Efficiency of Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures

Urethral Strictures Clinical Trial

— IU  

Official title:

Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01196572
• Other study ID #: SHEBA-10-7897-ZD-CTIL
• Status: Recruiting
• Phase: Phase 4
• First received: September 4, 2010
• Last updated: August 7, 2011
• Start date: September 2010
• Est. completion date: September 2013

Study information

• Verified date: August 2011
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men over 18 years old with urethral stricture

Exclusion Criteria:

• S/P urethral reconstruction

• Posterior urethral strictures

• Children

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Urethral Stricture
• Urethral Strictures

Intervention

Procedure:
• Internal Urethrotomy
surgical incision of urethral stricture using endoscopic cold knife vs. endoscopic laser

Locations

Country	Name	City	State
Israel	Sheba_Medical_Center	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	up to 2 years	No
Secondary	post operative complications	Complications such as urinary tract infection (UTI), bladder outlet obstruction (BOO), catheter re-insertion & re-operations will be assessed.	up to 2 years	Yes