CLINICAL ISSUES

A randomised controlled trial on the effect of clamping the indwelling

urinary catheter in patients with hip fracture
Maria Hälleberg Nyman, Jan-Erik Johansson and Margareta Gustafsson

Aim. To investigate the effect of clamping the urinary catheter before its removal in patients with hip fracture.
Background. Difficulties to return to normal bladder function after removal of the urinary catheter are frequent in patients with
hip fracture. Clamping the urinary catheter before removal is proposed to shorten the amount of time required to return to
normal bladder function.
Design. A randomised controlled trial was conducted at the orthopaedic clinic at a Swedish university hospital.
Methods. Patients with hip fracture aged ‡50 without a urinary catheter, without cognitive impairment or additional severe
physical problems at the time of admission (n = 113) were included. They were randomly assigned either to have their urinary
catheter clamped before removal or to have their catheter removed with free drainage. Blinding was not possible because of the
nature of the study. The primary outcome was the amount of time required to return to normal bladder function. Secondary
outcomes were need for re-catheterisation and length of hospital stay. All patients were analysed in accordance with the
intention-to-treat principle.
Results. The median time required to return to normal bladder function was six (Q1 4–Q3 8) hours in the clamped catheter
group and four (Q1 3–Q3 7Æ25) hours in the free drainage group. There were no significant differences between the groups
regarding the time required to regain normal bladder function (p = 0Æ156), the number of patients requiring re-catheterisation
(p = 0Æ904) and the mean time in hospital (p = 0Æ777).
Conclusion. This randomised trial did not show any advantage or disadvantage with clamping the urinary catheter before
removal.
Relevance to clinical practice. Clamping is an additional task for the nursing staff in the removal of the indwelling urinary
catheter. Therefore, when considering the present results, it seems that clamping the indwelling urinary catheters in patients
with hip fracture is not indicated.

Key words: clamping, hip fractures, nursing, randomised controlled trial, urinary catheterisation

Accepted for publication: 23 June 2009

Background
Some 20,000 patients in Sweden undergo surgery for hip
fracture each year. The majority of patients with hip
fracture are 75 years or older, and more than half of them
are women. In 2006, the mean hospital stay was 10Æ7 days
for hip fracture surgery, and the total hospital days for the
whole patient group was 263,000 (The National Board of
Health and Welfare, 2008). Confinement to bed and pain
may result in difficulty or inability to urinate in the

Authors: Maria Hälleberg Nyman, MSc, RN, PhD Student,
Department of Orthopaedics, Örebro University Hospital; Jan-Erik
Johansson, MD, Professor, Department of Urology, Örebro
University Hospital and Centre for Assessment of Medical
Technology, Örebro County Council; Margareta Gustafsson, PhD,
RN, Senior Lecturer, School of Health and Medical Sciences, Örebro
University and Centre for Assessment of Medical Technology,
Örebro County Council, Örebro, Sweden
Correspondence: Maria Hälleberg Nyman, Department of
Orthopaedics, ward 27, Örebro University Hospital, SE-701 85
Örebro, Sweden. Telephone: +46 196022227.
E-mail: maria.halleberg-nyman@oru.se

