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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urethral Stricture
• Intervention / Treatment: Combination product: Optilume; Device: UroMax Ultra

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Henrik Kjölhede, MD, PhD; Phone Number: +46-31-3421000; Email: henrik.kjolhede@vgregion.se

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Henrik Kjölhede, MD PhD; Phone Number: +46-31-3421000; Email: henrik.kjolhede@vgregion.se
  • Malmo, Sweden
    • Not yet recruiting
    • Skåne University Hospital
    • Contact: Wolfgang Soller, MD, PhD; Phone Number: +46-40-33 10 00; Email: wolfgang.soller@skane.se
  • Stockholm, Sweden
    • Not yet recruiting
    • Karolinska University Hospital
    • Contact: Christine Reus, MD, PhD; Phone Number: +46-8-123 70 000; Email: christine.reus@ki.se
  • Örebro, Sweden
    • Not yet recruiting
    • Orebro University Hospital
    • Contact: Beata Persson, MD; Phone Number: +46-19-602 10 00; Email: beata.persson@regionorebrolan.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paclitaxel-coated dilatation ballon; Dilatation of urethral stricture with paclitaxel-coated balloon	Combination product: Optilume; Dilatation with drug-coated balloon
Active Comparator: Non-coated dilatation balloon; Dilatation of urethral stricture with non-coated balloon	Device: UroMax Ultra; Dilatation with non-coated balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional recurrent stricture	Recurrence within 18 months of a functional urethral stricture, defined as: Use of clean intermittent dilatation or; Retreatment with dilatation balloon or internal urethrotomy or; Need for open urethroplasty or other open procedure	Within 18 months of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomical recurrent stricture	Anatomical recurrent stricture, defined as impassable with a 16 Fr flexible cystoscope	Within 18 months of treatment
Qmax	Change in maximum urinary flow after treatment	At 6 and 18 months after treatment
Time micturition	Change in time micturition (seconds for first 1dL voided urine)	At 6 and 18 months after treatment
Urethral Stricture Score	Patient reported outcome measure (Urethral Stricture Surgery (USS)-PROM). Score from 0-24, higher indicates worse symptoms. Also includes a quality-of-life question and Peeling's voiding picture.	At 6, 12 and 18 months after treatment

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Collaborators: Region Skane; Region Stockholm; Region Örebro

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2031

Study Registration Dates

• First Submitted: January 24, 2025
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: drug-coated dilatation balloon
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urethral Diseases; Urethral Obstruction; Urethral Stricture
• Other Study ID Numbers: RUSTIC; CIV-24-12-050340 (Other Identifier: Swedish Medical Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not allowed by ethical review authority

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes