Memokath® 044TW Stent for Treatment of Urethral Stricture

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Urethral Stricture

Intervention / Treatment
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* Device: Memokath stenting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Memokath stenting|Urethral Stenting|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent/control effectiveness - urethral patency |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak urinary flow rate |  | Immediate | 
| Re-intervention |  | Short term | 
| Standard survey instruments (QOL, IPSS etc.) |  | 15 mos | 
| Stent placement success |  | immediate | 
| Stent removal success |  | immediate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Memokath, Urethral stricture, urethral stent, Bulbar urethral stricture