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

NCT00804557 | Terminated

• 1 other identifier: 2008-065
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Retention; Urinary Catheterization

Keywords

Male Urinary Disorders; Urinary catheterization; Urinary retention

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks

Study Arms (2)

Uro-Ease Spirus Catheter

10 patients randomized to the Uro-Ease Catheter group for 1 week. In clinic, patients will be instructed in the use of the Uro-Ease Catheter. A QOL form will be filled out measuring comfort and ease of use and subsequently after each catheterization. Patients will also record time per catheterization and bladder drainage. Patients will return to Clinic in 1 week to check progress and will then change to a standard, non-helical urinary catheter. Patients will be followed up to 1 month.

Standard Urinary Catheter

10 patients randomized to a Standard Urinary Catheter group for 1 week. In clinic, patients will be instructed in the use of the catheter. A QOL form will be filled out measuring comfort and ease of use and subsequently after each catheterization. Patients will also record time per catheterization and bladder drainage. Patients will return to Clinic in 1 week to check progress and will then change to the UroEase Spirus Catheter. All patients will be followed up to 1 month.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Outpatients from Lahey Clinic Urology Service and colleague referrals

You may qualify if:

• Male patients
• Urinary retention defined as \>150cc retained in bladder on post void residual

You may not qualify if:

• 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

Sponsors & Collaborators

• Lahey Clinic: lead
• Spirus Medical, Inc.: collaborator

Study Sites (1)

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

Location

Related Publications (10)

• Kashefi C, Messer K, Barden R, Sexton C, Parsons JK. Incidence and prevention of iatrogenic urethral injuries. J Urol. 2008 Jun;179(6):2254-7; discussion 2257-8. doi: 10.1016/j.juro.2008.01.108. Epub 2008 Apr 18.

  PMID: 18423712 BACKGROUND

• Logan K, Shaw C, Webber I, Samuel S, Broome L. Patients' experiences of learning clean intermittent self-catheterization: a qualitative study. J Adv Nurs. 2008 Apr;62(1):32-40. doi: 10.1111/j.1365-2648.2007.04536.x.

  PMID: 18352962 BACKGROUND

• Jahn P, Preuss M, Kernig A, Seifert-Huhmer A, Langer G. Types of indwelling urinary catheters for long-term bladder drainage in adults. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004997. doi: 10.1002/14651858.CD004997.pub2.

  PMID: 17636782 BACKGROUND

• Webb RJ, Lawson AL, Neal DE. Clean intermittent self-catheterisation in 172 adults. Br J Urol. 1990 Jan;65(1):20-3. doi: 10.1111/j.1464-410x.1990.tb14653.x.

  PMID: 2310927 BACKGROUND

• Woodward S, Rew M. Patients' quality of life and clean intermittent self-catheterization. Br J Nurs. 2003 Oct 9-22;12(18):1066-74. doi: 10.12968/bjon.2003.12.18.11782.

  PMID: 14581839 BACKGROUND

• Shaw C, Logan K, Webber I, Broome L, Samuel S. Effect of clean intermittent self-catheterization on quality of life: a qualitative study. J Adv Nurs. 2008 Mar;61(6):641-50. doi: 10.1111/j.1365-2648.2007.04556.x.

  PMID: 18302605 BACKGROUND

• Liedberg H. Catheter induced urethral inflammatory reaction and urinary tract infection. An experimental and clinical study. Scand J Urol Nephrol Suppl. 1989;124:1-43.

  PMID: 2633310 BACKGROUND

• Ferrie BG, Groome J, Sethia B, Kirk D. Comparison of silicone and latex catheters in the development of urethral stricture after cardiac surgery. Br J Urol. 1986 Oct;58(5):549-50. doi: 10.1111/j.1464-410x.1986.tb05465.x.

  PMID: 3490896 BACKGROUND

• Bull E, Chilton CP, Gould CA, Sutton TM. Single-blind, randomised, parallel group study of the Bard Biocath catheter and a silicone elastomer coated catheter. Br J Urol. 1991 Oct;68(4):394-9. doi: 10.1111/j.1464-410x.1991.tb15359.x.

  PMID: 1933160 BACKGROUND

• Erickson BA, Navai N, Patil M, Chang A, Gonzalez CM. A prospective, randomized trial evaluating the use of hydrogel coated latex versus all silicone urethral catheters after urethral reconstructive surgery. J Urol. 2008 Jan;179(1):203-6. doi: 10.1016/j.juro.2007.08.174. Epub 2007 Nov 14.

  PMID: 18001794 BACKGROUND

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• John T. Stoffel, M.D.

  Lahey Clinic, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 9, 2008
• Study Start: October 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: May 6, 2011

Record last verified: 2011-05

Locations

US (1)