Urethral Stricture
Conditions
Keywords
drug-coated dilatation balloon
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.
Interventions
COMBINATION_PRODUCTOptilume
Dilatation with drug-coated balloon
DEVICEUroMax Ultra
Dilatation with non-coated balloon
Sponsors
Vastra Gotaland Region
Region Skåne
Region Stockholm
Region Örebro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional recurrent stricture | Within 18 months of treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anatomical recurrent stricture | Within 18 months of treatment | Anatomical recurrent stricture, defined as impassable with a 16 Fr flexible cystoscope |
| Qmax | At 6 and 18 months after treatment | Change in maximum urinary flow after treatment |
| Time micturition | At 6 and 18 months after treatment | Change in time micturition (seconds for first 1dL voided urine) |
| Urethral Stricture Score | At 6, 12 and 18 months after treatment | 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. |
Countries
Sweden
Contacts
CONTACTHenrik Kjölhede, MD, PhD
Outcome results
None listed