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| Tracking Information | |||||||||
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| First Received Date ICMJE | December 5, 2008 | ||||||||
| Last Updated Date | July 23, 2009 | ||||||||
| Start Date ICMJE | October 2008 | ||||||||
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00804557 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy And Safety Of The Uro-Ease® Urinary Catheter During Clean Intermittent Catheterization | ||||||||
| Official Title ICMJE | Efficacy And Safety Of The Uro-Ease® Urinary Catheter During Clean Intermittent Catheterization | ||||||||
| Brief 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. |
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| Detailed Description | Urinary retention can occur among men with Benign Prostatic Hypertrophy(BPH) or Neurologic co-morbidities. Many of these men are treated with Clean Intermittent Catheterization(CIC. For some, this can be a time consuming and often painful process due to difficulty with catheter insertion and manipulation, which may result in urethral injury or non-compliance. The blunt nose of a standard catheter can meet significant resistance at the external sphincter or within the prostate urethra. Spirus Medical has developed a urinary catheter, Uro-Ease, with a rounded helical thread formed on the surface of its distal end for use in CIC. This study is to determine whether the design of the Uro-Ease catheter allows for easier Clean Intermittent self-Catheterization(CIC) while maintaining safe bladder drainage. This is a prospective randomized study with two phases. Phase 1: Observational, 5 patients. In this phase, five patients meeting the inclusion criteria will be consented from the Urology Clinic. Participating Urology nurses who have been previously trained in the utilization of the Spirus Catheter, will perform the initial CIC on the patient with a 12 Fr Spirus Catheter(choice of 2 different flexibilities). The study nurse will document time per catheterization and effective drainage of bladder. Before leaving the clinic, patient's will be instructed in the use of the Spirus Catheter and demonstrate efficacy with using the Spirus Catheter. Patients will then fill out VAS Forms for ease and comfort of catheter insertion and after each subsequent catheterization. Patients will also record, for 3 consecutive days, time it takes for catheterization and time to drain the bladder . Patients will return to clinic in 1 week to return VAS forms and documentation. A follow-up phone call will be made to the patient in month to check on patient's status. All patients will be instructed to call clinic, nurse or on-call-urologist for any report of urethral trauma, which will be evaluated with flexible cystoscopy. These reports will be reviewed and documented. Phase 2: Randomized crossover trial, 20 patients. After successful completion of Phase 1, patients will be randomized into 2 groups-10 patients will first be randomized into the Spirus Catheter Group and 10 patients into the Standard 12 FR Bard Catheter Group.(Coude' or straight catheters may be utilized for standard group) As in Phase 1, all patients will receive CIC instruction for self-catheterization, specific to the selected catheter and can demonstrate efficacy with CIC using selected catheter, before they leave the clinic. Patients will then fill out VAS forms for catheter insertion ease and comfort and after each subsequent catheterization. Patient will also record time per catheterization and bladder drainage for 3 consecutive days. Patients will return to the clinic in 1 week for a progress report, return VAS forms and reports. At this time the patient will be switch over to the alternate catheter group for 1 week. All patients will be instructed to call clinic, nurse or on-call-urologist for any report of urethral trauma, defined as blood on catheter or per meatus. Any occurence of urethral trauma will be evaluated with flexible cystoscopy. These reports will be reviewed and documented. All patients will be followed up to one month to check on the patient's status. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case-Crossover, Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 25 | ||||||||
| Estimated Completion Date | December 2010 | ||||||||
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00804557 | ||||||||
| Responsible Party | John T. Stoffel, M.D., Lahey Clinic, Inc. | ||||||||
| Study ID Numbers ICMJE | 2008-065 | ||||||||
| Study Sponsor ICMJE | Lahey Clinic | ||||||||
| Collaborators ICMJE | Spirus Medical, Inc. | ||||||||
| Investigators ICMJE |
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| Information Provided By | Lahey Clinic | ||||||||
| Verification Date | July 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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