Paclitaxel-coated balloon adjunct for benign ureteral and ureteroenteric strictures: a narrative review and translational proposal for enhanced endourological patency

Introduction

Benign ureteral and ureteroenteric strictures remain a major challenge in reconstructive and oncologic urology. Despite advances in minimally invasive and robotic techniques, the incidence of benign strictures after urinary diversion or endoscopic procedures remains between 3% and 15%, depending on patient profile, surgical technique, and follow-up duration (1,2). These lesions typically arise from ischemia, inflammation, or fibroblast-driven fibrosis, leading to progressive luminal narrowing (3). The pathophysiological mechanisms of benign ureteral stricture formation are illustrated in Figure 1.

Figure 1 Normal ureter versus stenotic ureter: structural changes underlying ureteral lumen narrowing. Cross-sectional schematic representation of a normal ureter (left) and a stenotic ureter (right). The normal ureter shows a preserved urothelium, lamina propria, muscularis propria, and adventitia surrounding a wide ureteral lumen. In the stenotic ureter, focal proliferation of the lamina propria and smooth muscle hyperplasia of the muscularis propria lead to concentric thickening of the ureteral wall and marked narrowing of the ureteral lumen, illustrating the structural basis of ureteral stricture. Illustration created by the authors using BioRender.com (CC BY 4.0).

Open reconstruction provides the highest long-term patency, particularly for ischemic or long ureteroenteric strictures (4,5). Nonetheless, endourological therapy remains attractive because of its lower morbidity and feasibility as an initial option in carefully selected patients. Techniques such as balloon dilation and endoureterotomy achieve success rates of 60–80% in short, non-ischemic strictures (6), but recurrence is common, reflecting the limitation of purely mechanical therapy: neither dilation nor incision modulates the biological pathways that drive restenosis.

The central limitation of conventional endourology is its purely mechanical nature, which does not address fibroblast-driven scar formation. Paclitaxel-coated balloons introduce a biological dimension by delivering an antiproliferative drug directly to the stricture site. Paclitaxel accumulates within the urothelium, submucosa, and muscularis with minimal systemic exposure, modulating early wound-healing events (7,8). Early human experience suggests that DCBs may prolong patency after dilation or endoureterotomy (9).

At present, no drug-coated balloon (DCB) device holds a formal regulatory indication for ureteral or ureteroenteric strictures; its use in the ureter is off-label. Regulatory approvals for paclitaxel-coated balloons are currently limited to vascular territories, and within urology to the Optilume^® urethral DCB for anterior urethral strictures.

This manuscript summarizes the mechanistic rationale, technical considerations, and translational potential of paclitaxel-based ureteral DCB therapy by integrating mechanistic insights, pharmacologic considerations, and procedural strategies. This review aims to provide a conceptual translational framework to guide future research and clinical application of DCB technology in ureteral disease. We present this article in accordance with the Narrative Review reporting checklist (available at https://tau.amegroups.com/article/view/10.21037/tau-2025-1-921/rc).

Methods

This work is a narrative, non-systematic review of the translational rationale and early clinical experience with paclitaxel- and paclitaxel-dextran-coated balloons for benign ureteral and ureteroenteric strictures. A formal systematic review was not considered appropriate due to the paucity, heterogeneity, and predominantly preclinical or early-phase nature of the available ureter-specific literature, which currently precludes meaningful quantitative synthesis. Consistent with the narrative review methodology, no formal risk-of-bias assessment or meta-analysis was performed.

Relevant literature was identified through a targeted search of PubMed and major urologic and endovascular journals using combinations of the terms “ureteral stricture”, “ureteroenteric stricture”, “drug-coated balloon”, “paclitaxel”, and “endourology”. The primary search was performed in PubMed using the following term combinations: “paclitaxel coated balloon”, “paclitaxel AND ureter”, “paclitaxel coated balloon AND ureter”, and “ureteroenteric stricture AND paclitaxel”. Secondary exploratory searches using “paclitaxel” and “ureteral stricture” were conducted to identify additional relevant literature but were not intended to constitute an exhaustive systematic search, consistent with a narrative review methodology. The search covered the period from 1997 to 15 January 2026 and was limited to English-language publications.

Priority was given to preclinical ureteral pharmacokinetic studies; long-term clinical ureteral DCB series; vascular and urethral DCB platforms with translational relevance; and key guidelines or high-quality reviews on benign ureteral strictures.

Title and abstract screening were performed by L.D.A. Full texts of all eligible and relevant articles were reviewed by L.D.A. and J.P.N., with final study selection determined by consensus. No formal quality appraisal was conducted, consistent with the narrative review methodology.

