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

NCT ID: NCT01196572

Last Updated: 2011-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-09-30

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.

Conditions

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Urethral Strictures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laser IU

Urethral stricture incised by Holmium laser

Group Type EXPERIMENTAL

Internal Urethrotomy

Intervention Type PROCEDURE

surgical incision of urethral stricture using endoscopic cold knife vs. endoscopic laser

Cold knife IU

Urethral stricture incised by knife

Group Type ACTIVE_COMPARATOR

Internal Urethrotomy

Intervention Type PROCEDURE

surgical incision of urethral stricture using endoscopic cold knife vs. endoscopic laser

Interventions

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Internal Urethrotomy

surgical incision of urethral stricture using endoscopic cold knife vs. endoscopic laser

Intervention Type PROCEDURE

Other Intervention Names

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Holmium laser

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Urology department, Sheba Hospital, Israel.

Locations

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Sheba_Medical_Center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Barak Rosenzweig, Dr.

Role: primary

00-972-3-5302239

Other Identifiers

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SHEBA-10-7897-ZD-CTIL

Identifier Type: -

Identifier Source: org_study_id

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