Dataset Information

Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial.

ABSTRACT:

Objective

The aim of this study is to report the updated 2-year results of the intervention arm of the ROBUST III randomized trial evaluating the safety and efficacy of the Optilume drug-coated balloon (DCB) versus standard endoscopic management of recurrent male anterior urethral stricture.

Materials and methods

Eligible patients included men with recurrent anterior urethral stricture ≤3 cm in length and ≤12Fr in diameter, International Prostate Symptom Score (IPSS) ≥11 and peak flow rate (Qmax) <15 mL/s. Patients were randomized to treatment with the Optilume DCB or standard-of-care endoscopic management. Primary efficacy endpoints measured at 2 years included freedom from re-intervention and changes in IPSS, Qmax and post-void residual (PVR). Secondary endpoint was impact on sexual function using the International Index of Erectile Function (IIEF). Primary safety endpoint was freedom from serious procedure- or device-related adverse events (AEs).

Results

A total of 127 patients enrolled at 22 sites in the United States and Canada (48 randomized to standard-of-care dilation and 79 to DCB dilation). Seventy-five patients in the DCB arm entered the open-label phase after 6 months. Participants averaged 3.2 prior endoscopic interventions (range 2-10); most (89.9%) had bulbar strictures with an average stricture length of 1.63 cm (SD 0.76). Significant improvements in IPSS, average Qmax and PVR were maintained at 2 years. Freedom from repeat intervention was significantly higher in the Optilume DCB arm at 2 years versus the Control arm at 1 year (77.8% vs. 23.6%, p < 0.001). During the follow-up period, there were 15 treatment failures and two non-study-related deaths. Treatment-related AEs were rare and generally self-limited (haematuria, dysuria and urinary tract infection).

Conclusion

The Optilume DCB shows sustained improvement in both objective and subjective voiding parameters at 2-year follow-up. Optilume appears to provide a safe and effective endoscopic treatment alternative for short recurrent anterior urethral strictures among men who wish to avoid or delay formal urethroplasty.

SUBMITTER: VanDyke ME

PROVIDER: S-EPMC10927926 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature

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Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial.

VanDyke Maia E ME Morey Allen F AF Coutinho Karl K Robertson Kaiser J KJ D'Anna Richard R Chevli Kent K Cantrill Christopher H CH Ehlert Michael J MJ Te Alexis E AE Dann Jeffrey J DeLong Jessica M JM Virasoro Ramón R Hagedorn Judith C JC Levin Richard R DeSouza Euclid E DiMarco David D Erickson Brad A BA Olsson Carl C Elliott Sean P SP

BJUI compass 20231218 3

<h4>Objective</h4>The aim of this study is to report the updated 2-year results of the intervention arm of the ROBUST III randomized trial evaluating the safety and efficacy of the Optilume drug-coated balloon (DCB) versus standard endoscopic management of recurrent male anterior urethral stricture.<h4>Materials and methods</h4>Eligible patients included men with recurrent anterior urethral stricture ≤3 cm in length and ≤12Fr in diameter, International Prostate Symptom Score (IPSS) ≥11 and peak ...[more]

PMID: 38481667

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Project description:BackgroundUrethral stricture disease is detrimental to quality of life. The Optilume Urethral Drug Coated Balloon (DCB) offers a solution utilizing a paclitaxel-coated balloon to expand strictures and prevent recurrence. Following the ROBUST trials, it has been proposed that DCB is more effective than conventional endoscopic management for recurrent, small anterior urethral strictures. Our study provides insights into practical applications and outcomes using DCB for urethral stricture disease.MethodsA retrospective review was performed of patients who underwent DCB for urethral strictures at our institution from November 2022 to August 2023 with follow-up evaluated through January 2024. Demographics, stricture characteristics, operative details, and postoperative outcomes were collected. Primary endpoint was need for repeat intervention as determined by symptomatic burden and subsequently postoperative post-void residual if obtained. Secondary endpoint was complication rate. Statistical analysis was conducted using STATA/BE17.0 software to create Kaplan-Meier curves for time to repeat intervention after treatment with DCB.ResultsOf 43 patients, 16 had no prior treatment. The other 27 had endoscopic treatment and of this group, 11 also had additional urethroplasty. Stricture etiologies included 20 iatrogenic, 14 idiopathic, 5 radiation-related, 2 inflammatory, and 2 traumatic. Stricture locations were 2 fossa navicularis, 7 pendulous, 17 bulbar, 7 membranous, 3 prostatic, and 7 bladder neck contractures. Mean balloon dilation lasted 8.4±2.7 minutes. All patients had a minimum follow-up of 150 days postoperatively and the mean duration of follow-up for the cohort was 290.3±87.0 days. The average postoperative post-void residual was 33.4±90.6 milliliters. Two patients had immediate complications: 1 with urinary retention after catheter removal requiring suprapubic tube placement and 1 with urinary tract infection requiring antibiotics. Four patients required repeat interventions: 1 endoscopic dilation, 1 graft urethroplasty, and 2 repeat DCB procedures. Mean time to repeat intervention was 203.5±82.6 days, and no patient required repeat intervention within 145 days of initial surgery.ConclusionsDCB offers a safe and less invasive treatment for both treatment-naïve and recurrent urethral strictures with paclitaxel coating to prevent recurrence. Repeat intervention was not required for 90.7% of our cohort within an average follow-up duration of 9 months postoperatively. As DCB grows in clinical use, investigation into its long-term efficacy is justified.

