F.14 Do prophylactic antibiotics reduce the risk of ... filebacteria/cc urine plus fever, nausea,...

Urinary incontinence in neurological disease: management of lower urinary tract dysfunction in neurological disease

381 Urinary incontinence in neurological disease – appendices

F.14 Do prophylactic antibiotics reduce the risk of symptomatic urinary tract infections?

Children

Reference Study type No. pts Patient characteristics Intervention Comparison

Length of follow-

Outcome measures

Source

of



up funding

Clarke SA, Samuel M, Boddy SA. Are prophylactic antibiotics necessary with clean intermittent catheterisation? A randomised controlled trial. Journal of Pediatric Surgery 2005; 40: 568-571

RCT. Random number table used for randomisation. No mention of allocation concealment. No placebo – those discontinuing received nothing in place. Thus no blinding possible either.

85 entered the study. 4 lost to follow up and 28 excluded as did not comply with the randomisation. Thus 53 finished (37% drop-out rate) with 31 in the continuation group and 22 in the discontinuation group. No intention to treat analysis, nor any analysis of how those dropping out differed, was performed. The attrition bias in this study was very serious, and might have led to a bias that could have explained the overall results seen (ie poor responders in the discontinuation group were not analysed after they had dropped out). However, it is stated that the 28 exclusions were due to parental refusal to comply with the randomisation, so it is possible that the exclusions may have occurred before the children even started discontinuation. However the paper is not very clear on this issue.

Mean age in continuation group was 12.65 (2.1) and in the discontinuation group was 11.89 (2.3). All had a diagnosis of neuropathic bladder. The primary diagnosis in most was Spina bifida secondary to myelomeningocele. M:F ratio was 1.1:1 in the continuation group and 1:1.4 in the discontinuation group.

The antibiotic used for prophylaxis was not described. It is implied that the patients were all already on prophylaxis with an un-named antibiotic, but this is not at all clear.

Discontinuation of prophylactic antibiotics.

4 months Existence of a clinical UTI – 100,000 bacteria/cc urine plus fever, nausea, vomiting or abdominal pain. Such events were reported prospectively – ie patients were told to contact their doctors if they experienced symptoms.

A single symptomatic UTI was the end point for a patient in the study.

One major drawback of this study was that the infection status of each group at onset was not recorded.

Not stated

Results: The high attrition rate and lack of any intention to treat analysis was a potential confounder. Although the groups were well-matched for age and gender, they differed in the manner of IC – more in the continuation group used non-self IC, which seemed to be associated with infection (though no independent effects of this were presented after analysis). So this could have been a confounder as well. It was stated that a multivariate analysis was performed, but no results describing any



adjustments for such a confounder were given.

Continuation of antibiotics Discontinuation p

Confirmed urine infection 20/31 3/22 <0.0001

Reference Study type No. pts

Patient characteristics

Intervention Comparison

Length of follow-up

Outcome measures

Source

of

funding

Zegers B, Uiterwaal C, Kimpen J, van Gool J et al. Antibiotic prophylaxis for urinary tract infections in children with spina bifida on intermittent catheterisation. The Journal of Urology 2011; 186: 2365-2371

RCT. Computer based randomisation, with concealed allocation. Stratification for age (younger/older than 3 years), gender and participating centre. No use of placebo purposely, to mimic effects of ceasing prophlaxis in clinical practice, and also because it

176 randomised (88 to each group). None were lost to follow up. In the continuation group, none changed treatment. In the discontinuation group, 38 returned to LDCP. However an ITT analysis was used, and these patients were retained into the discontinuatio

All patients with Spina Bifida at two children’s hospitals who were performing CIC and using low dose chemoprophylaxis (LDCP) during the preceding 6 months.

Exclusion was for refusal of GP / carer consent, language barrier or use of LDCP for <6 months.

Baseline characteristics: None differed between groups.

Continuation

Discontinuation

age 8.7(6.7) 9.4(5.9)

males (%) 42 45

% overactive detrusor

31.4 35.3

% overactive

22.1 25

Continuation of LDCP. This meant continuation of whatever regime the patients were already prescribed, and these included trimethoprim, nitrofurantoin, cefuroxim, co-trimoxazole or a combination. Dosages and types were allowed to differ between

Discontinuation of LDCP.

18 months

Existence of a clinical UTI – significant bacteriuria (>10,000 cfu/ml urine; positive reading of leukocyturia on dipstick; clinical symptoms such as increasing incontinence, foul smelling/cloudy urine, with or without fever >38.5C.

Not stated



would have been difficult to make different and convincing placebos for all the varying drugs used. But blinded outcome evaluation was used.

n group. Hence zero attrition after ITT.

sphincter

bladder capacity

280(161) 270(143)

mean number UTIs in year before study

1.82 1.88

patients.

Results:

Continuation of antibiotics Discontinuation p

Confirmed urine infection during 18 months FU 2/88 4/88 0.42



Intervention Comparison Length of follow-up

Outcome measures

Source

of

funding

Johnson HW, Anderson JD, Chambers GK, Arnold WJD, Irwin BJ, Brinton JR. A short-term study of Nitrofurantoin prophylaxis in children managed with

Double blind randomised placebo controlled cross-over study. Cross-over design flawed by lack of ensuring sterility of urine on the second arm (ie placebo or Rx).

56. 4 dropped out during treatment but intention to treat principle used.

Inclusion: Children with neurogenic bladder secondary for meningocele, initially free from symptomatic or asymptomatic infection, managed by IC, with surgically closed meningocele, normal renal function and no additional urologic abnormalities.

12 boys and 17 girls, of mean age 12.3 years.

Nitrofurantoin (25mg 1xpd for those weighing 12.5-25kg, and 50mg for those weighing >25kg).

This was taken for 12 weeks, followed by the placebo; or vice versa for the other randomised group. Patients were allowed to take a 2 week break

Placebo (matching appearance)

24 weeks Clinical infection, defined as occurrence of at least one of – flank or abdominal pain, pyrexia, or incontinence.

Not stated



clean intermittent catheterisation. Pediatrics 1994; 93; 5: 752-755

No mention of randomisation method or allocation concealment.

A cross-over design so no need for baseline comparison.

(for any vacations) within the trial. Compliance with meds assessed with a monthly interview and pill count.

Results: Used a paired t test for cross-over data, but tested for homogeneity of variance.

Nitrofurantoin placebo p

Symptomatic UTIs 4/56 2/56 Not given




Length of follow-up

Outcome measures

Source

of

funding

Schlager TA, Anderson S, Trudell J, Hendley JO. Nitrofurantoin prophylaxis for bacteriuria and urinary tract infection in children with neurogenic bladder on intermittent catheterisation. The Journal of Pediatrics 1998; 132: 704-

Double blind cross-over placebo controlled trial.

No mention of randomisation or allocation concealment.

4 week wash-out period used.

15 completed the study (1 dropout due to torsion of ovarian cyst)

Inclusion:

Children aged 2-18 years with neurogenic bladder receiving CIC 4x per day with a normal renal US and living at home.

Children were not excluded if they had previously been receiving antibiotic prophylaxis, but were required to discontinue any existing prophylaxis 2 weeks before commencing the study.

Children continued to be treated by their doctor as normal during the study, and any prophylaxis (or placebo) was temporarily discontinued during treatment of UTIs.

5 months of nitrofurantoin taken 1xpd nightly (50mg tablet if >25 kb body weight, and 25mg tablet if <25kg body weight).

4 weeks washout before receiving the placebo for 5 months.

The order of nitrofurantoin and placebo was decided randomly,

See intervention

11 months

Incidence of symptomatic infections

Adverse events

Not stated



708.

10 female, 5 females. 14 myelomeningocele and 1 traumatic SCI.

and patients and those administering drugs were blinded.

Results: Failure to account for cross-over design in the analysis, using Fisher exact test.

Nitrofurantoin Placebo p

Number of patients developing symptomatic UTI infection 8/15 11/15 0.048

Adverse events

Carriage of klebsiella/pseudomonas

140/330 weeks of carriage

43/330 weeks of carriage

0.00004

Adults - new SCI cases




Outcome measures

Source

of

funding

Anderson RU. Prophylaxis of bacteriuria during intermittent catheterisation of the acute neurogenic bladder. The Journal of Urology 1980; 123:364-366

RCT. Use of a randomisation table to assign groups. No mention of allocation concealment. No mention of blinding.

64, divided into 4 groups.

Inclusion: SCI patients referred to a specialist centre within 30 days of injury. Sterile urine at onset of study.

Intermittent catheterisation done by trained technicians. Patients catheterised every 4 hours to keep balder volume <500ml.

Nitrofurantoin (100mg 1xpd); nitrofurantoin (100mg 1xpd) with or without 4 ampules of genitourinary irrigant (intravesical neomycin/polymyxin B [160mg neomycin, 800,000 units of polymyxin B per litre of sterile water] injected into the bladder after each IC.

Any episodes of

Sterile IC only (usual care); genitourinary irrigant (intravesical neomycin/polymyxin B).

Unclear but probably > 45 days for most.

Symptomatic UTI.

Not stated



significant bacteriuria were treated with an appropriate systemic antibiotic for 5 days (both groups), and the nitrofurantoin was ceased during this period, but intravesical irrigant was continued.

Results:

Nitrofurantoin nitrofurantoin plus genitourinary irrigant

Sterile IC only (usual care)

genitourinary irrigant only

p

Symptomatic UTIs 1/15 0/16 0/16 0/17 Not given




Length of follow-up

Outcome measures

Source

of

funding

Gribble MJ, Putterman ML. Prophylaxis of urinary tract infection in persons

Double blind placebo-controlled randomised trial.

131 randomised. 2 placebo subjects resumed

Inclusion:

Acute SCI 30 days or less prior to enrolment; neurogenic bladder dysfunction; commencement of IC 72 hours of less prior to enrolment;

Trimethoprim-sulphamethoxazole (TMP) 40mg given once daily at 10am, and continued

Identically administered placebo.

Up to 16 weeks

Counts of definite symptomatic bacteriuria, and possible

Not stated



with recent spinal cord injury; a prospective, randomised, double-blind, placebo-controlled study of Trimethoprim-sulphamethoxazole. The American Journal of Medicine 1993; 95: 141-152.

Computer-generated randomisation performed. Randomisation stratified for sex and level of baseline bacteriuria, and in blocks of 8. Stated that the randomisation code was not broken until data collection and entry were complete, but this does not completely confirm or ensure true allocation concealment (one person must always have the key to the code, and it is not stated that this person was not involved in allocation to groups).

spontaneous voiding and so were excluded. 66 randomised to the TMP prophylaxis group and 62 to the placebo group.

sterile urine at enrolment (but not enforced as inevitable that some would have some baseline bacteriuria); >18years.

Exclusion:

Known hypersensitivity to TMP, elevated serum creatinine and transaminase levels and pregnancy.

Baseline characteristics (all NS)

TMP (n=66)

Placebo (n=60)

age 36 (18-79)

31 (18-64)

M:F 57:9 52:8

Quad: Para 33:33 26:34

Concurrent major injuries

17 25

Duration of IC (days)

11 (1-29)

11 (1-29)

Bacteriuria before randomisation

33 30

Time on study (wks)

9 (1-16) 9 (1-16)

Total study weeks

612 580

until IC was discontinued, or until discharge, or a maximum of 16 weeks.

symptomatic bacteriuria.

Adverse events



Study was prematurely discontinued in 25 TMP subjects and 19 placebo subjects, but there were no significant differences between groups for each category of reasons for discontinuation.

