TerminatedNot Applicable

Efficacy And Safety Of The Uro-Ease® Urinary Catheter During Clean Intermittent Catheterization

Stopped: pending design changes to the device

United States25 participantsStarted 2008-10

Plain-language summary

To evaluate the ease of use and comfort of a new urinary catheter, the Uro-Ease, as used in the Clean Intermittent Catheterization (CIC)process.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male patients * Urinary retention defined as \>150cc retained in bladder on post void residual Exclusion Criteria: * Female patients * Known urethral stricture * Active symptomatic Urinary Tract Infection * History of pelvic fracture or urethral disruption * History of previous urethroplasty(urethral reconstructive surgery) * Known Latex allergy * Unable to physically perform CIC * Unable to provide follow up * Unable to give consent * Currently taking chronic narcotic pain medication

What they're measuring

To determine whether the design of the Uro-Ease Catheter device allows for easier, more comfortable clean intermittent self-catheterization (CIC) while maintaining safe bladder drainage. Using Visual Analog Scales and Timed procedure logs

Timeframe: 2 weeks

Trial details

NCT IDNCT00804557

SponsorLahey Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2010-08

View on ClinicalTrials.gov More Urinary Retention trials