 2010 Blackwell Publishing Ltd, Journal of Clinical Nursing, 19, 405–413 405
doi: 10.1111/j.1365-2702.2009.03050.x
MH Nyman et al.
perioperative phase. Because of these difficulties, the
patients usually have an indwelling urinary catheter inserted
before surgery. The catheter is removed as soon as possible
after surgery. Postoperative urinary retention and difficulties
to regain normal bladder function after removal of the
urinary catheter are frequent in patients with hip fracture
(Smith & Albazzaz 1996, Yarnold 1999, DeSouza 2002,
Olofsson et al. 2005).
Acute urinary retention is defined as the sudden inability to
pass any urine despite the presence of urine in the bladder and
the desire to urinate (Gray 2000). One study reported
frequencies of postoperative urinary retention of 18% in
patients with hip fracture (Skelly et al. 1992). The same study
reported that it took on average 9Æ4 days for the patients with
indwelling urinary catheters to return to normal bladder
function. Smith and Albazzaz (1996) found that urinary
retention in women with hip fracture was associated with
higher fatality.
Factors associated with increased frequency of postopera-
tive urinary retention in orthopaedic and other surgical
patients include advancing age (Sokol et al. 2005, Edmond
2006), male gender (Edmond 2006), systemically adminis-
tered spinal anaesthesia and morphine (Williams et al. 1995,
Souter & Pavlin 2005, Edmond 2006), pelvic surgery (Souter
& Pavlin 2005) and history of urinary problems (Tammela
et al. 1986, Waterhouse et al. 1987). However, these findings
vary considerably, and it is not clear to what extent these
factors have an impact on urinary retention in patients with
hip fracture.
Clamping the urinary catheter before its removal is
reported to decrease the frequency of urinary retention and
shorten the time to return to normal bladder function
(Williamson 1980). It is assumed that clamping stimulates
normal bladder filling and emptying by improving bladder
tone and sensation (Williamson 1980, Roe 1990). Roe
(1990) concluded that there is some evidence that catheter
clamping minimises postoperative neurogenic dysfunction
after short-term catheterisation up to six days. However, a
Cochrane review on removal of the urinary catheter
showed that the evidence is inconclusive as to whether
clamping is effective. The review comprised research
published up to 2006 (Griffiths & Fernandez 2007). Three
trials investigating clamping vs. free drainage before
removal were included. In two of the trials, the time to
first void was shorter after catheter clamping. Two of the
three trials had a small sample, and they all used different
clamping regimens. The authors of the Cochrane review
called for further randomised controlled trials using large
samples to study the effects of clamping before urinary
catheter removal.
406  2010 Blackwell Publishing Ltd, Journal of Clinical Nursing, 19, 405–413
Aim and objectives of the study
Aim
The aim of the study was to investigate the effect of clamping
the urinary catheter before removal in patients with hip
fracture.
Objectives
Specific objectives were to determine whether:
• Clamping has an effect on the time required to regain
normal bladder function.
• Clamping has an impact on the need for re-catheterisation.
• Clamping has an effect on the length of hospital stay.
Method
A randomised controlled trial following the CONSORT
statement (Consolidated Standards of Reporting Trials)
(Altman et al. 2001, Moher et al. 2001) was conducted at
the orthopaedic clinic at a Swedish university hospital. The
study took place between April 2006–March 2007. The
primary catchment area of the orthopaedic clinic includes
approximately 172,000 inhabitants. Because it is the only
clinic in the catchment area providing care for patients with
hip fracture, all patients with a hip fracture are admitted to
this clinic.
Sample selection
Eligible participants for the study were patients with a hip
fracture in need of surgery. The patients were included
consecutively. Patients were excluded if they were younger
than 50 years, had a urinary catheter at the time of
admission, showed signs of cognitive impairment or had
additional severe physical problems at admission. In this
study, cognitive impairment was defined as disorientation in
time, place or room, irrelevant conversation, disorganised
thinking or agitation.
At arrival to the orthopaedic ward, the patients who
fulfilled the criteria for participation were informed (orally
and in writing) of the investigational nature of the study. All
data were handled confidentially, and anonymous presenta-
tion of the data was ensured. Participants had the right to
withdraw from the study at any time, without effect on their
medical care. Those who agreed to participate signed
informed consent forms before data collection. Ethical
approval was obtained from the regional ethical review
board of Uppsala, Sweden.
Clinical issues
Randomisation
The registered nurses on duty at the orthopaedic ward
randomly assigned the patients through a concealed alloca-
tion to the clamped catheter group and the free drainage
group at admission to the orthopaedic ward. Gender was
supposed to have an impact on the ability to empty the
bladder. To ensure that men and women were equally
represented in both groups, the randomisation was stratified
according to gender. The researcher carried out randomisa-
tion using sealed envelopes placed in a random order in two
boxes, one for men and one for women. The envelope
contained instructions for removal of the catheter and the
study protocol for collecting data. Blinding of group assign-
ment for nurses and patients was not possible in this study.
Procedure
All participating patients had an indwelling urinary catheter
(Charrière 14 C.R. Bard, Inc., Corington, GA, USA) inserted
on arrival to the orthopaedic ward. Before insertion,
the participants were showered with a skin disinfectant.
The registered nurse or nurse assistant on duty inserted the
indwelling catheter. The catheter was removed in the
morning on day 2 after surgery. This procedure was in
accordance with common practice in the orthopaedic clinic.
Patients randomised to the clamped catheter group had their
indwelling catheter clamped, at 6 AM on postoperative day 2.
When a patient in the clamped catheter group needed to
urinate, the catheter was removed clamped. The patient
urinated in a toilet or in a bedpan. Every fourth hour until
normal bladder function resumed, the patients had their
bladder scanned to assure that urine volume in the bladder did
not exceed 450 ml. If the bladder volume exceeded 450 ml,
the patient was re-catheterised. Patients in the free drainage
group had their catheter removed at 6 AM on postoperative
day 2 without previous clamping. The patients were bladder-
scanned every fourth hour until normal bladder function
returned. If the bladder volume exceeded 450 ml and the
patient was unable to urinate, the patient was re-catheterised.
The registered nurse or assistant nurse on duty performed
the bladder scans, using a Bladder Volume Instrument (BVI)
2500 bladder scan unit (BVI 2500, Diagnostic Ultrasound,
Redmond, WA, USA). The measurements were made with
the patient in supine position and ultrasound transmission gel
placed above the symphysis pubis. The measurements were
repeated until the bladder was centred in the picture. The
largest measured volume was noted in the study protocol.
Measurements with the BladderScan BVI 2500 have docu-
mented high reliability (Bent et al. 1997).
 2010 Blackwell Publishing Ltd, Journal of Clinical Nursing, 19, 405–413
The effect of clamping the indwelling urinary catheter
Outcome measures and data collection
The primary outcome for this study was time required to
return to normal bladder control, which was confirmed with
a bladder scan. A decision to measure the amount of time to
return to normal bladder function, in the clamped catheter
group from the time the catheter was clamped and in the free
drainage group from the time the catheter was removed, was
made because these are the moments when a patient’s bladder
starts to fill. In this study, normal bladder function was
defined as a postmicturition residual urine volume of 150 ml
or less. Secondary outcomes included need for re-catheteri-
sation and length of hospital stay. The impact of gender
differences was also considered.
The nurses at the orthopaedic clinic noted the time for
clamping/removal of the urinary catheter, the amount of
time required to return to normal bladder function and
the numbers of re-catheterisations in a study protocol. Data
for checking baseline differences were collected from the
medical records and the national hip fracture register
(RIKSHÖFT) (Thorngren 2008). Baseline control-concerned
demographic data and data of significance for bladder
function: age, gender, ASA physical status classification
(I = normal healthy patient, II = patient with mild systemic
disease, III = patient with severe systemic disease, IV = pa-
tient with severe systemic disease that is a constant threat to
life, V = a moribund patient who is not expected to survive
without the operation, VI = a declared brain-dead patient
whose organs are being removed for donor purposes) (The
American Society of Anesthesiologists 2008), diabetes,
preinjury urinary problems, preinjury walking ability, type
of fracture, time from admission to surgery, type of surgery,
type of anaesthetics and analgesics and time between the
end of anaesthesia and catheter removal.
Sample size
The sample size calculation was based on a medical journal
study (n = 40) in the orthopaedic clinic (Gustafsson M,
unpublished data). It showed that the standard deviation of
the mean time to return to normal bladder function was
approximately five hours, irrespective of whether the urinary
catheter was clamped or not. As the patients in the clinic have
their bladder scanned every fourth hour, a three-hour mean
difference in the time to return to normal bladder function
between the clamped catheter group and the free drainage
group was considered to have clinical significance. Sample
size calculation showed that 100 patients were required (50
in each group) to detect a three-hour difference between the
groups (two-tailed, a = 0Æ05, power 85%) (Altman 1996).
407
MH Nyman et al.

However, it was decided to include some extra patients to
compensate for eventual attrition.
Statistical analysis
Statistical analyses were conducted to assess differences
between patients who participated in the study and the
attrition. The chi-square test was used for nominal data, the
chi-square test, linear-by-linear for data ordered in catego-
ries, Student’s t-test for data normally distributed and Mann–
Whitney test for skewed continuous data.
Data showing the amount of time required to normal
bladder function had a positive skewed distribution. The
central tendencies in the groups were described with median
value and the first and third quartile. Kaplan–Meier curves
were used to visually illustrate the difference between the two
groups concerning the distribution of time to return to
normal bladder function (Altman 1996). In this study, the
curves show at each time point the probability that the
patients had not returned to normal bladder function.
The Breslow test was performed to compare the equality of
the distributions over time in the clamped catheter group
and the free drainage group. Differences in the proportion of
patients in need of re-catheterisation were assessed using the
Fisher exact test. Length of hospital stay was analysed with
Student’s t-test. All patients were analysed in the group they
were randomised to, in accordance with the intention-to-treat
principle. The level of significance was set at 0Æ05. Statistical
analyses were conducted using the software package SPSS
15Æ0 for Windows (SPSS Inc., Chicago, IL, USA).
Results
During the study period, 348 patients were assessed for
eligibility (Fig. 1). Of the 159 patients who fulfilled the
inclusion and exclusion criteria of the study, 14 declined
participation and 32 were lost because of organisational
reasons. Thus, the final sample consisted of 113 patients.
Statistical analyses showed that the 46 patients lost to the
study did not differ significantly from the study participants
on age, gender, ASA class, walking ability before admission,
type of fracture, type of surgery or length of hospital stay.
Of the 113 patients, 55 were randomised to the clamped
catheter group (16 men and 39 women) and 58 to the free

