Urinary RetentionNCT01508767
Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia
A study testing Removal of urethral catheter in people with Urinary Retention, run by University College Hospital Galway at 1 site in Ireland.
Trial summary
Patients undergoing colon or rectal surgery will usually have a urinary catheter (silicone tube) placed in the bladder at the time of operating to monitor kidney function during surgery and in the post-surgery period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Retention
- What is being tested?
- Removal of urethral catheter
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteIreland
- Study dates
- Jan 2012to Jul 2013
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Competent to consent to participate in trial
- Undergoing colorectal surgery (any resection of large bowel, formation of colostomy, anterior resection, low anterior resection, panproctocolectomy, abdominoperineal resection).
- Receiving epidural analgesia post-operatively
- If male, international prostate symptom score <20.
Who cannot join
- Previous lower urinary tract surgery
- Chronic lower urinary tract disease
- Intermittent self-catheterisation
- Neurogenic bladder
- Urethral catheter inserted >24 hours pre-operatively
- Presence of pelvic sepsis/abscess at surgery
Show all 11Show fewer
- Previous trans-abdominal pelvic surgery
- Urethral catheter required for urine output monitoring beyond 24 hours post-operatively
- Presence of enterovesical fistula
- Pre-operative use of medications which alter detrusor function
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Trial of Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia
Patients undergoing colon or rectal surgery will usually have a urinary catheter (silicone tube) placed in the bladder at the time of operating to monitor kidney function during surgery and in the post-surgery period. Such patients will also have an infusion into the spine, known as an epidural, after surgery to provide them with continuous pain relief. Urinary catheters should be removed as early as possible once they are no longer required to facilitate patients becoming mobile after surgery and to reduce the risk of patients developing a urinary tract infection.
Traditionally these catheters are not removed until the patients epidural infusion is withdrawn, as in theory to do so would predispose the patient to developing acute retention of urine due to lack of sensation when the bladder is full. The investigators hypothesis is that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief without a significant increase in rates of urinary retention.
Read the detailed description
Patients undergoing colon or rectal surgery will be randomly assigned to one of two groups: Patients in study group 1 (SG1) will have their urinary catheters removed at 48 hours post-operatively; Patients in study group 2 (SG2) will have their urinary catheters removed only after the epidural has been withdrawn in the post-operative period. We will be primarily examining rates of urinary retention in both groups. We will also be examining rates of urinary tract infection, chest infection (frequently a result of poor mobility after surgery), and wound infection and other complications after surgery.
- Conditions
- Urinary Retention
- Being tested
- Removal of urethral catheter
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal of urethral catheterOther
Also called Urethral catheter, Indwelling Urinary catheter, Indwelling urethral catheter
All participants are to have a urethral catheter placed following successful placement of an epidural catheter for analgesia prior to undergoing colorectal resection. Following urethral catheter placement participants will be randomly assigned to either the experimental arm or the control arm. Participants assigned to the experimental arm will have their urethral catheters removed at 48 hours following surgery. Participants assigned to the control group will have their urethral catheters removed within 12 hours of withdrawal of the epidural infusion, as is standard practice in our institution.
| Study group | Role | What they receive |
|---|---|---|
| Study group 1 | Experimental | Early removal of urethral catheter 48 hours post-operatively. Receives: Other: Removal of urethral catheter |
| Study group 2 | Other | Removal of urethral catheter once epidural analgesia has been withdrawn. Receives: Other: Removal of urethral catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative urinary retention requiring re-catheterisation
Development of acute post-operative urinary retention demonstrated by a post-void residual >100mls on bladder ultrasound requiring re-catheterisation within 2 weeks of removal of urethral catheter in the post-operative period.
Measured: 14 days following urethral catheter removal
Secondary outcomes (3)
Symptomatic bacteruria
Should a patient experience lower urinary tract symptoms following catheter removal a mid-stream urine sample will be taken for microscopy and culture. A pure culture of a single organism of >100,000 colony forming units will be considered a positive culture.
Measured: Within 14 days of urethral catheter removal
Pulmonary complications
The development of post-operative pulmonary complications such as atelectasis, pneumonia occurring within 14 days of surgery will be considered.
Measured: For the first 14 days post-operatively
Surgical site infection
The development of wound and other surgical site infections within 7 days of undergoing colorectal surgery will be considered.
Measured: Within 7 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Hospital Galway
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myles Joyce, University College Hospital Galway
- Investigators
- Myles R. Joyce, MB, BCh, BAO, Principal investigator, University College Hospital Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508767
- Sponsor's protocol ID
- Joyce-2011
- Status last verified
- Aug 2013
- First submitted
- 4 Jan 2012
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
PubMed 34184246Coyle D, Joyce KM, Garvin JT, Regan M, McAnena OJ, Neary PM, Joyce MR. Early post-operative removal of urethral catheter in patients undergoing colorectal surgery with epidural analgesia - a prospective pilot clinical study. Int J Surg. 2015 Apr;16(Pt A):94-98. doi: 10.1016/j.ijsu.2015.03.003. Epub 2015 Mar 10.
PubMed 25769395
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial of Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia
- ClinicalTrials.gov ID
- NCT01508767
- Acronym / sponsor ID
- Joyce-2011
- Conditions
- Urinary Retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University College Hospital GalwayUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Jan 2012 (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.
Patients undergoing colon or rectal surgery will usually have a urinary catheter (silicone tube) placed in the bladder at the time of operating to monitor kidney function during surgery and in the post-surgery period. Such patients will also have an infusion into the spine, known as an epidural, after surgery to provide them with continuous pain relief. Urinary catheters should be removed as early as possible once they are no longer required to facilitate patients becoming mobile after surgery and to reduce the risk of patients developing a urinary tract infection.
Traditionally these catheters are not removed until the patients epidural infusion is withdrawn, as in theory to do so would predispose the patient to developing acute retention of urine due to lack of sensation when the bladder is full. The investigators hypothesis is that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief without a significant increase in rates of urinary retention.
Detailed description
Patients undergoing colon or rectal surgery will be randomly assigned to one of two groups: Patients in study group 1 (SG1) will have their urinary catheters removed at 48 hours post-operatively; Patients in study group 2 (SG2) will have their urinary catheters removed only after the epidural has been withdrawn in the post-operative period. We will be primarily examining rates of urinary retention in both groups. We will also be examining rates of urinary tract infection, chest infection (frequently a result of poor mobility after surgery), and wound infection and other complications after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group 1 | Experimental | Other: Removal of urethral catheterEarly removal of urethral catheter 48 hours post-operatively. |
| Study group 2 | Other | Other: Removal of urethral catheterRemoval of urethral catheter once epidural analgesia has been withdrawn. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18
- Competent to consent to participate in trial
- Undergoing colorectal surgery (any resection of large bowel, formation of colostomy, anterior resection, low anterior resection, panproctocolectomy, abdominoperineal resection).
- Receiving epidural analgesia post-operatively
- If male, international prostate symptom score <20.
Key exclusion criteria (11 listed)
- Previous lower urinary tract surgery
- Chronic lower urinary tract disease
- Intermittent self-catheterisation
- Neurogenic bladder
- Urethral catheter inserted >24 hours pre-operatively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Removal of urethral catheterAlso: Urethral catheter, Indwelling Urinary catheter, Indwelling urethral catheterAll participants are to have a urethral catheter placed following successful placement of an epidural catheter for analgesia prior to undergoing colorectal resection. Following urethral catheter placement participants will be randomly assigned to either the experimental arm or the control arm. Participants assigned to the experimental arm will have their urethral catheters removed at 48 hours following surgery. Participants assigned to the control group will have their urethral catheters removed within 12 hours of withdrawal of the epidural infusion, as is standard practice in our institution. | Other | Study group 1, Study group 2 |
Primary outcome
Post-operative urinary retention requiring re-catheterisation
Time frame: 14 days following urethral catheter removal
Development of acute post-operative urinary retention demonstrated by a post-void residual >100mls on bladder ultrasound requiring re-catheterisation within 2 weeks of removal of urethral catheter in the post-operative period.
3 secondary outcomes
Symptomatic bacteruria
Time frame: Within 14 days of urethral catheter removal
Pulmonary complications
Time frame: For the first 14 days post-operatively
Surgical site infection
Time frame: Within 7 days post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2013.
- Derived from this study: PubMed 34184246Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
- Derived from this study: PubMed 25769395Coyle D, Joyce KM, Garvin JT, Regan M, McAnena OJ, Neary PM, Joyce MR. Early post-operative removal of urethral catheter in patients undergoing colorectal surgery with epidural analgesia - a prospective pilot clinical study. Int J Surg. 2015 Apr;16(Pt A):94-98. doi: 10.1016/j.ijsu.2015.03.003. Epub 2015 Mar 10.
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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.
Myles R. Joyce, MB, BCh, BAO principal investigator
University College Hospital Galway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Removal of urethral catheter in people with Urinary Retention, run by University College Hospital Galway at 1 site in Ireland.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 19 Aug 2013. 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 Ireland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post-operative urinary retention requiring re-catheterisation (time frame: 14 days following urethral catheter removal). 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 NCT01508767, which also lists 2 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 19 Aug 2013.