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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
| Region Örebro County | OTHER |
| Helsinki University Central Hospital | OTHER |
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A multicentre, prospective, randomized study comparing bulbar urethroplasty with excision and primary anastomosis or with an onlay grafting procedure using buccal mucosa.
The study is a prospective, randomized study to compare two common techniques of urethroplasty used to treat bulbar urethral strictures. One technique is excision of the stricture and end-to-end anastomosis of the urethra. The other technique is an onlay grafting procedure with buccal mucosa where the corpus spongiosum is not divided. The study is designed to compare complications of sexual and penile function, and is not powered to compare the success rates of the two techniques. The primary endpoint will be degree of erectile dysfunction and penile complications. The secondary endpoint will be restricturing leading to reoperation, and other complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| End-to-end | Active Comparator | Excision of the stricture and end-to-end anastomosis of the urethra. |
|
| Graft | Active Comparator | Incision of the stricture and grafting procedure with buccal mucosa where the corpus spongiosum is not divided. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| End-to-end | Procedure | Excision of the stricture and end-to-end anastomosis of the urethra. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of erectile dysfunction after surgery | Measured by changes in IIEF-5 | up to one year |
| Penile complications | Measured by questionnaire made for this study | up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of failure within the follow up period | One year | |
| Occurrence of complications | From operation to one year |
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Inclusion Criteria:
Patient with bulbar urethral stricture, length estimated by urethrography or endoscopy ≤ 2 cm
Patient is able and willing to sign informed consent
Patient is able and willing to complete all study requirements
Exclusion Criteria:
Previous open urethroplasty
Previous hypospadia surgery
Previous surgery for congenital curvature or Mb Peyronie
Previous pelvic irradiation therapy
Known grave psychiatric disorder
Haemophilia or other clotting disorders that cause bleeding diathesis
Use of medication to increase erectile function, such as PDE5-inhibitors and intracavernous injections, during the study
Any condition or situation, which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Schultz, MD | Consultant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | 00029 | Finland | |||
| Oslo University Hospital, Dept of Urology |
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| ID | Term |
|---|---|
| D014525 | Urethral Stricture |
| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D014180 | Transplantation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Graft |
| Procedure |
Incision of stricture and grafting procedure with buccal mucosa where the corpus spongiosum is not divided |
|
| Oslo |
| 0424 |
| Norway |
| Sahlgrenska University Hospital, Dept of Urology | Gothenburg | 41345 | Sweden |
| Örebro University Hospital, Dept of Urology | Örebro | 70185 | Sweden |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |