Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
108 participants
INTERVENTIONAL
2017-05-24
2020-05-19
Brief Summary
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Detailed Description
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Traditional method: The catheter is removed and the patient will attempt to void.
Room temperature saline instillation: Room temperature saline will be placed in the patients bladder through the catheter. The catheter will be removed and the patient will attempt to void.
Warmed saline group: Saline that has been warmed to 37C will be placed in the patients bladder through the catheter. The catheter will be removed and the patient will attempt to void.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Standard of care group
No saline instillation
No saline instillation
No saline is used prior to catheter removal
Room temperature saline group
room temperature saline instillation
Room temperature saline instillation
Saline is used as room temperature
Warmed saline group
warmed saline instillation
Warmed saline instillation
Saline is warmed to 37Celcius prior to instillation
Interventions
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Room temperature saline instillation
Saline is used as room temperature
Warmed saline instillation
Saline is warmed to 37Celcius prior to instillation
No saline instillation
No saline is used prior to catheter removal
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patient has chronic indwelling urinary catheter or uses clean intermittent catheterization at home.
* Patient has documented neurogenic bladder.
* No trained person to administer the instillation or perform consent.
* Patient refusal to participate.
* Patient unable to give informed consent.
* Patient is a prisoner.
* Patient is pregnant.
* Patient unable to participate in notifying nursing of voids.
* Nursing is unable to measure post void residual with bladder scan machine secondary to body habitus or other anatomical abnormality.
18 Years
ALL
No
Sponsors
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Ronald Kaufman, MD
OTHER
Responsible Party
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Ronald Kaufman, MD
Associate Professor of Surgery
Principal Investigators
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Ronald P Kaufman, Jr., MD
Role: PRINCIPAL_INVESTIGATOR
Albany Medical College, Division of Urology
Locations
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Albany Medical College
Albany, New York, United States
Countries
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References
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Baldini G, Bagry H, Aprikian A, Carli F. Postoperative urinary retention: anesthetic and perioperative considerations. Anesthesiology. 2009 May;110(5):1139-57. doi: 10.1097/ALN.0b013e31819f7aea.
Emberton M, Fitzpatrick JM. The Reten-World survey of the management of acute urinary retention: preliminary results. BJU Int. 2008 Mar;101 Suppl 3:27-32. doi: 10.1111/j.1464-410X.2008.07491.x.
Boccola MA, Sharma A, Taylor C, Wong LM, Travis D, Chan S. The infusion method trial of void vs standard catheter removal in the outpatient setting: a prospective randomized trial. BJU Int. 2011 Apr;107 Suppl 3:43-6. doi: 10.1111/j.1464-410X.2011.10044.x.
Du J, Marshall D, Leyland J, Shaw L, Broome KE, Mason DF. Prospective, multicentre, randomized controlled trial of bladder filling prior to trial of void on the timing of discharge. ANZ J Surg. 2013 Apr;83(4):239-42. doi: 10.1111/j.1445-2197.2012.06253.x. Epub 2012 Sep 18.
Wilson ID, Bramwell SP, Hollins GW. A randomized trial comparing bladder infusion with standard catheter removal after transurethral resection of the prostate. BJU Int. 2000 Dec;86(9):993-5. doi: 10.1046/j.1464-410x.2000.00963.x.
Foster RT Sr, Borawski KM, South MM, Weidner AC, Webster GD, Amundsen CL. A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing after transvaginal surgery. Am J Obstet Gynecol. 2007 Dec;197(6):627.e1-4. doi: 10.1016/j.ajog.2007.08.017.
Pulvino JQ, Duecy EE, Buchsbaum GM, Flynn MK. Comparison of 2 techniques to predict voiding efficiency after inpatient urogynecologic surgery. J Urol. 2010 Oct;184(4):1408-12. doi: 10.1016/j.juro.2010.05.096. Epub 2010 Aug 19.
Lyth DR, Braslis K, Iacovou JW. The infusion trial of micturition. Br J Urol. 1997 Jan;79(1):94-5. doi: 10.1046/j.1464-410x.1997.30520.x.
Noble JG, Menzies D, Cox PJ, Edwards L. Midnight removal: an improved approach to removal of catheters. Br J Urol. 1990 Jun;65(6):615-7. doi: 10.1111/j.1464-410x.1990.tb14830.x.
Crowe H, Clift R, Duggan G, Bolton D, Costello A. Randomized study of the effect of midnight removal of urinary catheters. Urol Nurs. 1994 Mar;14(1):18-20.
Zimlichman E, Henderson D, Tamir O, Franz C, Song P, Yamin CK, Keohane C, Denham CR, Bates DW. Health care-associated infections: a meta-analysis of costs and financial impact on the US health care system. JAMA Intern Med. 2013 Dec 9-23;173(22):2039-46. doi: 10.1001/jamainternmed.2013.9763.
Richards MJ, Edwards JR, Culver DH, Gaynes RP. Nosocomial infections in combined medical-surgical intensive care units in the United States. Infect Control Hosp Epidemiol. 2000 Aug;21(8):510-5. doi: 10.1086/501795.
Klevens RM, Edwards JR, Richards CL Jr, Horan TC, Gaynes RP, Pollock DA, Cardo DM. Estimating health care-associated infections and deaths in U.S. hospitals, 2002. Public Health Rep. 2007 Mar-Apr;122(2):160-6. doi: 10.1177/003335490712200205.
Maki DG, Tambyah PA. Engineering out the risk for infection with urinary catheters. Emerg Infect Dis. 2001 Mar-Apr;7(2):342-7. doi: 10.3201/eid0702.010240.
Stenzelius K, Persson S, Olsson UB, Stjarneblad M. Noble metal alloy-coated latex versus silicone Foley catheter in short-term catheterization: a randomized controlled study. Scand J Urol Nephrol. 2011 Sep;45(4):258-64. doi: 10.3109/00365599.2011.560007. Epub 2011 Mar 31.
Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA; Healthcare Infection Control Practices Advisory Committee. Guideline for prevention of catheter-associated urinary tract infections 2009. Infect Control Hosp Epidemiol. 2010 Apr;31(4):319-26. doi: 10.1086/651091. No abstract available.
Hooton TM, Bradley SF, Cardenas DD, Colgan R, Geerlings SE, Rice JC, Saint S, Schaeffer AJ, Tambayh PA, Tenke P, Nicolle LE; Infectious Diseases Society of America. Diagnosis, prevention, and treatment of catheter-associated urinary tract infection in adults: 2009 International Clinical Practice Guidelines from the Infectious Diseases Society of America. Clin Infect Dis. 2010 Mar 1;50(5):625-63. doi: 10.1086/650482.
Tambyah PA, Oon J. Catheter-associated urinary tract infection. Curr Opin Infect Dis. 2012 Aug;25(4):365-70. doi: 10.1097/QCO.0b013e32835565cc.
Glynn A WV, Wilson J, et al. Hospital acquired infection: surveillance, policies and practice-a study of the control of hospital acquired infection in hospitals in England and Wales. In: Service PHL, ed. London1997.
Other Identifiers
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AMC4851
Identifier Type: -
Identifier Source: org_study_id
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