Urinary Tract InfectionsCAUTINCT03127280
Can Investigators Reduce Urinary Catheter Use and Lower Urinary Tract Infection Among Women Undergoing Benign Gynecologic Surgery?
A study testing Fast Track foley removal in people with Urinary Tract Infections and Urinary Retention, run by The Christ Hospital at 1 site in United States.
Trial summary
This is a randomized comparative trial investigating two different catheter management strategies among post-gynecologic surgery patients. Women undergoing any benign gynecologic surgery wherein they are anticipated to stay at least overnight and in whom no prolapse or urinary tract surgery was concurrently performed… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections, Urinary Retention, Satisfaction
- What is being tested?
- Fast Track foley removal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2014to 14 Jan 2018
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All women, over the age of 18, presenting to The Christ Hospital for gynecologic surgery anticipated to require an at least 1 night stay and in whom would be expected to have an indwelling catheter overnight are eligible to participate in the study.
Who cannot join
- Patients with a current urinary tract infection being treated with antibiotic(s), anticipated concomitant prolapse or incontinence surgery, a preoperative diagnosis of gynecologic malignancy, a history of chronic indwelling catheter use, a history of renal transplant or current dialysis use, or intraoperative lower urinary tract injury necessitating prolonged postoperative catheter use are to excluded from study participation.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized comparative trial investigating two different catheter management strategies among post-gynecologic surgery patients. Women undergoing any benign gynecologic surgery wherein they are anticipated to stay at least overnight and in whom no prolapse or urinary tract surgery was concurrently performed, will be randomly assigned to either conventional urinary catheter care removal on post-operative day 1 or same day surgery urinary catheter removal. Patient satisfaction and lower urinary tract symptoms including urine culture and antibiotic use will be tracked across both cohorts over the 2 weeks following the index surgery.
Read the detailed description
METHODS:
This study will be conducted at The Christ Hospital. Informed consent will be obtained from the patients in the pre-operative care unit prior to administration of any medications. Candidates for the study will clearly understand consenting to enroll in the study includes not only the randomized assignment of urinary catheter care postoperatively but also a follow-up phone survey to be administered approximately 2 weeks after discharge. Patient reasons for not enrolling in the study will be recorded.
Study population All women presenting to The Christ Hospital for gynecologic surgery anticipated to require an at least 1 night stay and in whom would be expected to have an indwelling catheter overnight are eligible to participate in the study. Patients with a current urinary tract infection being treated with antibiotic(s), anticipated concomitant prolapse or incontinence surgery, a preoperative diagnosis of gynecologic malignancy, a history of chronic indwelling catheter use, a history of renal transplant or current dialysis use, or intraoperative lower urinary tract injury necessitating prolonged postoperative catheter use are to excluded from study participation. Following application of the inclusion and exclusion criteria, postoperative urinary catheter care (conventional vs. fast track) will randomized upon arrive to the postoperative care unit (PACU). These patients will compose the study population.
Protocol:
Per routine anesthesia practice once a patient has met criteria for discharge from the PACU, and following randomization into either the conventional or fast track cohorts, the subject will either have immediate removal of the catheter with a trial of void or the catheter will remain in place over night per routine practice with a trial of void arranged at the time of discharge.
The trial of void protocol will consist of backfilling the existing catheter with 300cc of sterile saline (or to a volume the patient reports to be subjectively full) and recording her voided volume that should occur within 30 minutes. The patient's self-reported percent of normal force of stream will be recorded (0-100% in 10% increments) along with her voided volume. If the patient voids at least 150cc of the instilled volume OR reports at least a >50% of normal force of stream she will be considered to have passed the voiding trial. The patient will be scanned for residual urine volume following the next spontaneous void or any time she reports symptoms consistent with obstructed voiding.
Duration of catheter use will be determined as the time from placement in the operating room (time 0) to the time it is removed on the hospital ward. Time will be recorded in hours. Discharge from the hospital will occur per the attending physician's routine practice. At hospital discharge subjects will complete a brief survey recording bladder function before and during their hospitalization. Also included in this survey will be an assessment of their overall satisfaction with their catheter management and hospital stay. Institution standard practice is to obtain a urinalysis in the operating room on all patients anticipating an overnight stay. This urinalysis and any other urine studies obtained during the hospitalization will be extracted from the medical record. The number of subjects who fail the trial of voiding between cohorts will be collected from the electronic medical record (EMR). After discharge, subjects will be contacted by phone 2-3 weeks after the index surgery. At this call subjects will be administered a survey reviewing their post-surgery bladder function including symptoms of a bladder infection. A review of the patient's hospital record will also be conducted to identify any additional urine studies ordered during the 2-3 weeks following surgery.
Randomization protocol: Permuted block randomization will be used to ensure a balanced enrollment of patients in the clinical trial. Selecting a block size of 4 will ensure that for every four patients enrolled, 2 will be assigned to the "Fast-track" cohort and 2 will be assigned to the "Conventional" cohort. In order to effectively conceal the randomization sequence, investigators will use sequentially numbered, opaque sealed envelopes (SNOSE). It will not be feasible to blind the physician, nurse and patient in this study, they will all be aware of the randomized allocation assignment. The study personnel administering the postoperative telephone questionnaires will be blinded by simply not informing them of the group allocation of the patient. Plans to manage incomplete data between cohorts will include meeting with nursing managers and supervisors to ensure that questions are completed and to verify how to enter information into the EMR. At the completion of the study every effort will be made to have all patient questionnaire completed.
- Conditions
- Urinary Tract Infections, Urinary Retention, Satisfaction
- Being tested
- Fast Track foley removal
- Keywords
- urinary tract infections, postoperative voiding dysfunction, foley removal, patient satisfaction
- Medical subject headings
- Urinary Tract Infections, Urinary Retention, Personal Satisfaction, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast Track foley removalOther
Foley catheter is removed at 4 hours after surgery
| Study group | Role | What they receive |
|---|---|---|
| Conventional Foley Care | No intervention | Following surgery, the patient's Foley catheter is removed on the morning of post-operative day one. |
| Fast Tract Foley care | Experimental | Following surgery, the patient's Foley catheter is removed on post-operative day zero, four hours after the completion of surgery. Receives: Other: Fast Track foley removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foley Duration
Determine the duration (in hours) of urinary catheter use between conventional urinary catheter care and "fast track" urinary catheter care among women undergoing benign gynecologic surgery not involving lower urinary tract surgery or pelvic organ prolapse repair.
Measured: Between 4 hours after surgery completion to 24 hours after surgery completion
Secondary outcomes (3)
Incidence of urinary tract infection
Determine the number of women treated for a urinary tract infection between "conventional" urinary catheter care and "fast track" urinary catheter care over the 2 weeks following the index gynecologic surgery.
Measured: 2-3 weeks after surgery
Patient satisfaction
Determine patient satisfaction among women exposed to conventional catheter care and "fast track" catheter care as determined by completion of a researcher designed survey, entitled "Satisfaction with Urinary Catheter management and Expectations for bladder function after discharge", prior to discharge.
Measured: 2-3 weeks after surgery
Voiding dysfunction
Determine the numbers of women who fail a voiding trial between conventional catheter care and "fast track" catheter care.
Measured: Between 4 hours after surgery completion to 24 hours after surgery completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start4 Nov 2014
- Primary completion1 Jan 2018
- Study completion14 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christ Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Lang, The Christ Hospital
- Investigators
- Patrick Lang, MD, Principal investigator, The Christ Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127280
- Sponsor's protocol ID
- 14-38
- Acronym
- CAUTI
- Status last verified
- Jan 2018
- First submitted
- 13 Apr 2017
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Apisarnthanarak A, Rutjanawech S, Wichansawakun S, Ratanabunjerdkul H, Patthranitima P, Thongphubeth K, Suwannakin A, Warren DK, Fraser VJ. Initial inappropriate urinary catheters use in a tertiary-care center: incidence, risk factors, and outcomes. Am J Infect Control. 2007 Nov;35(9):594-9. doi: 10.1016/j.ajic.2006.11.007.
PubMed 17980238Umscheid CA, Mitchell MD, Doshi JA, Agarwal R, Williams K, Brennan PJ. Estimating the proportion of healthcare-associated infections that are reasonably preventable and the related mortality and costs. Infect Control Hosp Epidemiol. 2011 Feb;32(2):101-14. doi: 10.1086/657912.
PubMed 21460463Chenoweth CE, Saint S. Urinary tract infections. Infect Dis Clin North Am. 2011 Mar;25(1):103-15. doi: 10.1016/j.idc.2010.11.005. Epub 2010 Dec 18.
PubMed 21315996Saint S. Clinical and economic consequences of nosocomial catheter-related bacteriuria. Am J Infect Control. 2000 Feb;28(1):68-75. doi: 10.1016/s0196-6553(00)90015-4.
PubMed 10679141Jarvis WR. Selected aspects of the socioeconomic impact of nosocomial infections: morbidity, mortality, cost, and prevention. Infect Control Hosp Epidemiol. 1996 Aug;17(8):552-7. doi: 10.1086/647371.
PubMed 8875302Tambyah PA, Knasinski V, Maki DG. The direct costs of nosocomial catheter-associated urinary tract infection in the era of managed care. Infect Control Hosp Epidemiol. 2002 Jan;23(1):27-31. doi: 10.1086/501964.
PubMed 11868889Saint S, Veenstra DL, Lipsky BA. The clinical and economic consequences of nosocomial central venous catheter-related infection: are antimicrobial catheters useful? Infect Control Hosp Epidemiol. 2000 Jun;21(6):375-80. doi: 10.1086/501776.
PubMed 10879567Albo ME, Richter HE, Brubaker L, Norton P, Kraus SR, Zimmern PE, Chai TC, Zyczynski H, Diokno AC, Tennstedt S, Nager C, Lloyd LK, FitzGerald M, Lemack GE, Johnson HW, Leng W, Mallett V, Stoddard AM, Menefee S, Varner RE, Kenton K, Moalli P, Sirls L, Dandreo KJ, Kusek JW, Nyberg LM, Steers W; Urinary Incontinence Treatment Network. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med. 2007 May 24;356(21):2143-55. doi: 10.1056/NEJMoa070416. Epub 2007 May 21.
PubMed 17517855Yokoe DS, Mermel LA, Anderson DJ, Arias KM, Burstin H, Calfee DP, Coffin SE, Dubberke ER, Fraser V, Gerding DN, Griffin FA, Gross P, Kaye KS, Klompas M, Lo E, Marschall J, Nicolle L, Pegues DA, Perl TM, Podgorny K, Saint S, Salgado CD, Weinstein RA, Wise R, Classen D. A compendium of strategies to prevent healthcare-associated infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008 Oct;29 Suppl 1:S12-21. doi: 10.1086/591060.
PubMed 18840084Lo E, Nicolle L, Classen D, Arias KM, Podgorny K, Anderson DJ, Burstin H, Calfee DP, Coffin SE, Dubberke ER, Fraser V, Gerding DN, Griffin FA, Gross P, Kaye KS, Klompas M, Marschall J, Mermel LA, Pegues DA, Perl TM, Saint S, Salgado CD, Weinstein RA, Wise R, Yokoe DS. Strategies to prevent catheter-associated urinary tract infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008 Oct;29 Suppl 1:S41-50. doi: 10.1086/591066. No abstract available.
PubMed 18840088Dziura JD, Post LA, Zhao Q, Fu Z, Peduzzi P. Strategies for dealing with missing data in clinical trials: from design to analysis. Yale J Biol Med. 2013 Sep 20;86(3):343-58. eCollection 2013 Sep.
PubMed 24058309Ellahi 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 34184246Lang P, Quezada Y, Whiteside J. Urinary Catheter Management Approaches Among Women Undergoing Benign Gynecologic Surgery: A Randomized Trial. Female Pelvic Med Reconstr Surg. 2020 Dec 1;26(12):e73-e77. doi: 10.1097/SPV.0000000000000781.
PubMed 31688528
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Investigators Reduce Urinary Catheter Use and Lower Urinary Tract Infection Among Women Undergoing Benign Gynecologic Surgery?
- ClinicalTrials.gov ID
- NCT03127280
- Acronym / sponsor ID
- CAUTI / 14-38
- Conditions
- Urinary Tract Infections, Urinary Retention, Satisfaction
- Keywords
- urinary tract infections, postoperative voiding dysfunction, foley removal, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Christ HospitalUniversity, hospital or other
- Study start
- 4 Nov 2014 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 14 Jan 2018 (actual)
- First posted
- 25 Apr 2017 (actual)
- 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.
This is a randomized comparative trial investigating two different catheter management strategies among post-gynecologic surgery patients. Women undergoing any benign gynecologic surgery wherein they are anticipated to stay at least overnight and in whom no prolapse or urinary tract surgery was concurrently performed, will be randomly assigned to either conventional urinary catheter care removal on post-operative day 1 or same day surgery urinary catheter removal. Patient satisfaction and lower urinary tract symptoms including urine culture and antibiotic use will be tracked across both cohorts over the 2 weeks following the index surgery.
Detailed description
METHODS:
This study will be conducted at The Christ Hospital. Informed consent will be obtained from the patients in the pre-operative care unit prior to administration of any medications. Candidates for the study will clearly understand consenting to enroll in the study includes not only the randomized assignment of urinary catheter care postoperatively but also a follow-up phone survey to be administered approximately 2 weeks after discharge. Patient reasons for not enrolling in the study will be recorded.
Study population All women presenting to The Christ Hospital for gynecologic surgery anticipated to require an at least 1 night stay and in whom would be expected to have an indwelling catheter overnight are eligible to participate in the study. Patients with a current urinary tract infection being treated with antibiotic(s), anticipated concomitant prolapse or incontinence surgery, a preoperative diagnosis of gynecologic malignancy, a history of chronic indwelling catheter use, a history of renal transplant or current dialysis use, or intraoperative lower urinary tract injury necessitating prolonged postoperative catheter use are to excluded from study participation. Following application of the inclusion and exclusion criteria, postoperative urinary catheter care (conventional vs. fast track) will randomized upon arrive to the postoperative care unit (PACU). These patients will compose the study population.
Protocol:
Per routine anesthesia practice once a patient has met criteria for discharge from the PACU, and following randomization into either the conventional or fast track cohorts, the subject will either have immediate removal of the catheter with a trial of void or the catheter will remain in place over night per routine practice with a trial of void arranged at the time of discharge.
The trial of void protocol will consist of backfilling the existing catheter with 300cc of sterile saline (or to a volume the patient reports to be subjectively full) and recording her voided volume that should occur within 30 minutes. The patient's self-reported percent of normal force of stream will be recorded (0-100% in 10% increments) along with her voided volume. If the patient voids at least 150cc of the instilled volume OR reports at least a >50% of normal force of stream she will be considered to have passed the voiding trial. The patient will be scanned for residual urine volume following the next spontaneous void or any time she reports symptoms consistent with obstructed voiding.
Duration of catheter use will be determined as the time from placement in the operating room (time 0) to the time it is removed on the hospital ward. Time will be recorded in hours. Discharge from the hospital will occur per the attending physician's routine practice. At hospital discharge subjects will complete a brief survey recording bladder function before and during their hospitalization. Also included in this survey will be an assessment of their overall satisfaction with their catheter management and hospital stay. Institution standard practice is to obtain a urinalysis in the operating room on all patients anticipating an overnight stay. This urinalysis and any other urine studies obtained during the hospitalization will be extracted from the medical record. The number of subjects who fail the trial of voiding between cohorts will be collected from the electronic medical record (EMR). After discharge, subjects will be contacted by phone 2-3 weeks after the index surgery. At this call subjects will be administered a survey reviewing their post-surgery bladder function including symptoms of a bladder infection. A review of the patient's hospital record will also be conducted to identify any additional urine studies ordered during the 2-3 weeks following surgery.
Randomization protocol: Permuted block randomization will be used to ensure a balanced enrollment of patients in the clinical trial. Selecting a block size of 4 will ensure that for every four patients enrolled, 2 will be assigned to the "Fast-track" cohort and 2 will be assigned to the "Conventional" cohort. In order to effectively conceal the randomization sequence, investigators will use sequentially numbered, opaque sealed envelopes (SNOSE). It will not be feasible to blind the physician, nurse and patient in this study, they will all be aware of the randomized allocation assignment. The study personnel administering the postoperative telephone questionnaires will be blinded by simply not informing them of the group allocation of the patient. Plans to manage incomplete data between cohorts will include meeting with nursing managers and supervisors to ensure that questions are completed and to verify how to enter information into the EMR. At the completion of the study every effort will be made to have all patient questionnaire completed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Conventional Foley Care | No intervention | –Following surgery, the patient's Foley catheter is removed on the morning of post-operative day one. |
| Fast Tract Foley care | Experimental | Other: Fast Track foley removalFollowing surgery, the patient's Foley catheter is removed on post-operative day zero, four hours after the completion of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All women, over the age of 18, presenting to The Christ Hospital for gynecologic surgery anticipated to require an at least 1 night stay and in whom would be expected to have an indwelling catheter overnight are eligible to participate in the study.
Key exclusion criteria (1 listed)
- Patients with a current urinary tract infection being treated with antibiotic(s), anticipated concomitant prolapse or incontinence surgery, a preoperative diagnosis of gynecologic malignancy, a history of chronic indwelling catheter use, a history of renal transplant or current dialysis use, or intraoperative lower urinary tract injury necessitating prolonged postoperative catheter use are to excluded from study participation.
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 |
|---|---|---|
| Fast Track foley removalFoley catheter is removed at 4 hours after surgery | Other | Fast Tract Foley care |
Primary outcome
Foley Duration
Time frame: Between 4 hours after surgery completion to 24 hours after surgery completion
Determine the duration (in hours) of urinary catheter use between conventional urinary catheter care and "fast track" urinary catheter care among women undergoing benign gynecologic surgery not involving lower urinary tract surgery or pelvic organ prolapse repair.
3 secondary outcomes
Incidence of urinary tract infection
Time frame: 2-3 weeks after surgery
Patient satisfaction
Time frame: 2-3 weeks after surgery
Voiding dysfunction
Time frame: Between 4 hours after surgery completion to 24 hours after surgery completion.
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 30 Jan 2018.
- Background: PubMed 17980238Apisarnthanarak A, Rutjanawech S, Wichansawakun S, Ratanabunjerdkul H, Patthranitima P, Thongphubeth K, Suwannakin A, Warren DK, Fraser VJ. Initial inappropriate urinary catheters use in a tertiary-care center: incidence, risk factors, and outcomes. Am J Infect Control. 2007 Nov;35(9):594-9. doi: 10.1016/j.ajic.2006.11.007.
- Background: PubMed 21460463Umscheid CA, Mitchell MD, Doshi JA, Agarwal R, Williams K, Brennan PJ. Estimating the proportion of healthcare-associated infections that are reasonably preventable and the related mortality and costs. Infect Control Hosp Epidemiol. 2011 Feb;32(2):101-14. doi: 10.1086/657912.
- Background: PubMed 21315996Chenoweth CE, Saint S. Urinary tract infections. Infect Dis Clin North Am. 2011 Mar;25(1):103-15. doi: 10.1016/j.idc.2010.11.005. Epub 2010 Dec 18.
- Background: PubMed 10679141Saint S. Clinical and economic consequences of nosocomial catheter-related bacteriuria. Am J Infect Control. 2000 Feb;28(1):68-75. doi: 10.1016/s0196-6553(00)90015-4.
- Background: PubMed 8875302Jarvis WR. Selected aspects of the socioeconomic impact of nosocomial infections: morbidity, mortality, cost, and prevention. Infect Control Hosp Epidemiol. 1996 Aug;17(8):552-7. doi: 10.1086/647371.
- Background: PubMed 11868889Tambyah PA, Knasinski V, Maki DG. The direct costs of nosocomial catheter-associated urinary tract infection in the era of managed care. Infect Control Hosp Epidemiol. 2002 Jan;23(1):27-31. doi: 10.1086/501964.
- Background: PubMed 10879567Saint S, Veenstra DL, Lipsky BA. The clinical and economic consequences of nosocomial central venous catheter-related infection: are antimicrobial catheters useful? Infect Control Hosp Epidemiol. 2000 Jun;21(6):375-80. doi: 10.1086/501776.
- Background: PubMed 17517855Albo ME, Richter HE, Brubaker L, Norton P, Kraus SR, Zimmern PE, Chai TC, Zyczynski H, Diokno AC, Tennstedt S, Nager C, Lloyd LK, FitzGerald M, Lemack GE, Johnson HW, Leng W, Mallett V, Stoddard AM, Menefee S, Varner RE, Kenton K, Moalli P, Sirls L, Dandreo KJ, Kusek JW, Nyberg LM, Steers W; Urinary Incontinence Treatment Network. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med. 2007 May 24;356(21):2143-55. doi: 10.1056/NEJMoa070416. Epub 2007 May 21.
- Background: PubMed 18840084Yokoe DS, Mermel LA, Anderson DJ, Arias KM, Burstin H, Calfee DP, Coffin SE, Dubberke ER, Fraser V, Gerding DN, Griffin FA, Gross P, Kaye KS, Klompas M, Lo E, Marschall J, Nicolle L, Pegues DA, Perl TM, Podgorny K, Saint S, Salgado CD, Weinstein RA, Wise R, Classen D. A compendium of strategies to prevent healthcare-associated infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008 Oct;29 Suppl 1:S12-21. doi: 10.1086/591060.
- Background: PubMed 18840088Lo E, Nicolle L, Classen D, Arias KM, Podgorny K, Anderson DJ, Burstin H, Calfee DP, Coffin SE, Dubberke ER, Fraser V, Gerding DN, Griffin FA, Gross P, Kaye KS, Klompas M, Marschall J, Mermel LA, Pegues DA, Perl TM, Saint S, Salgado CD, Weinstein RA, Wise R, Yokoe DS. Strategies to prevent catheter-associated urinary tract infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008 Oct;29 Suppl 1:S41-50. doi: 10.1086/591066. No abstract available.
- Background: PubMed 24058309Dziura JD, Post LA, Zhao Q, Fu Z, Peduzzi P. Strategies for dealing with missing data in clinical trials: from design to analysis. Yale J Biol Med. 2013 Sep 20;86(3):343-58. eCollection 2013 Sep.
- 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.
- Individual participant dataSharing planned: No
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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.
Patrick Lang, MD principal investigator
The Christ Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast Track foley removal in people with Urinary Tract Infections and Urinary Retention, run by The Christ Hospital 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 1 inclusion and 1 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 30 Jan 2018. 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 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?
Foley Duration (time frame: Between 4 hours after surgery completion to 24 hours after surgery completion). 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 NCT03127280, which also lists 13 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 30 Jan 2018.