Results:

TMP Placebo p

Definite symptomatic bacteriuria 4/66 19/60 P values only reported for males and females separately in the paper

Possible symptomatic bacteriuria 16/66 24/60 ditto

Adverse events

Epididymo-orchitis

Skin and soft tissue infections

Bacteraemia arising from non-urinary sources

Clostridium difficile diarrhoea

Prolonged and unexplained fever

Severe skin rash

Neutropenia

Development of resistant bacteriuria after 3 years FU

0/66

15/66

2/66

1/66

1/66

2/66

2/66

47/66

1/60

20/60

1/60

0/60

0/60

1/60

3/60

45/60

Not given






Outcome measures

Source

of

funding

Lindan R, Joiner E. A prospective study of the efficacy of low dose nitrofurantoin in preventing urinary tract infections in spinal cord injury patients, with comments on the role of pseudomonas. Paraplegia 1984; 22: 61-65

Trial, but unclear if it was randomised, as no mention of randomisation at all.

60 SCI patients. 36 Cx, 13 Tx, 11 Lx. 49/60 male. 45/60 <20 years. Mean time from injury to study entry was 44 days. Groups not well matched (control group were older, more male, more lower spine injury).

50mg nitrofurantoin every 12 hours

No prophylaxis (no placebo)

Mean was 11.8 weeks

Symptomatic UTI - fever and leukocytosis, in the presence of bacteriuria.

Adverse events

Not stated

Results:

Nitrofurantoin No prophylaxis

Symptomatic UTIs 1/31 1/29 No statistical tests done

Adverse events

Pseudomonas colonisation

23/31

17/31

No statistical tests done




Length of follow-up

Outcome measures

Source

of

funding

Maynard FM, RCT. No 50 completed Patients with SCI Oral 80mg trimethoprim with No Average Symptomatic UTI Not



Diokno AC. Urinary infection and complications during clean intermittent catheterisation following spinal cord injury. The Journal of Urology 1984; 132: 943-946.

mention of randomisation method. No mention of allocation concealment.

the study, but no mention of how many were randomised. 27 were in subgroup B, which is the only subgroup relevant to this review (see intervention column for explanation)

who were <6 months post trauma at baseline. Sterile urine was ensured by a pre-study course of antibiotic if any infection was found. All were on clean IC.

27 quadriplegics and 23 paraplegics. 27 complete and 23 incomplete lesions. 32 men and 18 women. Age not given, but almost certainly adults.

400m sulphamethoxazole (TMP/SMX) daily [or 100mg Nitrofurantoin daily if allergic to TMP/SMX].

IMPORTANT: A subgroup (A) in each group also received a 10 day course of therapeutic antibiotic of choice for all episodes of laboratory and clinical infections. The other subgroup (B) only received the 10 day course for any symptomatic infections. Since sub-group A would be less likely to produce symptomatic infections on that regimen (as many pre-clinical infections showing up as asymptomatic bacteriuria would have been treated) that without treatment of asymptomatic infections, the results from that subgroup have been excluded from the first table below. Hence results in the table 1 only relate to the subgroup B, who only received prophylactic/control treatment until the end point of clinical infection. Results in table 2 give insight into the effects of two different strategies – treating when evidence of asymptomatic /symptomatic UTi was found versus treating only when

antibiotics(no placebo given)

of 50 days

infection – 1) temperature >100F orally plus >100,000 org/ml urine or pyuria (>25 WBC per high power field), 2) urethritis, or 3) other signs of abdominal or pelvic irritation.

Adverse events

stated



symptomatic UTI was found. This therefore contains all the subjects.

Results:

TABLE 1.

TMx/SMP or nitrofurantoin No prophylaxis

Symptomatic UTI EPISODES 1 7

Estimate of Symptomatic UTI COUNT 1/12 5-7/15*

Adverse events

Allergy to TMP/SMX

Heamaturia

Bladder stones

0/12

1/12

0/12

0/15

0/15

0/15

*the number of patients suffering clinical UTIs was 11 across all 4 subgroups, but there were 13 separate episodes. But for each subgroup the data given was the number of episodes! We know that one episode means one person (as more than one patients cannot share 1 episode and 0 patients can’t have any!) so we know the TMX/SMP count for the B subgroup (1/12). In the other 3 groups there is uncertainty. In the no prophylaxis subgroup B we could therefore have between 5 and 7 patients experiencing the 7 UTIs given. 7 is the maximum number of people as you cannot have 7 infections amongst 8 infected people (and would imply that no one had >1 infection in that subgroup, and that all the multiple infections occurred in the other 2 subgroups). 5 is the minimum, as that would be the number needed to make 11 people with an infection in total if the remaining 2 subgroups had not had anyone having > 1 infection. So we could regard a figure of 5/15 as a conservative estimate of a count that can be used in a meta-analysis.




Length of follow-up

Outcome measures

Source

of

funding

Mohler JL, Cowen DL, Flanigan RC. Suppression and treatment of

RCT. Use of a random number table to assign patient to the prophylactic Rx (n=25)

47 Inclusion: All adult patients admitted to a SCI rehab service, managed on admission by IC (or for whom IC would seem to be the Rx

Nightly tablet of 160mg Trimethoprim with 800 mg

Identical placebo tablet.

Mean 56.1 days

Infection rate of symptomatic UTI (38C fever, any symptoms

Not stated



urinary tract infection in patients with an intermittently catheterised neurogenic bladder. The Journal of Urology 1987; 138: 336-340

and placebo (n=21) groups. No mention of allocation concealment. This aspect of the study was double-blinded.

There was a further randomised splitting of both groups in terms of whether 1) any infection (n=19) or 2) only symptomatic infections (n=27) were treated (twice the prophylactic dose). Those in the original placebo group were treated with the real medication once found to have an infection.

The final randomised splitting concerned the length of treatment (NB not prophlyaxis) – 3 (n=28) or 10 (n=18) days of antibiotic.

It was stated that the distribution of patients originally randomised to the active prophylaxis and placebo groups was “identical” across the 2

of choice) and with anticipated stays of >1 month, were considered.

36 men, 10 women. Mean age 35.7 yrs. 14 Cx (12 complete quadriplegia); 5 T1-T6; 13 T6-T12; 9 Lx

At hospitalisation 35 were managed by IC. 6 voided independently, but were incontinent (3 of those required condom catheter drainage, the other 3 having no urological management). The other 5 had had a Foley indwelling catheter in situ for 7-56 days, after which IC was initiated. During the study, all patients were managed by sterile IC.

37 had no Hx of UTI, 6 had had 1 infection and 3 had had 2 or more.

4 patients had received chronic suppressive antibiotics and 3 had had medication to control detrusor instability.

All had sterile urine at admission, or entrance into the study was delayed until it was.

Sulfamethexazole given as prophylaxis.

For treatment of established infection (symptomatic or asymptomatic) then twice daily treatments were given.

or signs of a UTI, with +ve urine culture and WBC count >10,000/cc).



subsequent groupings, though in reality it seems that there was merely no statistically significant difference.

No drop outs reported after inception.

Results: Results appropriate for meta-analysis were not provided. The comparisons of 3 days vs 10 days and symptomatic vs symptomatic and asymptomatic relate to the second part of the guideline question.

Active prophylaxis with Trimethoprim/Sulfamethexazole Placebo p

Infection rate of symptomatic UTIs (infections/100 days at risk)

1.11 1.86 0.15




Length of follow-up

Outcome measures

Source

of

funding

Sandock DS, Gothe BG, Bodner DR. Trimethoprim-sulphamethoxazole prophylaxis against urinary tract infection in the chronic spinal cord injury patient. Paraplegia 1995;

RCT. No mention of randomisation method used.

43 Inclusion

Patients with SCI hospitalised in a specialist rehab centre. All were previously on prophylactic Trimethoprim-sulphamethoxazole (TMP-SMX).

Exclusion

Hospital stay < 3 months, antibiotic therapy for febrile illness other than UTI, peri-operative antibiotics, TMP-SMX allergy or intolerance.

Continuation of TMP-SMX prophylaxis (TMP 80mg combined with SMX 400mg daily)

Discontinuation of prophylaxis. No placebo given.

Up to 7 months

Symptomatic UTI was defined as a measure of 105 org/cc urine combined with any of fever, pyuria, malodorous

Not stated



33: 156-160 Baseline characteristics (sig diff for age, but NSD for all others)

Prophylaxis (n=20)

Discontinuation (n=23)

age 46 58.3

Male 20/20 23/23

C1-C7 13 12

T1-T6 1 5

T7-T12 4 3

Lx 2 3

Time from injury (yrs)

9.2 14.9

Time on study (months)

5.9 7

Using IC 15 6

Reflex voiding

2 7

Indwelling catheter

3 7

Suprapubic catheter

0 3

urine, suprapubic pain, lethargy, and increasing autonomic dysreflexia.

Levels of bacterial resistance

Results:

Prophylactic Discontinuation p

Number of symptomatic UTIs per week 0.043 0.035 NS

Cultures resistant to TMP-SMX (%) 42.5 37.5 NS



Adults - prior to urodynamics




Length of follow-up

Outcome measures

Source

of

funding

Darouiche RO, Smith MS, Markowski J. Antibiotic prophylaxis for urodynamic testing in patients with spinal cord injury: a preliminary study. Journal of Hospital Infection 1994; 28: 57-61

Double blind RCT. No mention of randomisation method or allocation concealment.

46 enrolled. 6 missed follow up, but no intention to treat was used. 18 prophylaxis, 22 placebo.

Inclusion:

Patients hospitalised at a specialised SCI unit.

Exclusion:

Patients receiving antibiotics for an infection or unable to give informed consent

Baseline characteristics (all NS)

Prophylaxis (n=18)

Placebo (n=22)

age 52.9 (18.3) 46.9 (13.2)

Male 18 22

Pre-procedure bacteriuria (>108 org/L

9 10

Pre-procedure pyuria (>107 WBC/L

8 9

Need for bladder catheterisation

12 14

Renal complications

2 6

Mean number symptomatic UTI in previous yr

0.7 (1.0) 1.4 (2.3)

500mg of Ciproflaxin orally 2x per day.

Given 2 days prior to urodynamic testing (aim of study was to assess the effect of prophylaxis on post-investigational infection).

placebo 18 months, but unclear

Symptomatic UTI defined as 108 org/L in association with at least one of: fever, leukocytosis, flank pain, suprapubic discomfort, change in voiding habits, nausea, vomiting, increase in muscular spasm.

Adverse effects

Not stated



Results:

Ciproflaxin placebo p

Symptomatic UTIs 0/18 3/22 0.24

Adverse events 0/18 0/22 1

Adults - established neurological cases with recurrent UTIs




Length of follow-up

Outcome measures

Source

of

funding

Biering-Sorensen F, Hoiby N, Nordenbo A, Ravnborg M, Bruun B, Rahm V. Ciproflaxacin as a prophylaxis for urinary tract infection: prospective, randomised, cross-over, placebo controlled study in patients with Spinal Cord Lesion. The Journal of Urology 1994; 151: 105-108

Prospective, randomised, cross-over, double blind placebo controlled study. Randomisation carried out in blocks of 4. No details of randomisation method given. No details of allocation concealment given.

1 patient is reported to have dropped out. The paper states that “Drop outs were substituted with subjects belonging to the same group”. This statement is

22 Inclusion: Age >18 yrs, neurogenic bladder dysfunction due to SCI/cauda equina lesion, a history of recurrent symptomatic UTIs (at least 3x in the past year or 2x in the past 3 months).

