Abstract
Urethral stents have been used for decades. Although this relatively low invasive treatment gave good results in the beginning, later revealed recurrence of the obstruction and serious adverse effect. In this chapter we provide an overview of the introduction of urethral stents in clinical practice and review the literature on studies using stents to relieve obstruction in the male urethra caused by benign and malignant prostatic enlargement or urethral stricture disease in the human adult male population.
For this book chapter we screened the Embase and PubMed databases for publications on stents used in the urethra. We excluded papers on stents elsewhere in the urinary system, including the bladder neck. The primary endpoint was cause and rate of complications and secondary endpoint was patency rate. After careful selection 118 publications were included in this review.
Stenting of the urethra, including the prostatic urethra, is prone to adverse effects including dislocation of the stent, dysuria, recurrence of obstruction, urinary incontinence, encrustation and patient discomfort. For urethral stricture disease, open urethral reconstruction is the treatment of choice, for prostate hyperplasia, surgical intervention [e.g. TURP] or pharmaceutical treatment are preferred over stenting. However, patients unfit for this major open surgery, may still benefit from urethral stenting as palliative solution. With this important patient population, research must continue for a better biocompatible stent.
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1 Introduction
Urine produced in kidneys should freely flow out through the ureters, bladder and urethra. Bladder outlet obstruction [BOO] by benign or malignant processes leads to Lower urinary tract symptoms [LUTS], reduced quality of life, and if left untreated it may damage kidneys and lead to loss of kidney function. BOO in the urethra is more prevalent in males compared to females, as the male urethra is much longer and can be caused by several conditions at different anatomical locations.
In this review we focus on the entire male urethra. Since no stents are used in female urethral obstructions, they will be excluded from this review [1].
At the prostatic urethra, the major cause for BOO is benign prostatic hyperplasia [BPH]. About 105 million men are affected globally of BPH [2]. Development of BPH typically begins after the age of 40, around half of males aged 50 and over are affected [3] with the majority [~90%] of males affected after the age of 80 [3]. Prostate cancer can also lead to BOO. More distal in the urethra, the major cause of obstruction is strictures of the urethra. Urethral strictures due to fibrosis occur in approximately 1% of the male population over 55 years of age [4].
2 Brief History of Lower Urinary Stents
The 1980s can be seen as the decade of various stent inventions in medicine, especially for use in vascular occlusions but also for prostatic obstructions. These stents were either self expandable or balloon expandable stents [5]. The use of urethral stents starts in 1980 with the introduction of the “partial catheter”/‘urological spiral’ invented by Fabian [6]. This was a 21F stainless steel coil for inserting into the occluded prostatic urethra, instead of an indwelling catheter. For reducing the risk of stone formation on the stainless steel, in 1987 a group in Denmark gold-plated the ‘urological spiral’ and named it Prostakath [7]. Since then, a variety of metals and biostable and biodegradable polymers have been used to produce temporary or permanent stents for the management of infravesical obstructions such as benign or malignant prostatic enlargement, bladder neck stenoses, urethro-vesical anastomotic stenoses or urethral strictures. Some stents originally developed for vascular use were also adapted for use along the urethra. Examples are: The balloon expandable Palmaz Stent [only for the prostatic urethra], the self-expanding Memotherm and the Urolume which was an adaptation of the vascular Wallstent. The Wallstent was developed by Hans Wallsten as a vascular stent and later adapted to urological use under the name Urolume Wallstent [8]. The design of this stent was based on a wire braiding technology similar to the “Chinese finger trap”; an old Chinese trick in which one can insert a finger that is trapped when the finger is retracted. This braiding technology allowed the stent to self-expand and apply radial force to the surrounding tissues. The Urolume Wallstent became a very popular stent for urethral stricture. Despite the initial enthusiasm for the use of permanent stents in recurrent urethra strictures, on longer follow up they could not prove themselves as a good alternative to urethroplasty and now they are used only in selected, frail, poor surgical risk patients.
The other self-expanding stent, the Memotherm was made of a nickel titanium alloy (nitinol) wire knitted to form a tube. This thermo-sensitive stent expanded to its maximal caliber at body temperature [9]. This stent also lost its initial enthousiasm for the same Reasons as the Urolume Wallstent.
The ProstaCoil, a large caliber (24/30F), nitinol made self-expanding temporary prostatic stent was based on the UroCoil which was developed for use in frequently recurring urethral strictures [10].
Almost at the same time different polymer made stents started to appear: The polyurethane made small caliber [16F] prostatic stent named ‘intra-urethral catheter—IUC’ [11], a similar 16F Barnes stent [12], the larger caliber silicone made Trestle and the more recent Spanner [13].
During the same years the Biofix/SpiroFlow biodegradable prostatic coil stent made of self-reinforced polyglycolic acid [SR-PLA] was also introduced. However, it failed to support the expectations because, after losing their radial force, they crushed into the urethral lumen and caused an obstruction that had to be solved by endoscopic removal of its segments [14].
