regarding age,height, gender,stone sizes, stone side,stone location, statistically significant differences did not exist between the groups(P >0 .05).

Table 1. Patient demographics in the study

Variables, mean±SD or n (%)	MSPF group (n=79)	DPUS group (n=81)	P value
Age,year	43.6±12.6	43.0±12.6	0.785
Height,mm
Male	174.8±4.0	173.3±4.1	0.061
female	161.3±4.1	160.5±2.8	0.544
Gender
Male	38(48.1)	43(53.1)	-
Female	41(51.9)	38(46.9)	0.528
Mean Stone size, mm	11.5±2.4	11.1±2.1	0.356
Side
Left	43(54.4)	39(48.1)	-
Right	36(45.6)	42(51.9)	0.427
Stone Location
Renal	61(77.2)	57(70.4)	-
Upper ureter	18(22.8)	24(29.6)	0.325

Analysis of USSQ domain scores between two groups during the stage of preoperative stenting (T1). The overall ureteral stent symptom score results during the stage of preoperative stenting (T1) are listed in Table 2 for both groups. MSPF had reduced SRSs highly. The stage of preoperative stenting USSQ responses showed that，the Urinary Symptom Index score (p<0.001), Pain Index score(p=0.042) and the percentage of patients complaining of body pain and discomfort (64.6% vs 88.9%; p<0.001) were significantly lower scores in MSPF group than in DPUS group. No differences between the two groups for other USSQ domains ( General Health Index, Work Performance Index, Sexual Matters Score and Additional questions) were observed.

Table 2. USSQ domain scores between two groups during the stage of preoperative stenting (T1)

USSQ domain scores, mean±SD or n (%)	MSPF group (n=79)	DPUS group (n=81)	P value
Urinary Symptom Index score （U1-U11）	25.0±2.3	31.1±2.1	0.001
Pain Index score（P3-P9）	16.7±2.4	17.8±1.9	0.042
General Health Index score（G1-G6）	11.1±1.8	11.4±1.6	0.249
Work Performance Index score（W5-W7）	6.1±1.7	6.2±1.3	0.625
Sexual Matters score（S3-S4）	3.3±0.8	3.4±0.7	0.610
Additional questions（A1-A4）	9.6±1.8	10.1±1.5	0.051
Body pain or discomfort（P1）	51(64.6)	72(88.9)	0.001

Analysis of USSQ domain scores between two groups during the stage of 2 weeks after URSL(T2). The USSQ domain scores results during the stage of 2 weeks after URSL (T2) are listed in Table 3 for two groups. MSPF had reduced SRSs greatly. The T2 results were comparable to the T1 results favoring MSPF group for Urinary Symptom Index score (p <0.001), Pain Index score(p <0.001), Sexual index scores (p=0.020) ,the percentage of patients complaining of body pain and discomfort (64.6% vs 85.2%; p=0.003). Nevertheless, there were no differences between the two groups on General Health Index, Work Performance Index, Additional questions USSQ domains.

Table 3. USSQ domain scores between two groups during the stage of 2 weeks after URSL（T2）

USSQ domain scores, mean±SD or n (%)	MSPF group (n=79)	DPUS group (n=81)	P value
Urinary Symptom Index score （U1-U11）	23.8±2.1	31.2±2.1	0.001
Pain Index score（P3-P9）	16.8±2.6	18.5±2.3	0.001
General Health Index score（G1-G6）	11.3±1.8	11.7±1.7	0.155
Work Performance Index score（W5-W7）	6.7±1.2	7.1±1.2	0.244
Sexual Matters score（S3-S4）	4.0±0.6	4.4±1.1	0.020
Additional questions（A1-A4）	10.1±1.3	10.4±1.7	0.139
Body pain or discomfort（P1）	51(64.6)	69(85.2)	0.003

Analysis of USSQ domain scores between two groups during the stage of 4 weeks after extubation (T3). The overall ureteral stent symptom score results during the stage of 4 weeks after extubation (T3) are listed in Table 4 for both groups. There were no differences between the two groups for USSQ domains ( Urinary Symptom Index score, Pain Index score, General Health Index, Work Performance Index and Sexual index scores ) as a baseline score were observed. However, The additional question about feeling about stenting in the future (question GQ) showed significantly lower scores in MSPF group than in DPUS group(p =0.034) .

Table 4. USSQ domain scores between two groups during the stage of 4 weeks after extubation (T3)

USSQ domain scores, mean±SD or n (%)	MSPF group (n=79)	DPUS group (n=81)	P value
Urinary Symptom Index score （U1-U11）	18.9±2.2	18.6±2.4	0.423
Pain Index score（P3-P9）	16.1±2.3	15.9±2.7	0.562
General Health Index score（G1-G6）	8.2±1.2	8.0±1.3	0.319
Work Performance Index score（W5-W7）	3.3±0.7	3.4±0.7	0.495
Sexual Matters score（S3-S4）	2.2±0.4	2.2±0.4	0.536
Feeling about stenting in the future (question GQ)	3.6±0.7	3.8±0.7	0.034

Analysis of complications and adverse events between two groups. The complications and adverse events during the surgery are listed in Table 5 for both groups. There was no statistical significance in the incidence of the complications and adverse events including severe postoperative hematuria, fever (Body temperature > 38.5℃), stent displacement and urinary sepsis between the two groups.

Table 5. The complications and adverse events between two groups

The complications and adverse events, n (%)	MSPF group (n=79)	DPUS group (n=81)	P value
Severe hematuria	1(1.3)	5(6.2)	0.224
Fever > 38.5℃	5(6.3)	6(7.4)	0.788
Stent dislodgment	3(3.8)	1(1.2)	0.595
Urosepsis	0(0)	0(0)	-

Ureteral stent is an indispensable tool in urology, with dual functions of stent and internal drainage, but its related complications seriously affect patient’s quality of life[6,7]. its discomfort symptoms include: body pain, frequent urination, urgent urination, hematuria and dysuria, which are clinical problems that can not be ignored. The symptoms are related to the quality difference of ureteral stents, improper length of ureteral stent, ureteral movement and ureteral reflux[8,9].

The necessity of routine preoperative stenting before ureteroscopic lithotripsy is widely debated. Previous research showed that preoperative preset ureteral stent can improve the soft ureter mirror lithotripsy for the treatment of kidney stones stone clearance rate, improve the soft lens channel sheath placement success rate, lower ureteral balloon expander utilization rate, reduce the incidence of intraoperative and postoperative complications, shorten the operation time, reduce intraoperative ureteral injury[10,11]. Ambani et al. retrospectively analyzed that the success rate of indwelling ureteral stent lithotripsy before soft ureteroscopy could reach 98.0%[12]. However, routine preoperative stenting before surgery can cause symptoms of lower urinary tract irritation, increase the risk of urinary tract infection, and even lead to ureteral stricture, which affects patient’s quality of life and increases the burden of patients[13]. Among them, ureteral stent-related symptoms (SRS) were a major problem.

The distal ureteral stent directly contacted with the bladder mucosa was involved in vesicoureteral reflux mechanism and lower urinary tract symptoms, which is considered to be one of the main factors affecting SRS[14,15]. It has been proposed that the distal end of ureteral stents is one of the main causes of stent-related urinary symptoms and pain, and the occurrence of stent-related symptoms can be significantly alleviated by the ureteral stenting tube not crossing the midline of bladder[16,17]. Vogt et al. used a pigtail suture stent instead of the lower part of the double J ureteral stent, and the study demonstrated a clear benefit of the pigtail suture stent in terms of urinary and pain symptom scores, along with dilatation of the ureter without inflammation around the suture[18]. Other studies have shown that the use of fishtail stent or pigtail suture stent can significantly reduce ureteral stent-related symptoms, but it has shortcomings such as expensive, poor practicality and others[19,20,21,22]. So we have designed a simple and practical ureteral stent tube improvement scheme, which was improved on the basis of the original Bard ureteral stents, further closer to the shape of the tail bracket, avoid the influence of the material the distal ureter and bladder mucous membrane irritation, hope to be able to alleviate symptoms of patients with ureteral stent, and reduce the economic costs for patients at the same time.

