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Políticas de lavado para el tratamiento de adultos con sonda urinaria permanente a largo plazo

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Referencias

References to studies included in this review

Airaksinen 1979 {published data only}

Airaksinen P, Sinkkonen S, Bolodin M, Jauhiainen R. A clinical study on patients with indwelling catheters [Kestokatetrihoiden Kliininen Tutkimus]. Duodecim 1979;95(4):164‐70. CENTRAL

Kennedy 1992 {published data only}

Kennedy AP, Brocklehurst JC, Robinson JM, Faragher EB. Assessment of the use of bladder washouts/instillations in patients with long‐term indwelling catheters. British Journal of Urology 1992;70(6):610‐5. [sr‐incont1356]CENTRAL

Linsenmeyer 2014 {published data only}

Linsenmeyer T, Goetz L, Kennelly M, Najafi RR, Costerton W, Stickler D, et al. Auriclosene irrigation solution reduces indwelling urinary catheter encrustation and prevents blockage: Results of a phase 2 clinical study (Abstract number PD37‐10). Journal of Urology 2014;191(4 Suppl 1):e949. [sr‐incont67145]CENTRAL
NCT01243125, Krantz KD. Study to evaluate NVC‐422 for urinary catheter blockage and encrustation. https://clinicaltrials.gov/ct2/show/NCT01243125 (accessed 15 June 2016). [sr‐incont60016]CENTRAL

McNicoll 2003 {published data only}

McNicoll D. Encrusted urinary catheters: how should nurses manage them?. Journal of Community Nursing 2003;17(12):10‐4. CENTRAL

Moore 2009 {published data only}

Moore KN, Hunter KF, McGinnis R, Bacsu C, Fader M, Getliffe K, et al. Do catheter washouts extend patency time in long term urethral catheters? A randomized controlled trial of acidic washout solution, normal saline washout, or standard care. Journal of Wound Ostomy and Continence Nursing 2009;36(1):82‐90. CENTRAL

Muncie 1989 {published data only}

Muncie HL, Hoopes JM, Damron DJ, Tenney JH, Warren JW. Once‐daily irrigation of long‐term urethral catheters with normal saline. Lack of benefit. Archives of Internal Medicine 1989;149(2):441‐3. CENTRAL

Waites 2006 {published data only}

Waites KB, Canupp KC, Roper JF, Camp SM, Chen Y. Evaluation of 3 methods of bladder irrigation to treat bacteriuria in persons with neurogenic bladder. Journal of Spinal Cord Medicine 2006;29(3):217‐26. CENTRAL

References to studies excluded from this review

Andersson 1986 {published data only}

Andersson H. A double‐blind randomized comparison of the effect and tolerance of Varidase versus saline when instilled in the urinary bladder in patients with catheter problems. Journal of International Medical Research 1986;14(2):91‐4. [ISSN 0300‐0605 (Print)]CENTRAL

Bach 1990 {published data only}

Bach D, Hesse A, Prange CH. Prevention of incrustations and urinary tract infections during transurethral continuous catheterization [Inkrustations‐ und Harnwegsinfekt‐ prophylaxe beim transurethralen Dauerkatheter]. TW Urologie Nephrologie 1990;2(1):25‐32. [ISSN 0936‐2002]CENTRAL

Bruun 1978 {published data only}

Bruun JN, Digranes A. Bladder irrigation in patients with indwelling catheters. Scandinavian Journal of Infectious Diseases 1978;10(1):71‐4. CENTRAL

Davies 1987 {published data only}

Davies AJ, Desai HN, Turton S, Dyas A. Does instillation of chlorhexidine into the bladder of catheterized patients help reduce bacteriuria?. Journal of Hospital Infection 1987;9(1):72‐5. [ISSN 0195‐6701 (Print)]CENTRAL

Elliott 1989 {published data only}

Elliott TSJ, Reid L, Gopal Rao G, Rigby RC, Woodhouse K. Bladder irrigation or irritation?. British Journal of Urology 1989;64(4):391‐4. [ISSN 0007‐1331]CENTRAL

Elliott 1990 {published data only}

Elliott TS. Disadvantages of bladder irrigation. Nursing Times 1990;86(4):52. CENTRAL

Furuno 1998 {published data only}

Furuno T. Usefulness of bladder irrigation with super oxidation water (Abstract). Japan Medical Society of Paraplegia. 1998; Vol. 12, issue 1:244‐5. [ISSN 0914‐6822]CENTRAL

Gelman 1980 {published data only}

Gelman ML. Antibiotic irrigation and catheter‐associated urinary tract infections. Nephron 1980;25(5):259. CENTRAL

Kennedy 1984 {published data only}

Kennedy A. Trial of a new bladder washout system. Nursing Times 1984;80(46):48‐51. [MEDLINE: 2583]CENTRAL

Meyers 1964 {published data only}

Meyers MS, Schroeder BC, Martin CM. Controlled trial of nitrofurazone and neomycin‐polymyxin as constant bladder rinses for prevention of post indwelling catheterisation bacteriuria. Antimicrobial Agents and Chemotherapy 1964;8:571‐81. CENTRAL

Robertson 1990 {published data only}

Robertson MH, Norton MS. Effect of 1% mandelic acid as a bladder irrigation fluid in patients with in‐dwelling catheters. British Journal of Clinical Practice 1990;44(4):142‐4. CENTRAL

Ruwaldt 1983 {published data only}

Ruwaldt MM. Irrigation of indwelling urinary catheters. Urology 1983;21(2):127‐9. CENTRAL

Vainrub 1977 {published data only}

Vainrub B, Musher DM. Lack of effect of methenamine in suppression of, or prophylaxis against, chronic urinary infection. Antimicrobial Agents and Chemotherapy 1977;12(5):625‐9. [ISSN 0066‐4804]CENTRAL

Warren 1978 {published data only}

Warren JW, Platt R, Thomas RJ, Rosner B, Kass EH. Antibiotic irrigation and catheter‐associated urinary‐tract infections. New England Journal of Medicine 1978;299(11):570‐3. [MEDLINE: 1068]CENTRAL

NCT02130518 {published data only}

NCT02130518, Krantz KD, Iovino SM. Efficacy study of auriclosene irrigation solution on urinary catheter patency [A multicenter, randomized, double‐blind, three‐arm efficacy study of auriclosene irrigation solution on indwelling urinary catheter patency]. https://clinicaltrials.gov/show/NCT02130518 2014 (accessed 15 June 2016) (first received 1 May 2014). [sr‐incont60927]CENTRAL

Atkins 2004

Atkins D, Best D, Briss PA, Eccles M, Falck‐Ytter Y, Flottorp S, and GRADE Working Group. Grading quality of evidence and strength of recommendations. BMJ 2004;328(7454):1490‐7.

Bibby 1993

Bibby JM, Hukins DW. Acidification of urine is not a feasible method for preventing encrustation of indwelling urinary catheters. Scandinavian Journal of Urology and Nephrology 1993;27(1):63‐5.

Capewell 1993

Capewell AE, Morris SL. Audit of catheter management provided by district nurses and continence advisors. British Journal of Urology 1993;71(3):259‐64.

ECDC 2014

European Centre for Disease Prevention and Control (ECDC). Surveillance report. Point prevalence survey of healthcare‐associated infections and antimicrobial use in European long‐term care facilities. April‐May 2013. http://ecdc.europa.eu/en/publications/_layouts/forms/Publication_DispForm.aspx?List=4f55ad51‐4aed‐4d32‐b960‐af70113dbb90&ID=1087 2014 (accessed 15 June 2016). [DOI: 10.2900/24172; ISBN 978‐92‐9193‐571‐0]

Evans 2000

Evans A, Pheby D, Painter D, Feneley R. The costs of long‐term catheterization in the community. British Journal of Community Nursing 2000;5(10):477‐88.

Garibaldi 1974

Garibaldi RA, Burke JP, Dickman ML, Smith CB. Factors predisposing to bacteriuria during indwelling urethral catheterization. New England Journal of Medicine 1974;291(5):215‐9.

Getliffe 1992

Getliffe KA. Encrustation of urinary catheters in community patients [PhD thesis]. Guildford (UK): University of Surrey, 1992.

Getliffe 1994

Getliffe KA. The use of bladder wash‐outs to reduce urinary catheter encrustation. British Journal of Urology 1994;73(6):696‐700. [MEDLINE: 94306075]

Getliffe 1996

Getliffe KA. Bladder instillations and bladder washouts in the management of catheterized patients. Journal of Advanced Nursing 1996;23(3):548‐54.

Getliffe 2003

Getliffe K. Managing recurrent urinary catheter blockage: problems, promises, and practicalities. Journal of Wound, Ostomy, and Continence Nursing 2003;30(3):146‐51.

Getliffe 2006

Getliffe K, Newton T. Catheter‐associated urinary tract infection in primary and community health care. Age and Ageing 2006;35(5):477‐81.

Gould 2010

Gould CV, Umscheid CA, Agarwal RK, Kuntz GK, Pegues DA: Healthcare Infection Control Practices Advisory Committee. Guideline for prevention of catheter‐associated urinary tract infections 2009. Infection control and Hospital Epidemiology 2010;31(4):319‐26.

GRADEpro GDT 2015 [Computer program]

McMaster University (developed by Evidence Prime Inc). GRADEpro GDT. Hamilton (ON), Canada: GRADE Working Group, McMaster University, 2015. Available at: http://gradepro.org (accessed 31 January 2017).

Hamory 1978

Hamory BH, Wenzel RP. Hospital‐associated candiduria: predisposing factors and review of the literature. Journal of Urology 1978;120(4):444‐8.

Hesse 1989

Hesse A, Schreyger F, Tuschewitzki GJ, Classen A, Bach D. Experimental investigations on dissolution of incrustations on the surface of catheters. Urologia Internationalis 1989;44(6):364‐9.

Hesse 1992

Hesse A, Nolde A, Klump B, Marklein G, Tuschewitzki GJ. In vitro investigations into the formation and dissolution of infection‐induced catheter encrustations. British Journal of Urology 1992;70(4):429‐34.

Higgins 2011

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.

HIS 2004

Healthcare Improvement Scotland. Urinary catheterisation and catheter care. Best practice statement. www.healthcareimprovementscotland.org/previous_resources/best_practice_statement/urinary_catheterisation__care.aspx June 2004 (accessed prior to 9 February 2017).

King 1991

King JB, Stickler DJ. An assessment of antiseptic bladder washout solutions using a physical model of the catheterized bladder. Journal of Hospital Infection 1991;18(3):179‐90. [MEDLINE: 92012952]

Kohler‐Ockmore 1996

Kohler‐Ockmore J, Feneley RCL. Long‐term catheterization of the bladder: prevalence and morbidity. British Journal of Urology 1996;77(3):347‐51.

Kunin 1987

Kunin CM, Chin QF, Chambers S. Indwelling urinary catheters in the elderly. Relation of "catheter life" to formation of encrustations in patients with and without blocked catheters. American Journal of Medicine 1987;82(3):405‐11.

Padawer 2015

Padawer D, Pastukh N, Nitzan O, Labay K, Aharon I, Brodsky D, et al. Catheter‐associated candiduria: Risk factors, medical interventions, and antifungal susceptibility. American Journal of Infection Control 2015;43(7):e19‐22.

Pellowe 2003

Pellowe CM, Pratt RJ, Harper P, Loveday HP, Robinson N, Jones SR, et al. Evidence‐based guidelines for preventing healthcare‐associated infections in primary and community care in England. Journal of Hospital Infection 2003;55(Suppl 2):S2‐127.

Pomfret 2004

Pomfret I, Bayait F, Mackenzie R, Wells M, Winder A. Using bladder instillations to manage indwelling catheters. British Journal of Nursing 2004;13(5):261‐7.

Reference Manager 2012 [Computer program]

Thomson Reuters. Reference Manager Professional Edition Version 12. New York: Thomson Reuters, 2012.

RevMan 2014 [Computer program]

Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager 5 (RevMan 5). Version 5.3. Copenhagen: Nordic Cochrane Centre, The Cochrane Collaboration, 2014.

Roe 1987

Roe BH, Brocklehurst JC. Study of patients with indwelling catheters. Journal of Advanced Nursing 1987;12(6):713‐8.

Saint 1999

Saint S, Lipsky BA. Preventing catheter‐related bacteriuria: should we? Can we? How?. Archives of Internal Medicine 1999;159(8):800‐8.

SIGN 2012

Scottish Intercollegiate Guidelines Network (SIGN). Management of suspected bacterial urinary tract infection in adults: a national clinical guideline. www.sign.ac.uk/guidelines/fulltext/88/. Edinburgh: SIGN, Healthcare Improvement Scotland, 2012 (updated edition published July 2012) (accessed 15 June 2016). [ISBN 978 1 905813 88 9]

Stark 1984

Stark RP, Maki DG. Bacteriuria in the catheterized patient. What quantitative level of bacteriuria is relevant?. New England Journal of Medicine 1984;311(9):560‐4.