No significant bacteriuria (>10,000/cc) at entry to the study (though of course at cross-over this could not be assured, especially with no reports of a wash-out period).

18 men and 3 women. Median age at entry: 38 years (range 19-73 years). Median duration of SC lesions was 16 years (range 1 to 31 years). One patient was respirator dependent (complete C1). There were also 2 C4, 4 C6, 2 C7, 1 T2, 3 T4, 1 T7, 2 T10 and 5 L1. In 11 cases lesion was complete. Mean number

100mg ciprofloxacin (each patient was treated with this continuously for 6 months, as well as 6 months continuously on the placebo, the order decided by randomisation). Both given after last bladder emptying at night.

Symptomatic UTIs were treated during the study with another antibiotic (in both groups).

See intervention

12 months

Bacterial cultures on mid stream urine were done at 1 month intervals, before treatment, during treatment and whenever a symptomatic UTI was suspected. The end point of the study was the number of treated symptomatic UTIs.

Adverse events

Not stated



very unclear, and the extent to which attrition bias was limited or avoided is therefore unclear, but as the dropout rate is <25% this is not a major problem.

No washout period described.

of symptomatic UTIs per patient in the past 12 months was 5.8 (maximum 14).

Bladder emptying methods included suprapubic tapping (n=8), abdominal pressure (n=5), suprapubic tapping, abdominal pressure and IC (n=1), suprapubic tapping and IC (n=2), IC (3), abdominal pressure and IC (n=1) and suprapubic tapping and abdominal pressure (n=1).

Results: Unclear statistical methods, and failure to account for cross-over design in the analysis. No counts of patients affected available (unless stated).

Ciproflaxin Placebo p

Number of symptomatic UTIs needing treatment with microbial agents

5 59 <0.00005

Clinical adverse events

Laboratory abnormalities

Resistant e-coli to cipaloflaxin

0

3 patients showed low Hb values, 2 showed elevated WBC, but all returned to normal during the study.

1

0

0 reported

None given

Adults – neurogenic bladder clinic cases




Outcome measures

Source

of

funding

Duffy L, Smith Double blind 31 Neurogenic bladder patients with 100mg 2xpd of Identical 6 months Bacterial Not



AD. Nitrofurantoin macrocrystals prevent bacteriuria in intermittent self-catheterisation. Urology 1982; 20: 47-49

cross-over study. Allocation concealment and blinding were rigorous, but no mention of the randomisation procedure.

sterile urine at inception. Self catheterising. 28 mean and 3 women. 6 had condom drainage devices. 15 were taking oxybutynin to control urgency and 2 were taking imipramine hydrochloride for nocturia.

nitrofurantoin macrocrystals. Switch to placebo after 3 months

tablet. See intervention.

resistance stated

Results: Unfortunately there is very poor reporting of symptomatic infection, with the only reference being: “symptoms of urinary tract infection were rare, and no patient required hospitalisation. A few complained of mild flank pain unaccompanied by fever, and 3 patients who usually were continent leaked urine”. This cannot be analysed, and gives no useful information about the efficacy of the antibiotic in preventing symptomatic infections. No details of statistical tests used, so unclear if cross-over design accounted for.

Nitrofurantoin (n=31) placebo (n=31) p

Resistant cultures* to nitrofurantoin (resistant/(resistant+sensitive)) 2/4 5/21 NS

Resistant cultures* to TMP/SMX (resistant/(resistant+sensitive)) 2/4 4/22 NS

Resistant cultures* to carbenicillin (resistant/(resistant+sensitive)) 1/4 4/21 NS

Resistant cultures* to aminoglycosides (resistant/resistant+sensitive) 0/4 0/21 NS

F.14 Do prophylactic antibiotics reduce the risk of ... filebacteria/cc urine plus fever, nausea,...

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