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

NCT06795074 | Recruiting Phase 4 FDA Drug FDA Device

• 2 other identifiers: RUSTICCIV-24-12-050340
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Urethral Stricture

Keywords

drug-coated dilatation balloon

Outcome Measures

Primary Outcomes (1)

• Functional recurrent stricture

  Recurrence within 18 months of a functional urethral stricture, defined as: 1. Use of clean intermittent dilatation or 2. Retreatment with dilatation balloon or internal urethrotomy or 3. Need for open urethroplasty or other open procedure

  Within 18 months of treatment

Secondary Outcomes (4)

• Anatomical recurrent stricture

  Within 18 months of treatment

• Qmax

  At 6 and 18 months after treatment

• Time micturition

  At 6 and 18 months after treatment

• Urethral Stricture Score

  At 6, 12 and 18 months after treatment

Study Arms (2)

Paclitaxel-coated dilatation ballon

EXPERIMENTAL

Dilatation of urethral stricture with paclitaxel-coated balloon

Combination Product: Optilume

Non-coated dilatation balloon

ACTIVE COMPARATOR

Dilatation of urethral stricture with non-coated balloon

Device: UroMax Ultra

Interventions

Optilume COMBINATION_PRODUCT

Dilatation with drug-coated balloon

Paclitaxel-coated dilatation ballon

UroMax Ultra DEVICE

Dilatation with non-coated balloon

Non-coated dilatation balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skåne: collaborator
• Region Stockholm: collaborator
• Region Örebro: collaborator
• Vastra Gotaland Region: lead

Study Sites (4)

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Skåne University Hospital

Malmo, Sweden

NOT YET RECRUITING

Örebro University Hospital

Örebro, Sweden

NOT YET RECRUITING

Karolinska University Hospital

Stockholm, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Henrik Kjölhede, MD, PhD

CONTACT

+46-31-3421000; henrik.kjolhede@vgregion.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 27, 2025
• Study Start: January 16, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2031
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)