Risk of Recurrent Urethral Stricture After Treatment With Paclitaxel-Coated Dilatation Balloon (Optilume) Compared With Non-coated Dilatation Balloon

Официальное название

Risk of Recurrent Urethral Stricture After Treatment With Paclitaxel-Coated Dilatation Balloon (Optilume) Compared With Non-coated Dilatation Balloon - a Prospective Randomised Multicentre Study

Обзор

Urethral strictures are often initially treated endoscopically with dilatation or direct visual internal urethrotomy (DVIU), a procedure where the stricture is incised through the vision of a cystoscope. These methods are easy to perform, they are often well tolerated under local anesthesia and they have a low risk of complications. One disadvantage is the relatively low success rate which is 20-60% when used as a first intervention and considerably lower after several interventions. Instead of repeated endoscopic procedures, it is advisable to perform open urethroplasty. Urethroplasty has a success rate of 65-91% but a higher risk of complications and requires general anesthesia. Therefore, there is a need for a treatment option for recurrent urethral strictures after DVIU or dilatation, before the urethroplasty is performed. Optilume is a CE-marked paclitaxel-coated dilatation balloon used for treatment of urethral strictures. The industry-sponsored randomised ROBUST III trial from 2022 showed a 75% success rate with Optilume but it is not sure if the results can be generalised to patients who would otherwise be candidates for open urethroplasty and whether the drug coating per se increases the efficacy of balloon dilatation. The aim of this study is to investigate whether the addition of paclitaxel-coating can increase the success rate and decrease the need for additional interventions and open urethroplasty for individuals who has a recurrent urethral stricture following at least one previous endoscopic intervention.

Вмешательства

• Комбинированный продукт Optilume
  Dilatation with drug-coated balloon
• Устройство UroMax Ultra
  Dilatation with non-coated balloon

Первичные конечные точки

• Functional recurrent stricture [Срок оценки: Within 18 months of treatment]

Вторичные конечные точки (4)

• Anatomical recurrent stricture [Срок оценки: Within 18 months of treatment]
• Qmax [Срок оценки: At 6 and 18 months after treatment]
• Time micturition [Срок оценки: At 6 and 18 months after treatment]
• Urethral Stricture Score [Срок оценки: At 6, 12 and 18 months after treatment]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Urethral stricture recurrence after at least one internal urethrotomy or dilatation
• Penile or bulbar stricture
• Length of stricture ≤ 2 cm
• Eligible for open urethroplasty
• Able to give informed consent

Критерии исключения

• Stricture of the meatus
• Sclerosis of the bladder neck
• Multiple strictures < 16 Ch
• Complete stricture without any lumen
• Previous dilatation with paclitaxel-coated balloon
• Previous radiation therapy of the pelvis (e.g. for prostate cancer)
• Previous pelvic fracture
• Urethral malignancy
• Presence of urethral fistula
• Presence of urethral condyloma
• Previous open urethroplasty
• Chronic urinary retention secondary to detrusor inactivity

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 4 центра

• Sahlgrenska University Hospital — Gothenburg
• Skåne University Hospital — Malmö
• Örebro University Hospital — Örebro
• Karolinska University Hospital — Stockholm

Идентификаторы

NCT: NCT06795074 · RUSTIC · CIV-24-12-050340

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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