|Year : 2021 | Volume
| Issue : 2 | Page : 40-44
Endoscopic treatment of vesicoureteral reflux with macroplastique in spinal cord injury patients: A comparison of video-urodynamic parameters between treated and failed cases
Vasileios Sakalis1, Rachel Oliver2, Peter Guy2, Melissa Davies2
1 Department of Urology, Agios Pavlos General Hospital of Thessaloniki, Thessaloniki, Greece
2 Department of Urology, Salisbury NHS Foundation Trust, Salisbury, England, UK
|Date of Submission||12-Oct-2021|
|Date of Decision||20-Oct-2021|
|Date of Acceptance||01-Nov-2021|
|Date of Web Publication||26-May-2022|
Department of Urology, Agios Pavlos General Hospital of Thessaloniki, Thessaloniki
Source of Support: None, Conflict of Interest: None
Context/Objective: Vesicoureteric reflux (VUR) is a well-known complication of neurogenic lower urinary tract dysfunction. VUR results to progressive renal deterioration and eventually renal failure. Our aim was to assess the efficacy of Macroplastique bulking agent in managing VUR in spinal cord injury population and correlate the pre- and postintervention VUDS (Video-urodynamics) findings with the outcome. Design: Retrospective cohort study. Participants: Spinal cord injury patients with VUR, treated with Macroplastique, had pre- and postintervention VUDS and followed up for at least 12 months. Interventions: Macroplastique injection and video-urodynamics. Outcome Measures: The primary endpoint was the overall treatment rate of VUR at 3 months. The secondary outcomes were the overall treatment rate of VUR at 12 months, the success rate at 3 and 12 months, the need for additional treatments, and the comparison of VUDS parameters in treated versus failed cases. Results: Forty-eight patients and 62 refluxing ureteric units were studied. At 3-month follow-up, the overall treatment rate was 79.1%. The overall success rate (treated + improved) was 90.3%. There is a statistically significant difference in baseline cystometric capacity (P = 0.047), degree of reflux (P < 0.01), and bladder compliance (P = 0.023) between the treated and failed cases. Conclusion: Macroplastique is effective in the management of VUR in spinal cord injury population. It is minimally invasive, quick, with low complication rates. Care should be taken to treat the parameters of the neurogenic bladder that contributes to secondary VUR development such as detrusor overactivity and poor bladder compliance.
Keywords: Macroplastique, neurogenic bladder, vesicoureteric reflux
|How to cite this article:|
Sakalis V, Oliver R, Guy P, Davies M. Endoscopic treatment of vesicoureteral reflux with macroplastique in spinal cord injury patients: A comparison of video-urodynamic parameters between treated and failed cases. Hellenic Urology 2021;33:40-4
|How to cite this URL:|
Sakalis V, Oliver R, Guy P, Davies M. Endoscopic treatment of vesicoureteral reflux with macroplastique in spinal cord injury patients: A comparison of video-urodynamic parameters between treated and failed cases. Hellenic Urology [serial online] 2021 [cited 2022 Nov 29];33:40-4. Available from: http://www.hellenicurologyjournal.com/text.asp?2021/33/2/40/346059
| Introduction|| |
Vesicoureteric reflux (VUR) is a well-known complication of neurogenic lower urinary tract dysfunction. It is secondary to high bladder pressures and differs etiologically from primary VUR that is typical for pediatric population. VUR leads to progressive renal deterioration and eventually renal failure. Talbot and Bunts, in 1949, suggested that kidney damage in paraplegics results from the combination of pressure-related changes due to persistent hydronephrosis and ascending urinary tract infections. Many studies have confirmed that VUR is not always simultaneous to involuntary detrusor contraction. Vírseda et al. suggested that in long-standing secondary VUR, it is possible that the antireflux mechanism is damaged and the reflux becomes primary. The gold standard treatment is the open or laparoscopic surgical correction and has become nowadays less popular due to the new minimally invasive treatment options that show promising results.
The use of Teflon for the endoscopic correction of VUR has been described in the early Eighties. Since then, several bulking agents have been developed such as polydimethylsiloxane, polytetrafluoroethylene, dextranomer/hyaluronic acid, and glutaraldehyde cross-linked bovine collagen. Numerous investigators reported encouraging results mostly in pediatric population and primary VUR. Macroplastique (polydimethylsiloxane) (Uroplasty Inc., Geleen, The Netherlands) is a solid, elastomeric silicone which is suspended in a hydrogel carrier. Distant migration is limited by the particle sizes, which are greater than 100 μm., Upon implantation, the hydrogel is substituted by body fluids and host fibroblasts deposit collagen around the Macroplastique particles which hold them in place., The hydrogel is later removed by the reticuloendothelial system and excreted unmetabolized from kidneys.
There is evidence that Macroplastique is effective in the management of primary VUR in children, but data on secondary VUR in neuropathic bladder and especially in the spinal cord-injured population are limited., The aim of this study was to assess efficacy of Macroplastique in this population and correlate the pre- and postinjection urodynamic findings with the outcome.
| Methods|| |
We conducted a retrospective review of all spinal cord-injured patients with unilateral or bilateral VUR who were managed with Macroplastique injection. The outcomes were recorded in prospective database over a 10-year period. The inclusion criteria were as follows: age >18 years, upper motor neuron lesion, baseline and follow-up video-urodynamic assessment, proved VUR, adequate follow-up (≥12 months), and at least 2 postinjection annual ultrasonographic assessments of urinary tract. Patients who were known nonattenders to clinic appointments and those whose medical records were not up-to-date were excluded. All patients with VUR who were treated with ureteric re-implantation, as well as those who had sacral anterior root stimulator implant, were excluded due to difficulties in assessing postoperative outcome.
VUR was confirmed by video-urodynamics (VUDS) and graded as per the International Reflux Study Committee grading system. VUDS were performed according to the Good Urodynamic Practice of the International Continence Society. The examinations were carried out in supine position using standard urodynamic catheters (6Fr dual bladder catheter and 8Fr slit balloon rectal line), and the filling rate was set at 20 ml/min. Detrusor overactivity provocation by coughing, bending forward, and suprapubic tapping were standard maneuvers at filling phase. Voiding phase was recorded only when possible.
The Macroplastique procedure was performed in all patients under general anesthesia as a day case procedure. The details of the procedure are described elsewhere. The injection is completed when the incompetent ureteric orifice achieves a crescent-shaped appearance. Those with bilateral reflux had their treatments in two sessions starting with the ureteric unit at risk (greater VUR grade and hydronephrotic changes).
All patients had a repeat VUDS at 3 months after injection and an annual US scan of the urinary tract.
The primary endpoint was defined as overall treatment rate of VUR at 3 months. Treatment was defined as the complete resolution of VUR in the follow-up VUDS. The secondary outcomes included the overall treatment rate of VUR at 12 months, the success rate (treated + improved) at 3 and 12 months, the need for additional treatments, the comparison of VUDS parameters (pre- and postinjection), and the study of the management for those who failed or improved. Data were retrieved from patient records while unclear information was verified during a telephone consultation for this study purposes. The operative notes, clinical follow-ups, and urodynamic traces were reviewed.
For the statistical analysis, the statistic software SPSS (IBM Corp. Released 2013. IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY: IBM Corp) was used. The Shapiro–Wilk test was used for normality before any analysis. Inferential statistics were used for demographic characteristics and baseline calculations. The t-test was used for the intragroup variability and the nonparametric Mann–Whitney test to assess the variability between the two groups. The local ethics committee approved the study, and patients gave their verbal consent for data publication.
| Results|| |
From 2005 to 2015, a total of 74 SCI patients were diagnosed with VUR with complete follow-up data. We have identified 48 (64.9%) patients who fulfilled the inclusion criteria, and we studied 62 refluxing ureteric units. The mean age at the time of injection was 48.3 years (standard deviation [SD]: 15.4, range: 20–71), while the median time from the diagnosis of VUR since injury was 13 months (mean: 51.8, SD: 91.8, range: 2–396). There were 20 quadriplegics and 28 paraplegics. The mean follow-up was 56.2 months (SD: 34.9, range: 12–150). The basic demographics are shown in [Table 1].
