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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-24-12-050340 | Other Identifier | Swedish Medical Agency |
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| Name | Class |
|---|---|
| Region Skane | OTHER |
| Region Stockholm | OTHER_GOV |
| Region Örebro | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel-coated dilatation ballon | Experimental | Dilatation of urethral stricture with paclitaxel-coated balloon |
|
| Non-coated dilatation balloon | Active Comparator | Dilatation of urethral stricture with non-coated balloon |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optilume | Combination Product | Dilatation with drug-coated balloon |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Functional recurrent stricture | Recurrence within 18 months of a functional urethral stricture, defined as:
| Within 18 months of treatment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henrik Kjölhede, MD, PhD | Contact | +46-31-3421000 | henrik.kjolhede@vgregion.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Recruiting | Gothenburg | Sweden |
Not allowed by ethical review authority
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| UroMax Ultra |
| Device |
Dilatation with non-coated balloon |
|
| 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 |
| Skåne University Hospital | Not yet recruiting | Malmö | Sweden |
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| Örebro University Hospital | Not yet recruiting | Örebro | Sweden |
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| Karolinska University Hospital | Not yet recruiting | Stockholm | Sweden |
|
| ID | Term |
|---|---|
| D014525 | Urethral Stricture |
| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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