Stickler 2010

Stickler DJ, Feneley RCL. The encrustation and blockage of long‐term indwelling bladder catheters: a way forward in prevention and control. Spinal Cord 2010;48(11):784‐90.

Sørbye 2005

Sørbye LW, Finne‐Soveri H, Ljunggren G, Topinková E, Bernabei R. Indwelling catheter use in home care: elderly, aged 65+, in 11 different countries in Europe. Age and Ageing 2005;34(4):377‐81.

Ware 1993

Ware JE. Measuring patients’ views: the optimum outcome measure. SF‐36: a valid, reliable assessment of health from the patient’s point of view. British Medical Journal 1993;306(6890):1429‐30.

Wilks 2015

Wilks SA, Fader MJ, Keevil CW. Novel insights into the Proteus mirabilis crystalline biofilm using real‐time imaging. PloS One 2015;10(10):e0141711.

Zigmond 1983

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatrica Scandinavica 1983;67(6):361‐70.

References to other published versions of this review

Hagen 2010

Hagen S, Sinclair L, Cross S. Washout policies in long‐term indwelling urinary catheterisation in adults. Cochrane Database of Systematic Reviews 2010, Issue 3. [DOI: 10.1002/14651858.CD004012.pub4]

Sinclair 2006

Sinclair L, Cross S, Hagen S, Niël‐Weise BS. Washout policies for the management of long‐term indwelling urinary catheterisation in adults. Cochrane Database of Systematic Reviews 2006, Issue 1. [DOI: 10.1002/14651858.CD004012.pub3]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Airaksinen 1979

Methods

Study design: RCT with 4 groups. The study set out to compare a washout with saline versus no washout and also different types of silicone catheters (Silicath and Silastic)

Study duration: Six months

Participants

Inclusion criteria: The inclusion criteria stated that participants required a long‐term indwelling catheter for a minimum of six months.

Setting: Hospital and home care

Country: Finland

Health status: Participants were in good general health

Number: treatment (N = 20); control (N = 20)

Age: Participants age range from 50 to 59 years up to 85 to 99 years

    • Treatment: Ages in groups (number of trials): 50 years to 59 years (2), 60 years to 69 years (3), 70 years to 74 years (2), 75 years to 79 years (3), 80 years to 84 years (7), 85 years to 99 years (3)

    • Control: Ages in groups (number of trials): 50 years to 59 years (1), 60 years to 69 years (2), 70 years to 74 years (6), 75 years to 79 years (5), 80 years to 84 years (3), 85 years to 99 years (3)

Sex: (m/f): 16/24

Exclusion criteria: Patients not in good general health or unlikely to survive the investigation period were excluded

Interventions

Treatment group 1

  • Intervention: Saline washout

  • Dose, duration, frequency, administration: Every two weeks, 10 mL or 20 mL

  • Other relevant information: Silicath catheter

Treatment group 2

  • Intervention: Saline washout

  • Dose, duration, frequency, administration: Every two weeks, 10 mL or 20 mL

  • Other relevant information: Silastic catheter

Control group 1

  • Intervention: No washout

  • Dose, duration, frequency, administration: Not applicable

  • Other relevant information: Silicath catheter

Control group 2

  • Intervention: No washout

  • Dose, duration, frequency, administration: Not applicable

  • Other relevant information: Silastic catheter

Outcomes

  • Bacteriuria rates

  • Symptomatic UTI rates

  • Visual encrustation rates

  • Rate of catheter obstruction/blockage

How outcomes were measured: Not provided in translated copy

Notes

Funding source: Not stated

Study written in Finnish and translated to English

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Stated random allocation but no description given

Allocation concealment (selection bias)

Unclear risk

Stated that 10 participants allocated to each of the 4 groups but no further details provided

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No mention

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No mention

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Numbers of participants who did not complete the trial is not clear and numbers do not appear to be consistent throughout the paper. Drop‐outs are given for different outcome measures

Selective reporting (reporting bias)

Unclear risk

Information on outcomes not fully reported in methods, therefore uncertainty about reporting bias

Other bias

Low risk

Appears to be free from other forms of bias

Kennedy 1992

Methods

Study design: 3 centre cross‐over RCT
‐ 3 interventions: A sodium chloride washout, B Suby G washout, C Solution R washout
‐ allocation by random number tables (i.e. to decide order in which 3 solutions administered)
Study duration: intervention duration: 12 weeks (1 week normal saline washout run‐in period, 3 x 3 week washout phase with each solution, and 1 week normal saline washout between interventions)

Participants

Inclusion criteria: Elderly women in long‐term geriatric care with long‐term catheter in situ

Setting: 3 geriatric hospitals

Country: UK

Health status: Not stated

Number: 25 entered trial. 11 women lost to follow up (5 died, 3 catheters removed, 2 withdrawn by nursing staff, 1 discharged). 14 women completed full 12 weeks of trial

Age: mean age 82 years, range 65 years to 100 years

Sex: Female

Other relevant Information: Catheter type and material not stated (type patient already wearing used); median duration catheter in situ at start of study: 12 months (range 1 month to 204 months)

Exclusion criteria: no exclusion criteria stated

Interventions

Intervention: Cross‐over study of 3 washout treatments

Group A: 3 weeks of twice weekly 0.9% sodium chloride washout
Group B: 3 weeks of twice weekly Suby G washout (citric acid 3.23%, light magnesium oxide 0.38%, sodium bicarbonate 0.7%, and disodium edetate 0.01%)
Group C: 3 weeks of twice weekly Solution R washout (citric acid 6%, gluconolactone 0.6%, light magnesium carbonate 2.8%, disodium edetate 0.01%)
Other relevant information: Each washout administered by attaching 100 mL sterile pre‐packed sachet to catheter and allowing to drain into bladder via gravity, clamped for 20 minutes to 30 minutes and then allowed to drain out. Catheters changed at weeks 1, 5, 9 and 12

Outcomes

  • Bacteriuria: patients with bacteria observed in washout fluid at end of washout period: A 100%, B 75%, C 76% (insufficient data presentation); conclusion was that treatment with acidic solutions did not prevent or reduce urease‐producers

  • Catheter blockage (definition of blocked catheter: eyes or lumen completely blocked, resulting in no flow of urine, definition of partially blocked catheter: still able to allow urine drainage): blocked catheters: A 18/44, B 14/29, C 7/27, partially blocked catheters: A 14/44, B 12/29, C 10/27, non‐encrusted catheters: A 12/44, B 3/29, C 10/27 (in each case denominator = no. of catheters)

  • Degree of visual encrustation: little difference between 3 treatments up to day 10, after which Solution R did not reduce encrustation (insufficient data presentation)

  • Mean episodes of bypassing per week: A 1.55, B 1.4, C 1.9 (insufficient data presentation); differences not statistically significant

  • Catheter removal/replacement: mean days catheter in situ: A 16.3, B 14.3, C 14.2 (insufficient data presentation); no significant differences between groups; only 3 patients retained catheter for full length of each trial period

  • Patients with red blood cells in washout fluid at end of washout period: A 21%, B 17%, C 14% (insufficient data presentation), higher counts during treatment B

  • Patients with urothelial cells in washout fluid at end of washout period: A 100%, B 86%, C 100% (insufficient data presentation), some evidence of a significant difference in the changes over time within the 3 treatments (Chi² (14) = 22.5, P = 0.068) but proportions all consistently high thus unlikely to be clinically significant

Other outcomes reported (not analysed within this review):

  • 1 patient developed haematuria following treatment with solution C

  • Type and volume of crystals observed in washout fluid: significantly more crystals found during saline washouts than during acidic solutions (Chi² (2) = 29.06, P < 0.001); struvite appeared significantly more often in the saline washouts than in the Suby G and Solution R washouts (Chi² (2) = 22.075, P < 0.001); uric acid crystals appeared with Suby G and Solution R; calcium oxalate was slightly more common in saline washouts than during the acidic treatments; urates were seen only during saline washouts; no difference between the 3 regimes at the end of each 3‐week washout period

  • White blood cells present in washout fluid: A 100%, B 87%, C 84% (insufficient data presentation); no significant differences between the 3 treatments (P not reported)

Notes

Funding source: Not stated

  • Analysis based on end‐point data available

  • Insufficient data to analyse any possible interactions involving treatment order

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random number tables used to determine the order of the solutions

Allocation concealment (selection bias)

Unclear risk

Procedure not described

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No mention of blinding

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No information given

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Stated numbers and reasons for drop‐outs/withdrawals

Selective reporting (reporting bias)

Low risk

All outcomes mentioned in methods appear in the results section. Protocol was not reviewed so some uncertainty regarding reporting bias

Other bias

Low risk

Appears to be free of other bias

Linsenmeyer 2014

Methods

Study design: prospective, randomised, double‐blind, cross‐over, multicentre clinical study, 3 part study

Study duration: 4 weeks

Participants

Inclusion criteria: Aged 18 years and older, spinal cord injury or other neurogenic bladder patient requiring a chronic indwelling urinary catheter with a history of 2 episodes of catheter blockage and/or encrustation, and urine pH 6.5

Setting: Not stated

Country: USA

Health status: Not stated

Number: 7 participants: Part 1 N = 20, Part 2 N = 28, Part 3 N = 19

Age: Age of total group (N = 67 years) mean 46.6 years (range = 21 years to 81 years)

Sex: male N = 50 (75%)

Other relevant Information: Catheter type: transurethral N = 34 (51%), suprapubic N = 33 (49%)

Exclusion criteria: Antibiotics within 7 days, current infections, recent history of autonomic dysreflexia

Interventions

  • Part 1: 0.2% auriclosene in preliminary formulation dosed over 2 weeks (3 times/week), Part 2: auriclosene dosed on same schedule as part 1, Part 3: auriclosene dosed for 4 weeks (2 times/week). The control for all parts was 0.9% w/v saline

  • Participants randomised to one irrigation solution for the first treatment regimen and after a washout period, irrigated with the other solution. A single treatment consisted of 2 sequential irrigations of 25 mL retained in the catheter for 15 minutes

Outcomes

Results are given from Part 3 of the study (N = 14 completed) only:

  • Mean % encrustation 'catheter patency' (95% CI): Auriclosene group 21.7 (2.1, 41.2), Saline group 76.9 (54.9, 98.8). Catheter luminal encrustations documented by computerised microscopic assessment

  • Percent of catheters removed for clinical blockage: Auriclosene group 14.3%, Saline group 64.3%

  • Percent of removed catheters that have 100% encrustation: Auriclosene group 0%, Saline group 64.3%

Notes

Funding source: NovaBay Pharmaceuticals

  • Numbers of participants completing parts 1, 2 and 3 were 14, 20 and 14 respectively

  • Further details of this study were found from the Clinical trials document (ClinicalTrials.gov: NCT01243125) and the pharmaceutical company responsible for the trial. Where appropriate, data has been used from these documents to augment the Linsenmeyer 2014 abstract.

  • Unclear how the data were analysed and whether analysis was appropriate for cross‐over trial design. Implied that the degree of encrustation data were analysed by group (i.e. all catheters after auriclosene vs all catheters after saline), and also within subject (i.e. paired analysis comparing each individual's encrustation after auriclosene and after saline)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Randomisation generation not reported

Allocation concealment (selection bias)

Unclear risk

Randomisation concealment not reported

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Described as double‐blinded in ClinicalTrials.gov: NCT01243125. As this trial compared one washout versus another, this would have been possible in this trial

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No information given

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No details provided although the number of drop‐outs per part of study can be calculated

Selective reporting (reporting bias)

Low risk

The outcomes mentioned in the methods section were reported in the results

Other bias

Low risk

Appears to be free of other bias

McNicoll 2003

Methods

Study design: Single centre parallel group RCT with 2 groups: Group A ‐ citric acid catheter maintenance solutions (CMS), Group B ‐ planned catheter changes

Study duration: 12 weeks

Participants

Inclusion criteria: Community‐based patients with long‐term catheters known to block with encrustation

Setting: Community

Country: UK

Health status: Not stated

Number: 11 participants enrolled in trial (number allocated to each group not stated), 7 participants lost to follow‐up (reasons not stated), 4 patients analysed (Group A N = 1, Group B N = 3)

Age: Not stated

Sex: Not stated

Other relevant Information: urethral catheters, material not stated, duration catheter in situ at start of study not stated

Exclusion criteria: Not stated

Interventions

  • Group A: daily instillation of citric acid CMS, volume used and method of administration not stated (108 patient contacts)

  • Group B: planned catheter removal (approximately 55 patient contacts). Planned catheter change intervention varied: 1 patient had catheter changed twice a week, 1 patient had catheter changed when it showed signs of blocking, 1 patient had weekly pH tests and had catheter changed at beginning and end of the study

Outcomes

  • Catheter replacements: Group A: mean 9 (SD 0) (N = 1), Group B mean: 14.3 (SD 11.2) (N = 3)

  • Resources: time for intervention, Group A: mean 37.25 hours (SD 0) (N = 1), Group B: not reported (insufficient data presentation)

  • Cost of intervention: Group A: mean GBP 975.51 (SD 0) (N = 1), Group B: mean GBP 188.70 (SD GBP 102.90) (N = 3)

Notes

Funding source: Not stated

  • Analysis based on end point data available

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No information given

Allocation concealment (selection bias)

Unclear risk

No information given

Blinding of participants and personnel (performance bias)
All outcomes

High risk

No mention of blinding but not possible in a trial of washout versus catheter change

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No information given

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Stated numbers only (no reasons given)

Selective reporting (reporting bias)

High risk

Methods state that symptomatic UTI rates would be monitored. These data were not reported in the results and no reasons were provided

Other bias

Low risk

Appears to be free of other biases

Moore 2009

Methods

Study design: Parallel group RCT, 3 groups: catheter flush with saline vs acidic solution vs standard care (no washout)
Study duration: 8 weeks

Participants

Inclusion criteria: Indwelling catheter in situ longer than 30 days, regular blocker that required catheter changed every 3 weeks or less

Setting: Long‐term care setting or received home care

Country: Canada

Health status: Sufficiently alert according the mini‐mental state examination (MMSE score > 24)

Number: 73 enrolled, 53 completed

Age: Mean age 66.24 years (Contisol group mean 63.92 years, saline group mean 66.24 years, control group mean 68.56 years)

Sex (m/f): 36/37

Exclusion criteria: Symptomatic UTI (individuals were eligible for the study following successful treatment of the UTI after a symptom‐free period of 14 days); urethral erosion allowing continuous bypassing (leakage) around urinary catheter; history of bladder cancer, or radiation or interstitial cystitis; impaired renal function as evidenced by a serum creatinine level of 2.0 mg/dL or higher; gross haematuria; or indwelling catheter that was changed less frequently than every 8 weeks

Interventions

  • Group A: 8 weeks of usual care, no washout (control)

  • Group B: 8 weeks of weekly washout with 50 mL sterile normal saline washout

  • Group C: 8 weeks of weekly washout with 50 mL sterile Contisol solution (containing citric acid 3.23%, light magnesium oxide 0.38%, sodium bicarbonate 0.7%, and disodium edetate 0.01%)

Outcomes

  • Mean time to first catheter change: Contisol 4.57 (SD 2.61) (N = 19), saline 5.18 (SD 2.90) (N = 16), no washout 4.55 (SD 2.91) (N = 20)

  • Incidence of symptomatic UTI (defined as at least one of five indications with no other recognised cause: fever ≥ 38 degrees C, urgency, dysuria or suprapubic tenderness, haematuria or positive urine culture (≥ 100,000 micro‐organisms per cc of urine with no more than two species of microorganisms). None were detected in any group: Contisol 0/17, saline 0/16, control 0/20.

  • Incidence of microscopic haematuria. All participants had haematuria consistently (no data provided).

  • Incidence of microscopic leukocytes. All participants had haematuria consistently (no data provided).

  • Urine pH: mean pH 6.3 (SD 1.04) (range 5 to 8.5), not reported for groups

  • Measurement of cross sectional catheter lumen. slicing of first 50 catheters supported the theory that biofilm or encrustations begins at the catheter tip, first at the eyes, proceeding down the shaft. % of catheters with encrustation was low and the majority were obstructed with thick biofilm

Notes

Funding source: Alberta Heritage Foundation for Medical Research and the Canadian Nurses Foundation

  • Cross sectional measurement of catheter was abandoned as the method did not prove useful for comparing effectiveness of washouts

  • Data on all available patients was included in the Kaplan Meier analysis of time to first catheter change (with censoring when an individual withdrew, died, had a UTI treated with antibiotics, etc), however results on mean time to first catheter change are based on data for those who completed the trial only

  • Authors gave reviewers access to data for further analysis

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated random numbers

Allocation concealment (selection bias)

Low risk

Group allocation placed in opaque envelope, opened by participant

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Blinding of the participants to washout type attempted, not possible to blind the research nurse due to nature of the intervention and the packaging of washouts

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No information given. Assumed not done

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Stated numbers and reasons

Selective reporting (reporting bias)

Low risk

All outcomes mentioned in methods section were reported in the results

Other bias

Low risk

Appears to be free of other biases

Muncie 1989

Methods

Study design: Single centre cross‐over RCT, 2 interventions: Group A: normal saline irrigation, Group B: no irrigation

Study duration: 24 weeks (2‐week no irrigation run‐in period, 2 x 10 week irrigation/no irrigation phase, and 2‐week no‐irrigation washout period before entering alternate phase)

Participants

Inclusion criteria: Indwelling catheter in situ > 30 days, Females aged 18 years +, were afebrile (temperature ≤ 37.7º) for 7 days, had not received antibiotics for 14 days

Setting: Hospital and medical centre

Country: USA

Health Status: Not stated

Number: 44 women entered the trial, 21 women did not complete the full intervention (10 died, 4 discharged, 3 catheter removed, 4 physician request), 23 women completed the 24 week intervention (A first 10, B first 13), 9 women completed at least one phase and five weeks of the second phase of the study

Age: mean age 71 years, range 37 years to 88 years, 33 women were aged 65 years or over

Sex: Female

Other relevant Information: Catheter type: double lumen, 18 F, silicone‐coated latex urethral catheters

Exclusion criteria: Patients with malignant bladder neoplasms or patients whose physician insisted on continued bladder irrigation

Interventions

  • Group A: 10 weeks of once daily normal saline irrigation (30 mL via bladder syringe)

  • Group B: 10 weeks of no irrigation

  • New catheters inserted at beginning and end of each study phase, drainage bags changed weekly in both groups

  • Drainage bags with built‐in irrigation ports used that enabled irrigation without disruption of the closed catheter system

Outcomes

  • Bacteriuria: mean number of species (at ≥ 10⁵) per urine specimen: group A 4.0, group B 3.8. No standard deviations reported. 4 most prevalent organisms in each phase: Providencia stuartii, Escherichia coli, P mirabilis and Enterococcus spp; percentage of specimens in which each present was similar in each phase.

  • All episodes of high temperature: mean number of episodes of high temperature of possible urinary origin, 1st period: irrigation 1.6 (SD 1.7) (N = 10), non‐irrigation 0.9 (SD 1.1) (N = 13), 2nd period: irrigation 1.0 (SD 1.6) (N = 13), non‐irrigation 0.6 (SD 0.7) (N = 10)

  • Episodes of high temperature of possible urinary origin per 100 days of catheterisation: group A mean1.2 (SD 1.3) (N = 32), group B mean 0.9 (SD 1.1) (N = 32). Definition of episode of high temperature: consecutive days of fever (temperature > 37.7º) classified using predefined criteria of 44 diagnosis of infection and other causes of fever. If not thought to be from any of these then classed as of possible urinary origin.

  • Catheter replacements per 100 days of catheterisation: group A mean 5.5 (SD not reported) (N = 32), group B mean 4.7 (SD not reported) (N = 32)

  • Number of catheter replacements due to obstruction (N = 32): A 39, B 32, definition of catheter obstruction: absence of urine flow from the catheter that irrigation could not restore

  • Number of catheter replacements due to leakage (N = 32): A 11, B 21, definition of catheter leakage: patient's bed being wet with urine with the catheter still connected to the connection tube; no. of non‐prescribed catheter removals (N = 32): A 87, B 63

  • Other outcomes reported (not analysed in this review): all episodes of high temperature per 100 days of catheterisation: group A mean 1.7 (SD 1.9) (N = 32), group B mean 1.1 (SD 1.6) (N = 32)

Notes

Funding source: National institute of Aging, National Institutes of Health

  • Daily irrigations administered by trained nurse

  • Routine catheter care included daily perineal cleansing with soap and water

  • Number of non‐protocol irrigations were similar during irrigation and non‐irrigation periods

  • Analysis based on end point data available

  • 2 analyses carried out: patients completing all 24 weeks of the study, patients who completed one period and at least 5 weeks of the next period

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

States random assignment determined but no further details provided

Allocation concealment (selection bias)

Unclear risk

No information given

Blinding of participants and personnel (performance bias)
All outcomes

High risk

No mention of blinding. As a washout solution versus no washout, can assume this was not possible

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No information given

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Stated numbers and reasons for drop‐outs/withdrawals

Selective reporting (reporting bias)

Low risk

All outcomes in methods were reported in results

Other bias

Low risk

Appears to be free of other biases

Waites 2006

Methods

Study design: parallel group RCT (double blind but no description given), 3 groups: Group A: normal saline irrigation, Group B: acetic acid irrigation, Group C: neomycin‐polymyxin GU irrigation, groups stratified by sex
Study duration: 8 weeks

Participants

Inclusion criteria: Community residing patients with neurogenic bladder managed by indwelling catheter, at least 6 months post spinal cord injury or onset of other neurological disease, evidence of microscopic bacteriuria and pyuria at time of study enrolment

Setting: Community

Country: USA

Health status: No other details provided

Number: 89 participants entered the trial (group A 29, group B 30, group C 30), 37 participants did not complete the full intervention (11 withdrew due to development of symptomatic UTI, 14 withdrew due to other health related reasons, 12 withdrew due to perceived difficulty, inconvenience or unwillingness to perform twice daily irrigations), 52 participants completed the intervention and were analysed (group A 21, group B 9, group C 22)

Age: mean age 45.8 years, range 19 years to 82 years

Sex (m/f): 49/40

Exclusion criteria: patients with serious UTIs requiring systemic antibiotics or with prior renal function abnormalities, patients who had used an acidifying agent, bladder irrigant or systematic antibiotic in previous 7 days, and patients who were pregnant or unable/unwilling to give informed consent

Other relevant Information: no differences in demographic and injury related variables by group at baseline

  • Years since injury or onset of disease significantly greater for participants who did not complete the study protocol

  • Catheter type 71 Foley catheter, 18 suprapubic tube, catheter material not stated

  • Duration catheter in situ pre‐study enrolment not stated

Interventions

  • group A: 8 weeks of twice daily normal saline irrigation

  • group B: 8 weeks of twice daily 0.25% acetic acid irrigation

  • group C: 8 weeks of twice daily neomycin‐polymyxin GU irrigation containing 40 mg/mL neomycin sulphate and 200,000 units/mL polymyxin B

  • 30 mL of each irrigant instilled for 20 minutes via bladder syringe

Outcomes

  • Bacteriuria or pyuria in urine: no data reported at group level except for Enterococcus species (see below)

  • Participants harbouring Enterococcus species alone or in conjunction with other types of bacteria after completing study: group A: 13/21, group B: 7/9, group C: 19/22

  • Increased occurrence of enterococci over time significant for group C (P 0.02) (data reported graphically hence unable to determine exact values by group)

  • Participants discontinuing use of irrigation due to development of symptomatic UTI: group A: 1/29, group B: 6/30, group C: 4/30

  • Adverse effects: bladder spasms attributed directly to participation in bladder irrigation: group A 0/29, group B 1/30, group C 2/30

  • Other outcomes reported (not analysed in this review): generation of antimicrobial‐resistant organisms, urinary pH, urinary leukocytes

Notes

Funding source: Paralyzed Vetrans of America Spinal Cord Research Foundation

  • First irrigation shown to patient in clinic setting, remaining irrigations administered at home by participant or carer

  • Participants advised to continue usual practices for perineal hygiene and catheter care

  • Drop‐out rate in group B significantly higher than other two groups

  • Analysis based on end point data available

  • Data analysis combined patients with urethral and suprapubic catheters (author contacted to request results separately for these groups however with no success)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

States that participants randomised but no further details provided

Allocation concealment (selection bias)

Unclear risk

No information given

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Study described as double blinded but further details not provided

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No information given

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Stated numbers and reasons for drop‐outs/withdrawals

Selective reporting (reporting bias)

Low risk

All outcomes in methods reported in results

Other bias

Low risk

Appears to be free of other biases

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Andersson 1986

Primary outcomes of interest to review (i.e. catheter‐associated infection and encrustation) not addressed. Outcomes studied related to cleansing of bladder rather than catheter blockage from pus, fibrin, necrotic tissue and blood clots

Bach 1990

Not long‐term catheterisation. RCT of citric acid versus saline to prevent catheter encrustation

Bruun 1978

Unable to determine duration of catheterisation. RCT (cross‐over design) of four irrigating solutions: saline, 0.25% acetic acid, 0.02% chlorhexidine, 0.25% silver nitrate

Davies 1987

Not all patients catheterised for more than 28 days. RCT of chlorhexidine versus saline on urinary bacterial count. 48 patients catheterised for 3 weeks or more. Unable to separate data of patients who met inclusion criteria for this trial

Elliott 1989

Study methods insufficiently described and insufficient data reported on the effect on bacteruria in treatment and control groups. Thus the study was excluded as it did not contribute information on any of the reviews primary outcome measures, rather it focused on urothelial exfoliations rates and presented these data only graphically. RCT (cross‐over design) of effect of washouts (2.5% noxythiolin or saline) on the urothelium

Elliott 1990

Unable to determine if patients randomised. Study methods insufficiently described. Insufficient data reported for calculating the effect on bacteruria in treatment and control groups

Furuno 1998

Not an RCT. Comparison of irrigation with super oxidation water and normal saline in 21 paraplegics (conference abstract at 33rd Annual Meeting of Japan Medical Society of Paraplgia 1998)

Gelman 1980

Not clear that this is an RCT. Duration of catheterisation at start of study less than 28 days for some patients. Comparison of three methods of irrigation with 0.25% acetic acid (no irrigation, one irrigation a week, two irrigations per day)

Kennedy 1984

Not an RCT. Cross‐over study of saline versus two Uro‐tainer solutions

Meyers 1964

Not all patients catheterised for more than 28 days. Analysis of long‐term catheterised patients not reported. RCT of nitrofurazone and neomycin/polymyxin for prevention of bacteriuria

Robertson 1990

Not an RCT. Comparison of effect of mandelic acid on two different bacterial species. There was only a single group of subjects who received a single regimen of 1% mandelic acid

Ruwaldt 1983

Unable to determine if RCT. Cross‐over comparison of twice daily irrigations with Suby G versus no irrigations

Vainrub 1977

Comparison with intermittent catheterised patients not relevant to review. Comparison of effect of methenamine mandelate and ascorbic acid on bacteriuria between indwelling and intermittent catheterised patients

Warren 1978

Not long‐term catheterisation. RCT of neomycin‐polymyxin irrigation versus no irrigation for prevention of UTIs

Characteristics of ongoing studies [ordered by study ID]

NCT02130518

Trial name or title

Efficacy study of auriclosene irrigation solution on urinary catheter patency

Methods

Multicentre, randomised, double blind

Participants

Estimated enrolment of 140 participants. Inclusion criteria: aged 18 years and older, history of catheter blockage and/or encrustation. Exclusion criteria: systemic antibiotic use within 14 days of first treatment, current infection

Interventions

Experimental group: Auriclosene irrigation solution 0.2%, 8 treatments over 4 weeks

Placebo group: Auriclosene Vehicle solution, 8 treatments over 4 weeks

Outcomes

Percent flow rate of catheters at time of removal

Number of catheters removed due to blockage

Number of subjects with serious and non‐serious adverse events

Starting date

September 2014

Contact information

[email protected]

Notes

Estimated completion date December 2016

Authors contacted in October 2015 but no results were available at that time

Data and analyses

Open in table viewer
Comparison 1. Any washout versus no washout

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants with symptomatic UTI Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 1.1

Comparison 1 Any washout versus no washout, Outcome 1 Number of participants with symptomatic UTI.

Comparison 1 Any washout versus no washout, Outcome 1 Number of participants with symptomatic UTI.

1.1 any washout versus no washout

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 saline washout versus no washout

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 citric acid washout versus no washout

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 weeks to first catheter change Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 1.2

Comparison 1 Any washout versus no washout, Outcome 2 weeks to first catheter change.

Comparison 1 Any washout versus no washout, Outcome 2 weeks to first catheter change.

2.1 any washout versus no washout

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 saline washout versus no washout

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 citric acid washout versus no washout

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Number of participants needing catheter replacement Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 1.3

Comparison 1 Any washout versus no washout, Outcome 3 Number of participants needing catheter replacement.

Comparison 1 Any washout versus no washout, Outcome 3 Number of participants needing catheter replacement.

3.1 saline washout versus no washout

1

40

Risk Ratio (M‐H, Fixed, 95% CI)

0.67 [0.34, 1.31]

4 Mean number of episodes of high temperature Show forest plot

1

Mean Difference (Fixed, 95% CI)

Subtotals only

Analysis 1.4

Comparison 1 Any washout versus no washout, Outcome 4 Mean number of episodes of high temperature.

Comparison 1 Any washout versus no washout, Outcome 4 Mean number of episodes of high temperature.

5 Mean number of episodes of high temperature of poss urinary origin Show forest plot

1

Mean Difference (Fixed, 95% CI)

Totals not selected

Analysis 1.5

Comparison 1 Any washout versus no washout, Outcome 5 Mean number of episodes of high temperature of poss urinary origin.

Comparison 1 Any washout versus no washout, Outcome 5 Mean number of episodes of high temperature of poss urinary origin.

Open in table viewer
Comparison 2. One washout solution versus another

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants with symptomatic UTI Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 2.1

Comparison 2 One washout solution versus another, Outcome 1 Number of participants with symptomatic UTI.

Comparison 2 One washout solution versus another, Outcome 1 Number of participants with symptomatic UTI.

1.1 citric acid verus saline

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 weeks to first catheter change Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 2.2

Comparison 2 One washout solution versus another, Outcome 2 weeks to first catheter change.

Comparison 2 One washout solution versus another, Outcome 2 weeks to first catheter change.

2.1 citric acid verus saline

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

Study flow diagram
Figuras y tablas -
Figure 1

Study flow diagram

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies
Figuras y tablas -
Figure 2

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies

Methodological quality summary: review authors' judgements about each methodological quality item for each included study
Figuras y tablas -
Figure 3

Methodological quality summary: review authors' judgements about each methodological quality item for each included study

Comparison 1 Any washout versus no washout, Outcome 1 Number of participants with symptomatic UTI.
Figuras y tablas -
Analysis 1.1

Comparison 1 Any washout versus no washout, Outcome 1 Number of participants with symptomatic UTI.

Comparison 1 Any washout versus no washout, Outcome 2 weeks to first catheter change.
Figuras y tablas -
Analysis 1.2

Comparison 1 Any washout versus no washout, Outcome 2 weeks to first catheter change.