At the time of diagnosis, 45 (93.8%) patients were on anticholinergics, 5 (10.5%) were on regular botulinum toxin injections, and 2 (4.2%) had previous external sphincterotomies. Twenty-two (45.8%) patients had an additional procedure at the time of Macroplastique treatment. Twenty (41.7%) had Botox, the majority of whom continued on a regular basis. One (2.1%) had external sphincterotomy and one (2.1%) had suprapubic catheter insertion. The procedures were carried out in day surgery settings. There were no immediate postoperative complications, except one case (1/62) of ureteric obstruction that required temporary ureteric stent.
At 3-month follow-up, the overall treatment rate was 79.1% since 49/62 refluxing ureteric units showed radiographic resolution of VUR. The overall success rate (treated + improved) was 90.3%. Seven (11.3%) units improved and downgraded, while six (9.7%) failed. One patient with unilateral VUR had successful outcome but developed contralateral VUR.
The results were similar at 12-month follow-up. The seven ureteric units that improved (downgraded) occurred in six patients. The patient with the bilateral VUR underwent augmentation cystoplasty as well as one who downgraded from grade 4–2. Three patients had a second injection with curative intent, which were successful. There was one complete resolution without any treatment (initially grade 2 and downgraded to 1). The six ureteric units that failed occurred in six patients. All underwent augmentation cystoplasty within 3–6 months.
There are limited data for long-term follow-up. At 48 months, 22 patients, who were initially considered as treated, did not show any signs of VUR recurrence; three of them underwent augmentation cystoplasty due to change in bladder behavior and worsening of compliance, eight remain on botulinum toxin injections, while the rest are still on surveillance.
[Table 2] presents the baseline VUDS parameters between the two groups (treatment vs. failures). There is a statistical significant difference in baseline cystometric capacity (P = 0.047) [Figure 1], degree of reflux (P < 0.01), and bladder compliance (P = 0.023) [Figure 2]. The maximum detrusor filling pressure was higher in the failure group [Figure 3] without reaching statistical significance (P = 0.077). Baseline detrusor overactivity was more common in the failure group as compared to the treatment group (92.3% vs. 73.5%).
|Table 2: Baseline video.urodynamic parameters and comparison between the groups|
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|Figure 1: Postintervention mean cystometric capacity in treated versus failed cases|
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|Figure 2: Postintervention mean compliance in treated versus failed cases|
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|Figure 3: Postintervention mean detrusor filling pressure in treated versus failed cases|
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The postinjection video-urodynamics revealed a nonsignificant increase of mean detrusor filling pressure (48.8 vs. 63.2 cmH2O, P = 0.11) in the failure group while as compared to the treated group which was literally unchanged (36.6 vs. 37.5 cmH2O, P = 0.808).
There was no difference in postinjection cystometric capacity as compared to baseline in both groups. Postinjection compliance was reduced in the failure group (7.86 vs. 5.01 ml/cmH2O, P = 0.034) as compared to baseline.
[Table 3] presents the comparison of injury level and grade to outcome. There were no statistically significant differences between the groups on the outcome based on the level of injury. Based on the American Spinal Injury Association Impairment Scale (ASIA), patients with incomplete ASIA D type injury showed a significant response (P < 0.001).
