Two-year outcomes of a paclitaxel-coated balloon for treatment of male bulbar urethral stricture
BAUS ePoster online library. Kayes O. 11/10/20; 304126; P6-10 Disclosure(s): Urotronic Inc - consultant
Mr. Olly Kayes
Mr. Olly Kayes
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Two-year outcomes of a paclitaxel-coated balloon for treatment of male bulbar urethral stricture

Kayes O1, Jordan G2
1St James Hospital, Leeds, United Kingdom, 2Devine-Jordan Center, Virginia Beach, USA

Introduction:
Urethral stricture disease is a common problem for all urologists. This multicentre, single-arm, open-label study assesses the safety and efficacy of urethral dilatation using an innovative paclitaxel drug-coated balloon (DCB) at 2-year follow up.
Patients (or Materials) and Methods: Men with bulbar urethral strictures <= 2cm with 1-3 prior endoscopic treatments were enrolled at 4 study sites following Ethics Committee approvals. The DCB was inflated under cystoscopy/fluoroscopy guidance. International Prostate Symptom Score (IPSS) was documented at 3, 6, 12 and 24 months. Cystoscopy was documented at 6 and 12 months. Primary efficacy endpoint was improvement in IPSS and primary safety endpoint was serious complications through 3 months. We also report updated results of our composite definition of success: (1) no retreatment; (2) no recurrence on cystoscopy; and (3) IPSS<=11 at last follow-up.

Results:
Fifty-three subjects were enrolled, and all successfully treated. Average subject age was 51 years (range 22-81). Average number of prior treatments was 1.8 per subject (range 1-4). There were no serious or unexpected device related adverse events. Mean IPSS decreased from 25.2 ±4.5 (baseline) to 7.3 ± 8.10 (p < 0.001) in 41 men with 24-month data. Two-year success based on the composite definition was 30/45 (67%), compared to 32/46 (70%) at 1 year. No man was retreated in year 2.

Conclusions:
Two-year data indicate that men with short bulbar urethral stricture refractory to standard endoscopic management, the paclitaxel DCB is safe and produces a durable improvement in IPSS.
Two-year outcomes of a paclitaxel-coated balloon for treatment of male bulbar urethral stricture

Kayes O1, Jordan G2
1St James Hospital, Leeds, United Kingdom, 2Devine-Jordan Center, Virginia Beach, USA

Introduction:
Urethral stricture disease is a common problem for all urologists. This multicentre, single-arm, open-label study assesses the safety and efficacy of urethral dilatation using an innovative paclitaxel drug-coated balloon (DCB) at 2-year follow up.
Patients (or Materials) and Methods: Men with bulbar urethral strictures <= 2cm with 1-3 prior endoscopic treatments were enrolled at 4 study sites following Ethics Committee approvals. The DCB was inflated under cystoscopy/fluoroscopy guidance. International Prostate Symptom Score (IPSS) was documented at 3, 6, 12 and 24 months. Cystoscopy was documented at 6 and 12 months. Primary efficacy endpoint was improvement in IPSS and primary safety endpoint was serious complications through 3 months. We also report updated results of our composite definition of success: (1) no retreatment; (2) no recurrence on cystoscopy; and (3) IPSS<=11 at last follow-up.

Results:
Fifty-three subjects were enrolled, and all successfully treated. Average subject age was 51 years (range 22-81). Average number of prior treatments was 1.8 per subject (range 1-4). There were no serious or unexpected device related adverse events. Mean IPSS decreased from 25.2 ±4.5 (baseline) to 7.3 ± 8.10 (p < 0.001) in 41 men with 24-month data. Two-year success based on the composite definition was 30/45 (67%), compared to 32/46 (70%) at 1 year. No man was retreated in year 2.

Conclusions:
Two-year data indicate that men with short bulbar urethral stricture refractory to standard endoscopic management, the paclitaxel DCB is safe and produces a durable improvement in IPSS.
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