The initial targeted search identified over 120 records across databases and supplementary sources. After title and abstract screening, approximately 35–40 publications were considered potentially relevant and underwent full-text review. Based on relevance to ureteral or ureteroenteric strictures, translational pharmacology, and clinical experience with DCBs, approximately 20–25 studies were ultimately included in the narrative synthesis.

Given the narrative and non-systematic design of this review, these figures represent approximate estimates derived from an iterative, expert-driven selection process rather than a formal systematic screening workflow.

Reference lists of selected articles were screened to identify additional eligible studies. No new data involving human participants or animals were generated. An overview of the search strategy and study selection process is summarized in Table 1.

Description of the technology

Pharmacologic and mechanistic basis

Paclitaxel stabilizes microtubules, induces G2/M-phase arrest, and inhibits fibroblast and smooth-muscle cell proliferation. In ureteral tissue, paclitaxel suppresses extracellular matrix production without cytotoxic injury (8). Experimental ureteral models show that paclitaxel delivered by coated balloons penetrates the urothelial barrier and distributes through the submucosa and muscularis in a time-dependent manner (7,10). Dextran and its derivatives serve as drug carriers and stabilizers in coated balloon platforms, improving local bioavailability (11). Whether these advantages translate to the ureter remains unclear. Paclitaxel-coated balloons developed for vascular applications—such as Lutonix^® (paclitaxel-only) and Elutax 3^® (paclitaxel-dextran)—are available in a wide range of diameters and lengths. For ureteral translational use, balloons of approximately 60 mm length and 12–18 French (Fr) external profile provide adequate wall contact in most benign strictures, although optimal device sizing requires formal evaluation (12).

Inflation time and drug delivery

Inflation duration directly affects drug transfer in DCB systems. In the coronary territory, prolonged inflations (>2 minutes) improve angiographic outcomes and reduce residual stenosis, reflecting contact-dependent diffusion of paclitaxel (13). In ureteral tissue, progressive paclitaxel penetration up to 24 hours after a single inflation has been demonstrated, supporting the biologic plausibility of sustained balloon-wall contact (7). Evidence from urethral DCBs (Optilume^®) also relies on standardized prolonged inflations to ensure consistent elution (14). A practical starting point in translational ureteral practice is maintaining balloon inflation for approximately 5 minutes at 8 atm to promote circumferential wall apposition. The optimal inflation duration in humans, however, remains undefined. The mechanics of these balloons in the ureter and their physiological effects on the tissue are summarized in Figure 2.

Figure 2 Paclitaxel-coated balloon catheter: mechanism of drug delivery and inhibition of ureteral stricture. (A) Schematic representation of a paclitaxel-coated balloon catheter deployed in the ureteral lumen. Upon inflation, paclitaxel particles are released from the balloon surface and penetrate through the urothelium into the lamina propria, muscularis propria, and adventitia. (B) At the molecular level, paclitaxel binds to and stabilizes microtubules, blocking tubulin dimer turnover at the plus end. This prevents fibroblast and smooth muscle cell proliferation, inhibits cell migration, and reduces extracellular matrix deposition in response to TGF-β and other profibrotic growth factors, thereby counteracting the mechanisms underlying ureteral stricture formation. Illustration created by the authors using BioRender.com (CC BY 4.0). TGF-β, transforming growth factor-beta.

Paclitaxel dose, exposure, and pharmacokinetics

Importantly, none of the described device characteristics, inflation parameters, or paclitaxel dose ranges have been prospectively validated for ureteral indications. The technical considerations summarized above should therefore be interpreted as translational proposals derived from preclinical ureteral data and cross-territory experience, rather than as evidence-based or standardized ureteral treatment protocols.

Available DCB platforms reported or adapted in translational ureteral contexts deliver paclitaxel at surface doses ranging from approximately 2.0 to 3.5 µg/mm², overlapping with doses validated in large vascular clinical trials. The urethral Optilume^® balloon uses a higher surface dose (3.5 µg/mm²) (15), whereas Lutonix^® and Elutax 3^® deliver 2.0 and 2.2 µg/mm², respectively (9,12). Other commercially available paclitaxel-coated balloons developed for vascular indications, such as the AcoArt™/Orchid™ platform (16), operate within a comparable dose range and employ alternative coating technologies, helping contextualize this dose spectrum across anatomical territories (Table 2).

Preclinical ureteral pharmacokinetic data are limited to a single porcine model, in which a paclitaxel-coated vascular balloon was inflated for 5 minutes in the distal ureter. Using immunohistochemistry and nuclear magnetic resonance spectroscopy, paclitaxel was detected in the urothelium and submucosa immediately after inflation, with progressive penetration into the muscular layer at 12 and 24 hours. Tissue signal intensity peaked at 12 hours and declined at 24 hours, indicating drug residence beyond the immediate post-procedural period (7).

Importantly, this ureteral model was designed to assess spatial and temporal distribution rather than absolute tissue concentrations, and quantitative pharmacokinetic values were not reported. In contrast, vascular porcine models comparing multiple paclitaxel-coated balloon platforms have demonstrated rapid drug transfer during balloon inflation followed by sustained tissue residence over hours to days, despite minimal systemic exposure (17). However, direct extrapolation of quantitative vascular pharmacokinetic data to the ureter remains limited by anatomical and biological differences.

To date, no studies have provided absolute paclitaxel concentration-time curves in ureteral tissue. This limitation should be explicitly addressed in future ureter-specific pharmacokinetic studies.

From a translational standpoint, differences in paclitaxel surface dose and coating technologies across platforms may influence drug transfer efficiency, tissue penetration, and residence time. The specific composition of the excipient used in the Optilume platform is not publicly disclosed in available technical documentation, although it is described as a carrier facilitating paclitaxel adhesion and release. Higher surface doses and advanced excipient matrices may theoretically enhance local drug delivery and antifibrotic effect, although comparative ureter-specific data are lacking. These device-related differences highlight the need for standardized pharmacokinetic evaluation in ureteral tissue and may represent an important determinant of future clinical outcomes.

Surgical technique and procedural considerations

The following section outlines a proposed procedural approach derived from established endourological experience, the translational and clinical evidence reviewed in this manuscript, and the authors’ expert opinion, and should be interpreted as a non-prescriptive, hypothesis-generating framework.

Ureteroenteric strictures

Procedures are typically performed under general anesthesia. An antegrade approach is commonly favored, allowing secure access to the collecting system and improved control across the anastomotic segment. Percutaneous renal access enables antegrade pyelography and passage of a guidewire through the stricture under fluoroscopic guidance. Establishment of through-and-through access (antegrade-retrograde) may be considered, as it facilitates stable device exchange and precise balloon positioning.

Stricture preparation is a critical step. Initial dilation is performed using a high-pressure balloon, with inflation pressures ranging from 8 to 18 atmospheres depending on stricture density and compliance. In the presence of dense or fibrotic rings, adjunctive endoureterotomy may be performed following established techniques, with the aim of disrupting circumferential fibrosis and exposing healthy tissue margins.

After stricture preparation, a 0.018-inch guidewire is used to position the DCB across the treated segment. Balloon length and diameter are selected to fully cover the stricture with minimal extension into normal ureter. DCB inflation is commonly performed as a prolonged low-pressure inflation to maximize circumferential wall apposition and drug transfer. Reported protocols in early ureteral experience and cross-territory practice use inflations of several minutes (from 5 to 8 minutes), although the optimal pressure and duration in the ureter remain undefined. Figure 3 illustrates a ureteroenteric stricture before and after adjuvant endoureterotomy followed by inflation of a paclitaxel-dextran DCB (Elutax 3^®).

Figure 3 Endoureterotomy surgery with an adjuvant drug-coated balloon of paclitaxel. (A) Ureteroenteric stricture prior to endoureterotomy using a Lovaco technique with a guidewire passed via an antegrade approach. (B) The ureteroenteric stricture treated after endoureterotomy and inflation of a paclitaxel + dextran balloon over the stricture.

Primary ureteral strictures

For primary ureteral strictures, a retrograde approach is generally preferred. Following cystoscopic access and retrograde pyelography, a guidewire is advanced across the stenosis under fluoroscopic control. Preliminary dilation with a standard high-pressure balloon may be performed to facilitate passage and assess stricture compliance.

Depending on stricture morphology, a limited endoureterotomy can be added to improve exposure of healthy tissue margins and potentially enhance drug penetration. Subsequently, a paclitaxel-coated balloon is positioned over a 0.018-inch guidewire under combined endoscopic and fluoroscopic guidance and inflated using the same parameters described for ureteroenteric strictures.

Stenting strategy and postoperative management

Postoperative stenting is individualized and based on intraoperative findings, including the extent of mucosal disruption, degree of edema, and use of endoureterotomy. At present, there is no evidence-based standard defining optimal stent use following DCB application in the ureter. When used, stent caliber and dwell time are selected according to surgeon preference and perceived risk of early obstruction.

Follow-up protocols typically include imaging to assess patency and hydronephrosis resolution, although standardized surveillance strategies have yet to be defined.

Figure 4 presents a proposed workflow for patient selection and procedural strategy.