We used the ureteral stent symptom Questionnaire (USSQ) first proposed by Joshi et al[23], which can better evaluate the patients' related symptoms, and further explore whether the modified ureteral stent can reduce the incidence of SRS compared with the traditional double pigtail ureteral stent. Compared with traditional ureteral stents, our prospective, randomized, double-blind trial proved that the modified single pigtail fishtail stent significantly reduced urinary tract symptoms, body pain symptoms, and other discomforts during 2 weeks after the preplacement of ureteral stents before URS and 2 weeks after URSL. We show for the first time that the modified single pigtail fishtail stent is better tolerated than traditional double pigtail ureteral stent, significantly reduces stent-related symptoms, improves patients’ quality of life, and is reasonably safe. Our data showed a significant reduction in urinary tract symptoms and pain scores and 20% reduction in the number of patients complaining of pain. In addition, modified stents showed good safety: complications and adverse events were similar in both groups. These results can justify the extensive use of modified stent tubes in preoperative and postoperation stenting in URSL, and may represent a change in stent management model and provide a more comfortable procedure before and after upper urinary endoscopic surgery. Therefore, the modified stent may represent an improvement in the accessibility of ureteral stents to patients undergoing URSL.

Our results may also help shed light on the pathogenesis of SRS: the reduction of foreign bodies in the bladder and distal ureter may play a key role in reducing some SRS, such as urinary frequency. The reduction of pain during urination may be related to the reduction of material in the ureter wall and the disappearance of vesicoureteral reflux. Compared with the traditional stent, our modified stent reduces the contact between the ureter stent and the bladder mucosa and the end of the ureter, further reduces the occurrence of inflammation and edema of the bladder mucosa, and thus further reduces the incidence of urinary tract symptoms and body pain.

In addition, the phenomenon of ureteral stent upward movement, which we were concerned about before surgery, did not occur on a large scale. Ureteral stent upward movement was happened in two groups and ureteroscopy was used to remove the stent tube. In addition, compared with the traditional ureteral stent, the modified ureteral stent is easier to be removed by ureteroscopy after the stent tube is moved up because of its suture line at the end. There was no significant difference in the occurrence of severe hematuria, fever, stent infection and other related symptoms between the two groups.

The limitations of our study are as follows. first, the cases into the group in this study were less, and only into the patients with unilateral upper ureteral calculi or renal calculi. Future studies should explore any patient characteristics influencing MSPF[1]related symptoms and MSPF applicability in different settings, such as distal ureteral lithiasis and used for PCNL or other surgeries. Second, the residual ureteral calculi, blood in urine, bladder emptying, the use of painkillers and other segmentation factors were not evaluated in the two groups. So, further improvement of the clinical application of the modified single pigtail fishtail stent is yet to be the multicenter, large sample clinical evidence-based medical research.

Compared with traditional ureteral stents, the use of modified ureteral stents during and after the preset catheter of FURS can significantly reduce SRS, especially urinary tract symptoms and body pain, with considerable safety. Based on these results, urologists can recommend preplacement and postoperative catheterization of modified stent rather than traditional ureteral stent before and after uncomplicated FURS for upper ureteral calculi, which can provide patients with a better postoperative experience.

FURS Flexible ureteroscopic lithotripsy

USSQ Ureteral stent symptom questionnaire

SRS Stent-related symptoms

MSPF Modified single pigtail fishtail stent

DPUS double pigtail ureteral stent

Acknowledgements

Te authors gratefully acknowledge fnancial support from the Quzhou municipal Department of Science and Technology (No.2021003).

Data availability

All data analyzed during this study are included in this paper.

Author contributions

Lijun Wan contributed to the conception of the study;

Rijian Guan performed the experiment, data analyses and manuscript preparation.

Competing interests

Te authors declare no competing interests.

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No competing interests reported.

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Clinical effectiveness of modified single pigtail fishtail stent on preoperative stenting and postoperative stenting during flexible ureteroscopic lithotripsy

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