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

Phase 4

• Conditions: Urethral Strictures
• Interventions: Procedure: Internal Urethrotomy

• Registration Number: NCT01196572
• Lead Sponsor: Sheba Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-04
• Study First Submitted QC: 2010-09-04
• Study First Posted: 2010-09-08
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-07
• Last Update Posted: 2011-08-09
• Primary Completion: 2012-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Men over 18 years old with urethral stricture

Exclusion Criteria

• S/P urethral reconstruction
• Posterior urethral strictures
• Children

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser IU	Internal Urethrotomy	Urethral stricture incised by Holmium laser
Cold knife IU	Internal Urethrotomy	Urethral stricture incised by knife

Primary Outcome Measures

Name	Time	Method
post operative clinical & imaging signs of urinary outflow obstruction or partial obstruction	up to 2 years	Urethral stricture \& urinary flow will be assessed by physical examination, urethrography, cystoscopy, sonographic bladder scan for urine rest, urine flowmetry \& clinical questionnaire (IPSS).

Secondary Outcome Measures

Name	Time	Method
post operative complications	up to 2 years	Complications such as urinary tract infection (UTI), bladder outlet obstruction (BOO), catheter re-insertion \& re-operations will be assessed.

Trial Locations

Locations (1)

Sheba_Medical_Center; 🇮🇱 Ramat-Gan, Israel