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hysterectomy for benign disease may include Methods
removal of the uterus and cervix; however, in Forty women treated by radical hysterectomy for early-
a radical hysterectomy, the upper part of the stage cervical cancer between 1 July 1999 and 31 June
vagina and supporting tissues are also removed. 2002 were recruited to the study. Information leaflets
Although nerve-sparing techniques are possible (Trimbos about the study were explained to the women to gain
et al, 2001), damage to the nerve supply of the bladder is informed and written consent before their surgery. Women
surgically induced and can cause a great deal of distress to were then randomized into ISC (intervention group)
women who are often struggling with the emotional effects and SPC (control group), which was carried out using
of their cancer diagnosis. Many women experience problems a sealed envelope system and an independent research
emptying their bladder following radical hysterectomy for nurse. Ethical approval for the study was obtained from
cervical cancer and this is estimated to be in excess of 30% Gateshead Research Ethics Committee.
(Naik et al, 2001). Baseline demographic data was collected preoperatively
At present, most departmental and nursing practice from all women and included their preferred method of
has been guided by personal experience, tradition and bladder care and their perception of bladder care. A mid-
anecdotal evidence. A definitive policy for the management stream specimen of urine (MSU) for culture and sensitivity
was taken, and a residual urine volume (RUV) was measured.
The ability to manage ISC following nurse education
Karen Roberts is Nurse Consultant and Raj Naik is Consultant was also assessed preoperatively, a urinary symptom
Gynaecological Oncologist, Northern Gynaecological Oncology questionnaire (USQ) and quality of life questionnaire
Centre, Queen Elizabeth Hospital, Gateshead, Tyne and Wear (EORTC QLQ C30) were completed. Figure 1 shows the
sequence of data collection.
Accepted for publication: June 2006 Protocols were developed for both methods of bladder
management and care. The ISC protocol consisted of a
transurethral indwelling catheter at the time of surgery that
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urinary catheters
remained on free drainage until day 5, at which time it Figure 1. The sequence of data collection.
was removed and the woman commenced on ISC. Women
would pass urine normally of at least 200 mls every 4 hours, Recruitment to trial (n=40)
then insert the catheter to determine if there was any residual Baseline data collected
urine left in the bladder. ISC was continued until residual
urine volumes of less than 100 mls was achieved. ISC could
then be discontinued. A sterile aseptic technique for ISC Randomization
was advised by the urology nurse specialist while women
were in hospital, and they could then move to a non-sterile,
but clean, technique once discharged home. The catheter
used for ISC was a hydrophilic-coated LoFric® (Astra Tech Active intervention Control group SPC
Ltd, Stroudwater Business Park, Stonehouse). Women were group ISC (n=21) (n=19)
given an advice leaflet with education and support from a Preoperative
clinical nurse specialist. nurse education
The SPC protocol included insertion of a Bonanno
suprapubic catheter (Becton Dickenson, Franklin Lakes,
New Jersey, USA) (Figure 2) at the time of surgery
followed by free drainage until day 5 at which time it
was clamped. Nursing staff then asked the women to pass
urine normally at least once every 4 hours during the day, Postoperative data collection
• CSU/MSU at day 3, 5, 7,
and then measure the residual urine volume by releasing
14, 21 and when clinically
the clamp. SPC was continued until satisfactory residual indicated
urine volumes of less than 100 mls was achieved, then the • Urinary Symptom
catheter was removed. The nursing staff observed the SPC Questionnaire (USQ)
site daily to assess for signs of infection or urine leakage, at 3, 6 and 12 weeks
and an occlusive dressing was used without any antibiotic postoperatively
cream. All women received a single dose of intraoperative • EORTC QLQ C30
antibiotics; however, prophylactic antibiotics were not questionnaire at 3, 6 and 12
given at any other time during the study. Antibiotics were weeks postoperatively
prescribed when clinically indicated, i.e. a positive MSU/ • Documentation of all SPC site
catheter specimen of urine (CSU) culture or positive SPC problems, need for bladder
support and difficulties with
site swab.
bladder care
Data analysis was performed using the statistical package • All data reviewed on an
SPSS Version 11, and included Pearson’s chi-squared intention-to-treat basis
test and Fisher’s exact test for categorical data, and the • Compliance with ISC or SPC
Mann-Whitney U test for non-parametric continuous data. protocol documented
• Date of cessation of bladder
Results care.
All women recruited to the study had a stage 1B1 carcinoma
of the cervix and were treated with a radical hysterectomy.
The ages of women recruited were 20–78 years, and the
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Figure 2. Bonanno catheter suturing in place to ensure it remained secure. (55%) were unsure or anxious and 5 (13%) were negative in
their views. There was no statistically significant difference
in attitude/perception between the two groups, p=0.267
(Fisher’s exact). Preoperative baseline RUVs were 0–75 ml,
mean 10 ml. There was no significant difference between
the two groups, p=0.246 (Mann–Whitney U). The baseline
preoperative USQs and EORTC QLQ C30 questionnaires
showed no statistically significant differences between
the two groups. One woman was treated with antibiotics
following a positive MSU test. All women randomized
to the ISC group were considered to be performing this
technique without difficulty within 2 days of removal of
the indwelling urethral catheter, which followed a period
of preoperative training by a nurse.
