Memokath® 044TW Stent for Treatment of Urethral Stricture

Urethral Stricture Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270504
• Other study ID #: 1-044TWUS
• Status: Completed
• Phase: Phase 3
• First received: December 23, 2005
• Last updated: November 17, 2009
• Start date: December 2002
• Est. completion date: November 2009

Study information

• Verified date: December 2008
• Source: Pnn Medical DK
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 urethral patency during the first year of follow-up when compared to the control group that does not receive a stent.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Males > 21 years of age

2. 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

3. Healthy tissue on both sides of stent

4. Urinary flow in the abnormal range of the Siroky nomogram.

5. Written informed consent obtained prior to participation in the study

6. Patients must be available for all follow-up visits.

Exclusion Criteria:

1. Strictures:

1. outside the bulbous urethra

2. associated with, or suspected to be, urethral carcinoma

3. secondary to pelvic distraction injuries

2. Inability to enlarge the bulbar urethral stricture to > 26 Fr.

3. Presence of any other urologic implant

4. Presence of urethral diverticuli

5. History of hypospadias repair

6. Presence or prior history of balanitis xerotica obliterans.

7. Uncontrolled bleeding disorder

8. Active urinary tract infection

9. 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.

10. Serum creatinine > 2.0 mg/dl or evidence of progressive renal disease

11. Concurrent participation in another clinical investigation

12. Current illness that might confound the results of this investigation

13. Inability to participate in all of the necessary study activities

14. Inability or unwillingness to return for all required follow-up visits

15. Inability or unwillingness to sign the patient informed consent document

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Urethral Stricture

Intervention

Device:
• Memokath stenting
Urethral Stenting

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pnn Medical DK

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent/control effectiveness - urethral patency		1 year	No
Secondary	Peak urinary flow rate		Immediate	No
Secondary	Re-intervention		Short term	Yes
Secondary	Standard survey instruments (QOL, IPSS etc.)		15 mos	No
Secondary	Stent placement success		immediate	Yes
Secondary	Stent removal success		immediate	Yes