Stenting the lower urinary tract is minimally invasive approach to relieve BOO in patients unfit for surgery or in others as an alternative to surgery. What we need from a urinary stent is a patent lumen so it can support both micturition and sexual activity without serious adverse effects. The ideal urethral stent is flexible so it can support the urethral lumen in both the flaccid or erect status of the penis. In addition, the ideal stent is an off-the-shelf product, so that each patient can be treated directly.
Since their introduction in the late 1980s, stents have been studied in the urinary tract to prevent scaring contraction and re-modelling of the strictured urethral segments. Although the first reports seemed to promise excellent outcomes, longer follow-up began to cast doubts on the usefulness of urethral stenting as a primary treatment modality for urethral stricture disease [15]. Especially permanently implanted stents lead to tissue ingrowth and re-stenosis. Temporary stents prevented tissue ingrowth in their lumen but induces tissue ingrowth at their ends. Resection of this tissue or removal of the stent opened the obstructed lumen.
3 Classification of Stents
First use of a stent in the urinary tract was the permanent use of a 22F catheter for 1–4 years in a small group of 19 patients [16]. Later vascular stents were used ‘off label’. The Palmaz stent, Wallstent and the Memotherm were supposed to be completely covered by urothelial tissue within a few weeks after their implantation like in the vascular tract. Less than satisfying results with these stents especially in the prostatic urethra led to development of urethral specific stents. Most of these stents had either a fixed caliber, or are self-expandable or thermo-expandable.
Differing from other tubular organs, the cross section of the prostatic urethra is rarely round. For this reason, some of the permanent stents could not become fully covered with tissue as they were supposed to become and stones could develop on the uncovered bare metal wires. Despite this drawback both the Urolume and the Memotherm are still used in selected high surgical risk patients [17]. The Palmaz stent dropped from use because its lack of radial self-expanding force.
Urethral stents can be classified in several groups. First, we can make a distinction on anatomical location. We have prostatic urethral stents—both for benign and malignant obstructions and bulbar and distal urethra stents, these are used to open the urethral lumen after traumatic pelvic bone fractures, endoscopic manipulations related and in case of recurrent infection (e.g. lichen sclerosis, gonorrhoea). An additional classification is based on the type of stent, there are permanent and removable stents, mesh stents can be either balloon expandable and self-expandable. Examples of the removable stents are among others Fabian stent/Prostacath, InStent’s ProstaCoil and UroCoil, Allium’s TPS, BUS and RPS. Lastly few experimental trials are reported on degradable stents.
The use of a permanent stent positioned in distal urethra may look to be an attractive treatment in the treatment of strictures. The Urolume/Wallstent and the Memotherm which are permanent stents were used as an alternative approach in such stenoses [18]. Time showed that the use of permanent stents is a contraindication in these cases because of intra-stent obstructive tissue proliferation [19, 20]. Significant complication rates were also observed when such stents were used for benign prostatic obstructions [21].
4 Aim of This Chapter
In the present chapter we provide an overview of the current literature to summarize the most common complications seen with different urethral stents for male patients with benign or malignant urethral obstruction of the urethra. Full data extraction is ongoing, this is our initial report.
5 Materials and Methods
5.1 Literature Search
Following search string: [[[[urethra] OR urethral]] AND [[[[stent] OR endoprothesis] OR endoprosthesis] OR stents]] was initially used both in Embase and PubMed, in February 2019 and a re-run in March 2020. Cross references were added. Figure 1 presents an outline of the literature search in a Prisma Flow Diagram [22]. Prospective, retrospective, comparative studies, case reports and case series were included.
Study selection process [22]. For more information, visit www.prisma-statement.org
5.2 Study Selection
Results from PubMed and the Embase were imported in Rayyan [https://rayyan.qcri.org/], where duplicates were removed. The title and abstract screen was performed by two authors independently [PdG, DR]; the full text screen was performed by the same authors, also independently of each other. Any differences in the screening results were solved by discussion. Studies were excluded when written in languages other than English, non-original papers [abstract, comment or review paper], when describing pre-clinical studies and non-human use, when studying wrong population, e.g. wrong etiology of the urethral obstruction [mainly detrusor sphincter dyssynergia] or stenting by catheter after reconstruction surgery. The primary endpoint was cause [restricture, infection, migration and other causes for stent failure] and rate of complications and secondary endpoint was patency rate. Stent patency was calculated as number of failed stented urethra over number of total stented urethra and failed stented urethra is defined as stent not being able to do as expected so an unplanned stent removal.
6 Results
After search has been run, 1551 publications were identified and their abstracts were screened independently by two authors [PdG, DR] resulting in consensus on 412 acceptable full text papers which were thoroughly read by same authors and of those 118 were finally included in systematic review. Reasons for exclusions were listed in Fig. 1.
