|Year : 2020 | Volume
| Issue : 5 | Page : 233-237
Stented Foley's catheter is a versatile, highly useful, easy-to-use way of double J stenting for a short time: A randomized study
Ketan P Vartak, Kshitij Raghuvanshi, Abid Raval, Devendra Kumar Jain
Department of Urology, Bharati Vidyapeeth Hospital and Medical College, Pune, Maharashtra, India
|Date of Submission||04-Apr-2020|
|Date of Decision||22-May-2020|
|Date of Acceptance||30-May-2020|
|Date of Web Publication||27-Oct-2020|
Department of Urology, Bharati Vidyapeeth Medical College and Hospital, Pune - 411 043, Maharashtra
Source of Support: None, Conflict of Interest: None
Purpose: A stented Foley's catheter was designed to combine two catheters into a single catheter to reduce the postureteroscopy (URS) pain and complications. This study evaluated the pain score and complications associated with the use of stented Foley's catheter in double J (DJ) stenting compared to the use of infant feeding tube (IFT) or a ureteric catheter in patients undergoing DJ stenting. Materials and Methods: A randomized parallel-group study was conducted in patients undergoing DJ stenting along with URS and stone fragmentation with pneumatic lithotripsy/LASER. The patients were randomized to be managed with either stented Foley's catheter or IFT along with Foley's catheter. The postoperative pain and complications were recorded. Results: A total of 200 patients were randomized (1:1) into Group A (100 patients with stented Foley's catheter) and Group B (100 patients with IFT). Male preponderance was observed in Group A (73%) and Group B (69%). A significantly higher number of patients from Group B (n = 20) had pericatheter leakage compared to Group A (n = 2). In Group B, the pericatheter leakage resolved in three males and three females, whereas six males and eight females continued to leak, which is managed by diapers. The number of patients with no pain was higher in Group A (52%) than Group B (36%), whereas none of the patients from both groups had severe pain scores (V or VI). Conclusion: The patients undergoing DJ stenting were tolerant to the use of stented Foley's catheter compared to those with the IFT.
Keywords: Infant feeding tube, pain score, pericatheter leakage, ureteroscopy
|How to cite this article:|
Vartak KP, Raghuvanshi K, Raval A, Jain DK. Stented Foley's catheter is a versatile, highly useful, easy-to-use way of double J stenting for a short time: A randomized study. Urol Sci 2020;31:233-7
|How to cite this URL:|
Vartak KP, Raghuvanshi K, Raval A, Jain DK. Stented Foley's catheter is a versatile, highly useful, easy-to-use way of double J stenting for a short time: A randomized study. Urol Sci [serial online] 2020 [cited 2020 Nov 30];31:233-7. Available from: https://www.e-urol-sci.com/text.asp?2020/31/5/233/299259
| Introduction|| |
Over the past 20 years, ureteroscopy (URS) has evolved into a first-line preference for the management of urinary stones. Ureteral double J (DJ) stents have become a standard choice of many urologists as they help in relieving ureteral obstruction with comparatively less severe complications. After URS, long- or short-term placement of a urethral catheter is a standard practice that prevents reflux alongside DJ stent by maintaining the low-pressure bladder. However, complications such as hematuria, dysuria, flank pain, suprapubic pain, vesicoureteral reflux, migration, encrustation, urinary tract infection (UTI), and stent fracture can occur.
The use of ureteral stents and Foley's catheters has become very common across the globe, and Foley's catheter benefits the patients by maintaining low-pressure bladder, thereby avoiding further complications. However, in India, there is another common practice, that is, to keep an infant feeding tube (IFT) or a ureteric catheter by the side of the Foley's catheter. In this scenario, patients suffer severe postoperative pain owing to the two catheters coming out through the urethra and also experience bladder spasms and suprapubic pain. At the same time, if one keeps a DJ stent, an additional procedure is required for the removal of the DJ stent. Few companies manufacture stents with a nylon thread, which stays in the urethra and needs to be pulled out for stent removal. However, it is not commonly available in India, and higher cost is involved. Moreover, patients keep on complaining about pain in the urethra due to the foreign body sensation. Therefore, the present study used a novel idea of using “stented Foley's catheter” where two catheters were combined into a single catheter to improve the complaints and the complications of the patient. The aim was to evaluate the efficacy, pain score, and complications associated with the use of stented Foley's catheter compared to the use of IFT in patients undergoing DJ stenting.
| Materials and Methods|| |
A randomized parallel-group study was conducted at the Department of Urology, Bharati Vidyapeeth Hospital and Medical College, Pune, Maharashtra, India, between January 2018 and March 2019. Written informed consent was obtained from all patients before the enrollment.