Assessed for eligibility (n = 348)

Not meeting the inclusion criteria (n = 189)

Catheter at admission (n = 20)
Cognitive impairment (n = 125)
Severe physical problems (n = 38)
< 50 years (n = 6)

Enrolment (n = 159)

Lost to the study (n = 46)

Declined participation (n = 14)
Missing because of organisational
reasons (n = 32)

Randomised (n = 113)

Allocated to Allocated to
clamped catheter free drainage
group (n = 55) group (n = 58)

Intention-to-treat
analysis

Analysed (n = 55) Analysed (n= 58)

Received the intervention (n = 48)
Removed the catheter themselves
(n = 3)
Transferred with catheter (n = 2)
Did not get intervention (n = 2)
Received the intervention (n = 53)
Removed catheter themselves
(n = 1)
Transferred with catheter (n = 1)
Did not get the intervention (n = 3)
Figure 1 Flow diagram for the randomised
trial.

408  2010 Blackwell Publishing Ltd, Journal of Clinical Nursing, 19, 405–413
Clinical issues The effect of clamping the indwelling urinary catheter

drainage group (15 men and 43 women). The majority (i.e. group and three randomised to the free drainage group), four
101 patients) received the allocated intervention (Fig. 1). Five patients removed their indwelling urinary catheter themselves
patients did not receive the treatment they were initially by mistake (three in the clamped catheter group and one in
randomised to (two randomised to the clamped catheter the free drainage group), and three patients were transferred
to other wards before the urinary catheter was removed (two
Table 1 Baseline characteristics of the study participants in the
in the clamped catheter group and one in the free drainage
clamped catheter group and the free drainage group
group). Adherence to the randomisation was over 95%.
Clamped Free Baseline data did not differ between the participants in the
catheter drainage
clamped catheter group and the free drainage group
group group
Variables (n = 55) (n = 58) (Table 1).

Age, years mean (SD) 79 (11Æ0) 80 (11Æ2)

Gender, n (%) Primary outcome
Male 16 (29) 15 (26)
Female 39 (71) 43 (74) The median time, from 6 AM when the measurement of time
ASA class*, n (%) started until the participants recovered their normal bladder
ASA 1 5 (9) 9 (15)
ASA 2 34 (62) 34 (59)
function, was six (Q1 4–Q3 8) hours in the clamped catheter
ASA 3 16 (29) 15 (26) group and four (Q1 3–Q3 7Æ25) hours in the free drainage
Diabetes, n (%) 7 (13) 4 (7) group (Table 2). The Kaplan–Meier curves show the distri-
Preinjury urinary problems, n (%) 11 (20) 9 (16) bution of the time measurements in the two groups (Fig. 2).
Urinary tract infection 1 (2) 1 (2)
Patients censored in the data analyses were those transferred
Urinary incontinence 5 (9) 6 (10)
Nocturia 1 (2) 1 (2) to another ward before their urinary catheter was removed
Other 4 (7) 1 (2) (n = 3), those who removed the urinary catheter themselves
Preinjury walking ability, n (%) (n = 4) and those who needed re-catheterisation and did not
Walked alone outdoor 47 (85) 46 (79)
recapture normal bladder function (n = 4). At each time
Walked with company outdoor 3 (6) 3 (5)
Walked indoor alone 5 (9) 9 (16) point, the curves show the probability that the patients failed
Type of fracture, n (%) to recapture normal bladder function. For example, when the
Cervical 31 (56) 39 (68) first bladder scan took place four hours after the catheter was
Intratrochanteric 17 (31) 17 (29)
either removed or clamped, 78% in the clamped catheter
Subtrochanteric 7 (13) 2 (3)
Time to surgery, hours median 21 20 group and 50% in the free drainage group had not returned
(quartiles) (16Æ4–27Æ1) (16Æ9–25Æ5) to normal bladder function. When the second bladder scan
Type of surgery, n (%) was performed at eight hours, 22% of the patients in the
One or more screws, pins or nails 15 (27) 14 (24)
clamped catheter group and 18% in the free drainage group
Screw, pin or nail with side plate 24 (43) 22 (38)
Intramedullary nail 2 (4) 0 had not recaptured their normal bladder function. The
Partial hip replacement 12 (22) 19 (33)
Total hip replacement 2 (4) 3 (5) Table 2 Primary and secondary outcomes in the clamped catheter
Type of anaesthesia, n (%) group and the free drainage group
General 10 (18) 10 (17)
Spinal 45 (82) 48 (83) Clamped Free
Analgesic, n (%) catheter drainage
Paracetamol 8 (15) 9 (16) Primary and secondary group group
Paracetamol + tramadol/codeine 25 (45) 35 (60) outcomes (n = 55) (n = 58) p-value
Paracetamol + opioid 20 (36) 14 (24)
Time required to return to 6 (4–8) 4 (3–7Æ25) 0Æ156*
Other 2 (4) –
normal bladder function,
Time between end of anaesthesia 45 43
and catheter removal, hours (41Æ5–61Æ0) (39Æ2–58Æ1) hours, Median (quartiles)
median (quartiles) Need for re-catheterisation, 5 (10) 6 (11) 0Æ904
n (%)
*ASA class, (I = normal healthy patient, II = patient with mild sys- Length of hospital stay, 10Æ9 (6Æ2) 10Æ6 (6Æ5) 0Æ777
temic disease, III = patient with severe systemic disease, IV = patient days, mean (SD)
with severe systemic disease that is a constant threat to life,
V = moribund patient who is not expected to survive without the Not significant at p > 0Æ05.
operation and VI = declared brain-dead patient whose organs being *p-value from Breslow test.

removed for donor purposes) (The American Society of Anesthesi- p-value from Fisher exact test.

ologists 2008). p-value from Student’s t-test.

