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

This study is currently recruiting participants.

Verified August 2011 by Sheba Medical Center

Sponsor:

Information provided by:

Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT01196572

First received: September 4, 2010

Last updated: August 7, 2011

Last verified: August 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 4, 2010
Last Updated Date	August 7, 2011
Start Date ^ICMJE	September 2010
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 4, 2010)	post operative clinical & imaging signs of urinary outflow obstruction or partial obstruction [ Time Frame: up to 2 years ] [ Designated as safety issue: No ] Urethral stricture & urinary flow will be assessed by physical examination, urethrography, cystoscopy, sonographic bladder scan for urine rest, urine flowmetry & clinical questionnaire (IPSS).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01196572 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 4, 2010)	post operative complications [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ] Complications such as urinary tract infection (UTI), bladder outlet obstruction (BOO), catheter re-insertion & re-operations will be assessed.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficiency of Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures
Official Title ^ICMJE	Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures
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 Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Urethral Strictures
Intervention ^ICMJE	Procedure: Internal Urethrotomy surgical incision of urethral stricture using endoscopic cold knife vs. endoscopic laser Other Name: Holmium laser
Study Arm (s)	Experimental: Laser IU Urethral stricture incised by Holmium laser Intervention: Procedure: Internal Urethrotomy Active Comparator: Cold knife IU Urethral stricture incised by knife Intervention: Procedure: Internal Urethrotomy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	40
Estimated Completion Date	September 2013
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Men over 18 years old with urethral stricture Exclusion Criteria: S/P urethral reconstruction Posterior urethral strictures Children
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT01196572
Other Study ID Numbers ^ICMJE	SHEBA-10-7897-ZD-CTIL
Has Data Monitoring Committee	No
Responsible Party	Dr. Barak Rosenzweig, Urology department, Sheba Hospital, Israel.
Study Sponsor ^ICMJE	Sheba Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Sheba Medical Center
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top