Efficiency of Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures (IU)

August 7, 2011 updated by: Sheba Medical Center

Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat-Gan, Israel
        • Recruiting
        • Sheba_Medical_Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men over 18 years old with urethral stricture

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser IU
Urethral stricture incised by Holmium laser
Procedure: Internal Urethrotomy
surgical incision of urethral stricture using endoscopic cold knife vs. endoscopic laser
Other Names:
  • Holmium laser
Active Comparator: Cold knife IU
Urethral stricture incised by knife
Procedure: Internal Urethrotomy
surgical incision of urethral stricture using endoscopic cold knife vs. endoscopic laser
Other Names:
  • Holmium laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
up to 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

September 4, 2010

First Submitted That Met QC Criteria

September 4, 2010

First Posted (Estimate)

September 8, 2010

Study Record Updates

Last Update Posted (Estimate)

August 9, 2011

Last Update Submitted That Met QC Criteria

August 7, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-10-7897-ZD-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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