 2010 Blackwell Publishing Ltd, Journal of Clinical Nursing, 19, 405–413 409
MH Nyman et al.
Breslow test showed no significant difference between the
time distributions to normal bladder function in the groups
(p = 0Æ156).
Secondary outcome
In the clamped catheter group, five patients (10%) needed
re-catheterisation (four females and one male) (Table 2).
Two of these five patients did not return to normal bladder
function and were therefore discharged from hospital with an
indwelling urinary catheter. Six patients (11%) in the free
drainage group needed re-catheterisation (four females and
two males). Two of these six patents did not return to normal
bladder function during their hospital stay. There was no
significant difference between the two groups regarding the
frequency of re-catheterisation (p = 0Æ904). Furthermore,
mean time in hospital did not differ significantly between
the clamped catheter group (mean 10Æ9 days SD 6Æ2) and free
drainage group (mean 10Æ6 days SD 6Æ5) (p = 0Æ777).
Discussion
The study showed that clamping had no effect on the time
required to return to normal bladder function in patients with
hip fracture. The median time to normal bladder function
differed by two hours between the clamped catheter group
and the free drainage group. The Kaplan–Meier curves
crossed each other indicating that the difference was in
favour of the clamped catheter group at some time points and
in favour of the free drainage group at other time points.
When the entire time period was taken into consideration,
there were no significant differences in the time distributions
410  2010 Blackwell Publishing Ltd, Journal of Clinical Nursing, 19, 405–413
Figure 2 Kaplan–Meier curves showing the
distribution of time required to return to
normal bladder function in the clamped
catheter group and the free drainage group.
to normal bladder function in the two groups. At eight hours,
four of five patients in each group had their voiding ability
restored.
In the Cochrane review (Griffiths & Fernandez 2007), two
trials reported that clamping reduced the time patients
needed to return to normal bladder function. However, the
present randomised controlled trial could not verify those
findings. A possible explanation is that those two trials
(Williamson 1980, Oberst et al. 1981) tested different
clamping regimes than used in our study and were performed
on patients with other types of surgery. In the study by
Oberst et al. (1981), the patients in the clamping group had
their urinary catheter removed on the ninth postoperative day
and the patients in the free drainage group on the tenth
postoperative day.
Compared with the study by Skelly et al. (1992), the time
required to return to normal bladder function in our study
was considerably shorter. The definition of normal bladder
function and the distribution of men and women were similar
in both studies, and thus the difference could not have been
caused by these two factors. A plausible explanation of the
differences is that during the 20 years that have passed
between the studies, circumstances in treatment and nursing
care have changed. According to our knowledge of caring for
the patients with hip fracture, anaesthetic methods and
analgesics have developed, and catheterisation regimes have
changed during the last 20 years. An important innovation
now is the widely spread use of bladder scan to monitor the
bladder volume to minimise the risk for over extension of the
urinary bladder.
No differences between the groups were observed regard-
ing the number of patients in need of re-catheterisation. The
Clinical issues
low frequency of urinary retention requiring re-catheterisa-
tion in our study is consistent with the results in the study by
Olofsson et al. (2005) but differs from the results in other
studies of patients with hip fracture(Smith & Albazzaz 1996,
Yarnold 1999, DeSouza 2002). In the latter, the frequency of
urinary retention was about 50%. However, it is unclear
whether the patients in those studies had an indwelling
urinary catheter. Studies of other orthopaedic patients (e.g.,
hip and knee replacement patients) also reported higher
frequency of urinary retention compared with our study. The
difference could partly be explained by a high frequency of
men in those studies (Redfern et al. 1986, Waterhouse et al.
1987, O’Riordan et al. 2000, Butwick et al. 2003, Macdo-
well et al. 2004, Sarasin et al. 2006).
All patients with cognitive impairment were excluded in
this study. This criterion was selected because confused
persons may not inform the nursing staff when they need to
urinate. The intervention applied in the present study could
have been a risk for them in the sense that clamping can cause
overfilling of the urinary bladder. Olofsson et al. (2007)
showed in their study that about one-third of the patients
with hip fracture suffer from dementia. During the
12 months of recruiting patients with hip fracture for this
study, about 36% were cognitively impaired at the time of
admission. The patients with hip fracture and cognitive
impairment are older and with greater risk for poor
functional outcomes (Gruber-Baldini et al. 2003, Givens
et al. 2008). With this point in mind, it could be questioned
whether the results of this study would have been different if
such patients had been included.
The exclusion criterion of patients <50 years in age was
used, because the national hip fracture register in Sweden (i.e.
RIKSHÖFT) only includes patients ‡50 years, and because
most of the hip fractures in young people are caused by
trauma or pathology. The decision to exclude patients with
severe physical disabilities (e.g., severe heart failure or suspect
brain damage) was adopted because persons with such
problems may have difficulty in removing the urinary
catheter as early as two days after surgery.
