- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00270504
Memokath® 044TW Stent for Treatment of Urethral Stricture
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
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94110
- Jack McAninch
-
-
Mississippi
-
Jackson, Mississippi, United States, 39202
- Mississippi Urology
-
-
Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
Pennsylvania
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Bryn Mawr, Pennsylvania, United States, 19010
- Bryn Mawr Urology
-
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Rhode Island
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Providence, Rhode Island, United States, 02904
- University Urological Associates
-
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Virginia
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Norfolk, Virginia, United States, 23510
- Devine-Tidewater Urology
-
-
Washington
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Seattle, Washington, United States, 98104
- Harborview Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stent/control effectiveness - urethral patency
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peak urinary flow rate
Time Frame: Immediate
|
Immediate
|
Re-intervention
Time Frame: Short term
|
Short term
|
Standard survey instruments (QOL, IPSS etc.)
Time Frame: 15 mos
|
15 mos
|
Stent placement success
Time Frame: immediate
|
immediate
|
Stent removal success
Time Frame: immediate
|
immediate
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gerry Jordan, MD, Sentara/Engineers and Doctors
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-044TWUS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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