Efficiency of Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures (IU)
Primary Purpose
Urethral Strictures
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Internal Urethrotomy
Sponsored by
About this trial
This is an interventional treatment trial for Urethral Strictures focused on measuring stricture, urethra, laser, urethrotomy, holmium, bladder outlet obstruction
Eligibility Criteria
Inclusion Criteria:
- Men over 18 years old with urethral stricture
Exclusion Criteria:
- S/P urethral reconstruction
- Posterior urethral strictures
- Children
Sites / Locations
- Sheba_Medical_CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laser IU
Cold knife IU
Arm Description
Urethral stricture incised by Holmium laser
Urethral stricture incised by knife
Outcomes
Primary Outcome Measures
post operative clinical & imaging signs of urinary outflow obstruction or partial obstruction
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
post operative complications
Complications such as urinary tract infection (UTI), bladder outlet obstruction (BOO), catheter re-insertion & re-operations will be assessed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01196572
Brief Title
Efficiency of Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures
Acronym
IU
Official Title
Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Strictures
Keywords
stricture, urethra, laser, urethrotomy, holmium, bladder outlet obstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laser IU
Arm Type
Experimental
Arm Description
Urethral stricture incised by Holmium laser
Arm Title
Cold knife IU
Arm Type
Active Comparator
Arm Description
Urethral stricture incised by knife
Intervention Type
Procedure
Intervention Name(s)
Internal Urethrotomy
Other Intervention Name(s)
Holmium laser
Intervention Description
surgical incision of urethral stricture using endoscopic cold knife vs. endoscopic laser
Primary Outcome Measure Information:
Title
post operative clinical & imaging signs of urinary outflow obstruction or partial obstruction
Description
Urethral stricture & urinary flow will be assessed by physical examination, urethrography, cystoscopy, sonographic bladder scan for urine rest, urine flowmetry & clinical questionnaire (IPSS).
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
post operative complications
Description
Complications such as urinary tract infection (UTI), bladder outlet obstruction (BOO), catheter re-insertion & re-operations will be assessed.
Time Frame
up to 2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men over 18 years old with urethral stricture
Exclusion Criteria:
S/P urethral reconstruction
Posterior urethral strictures
Children
Facility Information:
Facility Name
Sheba_Medical_Center
City
Ramat-Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barak Rosenzweig, Dr.
Phone
00-972-3-5302239
Email
barak22@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Efficiency of Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures
We'll reach out to this number within 24 hrs