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
  Purpose

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 Intervention Phase
Urethral Strictures
Procedure: Internal Urethrotomy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 4, 2010
Last Updated: August 7, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

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

ClinicalTrials.gov processed this record on August 01, 2014