scholarly journals A drug-coated balloon treatment for urethral stricture disease: Interim results from the ROBUST I study

2020 ◽  
Vol 14 (6) ◽  
Author(s):  
Ramon Virasoro ◽  
Jessica DeLong ◽  
Rachel Mann ◽  
Rafael Estrella ◽  
Merycarla Pichardo ◽  
...  
Keyword(s):  
Urethral Stricture ◽  
Balloon Dilation ◽  
Serious Adverse Events ◽  
Urethral Strictures ◽  
Safety Endpoint ◽  
Study Population ◽  
Study Sites ◽  
One Year ◽  
Drug Coated Balloon ◽  
Anatomic Success

Introduction: We aimed to investigate the safety and preliminary efficacy of the OptilumeTM paclitaxel-coated balloon for the treatment of recurrent urethral stricture. Methods: Men with bulbar urethral strictures ≤2 cm with 1–4 prior endoscopic treatments were enrolled at four study sites after Ethics Committee approvals. All subjects were treated with mechanical balloon dilation or direct visualization internal urethrotomy prior to drug-coated balloon treatment. Patients were evaluated at 2–5 days, 14 days, three, six, and 12-months post-treatment. The primary safety endpoint was serious complications through 90 days post-procedure. The preliminary efficacy endpoint was anatomic success, defined as urethral lumen ≥14 Fr at 12 months. Results: A total of 53 subjects were enrolled and treated; 46 completed the 12-month followup. Forty-three percent of men had undergone >1 previous dilation; the mean for the overall study population was 1.7 prior dilations. There were no serious adverse events related to the treatment within 90 days. Anatomic success was achieved in 32/46 (70%; 95% confidence interval [CI] 54–82%) at 12 months. The 14 failures included seven cystoscopic recurrences, five retreatments, and two patients who exited the study early due to symptom recurrence. Conclusions: One-year data indicates the OptilumeTM paclitaxel-coated balloon is safe for the treatment of recurrent bulbar urethral strictures. Early efficacy results are encouraging and support further followup of these men through five years, as well as further investigation with a randomized trial.

One-Year Outcomes of the ROBUST II Study Evaluating the Use of a Drug-Coated Balloon for Treatment of Urethral Stricture

2022 ◽  
Vol 3 (1) ◽  
Author(s):  
Jessica DeLong ◽  
Michael J. Ehlert ◽  
Bradley A. Erickson ◽  
Kaiser J. Robertson ◽  
Ramón Virasoro ◽  
...  
Keyword(s):  
Urethral Stricture ◽  
Erectile Function ◽  
Symptomatic Improvement ◽  
Additional Treatment ◽  
Adult Men ◽  
Urethral Strictures ◽  
Safety Endpoint ◽  
One Year ◽  
Drug Coated Balloon ◽  
Anatomic Success

Objective To report 1-year results of the ROBUST II study investigating the safety and efficacy of a paclitaxel-coated balloon for the treatment of recurrent urethral strictures. Methods Subjects were adult men with a single anterior urethral stricture ≤ 3 cm in length and at least 2 prior stricture treatments. After treatment with the Optilume urethral drug-coated balloon (DCB), subjects were followed through 1 year. The primary safety endpoint was the rate of treatment-related serious complications at 90 days post-procedure. Efficacy outcomes included symptomatic assessments, erectile function measured using the International Index of Erectile Function (IIEF), Qmax, and anatomic success. Results Sixteen men with an average of 4.1 prior dilations were treated with the DCB. Anatomic success was achieved at 6 months in 73%. Average IPSS improved from 18.4 to 6.0 at 1 year (P < 0.001). Qmax improved from 6.9 mL/sec to 20.8 mL/sec (P < 0.001). There was no change in IIEF. Four subjects received additional treatment within 1 year. There were no treatment-related serious complications. Conclusions Short-term follow-up of men with urethral stricture treated with the Optilume DCB showed durable anatomic results at 6 months and sustained symptomatic improvement through 1 year. Treatment with the device was safe.

scholarly journals Optilume® drug-coated balloon dilation in complex female urethral stricture

2021 ◽  
pp. 101987
Author(s):  
Jannik Stuehmeier ◽  
Lukas Andrius Jelisejevas ◽  
Patricia Kink ◽  
Alexandra Gulacsi ◽  
Wolfgang Horninger ◽  
...  
Keyword(s):  
Urethral Stricture ◽  
Balloon Dilation ◽  
Drug Coated Balloon ◽  
Female Urethral Stricture

Balloon dilation of a urethral stricture caused by a congenital obstructive proximal urethral membrane (COPUM) in a dog

2020 ◽  
Vol 8 (2) ◽  
pp. e001084
Author(s):  
Darren Kelly ◽  
Ingrid Isaac ◽  
Judith Cruzado-Perez ◽  
Florence Juvet
Keyword(s):  
Urethral Stricture ◽  
Balloon Dilation ◽  
Clinical Signs ◽  
Human Beings ◽  
Membranous Structure ◽  
First Report ◽  
Urethral Strictures ◽  
The Future ◽  
History Of ◽  
Proximal Urethra

