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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
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

First Posted
September 4, 2010
Last Updated
August 7, 2011
Sponsor
Sheba Medical Center
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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

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