Abstract
Objective:
To determine the early experience with paclitaxel-drug coated balloon (DCB) for both anterior urethral stricture disease (aUSD) and posterior urethral stenoses (PUS).
Methods:
A retrospective review of patients undergoing Optilume DCB in the Trauma and Urologic Reconstructive Network of Surgeons (TURNS) database was performed. Both functional (improved subjective voiding without a secondary procedure) and anatomic (open lumen on cystoscopy) success rates were determined. Kaplan Meier estimates were used to determine the risk of failure by LSE classification and LSE Stage.
Results:
A total of 319 patients were treated with the DCB, of which 260 were for aUSD and 59 were for PUS. Median age was 64 years (Interquartile range [IQR] 48-73). Recurrence was noted in 119 patients (37.3%) at a median follow-up of 5.7 months (IQR 3-12). For aUSD, the 1-year functional recurrence-free survival was 78.4% (95% CI 71.8-85.4) and anatomical recurrence-free survival was 66.4% (95% CI 59.5-74.2). For PUS, the 1-year functional recurrence-free survival was 75.8% (95% CI 61.4-93.7) and anatomical recurrence-free survival was 59.4% (95% CI 44.1-80). Recurrences of any kind were significantly more likely in patients with strictures after hypospadias repair (HR 5.21, 95% CI 1.06-25.6, P = .042), and use of 24 Fr, 3 cm DCB (HR 3.64, 95% 1.10-12.09, P = .035). These were also significant predictors of anatomical recurrences.
Conclusion:
Multi-institutional utilization of the DCB for aUSD and PUS demonstrates a low effectiveness among high-risk strictures. Recurrence after DCB varies based on stricture characteristics and subtype, which are important for preoperative counseling and postoperative surveillance.
Urethral strictures occur due to various etiologies that ultimately result in fibrosis and narrowing of the urethral lumen. Initial endoscopic management with dilation or internal urethrotomy is a guideline-recommended treatment strategy for urethral strictures.1 In the setting of stricture recurrence, urethroplasty has remained the gold standard of care.2 Recently, the advent and success of the paclitaxel drug-coated balloon (DCB) in treating recurrent anterior urethral stricture disease (aUSD) has made it a recommended option for patients with recurrent bulbar urethral strictures < 3 cm in length.1
The DCB expands and delivers this antimitotic agent into the wall of the urethra to prevent scar recurrence. The Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease (ROBUST) III randomized, controlled trial demonstrated a 2-year success, defined as freedom from repeat intervention, of 77.8% compared to the 23.6% for standard dilating balloon or internal urethrotomy.3 Based on the results of this trial, the DCB was approved for treatment of recurrent aUSD that are ≤3 cm in length and not associated with prior hypospadias repair, prior urethroplasty, or lichen sclerosus.4,5 Given the widely adopted endoscopic management strategies for urethral strictures, the DCB offers a familiar surgical technique with the benefit of reducing recurrence. As a result, the DCB is likely widely adopted for off-label use. However, real-world data on how DCB performs outside of its approved indication is lacking.
We sought to understand the real-world experience with the DCB for aUSD and posterior urethral stenoses (PUS) using multi-institutional data. We determined the factors that are associated with recurrence after DCB. The findings of this study will inform the efficacy of the DCB in treating various stages of aUSD and PUS, which is pertinent for patient counseling, ongoing surveillance, and potentially to help direct patients to urethral reconstruction.
MATERIALS AND METHODS
Data Source
The Trauma and Urologic Reconstruction Network of Surgeons (TURNS) is a multi-institutional (n = 11) surgical outcomes collaborative that prospectively enters data into a single database on surgical outcomes of reconstructive urological diseases. This study included all men that underwent a paclitaxel-coated balloon dilation (Optilume, Urotronic, Plymouth, MN) from July 2021 to December 2024 for strictures of all types and locations, including PUS. The prospective database was used to identify the cases, and a retrospective chart review was then performed to assess longitudinal outcomes. Institutional review board approval was previously obtained at all participating institutions.
