Urinary RetentionNCT00804557
Efficacy And Safety Of The Uro-Ease® Urinary Catheter During Clean Intermittent Catheterization
An observational study of Urinary Retention and Urinary Catheterization, run by Lahey Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Retention, Urinary Catheterization
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients from Lahey Clinic Urology Service and colleague referrals
Who may be able to join
- Male patients
- Urinary retention defined as >150cc retained in bladder on post void residual
Who cannot join
- 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
Show all 10Show fewer
- Unable to physically perform CIC
- Unable to provide follow up
- Unable to give consent
- Currently taking chronic narcotic pain medication
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Urinary Retention, Urinary Catheterization
- Keywords
- Male Urinary Disorders, Urinary catheterization, Urinary retention
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: pending design changes to the device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Spirus Medical, Inc.
- Investigators
- John T. Stoffel, M.D., Principal investigator, Lahey Clinic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804557
- Sponsor's protocol ID
- 2008-065
- Status last verified
- May 2011
- First submitted
- 5 Dec 2008
- Last updated
- 6 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18423712Logan 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.
PubMed 18352962Jahn 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.
PubMed 17636782Webb 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.
PubMed 2310927Woodward 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.
PubMed 14581839Shaw 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.
PubMed 18302605Liedberg H. Catheter induced urethral inflammatory reaction and urinary tract infection. An experimental and clinical study. Scand J Urol Nephrol Suppl. 1989;124:1-43.
PubMed 2633310Ferrie 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.
PubMed 3490896Bull 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.
PubMed 1933160Erickson 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.
PubMed 18001794
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy And Safety Of The Uro-Ease® Urinary Catheter During Clean Intermittent Catheterization
- ClinicalTrials.gov ID
- NCT00804557
- Acronym / sponsor ID
- 2008-065
- Conditions
- Urinary Retention, Urinary Catheterization
- Keywords
- Male Urinary Disorders, Urinary catheterization, Urinary retention
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: pending design changes to the device
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Collaborators
- Spirus Medical, Inc.
- Study start
- Oct 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients from Lahey Clinic Urology Service and colleague referrals
Key inclusion criteria (2 listed)
- Male patients
- Urinary retention defined as >150cc retained in bladder on post void residual
Key exclusion criteria (10 listed)
- Female patients
- Known urethral stricture
- Active symptomatic Urinary Tract Infection
- History of pelvic fracture or urethral disruption
- History of previous urethroplasty(urethral reconstructive surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: pending design changes to the device). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2011.
- Background: PubMed 18423712Kashefi 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.
- Background: PubMed 18352962Logan 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.
- Background: PubMed 17636782Jahn 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.
- Background: PubMed 2310927Webb 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.
- Background: PubMed 14581839Woodward 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.
- Background: PubMed 18302605Shaw 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.
- Background: PubMed 2633310Liedberg H. Catheter induced urethral inflammatory reaction and urinary tract infection. An experimental and clinical study. Scand J Urol Nephrol Suppl. 1989;124:1-43.
- Background: PubMed 3490896Ferrie 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.
- Background: PubMed 1933160Bull 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.
- Background: PubMed 18001794Erickson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John T. Stoffel, M.D. principal investigator
Lahey Clinic, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Retention and Urinary Catheterization, run by Lahey Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: pending design changes to the device). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00804557, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2011.