Project description:BackgroundThis study describes and compares three surgical procedures for the construction of urethral stricture (US) models in rabbits.MethodsForty adult male rabbits were allocated to four groups: 36 rabbits were randomly assigned to three experimental groups, while the remaining 4 were assigned to a sham group. The penis was separated from the rectum. Then along the ventral midline, a longitudinal penile skin incision was made while ensuring that the urethral mucosa was intact and the muscular layer was not completely incised. In group 1 (n=12), ventral semi-circumferential mucosa electrocoagulation of a 1-cm length of the anterior urethra was performed until ulceration occurred. In group 2 (n=12), the ventral urethral mucosa was incised, and electrocoagulation of the dorsal semi-circumferential mucosa was performed. In group 3 (n=12), whole-circumferential mucosa electrocoagulation was performed. In group 4 (n=4), no special treatment was performed. Four weeks later, urethrography, urethroscopy, and histological evaluation were carried out.ResultsThe weights of the rabbits in the four groups were comparable. There was no significant difference between groups 2 and 3 with regard to operative time, but the operative time in these groups was significantly longer than that in group 1 (group 2 vs. group 1: P<0.05, group 3 vs. group 1: P<0.001). After the surgery, urinary fistula with infection occurred in one rabbit in group 1, and one rabbit died due to urethral atresia in group 3. According to the urethrography and urethroscopy findings, 9 out of 12 rabbits in group 1, 5 out of 12 rabbits in group 2, and 11 out of 11 rabbits in group 3 developed US, while no rabbits in the sham group developed US. Histopathological examination revealed injury to the urothelium, inflammatory infiltration, a decrease in the amount of blood vessels and smooth muscle fibers, and a decrease in the amount of collagen fibers.ConclusionsCompared with the semi-circumferential procedures, the whole-circumferential procedure had a higher success rate. Therefore, this procedure seems to have potential for the construction of long-segment rabbit US models.

Project description:IntroductionScoring balloon angioplasty (SBA) for lumen gain prior to stent implantations or drug-coated balloon angioplasty (DCB) is considered an essential interventional tool for lesion preparation. Recent evidence indicates that SBA may play a pivotal role in enhancing the angiographic and clinical outcomes of DCB angioplasty.MethodsWe studied the systematic use of SBA with a low profile, non-slip element device prior to DCB angioplasty in an unselected, non-randomized patient population. This prospective, all-comers study enrolled patients with de novo lesions as well as in-stent restenotic lesions in bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR). The primary endpoint was the target lesion failure (TLF) rate at 9 months (ClinicalTrials.gov Identifier NCT02554292).ResultsA total of 481 patients (496 lesions) were recruited to treat de novo lesions (78.4%, 377), BMS-ISR (4.0%, 19), and DES-ISR (17.6%, 85). Overall risk factors were acute coronary syndrome (ACS, 20.6%, 99), diabetes mellitus (46.8%, 225), and atrial fibrillation (8.5%, 41). Average lesion lengths were 16.7 ± 10.4 mm in the de novo group, and 20.1 ± 8.9 mm (BMS-ISR) and 16.2 ± 9.8 mm (DES-ISR) in the ISR groups. Scoring balloon diameters were 2.43 ± 0.41 mm (de novo), 2.71 ± 0.31 mm (BMS-ISR), and 2.92 ± 0.42 mm (DES-ISR) whereas DCB diameters were 2.60 ± 0.39 mm (de novo), 3.00 ± 0.35 mm (BMS-ISR), and 3.10 ± 0.43 mm (DES-ISR), respectively. The overall accumulated TLF rate of 3.0% (14/463) was driven by significantly higher target lesion revascularization rates in the BMS-ISR (5.3%, 1/19) and the DES-ISR group (6.0%, 5/84). In de novo lesions, the TLF rate was 1.1% (4/360) without differences between calcified and non-calcified lesions (p = 0.158) and small vs. large reference vessel diameters with a cutoff value of 3.0 mm (p = 0.901).ConclusionsThe routine use of a non-slip element scoring balloon catheter to prepare lesions suitable for drug-coated balloon angioplasty is associated with high procedural success rates and low TLF rates in de novo lesions.

Dataset Information

Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial.

Objective

Materials and methods

Results

Conclusion

Publications

Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial.

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