Outcomes and Covariates
Our study had two primary outcomes: functional and anatomic recurrence. Functional recurrence was defined as redevelopment of urinary symptoms that required retreatment. Anatomic recurrence was defined as inability to pass a 15-17 Fr cystoscope through the treatment area on routine postoperative cystoscopy, which was generally performed 3-6 months after treatment, regardless of symptoms. Secondary outcomes were postoperative complications, including hematuria, pain, erectile dysfunction and urinary tract infection. Demographic data included patient age and body mass index. Stricture-specific data included length (L, cm), location (S) and etiology (E), as well as LSE stage.6,7 Stricture treatment data included the number of prior endoscopic procedures and history of prior urethroplasty. Treatment-specific data included the details of any dilation or urethrotomy performed immediately prior to the DCB procedure, as well as the length (3 cm, 5 cm) and circumference (18 F, 24 F, 30 Fr) of the DCB balloon.
Statistical Analysis
Survival time was calculated as the time from surgery to date of any recurrence. Freedom from retreatment (urethrotomy, dilation, DCB, urethroplasty) was calculated at 1 year. Patients without recurrence were censored at their most recent follow-up visit. Kaplan-Meier estimation and log-rank test were used to compare anatomical and functional recurrence-free survival. Kaplan-Meier estimation and log-rank test were performed to compare any recurrence-free survival for subgroups of clinical interest: FDA-indicated strictures to strictures after prior urethroplasty (E3b), radiation-induced strictures (E3c), treatment-naïve (no prior endoscopic treatments) strictures, bulbar strictures (S1), and stage IIC (bulbar strictures of any length due to recurrence after prior urethroplasty, lichen sclerosus, radiation injury, or hypospadias) strictures.
A time-to-event analysis was performed to determine risk factors for both any recurrences and anatomic recurrence for anterior urethral strictures. Using Cox proportional hazards regression, models were adjusted for age, body mass index, stricture location, stricture length, history of prior endoscopic procedures, history of urethral reconstruction or bladder neck repair, type of pretreatment, and DCB balloon characteristics. Missing covariate data was excluded from the analysis. Categorical data were compared using chi-square test. All statistical tests were performed using jamovi statistical software (version 2.6.19).
RESULTS
Demographic and Clinical Characteristics
Our initial cohort consisted of 397 patients, of which 33 patients without follow-up data and/or 43 patients managed with intermittent catheterization were excluded, leaving a final cohort of 319 patients. The median age of the final cohort was 64 (interquartile range [IQR] 48-73), with a median follow-up time of 5.7 months (IQR 3.1-12). The cohort included 260 with aUSD and 59 with PUS, which included 44 with bladder neck contracture or vesicourethral anastomotic stenosis (BNC/VUAS). The majority of strictures were ≤2 cm (66%) and bulbar (67%). Common etiologies included idiopathic (E2; 28%), posturethroplasty failure (E3b; 20%), and radiation (E3c; 17%). Only 61% of the cohort had a prior DVIU/dilation and approximately 27% had prior urethroplasty. Baseline clinical characteristics are presented in Table 1.
Table 1.
Patient characteristics.
| Characteristic | N = 319 |
|---|---|
| Median age (IQR) | 64 (48, 73) |
| Median BMI (IQR) | 29 (26, 33) |
| Median follow up in patients without recurrence (mo) (IQR) | 7.2 (3.4-12.8) |
| Primary stricture length (%) | |
| L1 - ≤2 cm | 170 (65.9) |
| L2 - > 2-≤7 cm | 84 (32.6) |
| L3 - > 7 cm | 4 (1.6) |
| Primary stricture location (%) | |
| S1 – Bulbar | 215 (67.4) |
| S2 – Penile | 43 (13.5) |
| S3 – Pan-urethral | 2 (0.6) |
| Membranous | 11 (3.4) |
| Prostatic | 5 (1.6) |
| Bladder neck | 43 (13.5) |
| Etiology (%) | |
| E1 – External trauma | 16 (5.0) |
| E2 – Idiopathic | 89 (28.1) |
| E3a – Internal trauma | 39 (12.3) |
| E3b – Recurrent stricture | 81 (25.6) |
| E3c – Radiation | 71 (22.4) |
| E4 – Infectious/Inflammatory | 3 (0.9) |
| E5 – Hypospadias repair | 8 (2.5) |
| E6 – Lichen sclerosus | 10 (3.2) |
| LSE stage | |
| 1 | 65 (21.1) |
| 2 | 152 (49.4) |
| 3 | 19 (6.2) |
| 4 | 23 (7.5) |
| 5 | 2 (0.6) |
| Prior urethroplasty (%)* | 87 (27.3) |
| Prior dilation/DVIU (%) | 195 (61.1) |
| Prior bladder neck repairs (%) | 4 (1.3) |
| Pre-Optilume treatment (%) | |
| Balloon dilation | 149 (50.3) |
| DVIU | 73 (24.7) |
| None | 74 (25.0) |
| DCB type (%) | |
| 18 Fr, 3 cm | 1 (0.3) |
| 24 Fr, 3 cm | 8 (2.8) |
| 24 Fr, 5 cm | 41 (14.1) |
| 30 Fr, 3 cm | 47 (16.2) |
| 30 Fr, 5 cm | 191 (65.9) |
| 36 Fr, 3 cm | 1 (0.3) |
BMI, body mass index; DVIU, direct visual internal urethrotomy; IQR, interquartile range.
Patients with the history of urethroplasty where involved segment is not associated with prior areas of reconstruction.
Anterior Urethral Stricture Recurrence
A total of 96 patients (37.2%) experienced any recurrence after DCB, of which 18 (19.1%) had a functional recurrence, 48 (51.1%) had an anatomical recurrence, and 28 (29.8%) had both. Median recurrence-free survival was 15.2 months (95% CI 12.7-18.6). Table 2 reports on the functional and anatomical recurrences based on LSE classification and staging. The probabilities of functional recurrence (Fig. 1) and anatomical recurrence (Fig. 2) were not significantly different based on LSE stage or etiology.
Table 2.
Functional and anatomical recurrence based on LSE classification and staging for anterior urethral strictures.
| Characteristic | Any Recurrence N (%) |
Functional N (%) |
Anatomical N (%) |
|---|---|---|---|
| LSE length | |||
| L1 - ≤2 cm | 58 (35.8) | 28 (17.3) | 44 (27.2) |
| L2 – > 2-≤7 cm | 29 (38.2) | 10 (13.2) | 27 (35.5) |
| L3 - > 7 cm | 2 (50) | 2 (50) | 1 (25) |
| LSE segment | |||
| S1 – Bulbar | 82 (38.5) | 42 (19.7) | 65 (30.5) |
| S2 – Penile | 14 (32.6) | 4 (9.3) | 11 (25.6) |
| S3 – Pan-urethral | 0 (0) | 0 (0) | 0 (0) |
| LSE etiology | |||
| E1 – External trauma | 5 (38.5) | 2 (15.4) | 5 (38.5) |
| E2 – Idiopathic | 26 (29.9) | 9 (10.3) | 25 (28.7) |
| E3a – Internal trauma | 13 (40.6) | 7 (21.9) | 9 (28.1) |
| E3b – Recurrent stricture | 29 (43.9) | 17 (25.8) | 20 (30.3) |
| E3c – Radiation | 14 (35.9) | 8 (20.5) | 10 (25.6) |
| E4 – Infectious/Inflammatory | 1 (33.3) | 0 (0) | 1 (33.3) |
| E5 – Hypospadias repair | 5 (62.5) | 2 (25) | 4 (50) |
| E6 – Lichen sclerosus | 2 (22.2) | 1 (11.1) | 1 (11.1) |
| LSE stage | |||
| 1 | 24 (36.9) | 10 (15.4) | 22 (33.8) |
| 2 | 56 (39.2) | 30 (21) | 42 (29.4) |
| 3 | 5 (26.3) | 1 (5.3) | 5 (26.3) |
| 4 | 8 (34.8) | 3 (13) | 5 (21.7) |
| 5 | 0 (0) | 0 (0) | 0 (0) |
Figure 1.