Over 4000 patients are described, with varying follow up. Several different stents were used, including off label use of covered metal stents designed for vascular use, drug eluting stents, biodegradable stents.
Papers were divided on use in anatomical location [prostate, urethra or report on both locations]. In total, 94 papers recorded on results, 24 papers on complications only. Here we summarize the results based on this division.
6.1 Prostatic Stents
Thirty-six studies report on stent use in the prostatic urethra. Of these, 34 reported on results, 2 on complications. An overview of the studies is given in Table 1. At the prostatic region the UroLume was the most used stent, used in 8 studies, other stents used were MemoKath (3), Memotherm (2), 4 reported on ProstaKath, 3 on ProstaCoil, 2 on Urospiral, 4 on Spanner and a variety of others, including 4 studies on biodegradable stents. As a full data extraction and analysis is currently performed by the authors, we can only preliminary summarize the common adverse effects, including dislocation of the stent, dysuria, retention, recurrence of obstruction and urinary incontinence. Meta-analysis cannot be performed due to different endpoints, differences in stents and most of all, differences in follow up. Overall, in studies with short follow up, success rates are much higher than in studies with longer follow up.
6.2 Stents in Both Prostatic and Urethral Region
Twenty studies reported on urethral stents both in the prostatic and the bulbar urethral region, without making clear distinction or made a combinations of results/complications in both regions. Of these, 16 reported on results, and 4 on complications. An overview of these studies is given in Table 2. Again, the Urolume was used most in this combined region (8), the other 12 studies were using a variety of stents, including a 22F catheter [16] and some titanium alloys based stents [see Table 2 for description]. Success rate in up to 50% of cases, however, short follow up may bias these results, as some complications take longer to develop.
6.3 Urethral Stents
The largest set of studies was found for urethral stenting, 62 studies were selected, 44 reported on results, 18 on complications. An overview of these studies is given in Table 3. Urolume was used in 26 studies, 3 of these studies compared the stent to the Wallstent. 10 studies reported on Wallstent alone. Six studies reported on the use of MemoKath, 1 on MemoTherm, 2 on UroCoil and 3 on Allium stents. The other 17 studies used other stents, described a variety of stents or the stents used were ill-defined. Reported complications included stent migration, haematuria, recurrent strictures or obstructed stents by encrustation, urinary tract infections, perineal pain and sexual dysfunction. Despite their relatively high complication rates, externally covered stents seemed more effective with fewer complications than either uncovered or internally covered stents. However, all stents intrinsically generate the risk to turn a simple stenosis into a complex stenosis requiring a staged urethroplasty, a definitive urethrostomy, or a permanent suprapubic diversion [23].
7 Discussion
In total, we analyzed 118 studies on urethral stenting, 94 on results and 24 on complications. In the studies analyzed, the UroLume was used most frequently. Full extraction of the data is in progress, we will report later on this based on this book chapter.
In modern urological practice, ureter stents and bladder catheters have become indispensable tools. The use urethral and prostate stents was introduced with optimism and hope; however, these latter stents have not shown their benefits over current procedures to treat urethral obstruction. Over the course of time, many improvements in designs and constitutive materials for urinary stents have taken place in an attempt to improve their efficacy. Nevertheless, they remain associated with several adverse effects that limit their value as tools for long-term urinary drainage. Infection, encrustation, migration, hyperplastic epithelial reaction, and patient discomfort are the most common problems [24] and, especially for urethral stricture disease, open urethral reconstruction is the treatment of choice for patients with traumatic strictures and those with previously failed urethroplasty [19]. For patients unfit for this major open surgery, research for better stents, potentially biodegradable or a combination of materials and cells will be a better option [25].
8 Limitations and Risk of Bias
The included studies used different approach on reporting complications therefore a quantitative report on the adverse effects was not possible. Publication bias is likely on the included reports, both biased on complication in the case reports, as well as bias on the outcome due to short follow up.
9 Conclusion and Future Perspectives
It is clear from papers we have analyzed that purpose-built urethral stents have outperformed off-label vascular stents, but still the ideal stent has not been identified. Despite many adverse effects, urethral stents may still be useful, in particular to the elderly unfit patient in whom a major operation is contraindicated, providing a rapid treatment that can be performed with the patient under local anesthesia. For this we need to develop better stents that can avoid the current complications and disadvantages. Cross pollination is needed between basic, translational, preclinical and clinical research, thereby combining knowledge on materials, cells, rheology, tissue, pathophysiology and pathology, with the ultimate aim better treatment options for our patients.
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This systematic review was part of activities from Workgroup State of art of urinary stents within COST Action 16217 ENIUS European Network of multidisciplinary research to Improve the Urinary Stents.
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de Graaf, P., Yachia, D., Soria, F., Rako, D. (2022). Urethral Stents. Indications, Complications and Adverse Effects. In: Soria, F., Rako, D., de Graaf, P. (eds) Urinary Stents. Springer, Cham. https://doi.org/10.1007/978-3-031-04484-7_4
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