Clinical trial NCT03609476: Trial of Void With Saline Bladder Instillation
Official title: Trial of Void With Saline Bladder Instillation, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urethral Catheter Removal After Urologic Procedure
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is being done to see if there is a difference between the traditional method of removing a urethral catheter after surgery and waiting for the patient to urinate on their own to the saline instillation method which places either room temperature or warmed saline into the patient's bladder through the catheter before removing the catheter.

Detailed description: Voiding trials after surgery to remove a catheter can be done in different ways.

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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing trial of void after placement of indwelling urethral catheter after urologic procedure

Exclusion Criteria:

* Patient incontinent at baseline.
* 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.

Primary outcomes:
measure: Time from catheter removal to determination of passing void trial
timeFrame: 6 hours
Secondary outcomes:
measure: Catheter free rate
timeFrame: 30 days
measure: Urinary tract infection free rate
timeFrame: 30 days
measure: Post void residual (PVR)
timeFrame: Within 30 days
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical College
state: New York
Study officials:
affiliation: Albany Medical College, Division of Urology
name: Ronald P Kaufman, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Tambyah PA, Oon J. Catheter-associated urinary tract infection. Curr Opin Infect Dis. 2012 Aug;25(4):365-70. doi: 10.1097/QCO.0b013e32835565cc.
citation: 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.