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

Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01196572

Acronym

Enrollment

Registered

2010-09-08

Start date

2010-09-30

Completion date

2013-09-30

Last updated

2011-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urethral Strictures

Keywords

stricture, urethra, laser, urethrotomy, holmium, bladder outlet obstruction

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.

Interventions

PROCEDUREInternal Urethrotomy

surgical incision of urethral stricture using endoscopic cold knife vs. endoscopic laser

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Men over 18 years old with urethral stricture

Exclusion criteria

* S/P urethral reconstruction * Posterior urethral strictures * Children

Design outcomes

Primary

Measure	Time frame	Description
post operative clinical & imaging signs of urinary outflow obstruction or partial obstruction	up to 2 years	Urethral stricture & urinary flow will be assessed by physical examination, urethrography, cystoscopy, sonographic bladder scan for urine rest, urine flowmetry & clinical questionnaire (IPSS).

Secondary

Measure	Time frame	Description
post operative complications	up to 2 years	Complications such as urinary tract infection (UTI), bladder outlet obstruction (BOO), catheter re-insertion & re-operations will be assessed.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026