Figure 4 Proposed workflow for the endourological management of benign ureteral and ureteroenteric strictures incorporating drug-coated balloon technology. The algorithm outlines a conceptual approach to patient selection, stricture preparation, and adjunctive use of paclitaxel-coated balloons following conventional endourological techniques. This workflow is intended as a schematic representation based on available translational and early clinical evidence and does not represent a clinical guideline.

Role of paclitaxel-coated balloons in endourology

Conventional dilation and endoureterotomy restore luminal patency but do not directly address the biological drivers of restenosis. The currently available ureter-specific clinical evidence remains limited but provides important early feasibility signals. One of the largest prospective datasets currently available in humans derives from a single-arm pilot study evaluating off-label endoscopic treatment with DCB dilation following conventional balloon predilation in patients with non-malignant ureteral strictures. In this study, 25 patients with benign strictures of heterogeneous etiology—including ureteroenteric anastomosis, lithiasis-related, post-surgical, post-radiotherapy, and transplant-related strictures—underwent DCB treatment following successful lesion crossing and high-pressure balloon predilation (9).

Procedures were primarily performed via an antegrade percutaneous approach, with optional combined antegrade-retrograde (“rendezvous”) access in complex anatomy. DCB inflation was typically performed for approximately 4 minutes following lesion preparation. Mean stricture length was approximately 40 mm, and mean follow-up reached 36 months. Overall radiologic success at 12 months was 88%, with primary patency achieved in 56% of patients after a single treatment session. Additional dilation sessions were required in a subset of cases to maintain long-term patency, and the overall failure rate at 12 months was 12% (9).

The safety profile appeared favorable, with only one reported case of febrile urinary tract infection requiring hospitalization and no evidence of systemic paclitaxel-related toxicity.

Additional feasibility data are supported by isolated case reports. In one reported case of ureteroileal anastomotic stricture following radical cystectomy with orthotopic neobladder, antegrade DCB placement following nephrostomy decompression resulted in resolution of hydronephrosis at 30-day follow-up, allowing nephrostomy removal without ureteral stent placement (18).

Beyond isolated case reports, a small series of four patients with ureteropelvic junction strictures after failed pyeloplasty treated with a multimodal approach—including laser endopyelotomy, paclitaxel-dextran DCB dilation, and temporary self-expandable ureteral stent placement—has been reported, with resolution of the treated strictures during follow-up (19).

Systemic safety concerns appear minimal. Large patient-level meta-analyses of vascular DCBs have shown no association between paclitaxel exposure and increased mortality (20). Translational interest in local paclitaxel delivery is further informed by experience in urethral stricture disease, where the Optilume^® DCB has demonstrated improved durability over standard endoscopic management in randomized and prospective studies and is approved for anterior urethral strictures (14).

Discussion and future directions

Paclitaxel-coated balloon therapy aligns with the known wound-healing biology pathways implicated in ureteral strictures and is supported by mechanistic, preclinical, and early clinical evidence. Although the ureter differs from vascular or urethral tissue, key restenosis pathways appear shared across territories. Early ureter-specific clinical reports suggest technical feasibility and encouraging short-term patency; however, current evidence remains limited, heterogeneous, and insufficient to support standardized clinical adoption.

From a clinical perspective, DCB therapy may be particularly relevant in selected scenarios where conventional endourological approaches show limited durability or where reconstructive surgery carries significant morbidity. Potential candidate situations include short recurrent strictures, post-surgical or post-radiotherapy fibrosis, and patients considered high-risk for reconstructive procedures. In these contexts, adjunctive local antiproliferative therapy may theoretically improve long-term patency by targeting fibroproliferative mechanisms that are not addressed by mechanical dilation alone. However, these potential indications remain hypothesis-generating and require prospective validation.

Ureter-specific systemic exposure is expected to be minimal given the small total drug load delivered by ureteral balloons. Even in the theoretical scenario of local drug leakage or extravasation into the retroperitoneal or intraperitoneal space, the absolute amount of paclitaxel involved is several orders of magnitude lower than doses routinely and safely administered during hyperthermic intraperitoneal chemotherapy (21), supporting a low likelihood of clinically relevant toxicity to adjacent organs. Moreover, extensive vascular experience and prospective urethral DCB studies—including the randomized and regulatory dataset supporting Food and Drug Administration (FDA) approval of Optilume^®—have not identified excess mortality attributable to paclitaxel exposure (14,20).