Functional recurrence-free survival for anterior urethral strictures based on (A) LSE staging and (B) stricture etiology. P-value based on log-rank test.
Figure 2.
Anatomical recurrence-free survival for anterior urethral strictures based on (A) LSE staging and (B) stricture etiology. P-value based on log-rank test.
We performed several subgroup analyses to determine if the DCB efficacy varied based on different treatment subgroups (Table 3). Among patients with FDA-indicated stricture disease (prior failed non-Optilume endoscopic management, < 3 cm in length), the 1-year recurrence-free survival was 65.6% (95% CI 54.1-79.6), whereas patients with all types of bulbar urethral strictures (S1) had a 1-year recurrence-free survival of 59.8% (95% CI 52.2-68.5). Patients with treatment-naïve strictures had a 59.9% 1-year recurrence-free survival rate (95% CI 46.8-76.5), which was statistically similar to those with prior endoscopic management.
Table 3.
Subgroup analysis of any recurrence-free survival.
| Characteristic | Recurrence-Free Survival | |||
|---|---|---|---|---|
| N | No. Events | Median Survival (95% CI) (Months) | 1-Year Survival (95% CI) (%) | |
| Entire cohort | 319 | 153 | 15.2 (12.7–18.6) | 58.6 (52.2–65.7) |
| FDA-Indication | 79 | 28 | 17.1 (13.0-NA) | 65.6 (54.1-79.6) |
| E3b (urethroplasty failure) | 68 | 31 | 14.6 (12.7-NA) | 64.4 (53.1-78.0) |
| E3c (radiation) | 71 | 27 | 16.7 (12.0-NA) | 61.7 (49.0-77.7) |
| Treatment-naive (no prior treatments) | 90 | 26 | 24.5 (12.0-NA) | 59.9 (46.8-76.5) |
| S1 (bulbar strictures) | 214 | 82 | 14.9 (12.6-18) | 59.8 (52.2-68.5) |
| Stage IIC | 120 | 47 | 15.2 (12.1-NA) | 59.8 (50.0-71.5) |
After adjusting for age, body mass index, urethral stricture staging, history of prior treatments, pre-DCB treatment type, length and circumference of DCB, the factors associated with any recurrence and anatomical recurrence after DCB use were identified (Table 4). Compared to patients with idiopathic strictures (E2), strictures after hypospadias repair (E5) were 5.21 (HR 5.21, 95% CI 1.06-25.6, P = .042) more likely to any recurrence after DCB and 7.92 (HR 7.92, 95% CI 1.81-34.74, P = .006) more likely to anatomical recurrence after DCB. Additionally, the use of the smaller 24 Fr, 3 cm DCB were significant predictors of any recurrences (HR 3.64, 95% 1.10-12.09, P = .035) and functional recurrences (HR 4.58, 95% 1.44-14.54, P = .010).
Table 4.
Adjusted hazard ratios for all recurrence and anatomical recurrence after Optilume drug-coated balloon use for anterior urethral strictures.
