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Clinical Trials/NCT01196572
NCT01196572
Unknown
Phase 4

Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures

Sheba Medical Center1 site in 1 country40 target enrollmentSeptember 2010

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Urethral Strictures
Sponsor
Sheba Medical Center
Enrollment
40
Locations
1
Primary Endpoint
post operative clinical & imaging signs of urinary outflow obstruction or partial obstruction
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
September 2013
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • Men over 18 years old with urethral stricture

Exclusion Criteria

  • S/P urethral reconstruction
  • Posterior urethral strictures

Outcomes

Primary Outcomes

post operative clinical & imaging signs of urinary outflow obstruction or partial obstruction

Time Frame: 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 Outcomes

  • post operative complications(up to 2 years)

Study Sites (1)

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