Comparison 1 Any washout versus no washout, Outcome 3 Number of participants needing catheter replacement.
Figuras y tablas -
Analysis 1.3

Comparison 1 Any washout versus no washout, Outcome 3 Number of participants needing catheter replacement.

Comparison 1 Any washout versus no washout, Outcome 4 Mean number of episodes of high temperature.
Figuras y tablas -
Analysis 1.4

Comparison 1 Any washout versus no washout, Outcome 4 Mean number of episodes of high temperature.

Comparison 1 Any washout versus no washout, Outcome 5 Mean number of episodes of high temperature of poss urinary origin.
Figuras y tablas -
Analysis 1.5

Comparison 1 Any washout versus no washout, Outcome 5 Mean number of episodes of high temperature of poss urinary origin.

Comparison 2 One washout solution versus another, Outcome 1 Number of participants with symptomatic UTI.
Figuras y tablas -
Analysis 2.1

Comparison 2 One washout solution versus another, Outcome 1 Number of participants with symptomatic UTI.

Comparison 2 One washout solution versus another, Outcome 2 weeks to first catheter change.
Figuras y tablas -
Analysis 2.2

Comparison 2 One washout solution versus another, Outcome 2 weeks to first catheter change.

Summary of findings for the main comparison. Any washout compared to no washout for participants with long‐term indwelling urinary catheterisation

Any washout compared to no washout for participants with long‐term indwelling urinary catheterisation

Patient or population: Long‐term indwelling urinary catheterisation in adults
Settings: Hospital and home
Intervention: Any washout
Comparison: No washout

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

No washout

Any washout

Symptomatic UTI

(Number of participants with symptomatic UTI, citric acid or saline washout versus no washout)

0 per 1000

0 per 1000

(0 to 0)

Not

estimable

53
(1 study)

⊕⊕⊝⊝
low1

No participants met the study criteria for symptomatic UTI

Symtomatic UTI

Mean number of episodes of high temperature (saline washout versus no washout)

The mean number of episodes of high temperature (saline washout versus no washout) in the intervention groups was:

0.78 (‐0.14 to 1.70)

Not estimable

23
(1 study)

⊕⊝⊝⊝
very low4,5

Symptomatic UTI

Mean number of episodes of high temperature due to possible urinary origin (saline washout versus no washout)

The mean number of episodes of high temperature of possible urinary origin (saline washout versus no washout) in the intervention groups was:

1.80 (1.02 to 2.58)

Not estimable

23
(1 study)

⊕⊝⊝⊝
very low4,6

Number of catheters used

(Number of participants needing catheter replacement, saline washout versus no washout)

526 per

1000

353 per 1000 (179 to 689)

RR 0.67
(0.34 to 1.31)

40
(1 study)

⊕⊝⊝⊝
very low2,3

Length of time each catheter was in situ

Not estimable

Not reported

No data available

Catheter removal rates due to blockage/infection

Not estimable

Not reported

No data available

Rates of asymptomatic bacteriuria

Not estimable

Not reported

No data available

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Downgraded two levels: The sample size was small (N = 53). Personnel not blinded to allocation of treatment. Blinding of outcome assessment not clear.
2 Downgraded two levels: The sample size was small (N = 40). The following were judged to be unclear: Random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessor, incomplete outcome data and selective reporting).
3 Downgraded one level for imprecision (95% CI was very wide: 0.34 to 1.31).
4 Downgraded two levels: The sample size was small (N = 23). The following domains were judged to be unclear: Random sequence generation, allocation concealment, and blinding of outcome assessor. Blinding of participants and personnel was judged to be at high risk of bias. Incomplete outcome data and selective reporting was judged to be at low risk of bias).
5 Downgraded one level for imprecision (95% CI ‐0.14 to 1.70). CI was very wide and crossed the line of no effect
6 Downgraded one level for imprecision (95% CI 1.02 to 2.58).

Figuras y tablas -
Summary of findings for the main comparison. Any washout compared to no washout for participants with long‐term indwelling urinary catheterisation
Summary of findings 2. One washout solution versus another for participants with long‐term indwelling urinary catheterisation

One washout solution versus another for participants with long‐term indwelling urinary catheterisation

Patient or population: Long‐term indwelling urinary catheterisation in adults
Settings: Hospital
Intervention: One washout solution versus another

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

One washout solution versus another

Symptomatic UTI

Number of participants with symptomatic UTI (citric acid versus saline)

0 per 1000

0 per 1000

(0 to 0)

Not estimable

33
(1 study)

⊕⊕⊝⊝
low1

No participants met the study criteria for symptomatic UTI

Symtomatic UTI

Mean number of episodes of high temperature

Not estimable

Not reported

No data available

Symptomatic UTI

Mean number of episodes of high temperature due to possible urinary origin

Not estimable

Not reported

No data available

Number of catheters used

Number of participants needing catheter replacement

Not estimable

Not reported

No data available

Length of time each catheter was in situ

Not estimable

Not reported

No data available

Catheter removal rates due to blockage/infection

Not estimable

Not reported

No data available

Rates of asymptomatic bacteriuria

Not estimable

Not reported

No data available

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Downgraded two levels: The sample size was small (N = 33). Personnel not blinded to allocation of treatment. Blinding of outcome assessment not clear.

Figuras y tablas -
Summary of findings 2. One washout solution versus another for participants with long‐term indwelling urinary catheterisation
Comparison 1. Any washout versus no washout

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants with symptomatic UTI Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 any washout versus no washout

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 saline washout versus no washout

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 citric acid washout versus no washout

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 weeks to first catheter change Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2.1 any washout versus no washout

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 saline washout versus no washout

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 citric acid washout versus no washout

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Number of participants needing catheter replacement Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 saline washout versus no washout

1

40

Risk Ratio (M‐H, Fixed, 95% CI)

0.67 [0.34, 1.31]

4 Mean number of episodes of high temperature Show forest plot

1

Mean Difference (Fixed, 95% CI)

Subtotals only

5 Mean number of episodes of high temperature of poss urinary origin Show forest plot

1

Mean Difference (Fixed, 95% CI)

Totals not selected

Figuras y tablas -
Comparison 1. Any washout versus no washout
Comparison 2. One washout solution versus another

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants with symptomatic UTI Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 citric acid verus saline

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 weeks to first catheter change Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2.1 citric acid verus saline

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 2. One washout solution versus another