Long-term prognosis of urethral balloon dilation for urethral strictures: experience from a tertiary care center in China

Introduction

Urethral stricture, an abnormal narrowing of the urethral lumen, is a common urological condition primarily affecting males, leading to impaired voiding and significant impacts on quality of life (1,2). While causes vary globally, trauma and iatrogenic injury are prominent, particularly in developing countries and China (1,3).

While urethroplasty is often favored for definitive repair, endoluminal treatments such as direct vision internal urethrotomy (DVIU) and urethral dilation are often initial options for single, short strictures (≤2 cm) due to their minimally invasive nature, ease of performance, and lower cost compared to urethroplasty (4-6). However, these less invasive options are associated with higher recurrence rates (38–68%) compared to urethroplasty (7-9). While urethroplasty generally offers higher success rates for complex strictures, its greater invasiveness, potential for complications, and limited availability mean many patients opt for endoluminal procedures (1,10-12).

High-pressure balloon dilation is a widely used endoluminal technique with demonstrated efficacy and safety (13-21). The advent of novel drug-coated balloons (DCBs), which may reduce recurrences and broaden indications, highlights the need for a clear baseline of conventional balloon dilation outcomes in China (22,23). Given these advancements and the potential of DCBs, establishing a clear clinical baseline for conventional (non-drug coated) balloon dilation is essential, particularly in China, to serve as a reference for future research and clinical applications.

Therefore, this study aimed to define this baseline by comprehensively evaluating the efficacy and safety of conventional balloon dilation at our tertiary care center. This evaluation specifically included assessing its performance across the spectrum of urethral strictures treated, a focused analysis of its utility in challenging long-segment (≥2 cm) urethral strictures, and a retrospective comparison with the outcomes of DVIU/dilation performed at our institution to contextualize the clinical value of conventional balloon dilation. We present this article in accordance with the STROBE reporting checklist (available at https://tau.amegroups.com/article/view/10.21037/tau-2025-223/rc).

Methods

This retrospective analysis included 128 patients who underwent high-pressure balloon dilation and DVIU/dilation for urethral stricture at Peking University First Hospital between November 2017 and September 2023. Demographic data, stricture characteristics, and surgical outcomes were collected from electronic medical records, outpatient follow-up and telephone follow-up. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of the Peking University First Hospital (No. 2022Yan467-002) and informed consent was obtained from all individual participants.

The surgeries were conducted by senior urologists at our center. Following general anesthesia administered via laryngeal mask or tracheal intubation, patients were placed in the lithotomy position. The location and length of the urethral stricture were determined using an 8F or finer ureteroscope. Under direct visualization through the ureteroscope, a hydrophilic guide wire was passed through the stricture segment into the bladder. In the balloon dilation group, a 24F, 6 cm balloon catheter (X-Force™, C.R. Bard Inc., USA) was then positioned at the urethral stricture site via hydrophilic guide wire under direct vision. Subsequently, the balloon pressure was inflated to 25–30 atm and maintained for 5 minutes before the catheter was withdrawn. In the DVIU/dilation group, the urethral sound was lubricated and gently inserted along the guide wire until the tip was positioned within the bladder, with the objective of dilating the stenotic urethra. If the dilation is satisfactory (i.e., the urethral sound passes the stricture with acceptable resistance allowing for progressive dilation), the diameter of the sound would be increased gradually to 24F. In the event that the dilation proves challenging, an endoscopic cold knife will be employed to incise the narrow site in multiple directions under direct vision, subsequently, the urethral sound will be reinserted to gradually dilate the lumen to 24F. In both groups, the ureteroscopy was reintroduced along the guidewire to assess the dilation effect. A 22F urethral catheter was then inserted and kept for 2 to 4 weeks post-operation.

After the patients were discharged from the hospital, we collected patient demographics, stenosis characteristics, and perioperative data by reviewing the electronic medical record. Subsequently, follow-up assessments were conducted at 3–6-month intervals postoperatively to evaluate the efficacy and complications. The endpoint was defined as the recurrence of urethral strictures that require medical intervention such as catheterization, suprapubic cystostomy, urethral endoluminal therapy, and urethroplasty.

Statistical analysis

Data were analyzed using the SPSS 26.0 software and R (version 4.4.2). We performed univariate analyses using unpaired t-test, χ² test, Fisher’s exact test, or Wilcoxon test depending on the type of the variables. Kaplan-Meier survival analysis was utilized to evaluate patients’ stenosis-free time after surgery. Stenosis-free time refers to the period between the start of treatment and the occurrence of the endpoint. Cox proportional hazards test was used to compare differences in efficacy between groups. A statistically significant difference was determined at a two-sided P<0.05.

Results

This study retrospectively analyzed 128 patients with urethral stricture who underwent urethral endoluminal treatment at our center between November 2017 and September 2023. The median follow-up duration was 26 months for the balloon dilation group and 43 months for the DVIU/dilation group. Of these patients, 64 underwent high-pressure balloon dilation and another 64 underwent DVIU/dilation.

Demographics and stricture characteristics were summarized (Table 1). The mean age of the balloon group was 52.70±14.43 years, while the mean age of the DVIU group was 53.41±15.22 years (P=0.79). Traumatic and iatrogenic injuries were the most common causes of urethral strictures in both groups (balloon vs. DVIU/dilation: traumatic 29.7% vs. 25%, iatrogenic 15.6% vs. 40.6%). In terms of stricture characteristics, the balloon group exhibited a majority of strictures at the penile level (70.3%), with a longer average length of 3.22±3.09 cm. In contrast, the DVIU/dilation group demonstrated a higher proportion of bulbar strictures (76.6%) (P<0.001), with a shorter average length of 1.04±0.86 cm (P<0.001). A greater proportion of the balloon group patients (68.8%) were undergoing surgery for urethral strictures for the first time, in comparison to the DVIU/dilation group, where 51.6% (P=0.047) of patients had previously undergone surgery. 29.7% of the patients in the balloon group had multiple stricture lesions, while only 1.6% (P<0.001) of the patients in the DVIU/dilation group had this condition. The duration of catheterization and hospitalization for both groups was similar. In general, the urethral strictures in the balloon group were more complicated than those in the DVIU/dilation group.

The occurrence of postoperative adverse events related to the surgery within 1 year was documented. A total of 13 patients (20.3%) in the balloon group reported postoperative adverse events, including urinary tract infections (UTIs) (4, 6.3%), urolithiasis (3, 4.7%), erectile dysfunction (3, 4.7%), and urinary incontinence (3, 4.7%). Twenty-two patients (34.4%) in the DVIU/dilation group reported postoperative adverse events, including UTIs (9, 14.1%), urolithiasis (3, 4.7%), erectile dysfunction (4, 6.3%), urinary incontinence (1, 1.6%), frequent urination (4, 6.3%), and hematuria (1, 1.6%). No statistically significant difference was observed in the incidence of adverse events between the two groups (Table 2).

In this study, the endpoint was defined as the recurrence of urethral strictures that require medical intervention. The Kaplan-Meier survival analysis revealed no statistically significant difference in the 6-month and 1-year recurrence rates between the two groups (balloon vs. DVIU/dilation: 6 months 23.4% vs. 21.9%, 1 year 29.9% vs. 29.8%). The Cox proportional hazards test indicated that there was no statistically significant difference in recurrence-free survival (RFS) between the two groups [P=0.77, hazard ratio (HR) =1.09, 95% confidence interval (CI) for HR: 0.61–1.93; Figure 1]. Given the observed differences in stenosis characteristics between the two groups, we conducted further exploratory subgroup analyses of patients stratified by different stenosis characteristics.

Figure 1 Kaplan-Meier curve of free from medical intervention between two groups. DVIU, direct vision internal urethrotomy; HR, hazard ratio; CI, confidence interval.

The mean length of urethral strictures in the balloon group was 3.22±3.09 cm, which was significantly longer than the 1.04±0.86 cm observed in the DVIU group (P<0.001). Patients with urethral stricture lengths shorter than and longer than 2 cm were categorized into different subgroups. Kaplan-Meier survival analysis revealed that in the subgroup with a stenosis length of less than 2 cm, the one-year recurrence rates in the balloon group and the DVIU/dilation group were 29.4% and 22.7%, respectively. The results of the Cox proportional hazards test indicated that there was no statistically significant difference in RFS between the two groups (P=0.92, HR =1.05, 95% CI for HR: 0.39–2.84; Figure 2). In the subgroup of patients with urethral strictures ≥2 cm in length (comprising 47 patients in the balloon dilation group and 11 in the DVIU/dilation group), where baseline characteristics differed significantly between the treatment arms only in stricture location (P=0.005, with a higher proportion of penile strictures in the balloon group and more bulbar/membranous strictures in the DVIU/dilation group; Table S1), the one-year recurrence rate in the DVIU/dilation group was 63.6%, which was significantly higher than the 30.0% observed in the balloon group. The Cox proportional hazards test demonstrated that the DVIU/dilation group exhibited a higher risk of stenosis recurrence (P=0.03, HR =2.48, 95% CI for HR: 1.07–5.76; Figure 3). These findings suggest that balloon dilation may be more efficacious than DVIU in patients with urethral strictures of 2 cm or longer in length. Furthermore, subgroup analyses were conducted to investigate the potential influence of other factors on efficacy. The results demonstrated no significant heterogeneity in the analyses of these subgroups (Figure 4).

Figure 2 Kaplan-Meier survival analysis of the subgroup with a stenosis length of <2 cm. DVIU, direct vision internal urethrotomy; HR, hazard ratio; CI, confidence interval.

Figure 3 Kaplan-Meier survival analysis of the subgroup with a stenosis length of ≥2 cm. DVIU, direct vision internal urethrotomy; HR, hazard ratio; CI, confidence interval.

Figure 4 Forest plot for subgroup analysis. DVIU, direct vision internal urethrotomy; HR, hazard ratio; CI, confidence interval.

To further elucidate the risk factors associated with postoperative recurrence, we conducted a Cox regression analysis of various variables. The results demonstrated that no factors exhibited a statistically significant influence on recurrence (Table 3).

Discussion

The treatment of urethral strictures represents a significant challenge in the field of urology, particularly for patients with long and complex urethral strictures. Given the minimally invasive nature of endoluminal treatment, it remains the preferred option for some patients with complex urethral strictures (11,12). Although a large number of studies have suggested that for long-segment complex urethral strictures, urethroplasty is more effective than endoluminal treatment. Indeed, while urethroplasty is often the gold standard, factors such as the limited availability of experienced urology specialists and the relatively small number of medical centers in China that perform the procedure, as well as patient concerns about the potential surgical risks and trauma associated with urethroplasty, have resulted in an increasing number of patients with urethral strictures selecting to pursue endoluminal treatment as their initial course of action (1,10). While urethroplasty carries a risk of postoperative complications, the specific types and rates of such issues, including pain, urinary fistula, or erectile dysfunction, can vary considerably depending on the type of urethroplasty performed, the complexity of the stricture, and other clinical factors. Urethroplasty also has a certain recurrence rate after surgery. The presence of these defects may influence the patient’s selection of surgical plan. The discrepancy between scientific recommendations based on a large number of clinical studies and actual clinical practice also occurs frequently in our center, despite the availability of experienced urethral repair specialists (4,24-26). Nevertheless, this trend is also consistent with the current global trend in surgical procedures, which is minimally invasive. This suggests a potential future direction in the treatment of urethral strictures, namely the development of innovative endoluminal treatments to further improve the success rate of urethral stricture surgery. The recent application of a novel drug (paclitaxel)-coated balloon has demonstrated superior efficacy compared to conventional endoluminal treatments like standard balloon dilation or DVIU in patients with recurrent complex urethral strictures (22,27-29). Furthermore, the drug (paclitaxel)-coated balloons have also shown promising outcomes in patients with long-segment urethral strictures (23,30). The objective of this study is to review the experience of our center in the conventional high-pressure balloon dilation of urethral strictures in recent years and to establish a reference and clinical baseline for future clinical research and the application of DCBs in patients with long urethral strictures in China.