Method discussion
A consecutive recruitment of patients took place during one
year. Stratified randomisation was used to increase the power
of this randomised trial (Altman et al. 2001). In this study,
the randomisation was stratified by gender because prostate
hyperplasia occurs in old men. They are expected to require a
longer time to return to normal bladder function, have a
higher rate of re-catheterisation and to leave hospital more
often with the urinary catheter in place compared to women
 2010 Blackwell Publishing Ltd, Journal of Clinical Nursing, 19, 405–413
The effect of clamping the indwelling urinary catheter
(Edmond 2006). The frequency of men in the present study
was low. One alternative was to include as many men as
women. A disadvantage with such a strategy, however,
would be that the number of men and women in the sample
would have differed considerably from the total population
with hip fracture.
An optimal randomisation procedure would be to make a
computer generated randomisation list. In this study, the
researchers arranged sealed envelopes in random orders.
Thus, the allocation sequence was unpredictable, and the
person enroling the patients did not know in advance which
treatment the next patient would be assigned. These are the
two major defining features for successful randomisation
(Altman et al. 2001).
All randomised patients were analysed in the allocated
group. This was the case for the patients who did not receive
the randomised treatment as well. The intention-to-treat
analysis minimises the bias associated with non-random loss
of participants (Altman et al. 2001). The fact that there were
no significant differences in baseline data for the I and the C
group strengthens the results of the study.
Attrition was a threat to internal validity of this study. Of
the patients fulfilling the criteria for participation, 29% were
lost to the study for various reasons. Some declined partic-
ipation, but others were not enroled because of the heavy
workload in the clinic. The attrition analysis, however,
showed that those who were lost to the study did not differ in
study characteristics from those who participated in the
study.
A limitation in this study is that it was not blinded. There
was no possibility to blind the study because both the nurses
and the patients would have noticed whether the catheter was
removed clamped or not clamped. The fact that it was not
blinded for the nurses may have increased the risk of observer
bias. According to Altman et al. (2001), the risk of observer
bias is reduced when objective outcome measures are used.
The primary outcome in this study, return to normal bladder
function, was measured with a bladder scan, which is an
objective measure (Bent et al. 1997). The measurements were
performed in a similar way by the nurses. However, the
measurements were made by different persons, and a disad-
vantage in this study is that the reliability of the measure-
ments was not confirmed.
The study group did not differ from other patients with hip
fracture regarding age, gender or length of stay in hospital
(The National Board of Health and Welfare, 2008). It is
difficult to know whether the present results can be gener-
alised to all patients with hip fracture. Patients with cognitive
decline were excluded from our study, and the significance of
cognitive impairment is unclear. The possibility to generalise
411
MH Nyman et al.
the results also to other patients of surgery with short-term
indwelling catheter has to be verified in further research.
Conclusion
There were no significant differences in time to normal
bladder function, regardless of whether the indwelling
urinary catheter was clamped or not clamped before removal.
Furthermore, no differences in secondary outcomes were
observed between the clamped catheter group and the free
drainage group. In summary, this randomised trial did not
show any advantage or disadvantage with clamping the
urinary catheter before removal.
Relevance to clinical practice
Because the population in Sweden will be significantly older
in the future, the number of patients with hip fracture is likely
to increase. The large number of patients makes it important
to optimise all aspects of hip fracture treatment. One aspect
that should be considered is to develop a consistent strategy
for dealing with urinary catheters. In this study, there were no
significant differences between the clamped catheter group
and the free drainage group regarding re-catheterisation or
the time required to return to normal bladder function.
Because the present results did not show any advantages of
clamping or free drainage, other aspects such as workload or
costs have to be considered. Clamping is an additional task
for the nursing staff in the removal of an indwelling urinary
catheter. Even if clamping is not an expensive routine, it
involves a higher cost than removal with free drainage.
Therefore, it seems that clamping the indwelling urinary
catheters in patients with hip fracture is not indicated.
Acknowledgements
The authors are grateful to the patients with hip fracture
participating in the study and the nursing staff at the
Orthopaedic Department at Örebro University Hospital.
We would also like to gratefully acknowledge Dan
Gustafsson, MSc Statistics, for his excellent assistance with
the statistical evaluation of the data. This research was
supported by grants from the Department of Orthopaedics
Örebro University Hospital and Centre for Assessment of
Medical Technology, Örebro County Council.
Contributions
Study design: MHN, J-EJ and MG; data collection and anal-
ysis: MHN and manuscript preparation: MHN, J-EJ and MG.
412
Conflict of interest
All authors declare there is no conflict of interest associated
with this study.
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