| All Recurrences | Anatomical Recurrences | |
|---|---|---|
| Characteristic | HR (95% CI, P-Value) | HR (95% CI, P-Value) |
| Age | 1.01 (0.99-1.02, P = .495) | 1.00 (0.99-1.02, P = .564) |
| BMI | 0.98 (0.94-1.02, P = .280) | 0.98 (0.94-1.02, P = .315) |
| Stricture length | ||
| L1 (< 2 cm) | - | - |
| L2 (2-7 cm) | 1.32 (0.57-3.08, P = .514) | 1.88 (0.86-4.12, P = .116) |
| L3 (> 7 cm) | 2.24 (0.29-17.09, P = .437) | 3.67 (0.36-37.30, P = .271) |
| Stricture location | ||
| S1 (Bulbar) | - | - |
| S2 (Penile) | 3.88 (0.32-47.27, P = .288) | 2.72 (0.25-28.93, P = .408) |
| S3 (Pan-urethral) | NA | NA |
| Etiology | ||
| E2 – Idiopathic | - | - |
| E1 – External trauma | 1.98 (0.68-5.82, P = .213) | 1.06 (0.38-2.98, P = .910) |
| E3a – Internal trauma | 1.34 (0.54-3.36, P = .529) | 0.67 (0.26-1.72, P = .400) |
| E3b – Recurrent stricture | 1.00 (0.40-2.49, P = .998) | 1.03 (0.45-2.35, P = .942) |
| E3c – Radiation | 0.68 (0.20-2.34, P = .537) | 0.90 (0.30-2.68, P = .852) |
| E4 - Infectious | 0.96 (0.11-8.74, P = .972) | 0.87 (0.09-8.39, P = .906) |
| E5 – Hypospadias repair | 5.21 (1.06-25.60, P = .042) | 7.92 (1.81-34.74, P = .006) |
| E6 – Lichen sclerosus | NA | NA |
| LSE stage | - | |
| 1 | - | - |
| 2 | 1.16 (0.42-3.15, P = .775) | 0.71 (0.29-1.77, P = .466) |
| 3 | 0.13 (0.01-2.07, P = .150) | 0.16 (0.01-2.24, P = .173) |
| 4 | 0.19 (0.01-2.98, P = .235) | 0.06 (0.00-1.04, P = .053) |
| 5 | NA | NA |
| Type of use | ||
| FDA-Indicated | - | - |
| Off-label | 0.90 (0.51-1.60, P = .731) | 1.08 (0.63-1.85, P = .787) |
| Pre-treatment type | ||
| None | - | - |
| Balloon dilation | 2.21 (0.55-8.83, P = .263) | 0.64 (0.18-2.31, P = .494) |
| DVIU | 1.61 (0.48-5.38, P = .439) | 1.72 (0.48-6.24, P = .407) |
| Balloon type | ||
| 30 Fr, 5 cm | - | - |
| 30 Fr, 3 cm | 1.50 (0.65-3.44, P = .339) | 0.98 (0.45-2.13, P = .969) |
| 24 Fr, 5 cm | 1.47 (0.55-3.93, P = .444) | 0.79 (0.37-1.67, P = .533) |
| 24 Fr, 3 cm | 3.64 (1.10-12.09, P = .035) | 4.58 (1.44-14.54, P = .010) |
| 18 Fr, 3 cm | NA | NA |
| Prior urethroplasty | 1.24 (0.64-2.41, P = .525) | 1.38 (0.71-2.69, P = .340) |
| Prior dilation/DVIU | 1.04 (0.58-1.86, P = .889) | 1.00 (0.57-1.78, P = .994) |
BMI, body mass index; SD, standard deviation.
Bold values highlight statistically significant findings.
Posterior Urethral Stenosis Recurrence
Among the patients with PUS, 42 had bladder neck contracture/vesicourethral anastomotic stenosis, 11 had membranous urethral stenosis, and 5 had prostatic urethral stenosis. A total of 22 patients (37.9%) experienced a recurrence, of which 4 (18.2%) had a functional recurrence, 13 (59.1%) had an anatomical recurrence, and 5 (22.7%) had both types of recurrence. The median recurrence-free survival was 12.9 months (95% CI 9.5-NA) and 1-year recurrence-free survival was 53.6% (95% CI 39.1-73.5%). Table 5 reports on the functional and anatomical recurrences for PUS. There was no significant difference in survival based on etiology, balloon type or urethral segment.
Table 5.
Functional and anatomical recurrence for posterior urethral stenoses.
| Characteristic | Any Recurrence N (%) |
Functional N (%) |
Anatomical N (%) |
|---|---|---|---|
| Urethral segment | |||
| Membranous | 5 (23) | 4 (44) | 5 (28) |
| Prostatic | 2 (9.1) | 2 (22) | 0 (0) |
| Bladder neck | 15 (68) | 3 (33) | 13 (72) |
| Etiology | |||
| Radiation | 10 (48) | 6 (67) | 7 (41) |
| Pelvic surgery | 3 (14) | 0 (0) | 3 (18) |
| Pelvic surgery + Radiation | 4 (19) | 1 (11) | 4 (24) |
| Transurethral surgery | 2 (9.5) | 1 (11) | 2 (12) |
| Other | 2 (9.5) | 1 (11) | 1 (5.9) |
Other: Transurethral surgery + Radiation (n = 1), Trauma (n = 2), Idiopathic (n = 2).
