Memokath® 044TW Stent for Treatment of Urethral Stricture

Completed · Phase 3

Conditions studied: Urethral Stricture

In brief

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.

Key facts

Study ID

NCT00270504

Run by

Pnn Medical DK

People needed

92

Starts

2002-12-01

Expected to finish

2009-11-01

Last updated by the study team

2009-11-18

Who can join

Age: 21 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males > 21 years of age
• Recurrent stricture of the bulbar urethra:
• < 50 mm in length on urethrography; and which
• 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.

You may not qualify if…

• Strictures:
• outside the bulbous urethra
• associated with, or suspected to be, urethral carcinoma
• 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

Where it is running

• Jack McAninch — San Francisco, California, United States
• Mississippi Urology — Jackson, Mississippi, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Bryn Mawr Urology — Bryn Mawr, Pennsylvania, United States
• University Urological Associates — Providence, Rhode Island, United States
• Devine-Tidewater Urology — Norfolk, Virginia, United States
• Harborview Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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