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The purpose of this study is to determine whether laser internal urethrotomy (IU) is as efficient as cold knife internal urethrotomy for treatment of anterior urethral strictures regarding post operative urination outflow, stricture recurrence rate and possible post- operative complications
The current surgical treatment for anterior urethral stricture includes internal urethrotomy (IU) by cold knife. Recurrence rate after such procedure is quoted as 35-70% in 2 to 5 years follow-up. Possible surgical alternative procedures include: open surgical urethral re-construction, urethral stents usage & laser IU. According to existing data (Nd-YAG laser- retrospective) the recurrence rate after laser IU is far better comparing to cold knife urethrotomy. The current research intends to address this question using prospective randomized methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser IU | Experimental | Urethral stricture incised by Holmium laser |
|
| Cold knife IU | Active Comparator | Urethral stricture incised by knife |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internal Urethrotomy | Procedure | surgical incision of urethral stricture using endoscopic cold knife vs. endoscopic laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| post operative clinical & imaging signs of urinary outflow obstruction or partial obstruction | Urethral stricture & urinary flow will be assessed by physical examination, urethrography, cystoscopy, sonographic bladder scan for urine rest, urine flowmetry & clinical questionnaire (IPSS). | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| post operative complications | Complications such as urinary tract infection (UTI), bladder outlet obstruction (BOO), catheter re-insertion & re-operations will be assessed. | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba_Medical_Center | Recruiting | Ramat Gan | Israel |
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| ID | Term |
|---|---|
| D014525 | Urethral Stricture |
| D003251 | Constriction, Pathologic |
| D001748 | Urinary Bladder Neck Obstruction |
| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |