Efficiency of Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures

Conditions
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Urethral Strictures

Intervention / Treatment
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* Procedure: Internal Urethrotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men over 18 years old with urethral stricture Exclusion Criteria: S/P urethral reconstruction Posterior urethral strictures Children

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser IU<br>Urethral stricture incised by Holmium laser | Procedure: Internal Urethrotomy<br>* surgical incision of urethral stricture using endoscopic cold knife vs. endoscopic laser<br>* Other names: Holmium laser;|
| Active Comparator: Cold knife IU<br>Urethral stricture incised by knife | Procedure: Internal Urethrotomy<br>* surgical incision of urethral stricture using endoscopic cold knife vs. endoscopic laser<br>* Other names: Holmium laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stricture, urethra, laser, urethrotomy, holmium, bladder outlet obstruction