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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Pnn Medical DK · Industry
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Urethral Stricture

Interventions

Type	Name	Description
DEVICE	Memokath stenting	Urethral Stenting

Timeline

• Start date: 2002-12-01
• Primary completion: 2009-10-01
• Completion: 2009-11-01
• First posted: 2005-12-28
• Last updated: 2009-11-18

Locations

7 sites across 1 country: United States