Memokath® 044TW Stent for Treatment of Urethral Stricture - Full Text View

Sponsor:	Engineers & Doctors Wallsten Medical Group
Information provided by:	Engineers & Doctors Wallsten Medical Group
ClinicalTrials.gov Identifier:	NCT00270504

Purpose

The purpose of this study is to evaluate if the placement of a temporary urethral stent for up to 12 months, following dilation or internal urethrotomy (cutting open), results in a higher rate of urethral patency during the first year of follow-up when compared to the control group that does not receive a stent.

Condition	Intervention	Phase
Urethral Stricture	Device: Memokath stenting	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective, Randomized, Controlled, Multicenter Trial of the Memokath® 044TW Thermo-Expandable Stent for Maintaining Urethral Patency in Patients After Dilation or Internal Urethrotomy of Recurrent Stricture of the Bulbar Urethra

Further study details as provided by Engineers & Doctors Wallsten Medical Group:

Primary Outcome Measures:

Stent/control effectiveness - urethral patency [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Peak urinary flow rate [ Time Frame: Immediate ] [ Designated as safety issue: No ]
Re-intervention [ Time Frame: Short term ] [ Designated as safety issue: Yes ]
Standard survey instruments (QOL, IPSS etc.) [ Time Frame: 15 mos ] [ Designated as safety issue: No ]
Stent placement success [ Time Frame: immediate ] [ Designated as safety issue: Yes ]
Stent removal success [ Time Frame: immediate ] [ Designated as safety issue: Yes ]

Enrollment:	92
Study Start Date:	December 2002
Study Completion Date:	November 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Urethral Stenting

Detailed Description:

Patients with bulbar urethral stricture are 2:1 randomised for either urethral dilation or internal urethrotomy with (treatment group) or without (control group) subsequent stenting. All patients are followed for up to one year at 4-6 weeks, 3, 6, 9 and 12 months with visual assessment (urethroscopy) of urethral patency at the treated segment of the urethra. The stent is removed at one year. In case of premature stent removal the patient is also followed for up to one year unless further intervention is decided.

Control patients are offered the stent treatment option if the stricture recurs within the observation period but this group is separately analysed.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males > 21 years of age
Recurrent stricture of the bulbar urethra:
1. < 50 mm in length on urethrography; and which
2. has a segment unable to accommodate a 16Fr flexible cystoscope
Healthy tissue on both sides of stent
Urinary flow in the abnormal range of the Siroky nomogram.
Written informed consent obtained prior to participation in the study
Patients must be available for all follow-up visits.

Exclusion Criteria:

Strictures:
1. outside the bulbous urethra
2. associated with, or suspected to be, urethral carcinoma
3. secondary to pelvic distraction injuries
Inability to enlarge the bulbar urethral stricture to > 26 Fr.
Presence of any other urologic implant
Presence of urethral diverticuli
History of hypospadias repair
Presence or prior history of balanitis xerotica obliterans.
Uncontrolled bleeding disorder
Active urinary tract infection
Any urological condition that would be likely to require additional urethral instrumentation during the period of the investigation, including, but not limited to, benign prostatic hypertrophy requiring treatment; use of alpha blockers; active prostate cancer; an unevaluated elevated prostate-specific antigen (PSA); bladder malignancy; or any recurrent urinary stone formation.
Serum creatinine > 2.0 mg/dl or evidence of progressive renal disease
Concurrent participation in another clinical investigation
Current illness that might confound the results of this investigation
Inability to participate in all of the necessary study activities
Inability or unwillingness to return for all required follow-up visits
Inability or unwillingness to sign the patient informed consent document

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270504

Locations

United States, California
Jack McAninch
San Francisco, California, United States, 94110
United States, Mississippi
Mississippi Urology
Jackson, Mississippi, United States, 39202
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Bryn Mawr Urology
Bryn Mawr, Pennsylvania, United States, 19010
United States, Rhode Island
University Urological Associates
Providence, Rhode Island, United States, 02904
United States, Virginia
Devine-Tidewater Urology
Norfolk, Virginia, United States, 23510
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104

Sponsors and Collaborators

Engineers & Doctors Wallsten Medical Group

Investigators

Principal Investigator:

Gerry Jordan, MD

Sentara/Engineers and Doctors

More Information

No publications provided

Responsible Party:	Pnn Medical ( Director of Clinical and Regulatory )
Study ID Numbers:	1-044TWUS
Study First Received:	December 23, 2005
Last Updated:	November 17, 2009
ClinicalTrials.gov Identifier:	NCT00270504 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Engineers & Doctors Wallsten Medical Group:

Memokath
Urethral stricture
urethral stent
Bulbar urethral stricture

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Urologic Diseases
Urethral Obstruction

Urethral Stricture
Urethral Diseases
Constriction, Pathologic

ClinicalTrials.gov processed this record on February 04, 2010