NCT01196572

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

August 9, 2011

Status Verified

August 1, 2011

Enrollment Period

2 years

First QC Date

September 4, 2010

Last Update Submit

August 7, 2011

Conditions

Urethral Strictures

Keywords

strictureurethralaserurethrotomyholmiumbladder outlet obstruction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • post operative complications

    up to 2 years

Study Arms (2)

Laser IU

EXPERIMENTAL

Urethral stricture incised by Holmium laser

Procedure: Internal Urethrotomy

Cold knife IU

ACTIVE COMPARATOR

Urethral stricture incised by knife

Procedure: Internal Urethrotomy

Interventions

Internal UrethrotomyPROCEDURE

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

Also known as: Holmium laser
Cold knife IULaser IU

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men over 18 years old with urethral stricture

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba_Medical_Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Urethral StrictureConstriction, PathologicUrinary Bladder Neck Obstruction

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Urethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrinary Bladder Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 4, 2010

First Posted

September 8, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2013

Last Updated

August 9, 2011

Record last verified: 2011-08

Locations

IL(1)