Status:
COMPLETED
Memokath® 044TW Stent for Treatment of Urethral Stricture
Lead Sponsor:
Pnn Medical DK
Conditions:
Urethral Stricture
Eligibility:
MALE
21+ years
Phase:
PHASE3
Brief Summary
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 uret...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00270504
Start Date
December 1 2002
End Date
November 1 2009
Last Update
November 18 2009
Active Locations (7)
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1
Jack McAninch
San Francisco, California, United States, 94110
2
Mississippi Urology
Jackson, Mississippi, United States, 39202
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195
4
Bryn Mawr Urology
Bryn Mawr, Pennsylvania, United States, 19010