Preinjection ultrasonography showed hydronephrotic changes only in 2/48 patients. Interestingly, both failed to improve after Macroplastique.
| Discussion|| |
We present our experience on the efficacy of Macroplastique for the treatment of secondary VUR due to neurogenic bladder in spinal cord injury population. We report an overall treatment rate 79.1%, and a success rate (treated + improved) 90.3% at 3rd and 12th month of follow-up. Sugiyama et al. reported 79% success following Teflon paste injection in 16 patients with neurogenic bladder dysfunction. Shah et al. reported 77.2% success after single or repeat injection in a similar population. It is difficult to assess the long-term efficacy since, at 48 months, there were data available for only 22 patients who were initially considered as treated. None showed signs of VUR recurrence, but few patients had radical treatment of their poor compliance. Polackwich et al., in a series of 12 patients with neurogenic bladder, showed that the success reduced to 35% at 4.5 years (58% at 12 months). Our complication rate is 1/48 (Clavien IIIb). Our results agree with previous publications.
Although literature lacks evidence from randomized or sham-controlled trials, there are data from the pediatric literature regarding the efficacy of various bulking agents. Bae et al. reviewed retrospectively the efficacy of Macroplastique in 23 children versus Deflux (dextranomer/hyaluronic acid) in 48 children from a single center. Both treatments were equally effective (80.6% vs. 78.6%) without significant difference (P > 0.05). Dodat et al. reported superiority of Macroplastique over Teflon and silicone (93.3% vs. 85.7% vs. 52.6%). Chertin et al. compared the results of previous publications both and short and long terms. Engel et al. compared the surgical versus the endoscopic correction of VUR in children with neurogenic bladder. It was found that ureteroneocystostomy was superior to subureteral polytetrafluoroethylene (84.3% vs. 56.7%).
The efficacy of Macroplastique depends on the degree of reflux, bladder status, and type of injury. A hostile neurogenic bladder (small capacity, overactive, poorly compliant) is liable to Macroplastique failure. Lee et al. suggested that detrusor overactivity, high bladder filling pressures, and poor compliance are independent risk factors for secondary VUR in the neurogenic population. VUR grade in the failure group is higher (2 vs. 3) as compared to the treated group. Even though we failed to show that level and completeness of injury might influence outcome, Macroplastique injection is more successful in incomplete (ASIA D) type injuries.
It should be noted that unlike primary VUR, the success rate of surgical correction of secondary VUR in thickened trabeculated bladders is small. We have managed these patients with augmentation cystoplasty with excellent results. One had patient underwent ureteric re-implantation. The comparison between the treated group and the failure group shows that both bladder compliance and capacity significantly reduced in the latter (cystometric capacity: 396.9 mls vs. 293.8 mls, P = 0.047, and compliance: 18.06 vs. 7.86, P = 0.023). Filling detrusor pressures were higher in the failure group (36.6 vs. 48.8) without reaching statistical significance (P = 0.077). The treated group had more stable bladders (26.5% vs. 7.7%) and less overactivity (73.5% vs. 92.3%).
The complication rate after Macroplastique injection is low. In our study, there was one ureteric unit obstruction due to overcorrection. Similar are the results in the literature. Al-Hunayan et al. reported that ureteric obstruction occurred in less than 1%. Puri et al. had 1 ureteric obstruction in a series of 11 patients with neurogenic bladders. There is evidence that Macroplastique induces mucosal necrosis, erosion, and microscopic hematuria. The safety of silicone is also a concern, but unlike breast implants which were silicon gels, Macroplastique is composed of solid particles.,
To the best of our knowledge, this is one of the biggest series in the endoscopic management of VUR in neurogenic bladders due to spinal cord injury. We understand the limitation of the retrospective study and the lack of comparator, but we believe that we add more insight to the efficacy of this treatment as well as to the factors that contribute to VUR development.
| Conclusion|| |
Macroplastique is effective in the management of VUR in the spinal cord injury population. It is a minimally invasive procedure, quick, with low incidence of complications and high-resolution rate. Care should be taken though to treat the parameters of the neurogenic bladder that contributes to secondary VUR development like detrusor overactivity and poor bladder compliance.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3]