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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01196572
Recruitment Status : Unknown
Verified August 2011 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : September 8, 2010
Last Update Posted : August 9, 2011
Sponsor:
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Urethral Strictures Procedure: Internal Urethrotomy Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures
Study Start Date : September 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Holmium
U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: Holmium laser


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men over 18 years old with urethral stricture

Exclusion Criteria:

  • S/P urethral reconstruction
  • Posterior urethral strictures
  • Children
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196572


Locations
Israel
Sheba_Medical_Center Recruiting
Ramat-Gan, Israel
Contact: Barak Rosenzweig, Dr.    00-972-3-5302239    barak22@gmail.com   
Sponsors and Collaborators
Sheba Medical Center
More Information

Responsible Party: Dr. Barak Rosenzweig, Urology department, Sheba Hospital, Israel.
ClinicalTrials.gov Identifier: NCT01196572     History of Changes
Other Study ID Numbers: SHEBA-10-7897-ZD-CTIL
First Posted: September 8, 2010    Key Record Dates
Last Update Posted: August 9, 2011
Last Verified: August 2011

Keywords provided by Sheba Medical Center:
stricture
urethra
laser
urethrotomy
holmium
bladder outlet obstruction

Additional relevant MeSH terms:
Constriction, Pathologic
Urethral Stricture
Pathological Conditions, Anatomical
Urethral Obstruction
Urethral Diseases
Urologic Diseases