Efficiency of Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures (IU)

Sheba Medical Center

Status and phase: Unknown; Phase 4

Conditions: Urethral Strictures

Treatments: Procedure: Internal Urethrotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01196572

SHEBA-10-7897-ZD-CTIL

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men over 18 years old with urethral stricture

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Laser IU

Experimental group

Description:

Urethral stricture incised by Holmium laser

Treatment:

Procedure: Internal Urethrotomy

Cold knife IU

Active Comparator group

Description:

Urethral stricture incised by knife

Treatment:

Procedure: Internal Urethrotomy