Complication With DCB and Retreatment of Urethral Stricture Recurrence After DCB
There were 20 complications that were reported in our cohort. There were 6 patients with urinary retention, 4 with intractable lower urinary tract symptoms, 3 with urinary incontinence, 3 with intractable hematuria, and 3 with UTI/sepsis.
Among patients that had a recurrence after DCB, 52 (42%) were observed and 72 (58%) received additional therapy for recurrence, which included catheterization (n = 5, 4%), DCB (n = 19, 15.3%), Dilation/DVIU/TUR (n = 19, 15.3%), urethroplasty (n = 28, 22.6%), and bladder neck reconstruction (n = 1, 0.01%). The freedom from repeat reintervention in 1 year was 72.6% (95% CI 65.8-78.7) for the entire cohort, 71.8% (95% CI 64.9-79.5) for aUSD, and 70.5% (95% CI 55.4-89.8) for PUS.
DISCUSSION
Our study provides real-world insights into the effectiveness of the DCB for USD management, expanding on the findings of the ROBUST III Trial.3,4 There is limited long-term effectiveness data on the DCB since it was approved in December 2021 and it is unclear how the DCB performs in off-label uses.8 The FDA-approved indication for the DCB focuses on recurrent aUSD that are ≤3 cm; indeed, these had the highest 1-year success rate in our cohort. Our data demonstrates low effectiveness in off-label use across a broad range of strictures, including posterior urethral stenosis and hypospadias-related strictures and even lower risk subgroups such as treatment-naïve strictures.
The ROBUST III Trial demonstrated 74.6% anatomical recurrence-free survival 6 months after DCB treatment and 83.2% freedom from retreatment at 1 year. In our cohort, the 1-year recurrence-free survival was 78.4% for functional recurrence and 66.4% for anatomical recurrence. Freedom from retreatment was 72.6% at 1-year in our study. While these results align with prior studies, lower success rates are likely indicative of our heterogeneous cohort that included some higher risk strictures. Furthermore, a substantial portion of patients not included in our study were maintained with intermittent catheterization after treatment, suggesting that success rates are likely lower among all-comers. Additionally, even with short and incomplete follow-up, the overall functional and anatomic success rates after DCB we report here are significantly lower than the historical 80%-95% long-term success rates reported after urethroplasty.7,9,10 Thus, while it appears that DCB offers a more effective minimally invasive approach for aUSD than traditional endoscopic techniques, it should still not be viewed as a replacement to urethroplasty, which remains the gold standard.
The ROBUST III trial demonstrated 83.2% and 71.9% freedom from repeat intervention at 1 and 3 years, respectively, confirming the durability of the DCB in short recurrent strictures.11,12 Our data suggest a similar freedom from repeat intervention; however, our findings suggest higher recurrence rates in off-label applications, particularly in posterior urethral stenosis, where fibrotic remodeling and radiation-induced damage may limit drug efficacy.13 Our data indicate lower success rates for posterior stenosis, with 1-year recurrence-free survival at 53.6%. Patients with prior hypospadias repair had significantly higher recurrence rates consistent with previous findings. Recent work by VanDyke et al has suggested 80% success rate of the DCB for strictures after urethroplasty, which is likely higher than our success rate due to shorter follow-up period in their study.14 Taken together, success rates and median survival time varied significantly based on the involved urethral segment. When considering which patients may be candidates, it is important to recognize that urethral dilation with nondrug coated balloon can have recurrence rates as high as 100%, regardless of stricture characteristics, prior treatment, or radiation history.15,16 Taken together, these findings suggest that off-label use of Optilume DCB does not have the same success rate as for recurrent bulbar urethral strictures and should be discussed with the patient prior to its use.
While Optilume demonstrated a favorable safety profile, complications such as urinary retention, hematuria, and UTI/sepsis were observed in 6.3% of patients, consistent with prior studies.17 Additionally, a significant proportion of patients were maintained on chronic intermittent catheterization (CIC) postprocedure, of which 5 had strictures after urethroplasty, 13 had radiation-induced strictures, and 5 had lichen sclerosus. Although CIC patients were excluded from analysis, future studies should assess whether Optilume facilitates easier catheterization compared to standard dilation. Additionally, long-term follow-up studies are needed to assess whether Optilume maintains efficacy beyond 3 years, particularly in high-risk populations such as radiation-induced strictures. Our data also highlights that despite 119 recurrences, only 67 patients had repeat intervention for their recurrence, which suggests that while the Optilume DCB may not achieve an anatomically normal urethra, the resulting lumen size may be sufficient for the patient to achieve urination with minimal symptoms. Additionally, patients with a high risk of recurrence may have opted for intermittent catheterization to avoid potential repeated interventions. The integration of patient-reported outcomes and qualitative assessments will further refine treatment selection criteria, ensuring optimal patient-centered care.18-20
There are several limitations with our study. First, patients were seen at high-volume reconstructive centers and are subject to treatment selection and counseling per individual surgeon. Furthermore, the care provided in this setting may not represent care provided in the general urologic community. Our study is observational and retrospective in nature and therefore subject to inherent selection and ascertainment bias. Accordingly, a placebo arm with standard dilation was not included to confirm Optilume efficacy. Second, patients may have variable follow up patterns based on each individual center’s post-treatment surveillance protocol. Despite these limitations, our study provides the real-world efficacy of Optilume DCB in a diverse population of urethral strictures and stenoses.
CONCLUSION
We provide early evidence that Optilume DCB real-world results are similar to those seen in the randomized trial (ROBUST III) when limited to men with stricture characteristic of those in that trial: < 3 cm bulbar strictures that have failed prior endoscopic management. Further, we demonstrate lower effectiveness in higher risk strictures that were excluded from the trial. Still, success in these high-risk strictures appears high enough and risks lower enough that DCB use in these men seems appropriate, pending the results of additional studies with longer follow-up. Taken together, real-world data on DCB usage provides information for clinicians when counseling patients prior to use and should guide post-DCB surveillance.
Disclosures
This study was supported by NIDDK/NIH grant 1R21DK115945-01.
Footnotes
Ethical Declaration
Institutional review board approval was obtained at each individual site participating in this study.
CRediT Authorship Contribution Statement
Hiren V. Patel: Writing – review & editing, Writing – original draft, Methodology, Formal analysis, Conceptualization. Bradley A. Erickson: Writing – review & editing, Writing – original draft, Supervision, Methodology. Behzad Abbasi: Methodology, Data curation. Nejd F. Alsikafi: Writing – review & editing, Methodology, Data curation. Joshua A. Broghammer: Methodology, Data curation. Kshitij Pandit: Methodology, Data curation. Jill C. Buckley: Writing – review & editing, Methodology, Data curation. Sean P. Elliott: Writing – review & editing, Methodology, Data curation. Seyedeh Sima Daryabari: Methodology, Data curation. Jeremy B. Myers: Writing – review & editing, Methodology, Data curation. Thomas G. Smith III: Methodology, Data curation. Grady Lindekugel: Methodology, Data curation. Bryan B. Voelzke: Methodology, Data curation. Alex J. Vanni: Methodology, Data curation. Lee C. Zhao: Methodology, Data curation. Benjamin N. Breyer: Writing – review & editing, Writing – original draft, Supervision, Methodology, Data curation.
Declaration of Competing Interest
Bradley Erickson receives financial support from Urotronic. Sean P. Elliott is a paid consultant for Laborie. He was the principal investigator for ROBUST I, II, III clinical trials. Jeremy B. Myers reports on a consulting or advisory relationship with University of Utah. He is a paid consultant for Laborie. The other authors have no conflict of interest to declare.
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