A total of 200 patients who underwent DJ stenting along with URS through stone fragmentation with pneumatic lithotripsy/LASER, who did not require long-term DJ stents due to the good clearance of stones, were included in this study. Exclusion criteria were patients who needed long-term DJ stents, with any complications during URS such as perforation, incomplete stone fragmentation or stone migration, too narrow ureteral diameter which can give rise to postoperative pain, severe hydronephrosis, and UTI.
Out of 200 selected patients fulfilling the above-mentioned criteria, patients were selected randomly (1:1) for stented Foley's catheter (Group A) or IFT along with Foley's catheter as a temporary stent (Group B). Foley's catheter in both groups was removed 24 h postoperatively. The study was considered complete once the desired number of patients was enrolled.
Stented Foley's catheter was a new concept developed by us, where DJ stent of any caliber and any length can be used along with Foley's catheter of any size. In the present study, we used 6 French DJ stent (Urotech, Germany). The stent was assembled on operation theater trolley at the end of the URS and stone fragmentation. Only 18G needle, mosquito artery forceps, scissors, and boiled water were needed on the trolley. The decision of putting a stented Foley's catheter or an IFT (6 French, Romsons International, New Delhi, India) was taken for the patients in whom the stone cleared reasonably well, and those patients who were not expected to require a long-term stent.
The DJ stent of desired length and caliber was opened and cut at the distal end at a place of beginning of the curvature. The distal cut end was dipped in boiled saline for 2–3 s to make it soft so that it becomes pliable [Figure 1]a. The end of the DJ stent was splayed with the tip of 18 G needle. The 18G needle was inserted through the tip of 14F Foley's catheter and brought out through the side hole of Foley's catheter [Figure 1]b. The kidney end of the DJ stent was loaded on the needle, and the needle along with the stent was pulled out through the needle hole in the front tip of the Foley's catheter [Figure 1]c and [Figure 1]d. Once pulled out completely, the splayed end of the DJ stent stops at the tip of the Foley's catheter, thereby producing the stented Foley's catheter [Figure 1]e and f].
|Figure 1: Steps to prepare stented Foley's. (a) pliable softened distal end, (b) 18 G needle was inserted through the tip of 14 F Foley's catheter (c and d) kidney end of the DJ stent loaded on the needle and pulled out through the needle hole, (e and f) the splayed end of the DJ stent stopped at the tip of the Foley's catheter.|
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At the end of the URS procedure, once a decision was made to put a stented Foley's catheter, a Zebra guidewire was passed through the ureteroscope into the pelvicalyceal system under vision. After removing the URS with Zebra guidewire in place, the stented Foley's catheter was loaded over it. The guidewire goes through the stent and through the center of the Foley's catheter at which the stent is fixed and comes out from the distal end of the Foley's catheter. The stiff distal end was held by the assistant; the penis was pulled out by the surgeon's left hand to make the urethra straight; the whole assembly was introduced until the tip of Foley's catheter was in the bladder. As the stent is attached to the tip and the whole assembly is getting in over a stiff guidewire, with the end of guidewire in the pelvicalyceal system, the stent along with Foley's catheter is automatically placed properly. Once urine efflux from Foley's catheter is confirmed, the balloon is filled with 10cc normal saline, and the catheter is pulled out.
The postoperative pain was evaluated after 4 weeks by Wong–Baker Faces Pain Score. Complications were also recorded for each patient. Patients with pericatheter leakage and pain were treated with either tramadol, diclofenac sodium, or both along with mirabegron or solifenacin for bladder spasms causing pericatheter leaks.
No formal sample size calculation was employed. The goal was set for 200 cases, which, according to our experience and understanding, was an adequate sample size for this study. Statistical analysis was conducted using SPSS software (version 20, IBM, Chicago USA). Fisher's exact test was utilized to compare the quantitative data. P < 0.05 was considered statistically significant.
| Results|| |
A total of 200 patients (Group A, 100 patients who underwent the procedure using stented Foley's catheter; Group B, 100 patients who underwent the procedure using IFT along with Foley's catheter) were included in this study.
Overall, the mean age was 48.62 years and 51.73 years in Groups A and B, respectively. Male preponderance was observed with 73 males and 27 females in Group A and 69 males and 31 females in Group B [Table 1]. The majority of patients had calculi on the right side. Diabetes and hypertension were almost similar between the groups. Two male patients from Group A had pericatheter leakage as a complication, which was treated by one dose of anticholinergic postoperatively. In Group B, nine males and 11 females had pericatheter leakage treated with one dose of anticholinergic postoperatively. Out of nine males and 11 females, three males and three females resolved the complication of pericatheter leakage and six males and eight females continued to leak managed by diapers [Figure 2].
Fifty-two patients (52%) from Group A and 36 patients (36%) from Group B experienced no pain. Thirty-two patients (32%) from Group A and 24 patients (24%) from Group B had pain score II. Twelve (12%) and twenty patients (20%) experienced pain score III and four patients (4%) and twenty patients (20%) had pain score IV from Group A and Group B, respectively. None of the patients from both groups had severe pain scores (V or VI) [Table 2].