This study primarily focused on evaluating the outcomes of conventional balloon dilation in a cohort of 64 patients treated at our tertiary care center. These patients often presented with complex strictures; for instance, the mean stricture length in the balloon dilation group was 3.22 cm, and a high proportion had penile (70.3%), recurrent (68.8%), or multiple (29.7%) strictures. In this cohort, the overall 1-year success rate (freedom from re-intervention) for balloon dilation was 70.1%, which is comparable to success rates reported in other studies (13,16,18,21,31). For patients within the balloon dilation group with long-segment strictures (≥2 cm), the 1-year success rate was 70.0%, while for those with short-segment strictures (<2 cm), it was 70.6%, indicating consistent performance of balloon dilation across these lengths in our patient sample. For contextual purposes, we also analyzed a contemporaneous cohort of 64 patients treated with DVIU/dilation. This group generally presented with less complex strictures (e.g., shorter mean length of 1.04 cm, fewer multiple strictures) and the DVIU/dilation procedure itself was heterogeneous, with DVIU employed when simple dilation was insufficient. Given that our center is a tertiary referral hospital, a considerable proportion of patients have undergone one or more urethral dilation procedures in other hospitals, which increases the complexity of urethral strictures. Therefore, the study included a substantial number of patients with long-term, multiple, and recurrent complex urethral strictures. Furthermore, the scar tissue of patients with recurrent urethral strictures is typically more rigid, rendering DVIU/dilation procedures more challenging and time-consuming. For these patients, the surgeon tends to recommend balloon dilation as a viable treatment option. Consequently, the urethral stricture in the balloon group was observed to be more complex than that in the DVIU/dilation group in this study. An overall exploratory comparison, after attempting to adjust for baseline differences using multivariable Cox regression, found no statistically significant difference in the 1-year success rates between the balloon dilation group (70.1%) and the DVIU/dilation group (70.2%; HR for recurrence =1.09, P=0.77). In view of the potential impact of confounding factors on the outcome variable, a subgroup analysis was conducted to reduce their interference and investigate whether heterogeneity in efficacy exists across different populations.

Our subgroup analyses explored various factors, and notably, for patients with urethral strictures measuring at least 2 cm in length, the 1-year success rate of balloon dilation was 70.0%. In an exploratory comparison within this specific subgroup, balloon dilation demonstrated a superior success rate compared to the DVIU/dilation group (36.4%; P=0.03, HR for recurrence with DVIU/dilation vs. BD=2.48, 95% CI: 1.07–5.76). For patients with long and complex urethral strictures, urethroplasty is usually recommended as a standard treatment option, given that previous studies have demonstrated that the success rate of endoluminal treatment is relatively low (7-9,32). Nevertheless, the current mainstream surgical approach, urethroplasty, has been estimated to have a postoperative recurrence rate of up to 15.6% (33). In comparison to endoluminal treatment, urethroplasty is a highly invasive procedure with a relatively higher incidence of postoperative complications. Despite the availability of experienced urethral repair specialists in our center, many patients still opt for balloon dilation as a treatment method. Consequently, balloon dilation continues to exhibit considerable clinical value in the treatment of long urethral strictures. The clinical therapeutic value of the paclitaxel-coated balloon in patients with recurrent complex urethral strictures has been substantiated in the ROBUST I Study in recent years (22,27-29). In the ROBUST III trial, the investigators expanded the subject population to include men with recurrent anterior urethral strictures measuring between 2 and 3 cm in length. In patients with urethral strictures ≥2 cm in length, the paclitaxel-coated balloon achieved an impressive 1-year success rate of 91.3% (23). No statistically significant difference in efficacy was observed between this group and patients with urethral strictures <2 cm in length. This finding provides a valuable benchmark for conventional balloon dilation in such cases and supports its role as a viable treatment option for appropriately selected patients, especially when considering advancements like paclitaxel-coated balloons which have reported high efficacy in challenging populations.

Regarding safety, balloon dilation was found to be a safe procedure in our cohort. The overall incidence of complications in the balloon dilation group was 20.3%, with the most common being UTI, urolithiasis, erectile dysfunction, and urinary incontinence. Most of these events were mild and self-limiting. The incidence of complications was not statistically different from the DVIU/dilation group (34.4%), though numerically lower in the balloon dilation group. As noted, when interpreting complications such as urolithiasis and later UTIs, it’s plausible some were linked to developing recurrence rather than being direct early procedural sequelae; this study did not differentiate these for each case. Future prospective studies should aim to categorize complications more precisely in relation to stricture recurrence.

This study has several important limitations. Principally, its retrospective design introduces inherent risks of selection bias and confounding variables. A significant limitation, particularly concerning any comparison between the balloon dilation and DVIU/dilation groups, is the marked baseline heterogeneity between these cohorts. Patients in the balloon dilation group generally had more complex strictures (e.g., longer, more often recurrent, multiple strictures) compared to those in the DVIU/dilation group. While multivariable regression was used in an attempt to adjust for some measured baseline differences in exploratory comparative analyses, these factors severely restrict the ability to draw definitive conclusions about the comparative efficacy of the two modalities. Additionally, while intraoperative ureteroscopy (with adaptive sizing for challenging cases) was utilized for direct visualization, the manuscript does not comprehensively detail the extent of preoperative uroradiological evaluations, such as retrograde urethrography (RUG) or voiding cystourethrography (VCUG), for every patient. This lack of detailed preoperative imaging data for the entire cohort might have limited a complete characterization of all stricture features. The definition of the endpoint event (recurrence requiring intervention) is clinically relevant but relatively subjective, and the study lacks uniform postoperative anatomical assessment or objective uroflowmetry data for all patients if re-intervention was not sought. Urethral stricture disease itself is also inherently heterogeneous in its etiology, location, length, and scar density, which can influence outcomes. Finally, as a single-center study, our findings may have limited generalizability. Therefore, the efficacy of balloon dilation, particularly in long-segment complex urethral strictures, and its standing relative to other treatments, require validation through further multicenter, prospective, and ideally randomized controlled trials.

Conclusions

Acknowledging the specific definitions and limitations of this single-center retrospective study, balloon dilation demonstrated notable efficacy and safety as a treatment option at our institution. Specifically, for long-segment urethral strictures (≥2 cm), a 1-year success rate of 70.0% was achieved in the balloon dilation subgroup. Furthermore, the success rate of balloon dilation for short-segment strictures (<2 cm) was 70.6%, suggesting comparable performance of balloon dilation across these stricture lengths within our cohort.

These findings establish an important clinical baseline for balloon dilation. While this study observed superior outcomes for balloon dilation compared to DVIU/dilation in the exploratory subgroup analysis of long-segment strictures, this comparison must be interpreted with significant caution due to inherent baseline differences between the treatment groups and heterogeneity within the DVIU/dilation arm. Future research, ideally with prospective and controlled designs, is needed to further delineate the comparative effectiveness of these modalities. Nonetheless, our results suggest that conventional balloon dilation, particularly for long-segment strictures, can be a valuable component in the urologist’s armamentarium for managing urethral strictures, providing a useful benchmark for ongoing and future investigations into novel endoluminal therapies, including DCBs.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://tau.amegroups.com/article/view/10.21037/tau-2025-223/rc

Data Sharing Statement: Available at https://tau.amegroups.com/article/view/10.21037/tau-2025-223/dss

Peer Review File: Available at https://tau.amegroups.com/article/view/10.21037/tau-2025-223/prf

Funding: This study was financially supported by the National Natural Science Foundation of China (No. 82270708).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tau.amegroups.com/article/view/10.21037/tau-2025-223/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. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of the Peking University First Hospital (No. 2022Yan467-002) and informed consent was obtained from all individual participants.

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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