Congenital urethral strictures are well recognised in human beings and have recently been described in two cats but have not been previously reported in dogs. A 10-month-old female English Bull Terrier presented with a life-long history of being unable to pass a normal stream of urine. Urethrocystoscopy confirmed the presence of a stricture lesion in the proximal urethra. This thin, membranous structure was effaced under endoscopic visualisation using a 10 mm diameter balloon-dilation catheter. Complete and sustained resolution of clinical signs occurred after a single dilation procedure. To the best of our knowledge, this is the first report of a congenital urethral stricture in a dog and the term congenital obstructive proximal urethral membrane may be useful for describing these lesions in the future.

scholarly journals The one-stage balloon dilatation with stone extraction for a combination of short urethral stricture and urethral stone in men

2021 ◽  
Vol 9 (2) ◽  
pp. 16-24
Author(s):  
M. M. Alibekov ◽  
M. I. Katibov ◽  
A. S. Skorovarov ◽  
G. A. Gazimagomedov ◽  
K. M. Arbuliev ◽  
...  
Keyword(s):  
Urethral Stricture ◽  
Intraoperative Complications ◽  
Treatment Success ◽  
Balloon Dilation ◽  
Operation Time ◽  
Early Postoperative Period ◽  
Stone Extraction ◽  
Urethral Strictures ◽  
Urethral Stone ◽  
The One

Introduction. The literature highlights isolated studies examining approaches to the treatment of patients with a combination of stones and urethral stricture. In this regard, the problem of creating optimal tactics for managing such patients remains relevant.Purpose of the study. To analyze of own experience in treating patients with a combination of stricture and urethral stone using balloon dilation with urethral stone extraction.Materials and methods. The study included 7 men with short urethral stricture and stone, who underwent balloon dilation with urethral stone extraction. The age of patients ranged from 47 to 65 years (median - 52 years). The length of the urethral stricture ranged from 3 to 10 mm (median - 7 mm). The stricture in 2 (28.6%) cases was localized in the penile part of the urethra and 5 (71.4%) in the bulbous part. An etiology of urethral strictures: traumatic - in 2 (42.9%) patients, inflammatory - in 1 (14.3%) of cases, idiopathic - in 4 (57.1%) of cases. All patients had 1 urethral stone. The sizes of the stone ranged from 4 to 9 mm (median - 6 mm).Results. The operation time ranged from 11 to 19 min (median - 13 min). No patient had any intraoperative complications. UTIs was observed in the early postoperative period in 1 patient. The duration of postoperative hospital stay ranged from 1 to 5 days (median - 3 days). Postoperative follow-up ranged from 3 to 24 months (median - 14 months). Only 1 (14.3%) patient had a recurrence of urethral stricture 18 months after treatment. Thus, the overall treatment success in this group of patients was 85.7% (6/7).Conclusion. We used this conjunction approach when combined stricture and urethral stone in men for the first time in the world. It seems quite promising given the results.

scholarly journals PD22-06 ONE-YEAR SAFETY AND EFFICACY OUTCOMES ON A NOVEL DRUG COATED BALLOON (DCB) FOR URETHRAL STRICTURE DISEASE - THE ROBUST I STUDY

2019 ◽  
Vol 201 (Supplement 4) ◽  
Author(s):  
Sean Elliott* ◽  
Ramon Virasoro ◽  
Jessica DeLong ◽  
Rafael Estrella ◽  
Merycarla Pichardo ◽  
...  
Keyword(s):  
Urethral Stricture ◽  
Safety And Efficacy ◽  
Urethral Stricture Disease ◽  
One Year ◽  
Novel Drug ◽  
Drug Coated Balloon

Outcome of Patch Test on Crack Sole among Bangladeshi Population

2020 ◽  
Vol 7 (2) ◽  
pp. 64-67
Author(s):  
Abu Sayeed Mohammad ◽  
Shahadat Hossain ◽  
Zulfiqur Hossain Khan
Keyword(s):  
Patch Test ◽  
Clinical History ◽  
Significant Morbidity ◽  
Exclusion Criteria ◽  
Study Population ◽  
Bangladeshi Population ◽  
One Year ◽  
Medical University ◽  
Age Range ◽  
Test Result

Background: Crack sole may produce significant morbidity among the physical labourer. Objective: The purpose of this study was to find out the patch test result in crack sole which was due to allergic contactants. Methodology: This test was conducted in the Department at Dermatology and Venereology of Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh from July 2001 to June 2002 for a period of one year. Patients with crack sole were selected as study population. All patients were asked about the details clinical history. Patch test was done by individually prepared alminium Finn Chamber mounted on scanpore tape. Result: A total number of 15 patients were recruited for this study after fulfilling the inclusion and exclusion criteria. The age range was 8 years to 70 years. Among 15 patients 3 patients were patch test positive remaining 12 patients were patch test negative. Two patient were female and one was male. Conclusion: In conclusion patch test is positive among the crack sole patients. Journal of Current and Advance Medical Research 2020;7(2): 64-67

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