Patients who had pain score I were treated with a single dose of tramadol. Patients who had pain score II were treated with two doses of tramadol. Patients who had pain score III were treated with three doses of tramadol. Patients with pain score IV were treated with two doses of tramadol plus one dose of diclofenac [Table 3].
| Discussion|| |
Due to the lack of standard technique recommendations, DJ stent placement procedure used by urologist varies to a great extent across the globe. The ideal DJ stent technique should consider patient's comfort and safety while maintaining ureteral access throughout the procedure. The following important points are necessary and should be considered while introducing a new technique for DJ stent placement: the best way to select the optimal stent length; use of rigid versus soft stent material; whether to go longer or shorter if the measured ureteral length is in between sizes; management of common stent side effects and complications; and when DJ stents can be safely omitted after URS lithotripsy procedures.
It is a standard practice in India that once stone clearance is achieved, a ureteric catheter or an IFT is kept in the ureter as a short-term stent. However, it is observed that the patients complain of severe postoperative pain due to two catheters coming out through the urethra. They also get bladder spasms and suprapubic pain. The most common morbidities associated with ureteral stenting include irritative voiding symptoms, pain, and hematuria., The present study was conducted in patients undergoing DJ stenting with the novel idea of the usage of “stented Foley's catheter” where two catheters were combined into a single catheter to improve the complications of the patient.
In the present study, out of 200 patients, 100 patients underwent DJ stent using stented Foley's catheter and 100 patients underwent the procedure using IFT. Pericatheter leakage was reported in 20% of patients who underwent DJ stent using IFT compared to only 2% of patients who underwent DJ stent using stented Foley's catheter group. The comparatively lower incidence of pericatheter leakage in stented Foley's catheter group demonstrates a lower complication rate and suggests that the new technique was well tolerated in this study population.
A recent study by Biswas et al. reported a higher incidence of irritative voiding symptoms in the stented group (65%) compared to IFT group (9%). Previous studies have also demonstrated reduction in postoperative pain and irritative voiding symptoms with the omission of the ureteral stent.,, The present study did not report any patients with irritative voiding symptoms.
In the present study, postoperative pain was evaluated by Wong–Baker Faces Pain Score. Overall, the group with stented Foley's catheter required fewer analgesics, and pain was less in severity compared to patients with IFT. In the stented Foley's catheter group, 52%, 32%, and 12% of the patients required single, double, and triple doses of tramadol, respectively, and 4% of the patients required more than one analgesic a day. In IFT group, 26% of the patients required more than one analgesic a day. These results suggest that the use of stented Foley's catheter was safe in patients undergoing URS. A previous study by Biswas et al. reported that in the DJ stented group, the proportion of patients who required two or more analgesic tablets a day for pain control was higher than the IFT showing that IFT is a better option of DJ stent for uncomplicated ureteroscopic removal of stone. This was attributed to a higher incidence of pain to the increased intrapelvic renal pressure while voiding.
Stented Foley's catheter was designed to club two catheters together into a single catheter during DJ stent placement to minimize the postoperative complaints of the patients. Although several complications following the use of ureteric stents have been documented, none of the patients in the present study had any complication except pericatheter leakage. Nyamsogoro et al. study reported that, after the use of infant feeding tubes as internal ureteral stents, hematuria was the most common complication observed in 43.2% (n=19) of patients, of which 15 patients had hematuria due to IFT and four patients had due to DJ stent. This is in contrast with findings from Al-Marhoon et al., who studied the complications and outcomes of DJ stenting in Oman. They found that loin pain (10.9%) and UTI (10.9%) were the most common complications, followed by dysuria (7.7%). A study by Singh et al. also reported the absence of hematuria and the presence of UTI (1.5%), nondrainage (1.5%), and urinary leak (2.2%) in cases stented with IFTs.
One of the strengths of this study is that stented Foley's catheter is very cost-effective as no extra material had to be used than that of the routine. This stented Foley's was made on the table as an experimental model; however, with the help of the manufacturing industry, it can be made available with the choice of various sizes of Foley's catheter with various DJ stents' sizes and lengths. Another strength includes a lower risk of infection. The major concern of using internal–external stent could be a higher risk of infection; however, in this study, the 6 French tube (IFT) along with Foley's catheter there is no additional risk of infection as compared to a DJ stent which is totally inside the bladder. In addition, it is kept only for a short duration that is covered by antibiotics during the hospital stay. There were no limitations found for this procedure.
| Conclusion|| |
These observations indicate that the patients undergoing DJ stenting tolerated the use of stented Foley's catheter as the incidence of pericatheter leakage and severity of pain were lower compared to those with IFT.
The authors acknowledge Dr. Tejal Vedak for her medical writing assistance.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]