The urethral Optilume^® experience provides an important translational reference rather than a direct clinical analogue. Randomized and prospective studies demonstrate that combining mechanical dilation with local paclitaxel delivery can improve long-term patency compared with endoscopic therapy alone (14). While these data support the biological plausibility of local antiproliferative modulation, they should not be interpreted as evidence of clinical equivalence between ureteral and vascular or urethral applications.

Anatomical differences, continuous urine exposure, and distinct ureteral healing dynamics may significantly influence drug transfer, tissue retention, and biological response following local drug delivery.

Available evidence is limited by small sample sizes, heterogeneous techniques, and the absence of randomized comparisons. Despite these promising foundations, multiple uncertainties require clarification to guide clinical adoption. In this context, prospectively designed clinical studies are beginning to emerge. The ongoing ENDURE-1 study (ClinicalTrials.gov Identifier: NCT07020520) is a prospective, multicenter clinical trial designed to evaluate the safety and feasibility of the Optilume^® DCB for the endoscopic treatment of benign ureteral and ureteroenteric strictures. The study includes patients with single benign ureteric or ureteroenteric stricture measuring ≤4.0 cm and investigates a strategy combining mechanical dilation with local delivery of paclitaxel (22).

ENDURE-1 is planned to enroll up to 60 patients across multiple centers in the United States. Participants undergo scheduled follow-up to assess procedural safety and treatment durability over time. Primary outcome measures focus on technical success and freedom from reintervention, with additional secondary assessments exploring functional and clinical outcomes (22).

As one of the first prospective multicenter studies specifically evaluating DCB technology in benign ureteral strictures, ENDURE-1 represents an important step toward generating structured clinical evidence in a field currently dominated by preclinical data and small early clinical series.

Despite the emergence of prospective clinical studies, the translation of DCB technology to the ureter raises several unresolved mechanistic and technical questions. These issues are likely to determine not only treatment efficacy, but also reproducibility and safety across different clinical scenarios.

First, it remains unknown whether DCBs should be applied after simple dilation or in combination with endoureterotomy. In non-DCB ureteral series, the combination of dilation and incision demonstrated higher success rates than dilation alone (23), particularly when a full-thickness incision of the fibrotic ring is achieved and extended into healthy tissue margins, suggesting that adequate tissue preparation may influence long-term patency outcomes (24). From a mechanistic perspective, simple dilation largely preserves the urothelial barrier (6), whereas endoureterotomy produces controlled mucosal and submucosal disruption, which could theoretically facilitate deeper drug penetration into fibroproliferative layers and improve local drug retention. However, this hypothesis remains untested in ureter-specific paclitaxel pharmacokinetic models. Conversely, greater tissue disruption may increase the risk of edema, extravasation, or infectious complications and may therefore require tailored postoperative drainage and surveillance strategies (25). In this context, experience from urethral DCB therapy suggests that standardized mechanical preparation and uniform drug-tissue contact are important determinants of treatment durability, although whether similar principles apply to ureteral strictures remains unknown and warrants prospective evaluation.

Second, the optimal inflation duration and pressure for paclitaxel transfer in ureteral tissue remain undefined. While prolonged inflation appears rational based on cross-territory data, ureter-specific pharmacokinetic studies are needed.

Third, anatomical and technical factors—including balloon conformity to irregular luminal geometries, stricture vascularity, prior instrumentation, or ischemic changes—may influence drug uptake but are poorly characterized. Adjunctive strategies such as temporary self-expanding metallic stents could theoretically prolong drug-tissue contact but currently lack supporting evidence.

Several clinical scenarios remain unexplored, including recurrent strictures or the impact of stricture etiology (ischemia, radiation, chronic stenting). These represent populations where DCBs may offer particular benefit but require dedicated study.

Economic implications also warrant study; cost-effectiveness cannot be determined until long-term patency is established.

Future research should focus on standardized procedural protocols, optimization of device characteristics, and prospective multicenter comparisons of conventional endourology with and without DCB augmentation. Relevant endpoints include radiologic patency, symptoms, reintervention rates, safety, and cost-effectiveness.

Conclusions

Paclitaxel-coated balloon technology represents a promising biologically targeted adjunct for the endourological management of benign ureteral and ureteroenteric strictures. Preclinical and early clinical evidence support its mechanistic rationale and suggest a favorable safety profile. However, well-designed prospective studies are required to define optimal procedural strategies, patient selection, and long-term clinical outcomes.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the Narrative Review reporting checklist. Available at https://tau.amegroups.com/article/view/10.21037/tau-2025-1-921/rc

Peer Review File: Available at https://tau.amegroups.com/article/view/10.21037/tau-2025-1-921/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tau.amegroups.com/article/view/10.21037/tau-2025-1-921/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This article does not involve new studies of human participants or animals.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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