Clinical trial NCT06795074: Risk of Recurrent Urethral Stricture After Treatment With Paclitaxel-Coated Dilatation Balloon (Optilume) Compared With Non-coated Dilatation Balloon
Official title: Risk of Recurrent Urethral Stricture After Treatment With Paclitaxel-Coated Dilatation Balloon (Optilume) Compared With Non-coated Dilatation Balloon - a Prospective Randomised Multicentre Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Urethral Stricture
Keywords: drug-coated dilatation balloon
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Region Skåne
name: Region Stockholm
name: Region Örebro
First posted: 2025-01-27
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Functional recurrent stricture
timeFrame: Within 18 months of treatment
Secondary outcomes:
measure: Anatomical recurrent stricture
timeFrame: Within 18 months of treatment
measure: Qmax
timeFrame: At 6 and 18 months after treatment
measure: Time micturition
timeFrame: At 6 and 18 months after treatment
measure: Urethral Stricture Score
timeFrame: At 6, 12 and 18 months after treatment
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Malmö
country: Sweden
facility: Skåne University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
References: