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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Sheba Medical Center.
Recruitment status was  Recruiting
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

September 4, 2010
August 7, 2011
September 2010
September 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01196572 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Efficiency of Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures
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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Urethral Strictures
Procedure: Internal Urethrotomy
surgical incision of urethral stricture using endoscopic cold knife vs. endoscopic laser
Other Name: Holmium laser
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
September 2013
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men over 18 years old with urethral stricture

Exclusion Criteria:

  • S/P urethral reconstruction
  • Posterior urethral strictures
  • Children
Male
18 Years and older
No
Israel
 
NCT01196572
SHEBA-10-7897-ZD-CTIL
No
Dr. Barak Rosenzweig, Urology department, Sheba Hospital, Israel.
Sheba Medical Center
Not Provided
Not Provided
Sheba Medical Center
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP