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

Vastra Gotaland Region

Status and phase: Not yet enrolling; Phase 4

Conditions: Urethral Stricture

Treatments: Device: UroMax Ultra; Combination Product: Optilume

Study type: Interventional

Funder types: Other

Identifiers

NCT06795074

RUSTIC

CIV-24-12-050340 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 230 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Paclitaxel-coated dilatation ballon

Experimental group

Description:

Dilatation of urethral stricture with paclitaxel-coated balloon

Treatment:

Combination Product: Optilume

Non-coated dilatation balloon

Active Comparator group

Description:

Dilatation of urethral stricture with non-coated balloon

Treatment:

Device: UroMax Ultra