Four women were withdrawn from the study following
surgery, 2 from each group, as 1 woman developed a
ureteric fistula, 1 developed postoperative confusion,
1 had a stroke and 1 woman died. All women in the
SPC group managed to follow the clamping/unclamping
regimen easily except one woman who required additional
nursing support. No women randomized to ISC required
reinsertion of the catheter; however, 2 (12%) women
randomized to SPC required conversion to a transurethral
indwelling catheter due to SPC site problems. In addition,
1 woman (6%) requested removal of her SPC and transfer
to ISC due to discomfort.
Table 1 contains the positive CSU/MSU rates for days
3, 5, 7, 14 and 21. The organisms grown included: E coli,
enterococcus feacalis, Klebsiella and mixed growth. These
results show that more women in the ISC group developed
urine infections in the first 5 days following surgery than
the SPC group, and these results were significant. At 21 days,
8 of 17 SPC women (47%) were documented as having had
symptoms/problems arising from the SPC site, of which 4
(23%) had a positive wound swab requiring treatment by
antibiotics. The organisms grown included: staphylococcus
aureus, pseudomonas, haemolytic streptococcus and mixed
faecal/skin flora.
No significant differences were identified in the women’s
length and requirement for bladder care between the two
median was 45 years. Before randomization, 19 women groups, p=0.83 (Mann-Whitney U); ISC range 7–90 days
stated a preference to a specific technique of bladder (median, 17 days); SPC range 7–28 days (median 20 days).
care, 14 (74%) to ISC and 5 (26%) to SPC. Following There were no significant differences in questionnaire
recruitment and randomization, 13 women (32%) were response rates between the two groups, with 27 women
positive in their attitude towards bladder management, 22 (p=0.7), 23 women (p=0.7) and 19 women (p=0.5)
respectively, completed and returned the week 3, week 6
and week 12 USQs, patient acceptability questionnaires
Table 1. Positive CSU/MSU rate (PAQ) and EORTC QLQ C30 questionnaires. The results
are shown in Tables 2, 3 and 4.
ISC (n=19) SPC (n=17) Fisher’s exact
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urinary catheters
During the day how many times do you urinate on average? p = 0.8 NS p = 0.4 NS p = 1.0 NS
During the night, how many times do you get up to urinate, on average? p = 0.4 NS p = 0.006 p = 0.006
Do you have to rush to the toilet to urinate? p = 0.7 NS p = 0.8 NS p = 1.0 NS
Does urine leak before you can get to the toilet? p = 0.5 NS p = 0.7 NS p = 1.0 NS
Do you have pain in your bladder? p = 0.2 NS p = 0.4 NS p = 1.0 NS
Does urine leak when you are physically active, exert yourself, cough or sneeze? p =0.3 NS p = 0.7 NS p = 0.5 NS
Do you ever leak urine for no reason & without feeling that you want to go? p = 0.7 NS p = 0.2 NS p = 1.0 NS
Do you leak urine when you are asleep? p = 0.7 NS p = 0.2 NS p = 1.0 NS
Overall, how often do you leak urine? p = 1.0 NS p = 0.6 NS p = 0.7 NS
Overall, how much urinary leakage occurs? p = 0.8 NS p = 0.8 NS p = 1.0 NS
Do you wear some type of protection for your leakage? p = 0.3 NS p = 0.7 NS p = 1.0 NS
How many times a day do you change the above items because of leakage? p = 0.2 NS p = 0.4 NS p = 0.7 NS
Do you need to change your outer clothing during the day because of leakage? p = 0.1NS p = 0.4 NS p = 1.0 NS
Is there a delay before you can start to urinate? p = 0.2 NS p = 0.9 NS p = 0.5 NS
Do you have to strain to urinate? p = 0.4 NS p = 0.7 NS p = 0.5 NS
Do you stop and start more than once while you urinate? p = 0.9 NS p = 0.4 NS p = 0.3 NS
How would you say the strength of your urine stream is? p = 1.0 NS p = 0.7 NS p = 0.4 NS
Do you have a burning feeling when you urinate? p = 1.0 NS p = 0.8 NS p = 1.0 NS
How often do you feel that you bladder has not been emptied completely p = 0.2 NS p = 0.05 p = 0.1 NS
after you have urinated?
Can you stop the flow of urine if you try? p = 0.2 NS p = 0.5 NS p = 0.2 NS
Do you cut down on the amount of fluid you drink so that your bladder p = 0.5 NS p = 0.2 NS p = 0.7 NS
function improves?
To what extent have your urinary symptoms affected your ability to perform p = 0.05 p = 0.4 NS p = 1.0 NS
everyday tasks? (e.g. cooking, laundry)
Do you avoid places and situations where you know a suitable toilet is not p = 0.4 NS p = 0.9 NS p = 1.0 NS
nearby because of your urinary symptoms? (e.g. shopping, travelling, church)
Do your urinary symptoms interfere with physical activity? (e.g. walking, p = 0.6 NS p = 0.9 NS p = 1.0 NS
dancing, swimming)
To what extent has your sex life been spoiled by your urinary symptoms? p = 0.8 NS p = 0.8 NS p = 1.0 NS
Overall, do your urinary symptoms interfere with your relationship with p = 0.5 NS p = 0.9 NS p = 1.0 NS
your partner?
Overall, do your urinary symptoms interfere with your relationships with p = 0.7 NS p = 0.4 NS p = 1.0 NS
other people apart from your partner?
If you had to spend the rest of your life with your urinary symptoms as they p = 1.0 NS p = 0.8 NS p = 0.7 NS
are now, how would you feel?
All statistical tests performed using Pearson’s chi-squared test. NS = not significant
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Firstly, a greater incidence of urinary tract infections safely taught at home or in a clinical setting (Parmar et al,
within the first 5 days following surgery, during which time 1993; Bennett, 2002; Winder, 2002). The nurse teaching
women randomized to ISC were managed with a urethral the procedure must be alert to both verbal and non-verbal
catheter, and secondly, nursing support is required initially behaviour of the woman throughout the procedure and be
with ISC as women are still limited in their mobility due to able to respond positively. Women who require ISC face
a large mid-line abdominal wound. a change in both lifestyle and body image, therefore the
The results of this study supports previous work, as all communication skills of the nurse are as important as being
women were able to learn the technique of ISC without skilled in this technique. Psychosexual awareness is necessary
difficulty, and prior to randomization, the majority of as women may also have sexual concerns in relation to her
women with a preference preferred the option of ISC bladder care (Nwabineli et al, 1993) for which the nurse
compared to SPC. A clinical nurse specialist in the hospital may provide advice and support.
setting the day before the radical hysterectomy procedure The high incidence of urinary tract infections in the
taught the technique of ISC. However, it can also be present study was concerning, although it is interesting that
Has the method of bladder drainage (catheter) been acceptable to you? p = 0.000 p = 0.002 p = 0.009
Have you seen a community nurse at home? p = 1.0 NS p = 0.2 NS p = 0.4 NS
How much support from your community nurse have you required? p = 0.3 NS p = 0.1 NS p = 0.5 NS
Have you needed to seek advice about your catheter from the hospital or GP? p = 0.2 NS p = 0.3 NS p = 0.2 NS
Has it been necessary for you to revisit the hospital because of your bladder p = 0.4 NS p = 0.3 NS p = 1.0 NS
problems?
Have you required another person, e.g. a family member, to assist in care p = 0.6 NS p = 0.6 NS p = 1.0 NS
of your catheter or bladder care?
Has the use of a catheter caused you anxiety or embarrassment? p = 0.04 p = 0.03 p = 0.005
Have you experienced any difficulty in obtaining equiptment, e.g. pads, p = 0.5 NS p = 0.07 NS p = 1.0 NS
dressings, catheters, bags, etc?
Has the method of bladder drainage enabled you the freedom to lead p 0.000 p = 0.006 p = 0.000
a normal life?
All statistical tests performed using Fisher’s exact test. NS = not significant
Table 4. EORTC QLQ C30 preoperaive and 3, 6 and 12 weeks postoperative (ISC vs SPC)
Domains Preoperative Week 3 Week 6 Week 12
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the differences in infection rates between ISC and SPC following radical hysterectomy. These results should be
appear to be greatest within the first 5 days, during which considered in context to the full physical, psychological
the ISC women were managed by a transurethral indwelling and sexual problems that cervical cancer and consequent
catheter. There were no differences in urinary tract infection surgery can cause.
rates after this period and following the introduction of
ISC, although this may be accounted for by the higher use Conclusion
of antibiotics for confirmed infections in the preceding This study has shown that ISC is a simple bladder care
period. In light of these results, a logical step may be to technique that women prefer and are able to learn easily.
introduce SPC for these first 5 days postoperatively instead Although this study found the incidence of urinary tract
of an indwelling urethral catheter, as this may reduce the infection rates were higher with ISC, this has to be offset
urinary infection rates in this ISC group. SPC site problems against the SPC site problems that women experienced.
occurred during a later period. More importantly, women prefer to have fewer disturbances
The SPC catheter used in this study was a Bonanno at night, greater freedom to carry out normal activities
catheter which required suturing of the plastic base to during the day, and felt less embarrassed and anxious about
the surrounding skin to ensure it remained secure and their bladder care when compared to SPC. BJN
Key Points
n Clean intermittent self-catheterization (ISC) is an acceptable technique for bladder management following radical surgery
for cervical cancer.
n Although mobility is difficult with a mid-line laparotomy wound, all patients were able to learn the technique of ISC
without difficulty.
n ISC was more acceptable to women allowing fewer disturbances at night, greater freedom to lead a normal life during the
day and less anxiety and embarrassment compared to suprapubic catheterization.
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