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

Urinary Retention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00804557
• Other study ID #: 2008-065
• Status: Terminated
• Phase: N/A
• First received: December 5, 2008
• Last updated: May 5, 2011
• Start date: October 2008
• Est. completion date: August 2010

Study information

• Verified date: May 2011
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Urinary Catheterization
• Urinary Retention

Locations

Country	Name	City	State
United States	Lahey Clinic, Inc.	Burlington	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Lahey Clinic	Spirus Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. Epub 2007 Nov 14. — View Citation

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. — View Citation

Jahn P, Preuss M, Kernig A, Seifert-Hühmer A, Langer G. Types of indwelling urinary catheters for long-term bladder drainage in adults. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004997. Review. Update in: Cochrane Database Syst Rev. 2012;10:CD004997. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Webb RJ, Lawson AL, Neal DE. Clean intermittent self-catheterisation in 172 adults. Br J Urol. 1990 Jan;65(1):20-3. — View Citation

Woodward S, Rew M. Patients' quality of life and clean intermittent self-catheterization. Br J Nurs. 2003 Oct 9-22;12(18):1066-74. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes