Keywords
prostate cancer - radiotherapy - radical prostatectomy - urinary incontinence - fecal
incontinence
Introduction
Patients with prostate cancer (PC), depending on their staging, may be referred for
treatments that can lead to the onset or intensification of urinary and intestinal
symptoms.[1] Despite its favorable results, radiotherapy (RT) can cause several side effects,
and intestinal and urinary symptoms are of significant importance, since they can
compromise quality of life (QOL).[2] Fecal incontinence (FI) is one of the most common adverse effects, and its onset
is associated with actinic proctitis.[3] In turn, radical prostatectomy (RP) may also be responsible for complications, with
sexual dysfunction and urinary incontinence (UI) being the postoperative symptoms
that most impact QOL.[1]
The presence of FI or lower urinary tract symptoms (LUTS) after treatment for PC may
compromise labor activities, as well as social interaction.[2] Thus, there is an evident need to analyze the presence of FI and LUTS, as well as
the association of these symptoms in patients with PC before and after any therapeutic
approach. When addressing the frequency with which these symptoms occur and their
association, there the implementation of approaches that not only improve the QOL
of patients with PC, but also prevent or mitigate the possible adverse effects resulting
from the treatments, should be encouraged. Addressing the frequency and association
between these symptoms will encourage the application of measures to avoid or reduce
the adverse effects of treatments and, consequently, may reflect an improvement in
the quality of life of patients.
Methods
Patient selection
A cross-sectional study was conducted with men with PC assisted by urologists at Serviço
Estadual de Oncologia (CICAN), in the city of Salvador, state of Bahia, Brazil, from
April 30th to September 4th, 2020. We included men over the age of 18 years who were
scheduled for treatment (recent diagnosis) or who had undergone RT or RP in the last
5 years. Those with neurological and/or anatomical alterations of the urinary and/or
digestive tracts, patients using laxatives, patients who had had RT associated with
surgery, and those who did not fill out all questionnaires applied, in addition to
functionally-illiterate patients, were excluded.
Instruments used
Before the beginning of the research, all interviewers were trained on questions related
to intestinal and urological disorders, so that they could answer, through e-mails
or telephone calls, the questions of men during the application of the questionnaire.
Through telephone calls, the patients were evaluated regarding the inclusion and exclusion
criteria, and those who were within the target group of the research were invited
to participate. After agreeing provide informed consent, all respondents filled out
the Google Forms questionnaire made available to them by message or email. The self-report
instrument contained questions on age, type of treatment performed for PC, and presence
of FI and LUTS, and did not allow patients to leave unanswered questions. The research
team had no contact with the men prior to the interview, and no gastrointestinal or
urological recommendations were provided to improve these dysfunctions.
To evaluate FI, the Cleveland Clinic Incontinence Score (CCIS)[4] was used, which contains five items to be evaluated: incontinence to liquids, solids,
and gases, in addition to the use of liners and lifestyle alterations. The CCIS uses
a Likert scale with scores ranging from never (0), rarely (1 point), occasionally
(2 points), frequently (3 points), and always (4 points). A score of 0 point indicates
perfect continence; from 1 to 7, mild incontinence; from 8 to 14, moderate incontinence;
and, from 15 to 20, severe incontinence.
The Fecal Incontinence Quality of Life (FIQL)[5] questionnaire was used to assess the impact of FI on QOL. It consists of 29 questions
divided into 4 domains. The scores of each item range from 1 to 4, except for questions
1 and 4, which have scores of 5 and 6 points respectively. The the final score, the
better the QOL and the lower the impact on QOL. The final result is the sum of all
points, where the smaller the score, the greater the perceived severity of fecal incontinence.
The LUTS were evaluated through the International Consultation on Incontinence Questionnaire
Overactive Blader (ICIQ-OAB).[6] This score also uses a Likert scale. In question 3a, the urinary frequency is evaluated
as: 1-6 times (0); 7-8 times (1 point); 9-10 times (2 points); 11-12 times (3 points);
and ≥ 13 times (4 points). Men who report a urinary frequency of 9 times a day (2
points) are considered to have pollakiuria. In the 4a, nocturia is analyzed: no time
(0); 1 time (1 point); 2 times (2 points); 3 times (3 points); and ≥ 4 times (4 points).
Patients who get up more than 1 time a night (2 points) are classified as having nocturia.
Finally, 5a and 6a evaluate voiding urgency and UI respectively: never corresponds
to 0 point; a few times, 1 point; sometimes, 2 points; most of the time, 3 points;
and always, 4 points. Patients who answer “sometimes”, “most of the time”, or “always”
are considered carriers of these symptoms. This questionnaire also enables the evaluation
of the impact of LUTS on the QOL (questions 3b, 4b, 5b, 6b), with scores ranging from
0 to 10 points, in which zero corresponds to no impact, and 10, to a high impact.
As this part of the questionnaire contains 4 questions, its score ranges from 0 to
40 points, and the higher the score, the greater the impact on QOL. For the purposes
of better understanding, we named this section of the questionnaire related to the
impact of LUTS on QOL as the QOL score of the ICIQ-OAB.
Statistical Analysis
The statistical analysis was performed with the Statistical Package for the Social
Sciences (IBM SPSS Statistics for Windows, IBM Corp., Armonk, NY, United States) software,
version 21.0. The numerical variable representing age was expressed as a mean and
standard deviation value, and the scores were expressed as medians and interquartile
range (IQR). The variables included in the analysis were: age, patient subgroup (RT/RP/No
treatment), urinary symptoms (urgency, incontinence, pollakiuria, and nocturia), FI,
and the scores on the CCIS, the FIQL, and the ICIQ-OAB. Age, and the scores on the
CCIS, the FIQL and the ICIQ-OAB were defined as quantitative variables. The patient
subgroup, urinary symptoms, and FI were classified as categorical variables.
The calculation of the sample size considered a cross-sectional study[7] in which 5.9% of men diagnosed with PC presented FI and LUTS simultaneously. According
to the hypothesis that 50% of these individuals would present lower urinary tract
disorder and 50% would not, the sample size was calculated as 83 men for a power of
80% and an alpha error of 5%.
The Kruskal-Wallis test was used to evaluate the association between the scores and
subgroups of patients. In turn, the Chi-squared test evaluated the association between
the subgroups of patients and urinary symptoms (pollakiuria, nocturia, voiding urgency,
and UI) and FI, as well as the association between the presence of FI and LUTS. The
Mann-Whitney test was used to evaluate the association between FI and the FIQL.
In addition, to evaluate the association of FI and perfect continence in relation
to UI within the subgroups of patients, the Chi-squared test was used. To evaluate
the association of FI and perfect continence in relation to the FIQL, the Mann-Whitney
test was used. The associations regarding age and the scores on the CCIS, the FIQL
and the QOL section of the ICIQ-OAB were evaluated through the Spearman correlation.
Similarly, this test was used to evaluate the association between the scores on the
CCIS and FIQL and between those of the ICIQ-OAB and QOL for urinary symptoms. Values
of p < 0.05 were considered statistically significant.
The Ethics Committee of Escola Bahiana de Medicina e Saúde Pública approved the study
protocol under CAAE 26099319.4.0000.5544. Patients were only admitted to the study
after virtually signing the informed consent form provided in the research form, which
only allowed access to the questionnaires after approval of the term. All procedures
performed in the present study were in accordance with the national and institutional
ethical standards for research and with the Declaration of Helsinki of 1964 and its
subsequent changes.
Results
We included a total of 84 patients (mean age: 67.5 + 7.7 years) diagnosed with PC. Regarding treatment, of the 84 patients, 40 men had
not yet started it (47.6%), 31 were submitted to RP (36.9%), and 13 patients underwent
RT (15.5%).
The median scores on the ICIQ-OAB, CCIS and FIQL were of 4 (IQR: 3-8), 0 (IQR: 0-1.75),
and 116 (IQR: 115-117) respectively. A total of 25 patients (29.8%) had mild anal
incontinence according to the CCIS, with a median score of 3 (IQR: 2-5).
In the comparison of the groups of patients with PC, significant variations were found
in the ICIQ-OAB score (p = 0.01), regarding patients submitted to RT, RP and those without treatment, with
medians of 8 (IQR: 5-10.5), 4 (IQR: 3-7), and 4 (IQR: 1.25-8) respectively. In the
other questionnaires, there was no difference among the groups. Neither were there
differences among the groups in relation to the presence of LUTS (pollakiuria, nocturia,
urgency and UI) and FI ([Table 1]).
Table 1
Intergroup comparison regarding the ICIQ-OAB, CCIS, and FIQL scores and presence of
urinary symptoms and urinary and fecal incontinence
Variable
|
|
Radiotherapy
|
Radical prostatectomy
|
No treatment
|
p-value
|
|
|
n = 13
|
n = 31
|
n = 40
|
|
ICIQ-OAB
|
(M/IQR)
|
8 (5.0–10.5)
|
4 (3.0–7.0)
|
4 (1.25–8.0)
|
0.01a
|
CCIS
|
(M/IQR)
|
0 (0.0–3.0)
|
0 (0.0–1.0)
|
0 (0.0–1.75)
|
0.78
a
|
FIQL
|
(M/IQR)
|
116 (115.0–116.5)
|
116 (114.0–117.0)
|
116 (115.0–117.0)
|
0.75
a
|
Pollakiuria
|
n (%)
|
5 (38.5)
|
9 (29.0)
|
10 (25.0)
|
0.64
*
|
Nocturia
|
n (%)
|
11 (84.6)
|
21 (67.7)
|
26 (65.0)
|
0.40
*
|
Voiding urgency
|
n (%)
|
8 (61.5)
|
10 (32.3)
|
12 (30.0)
|
0.10*
|
Urinary incontinence
|
n (%)
|
6 (46.2)
|
10 (32.3)
|
10 (25.0)
|
0.35
*
|
Fecal incontinence
|
n (%)
|
5 (38.5)
|
8 (25.8)
|
12 (30.0)
|
0.70
*
|
Abbreviations: CCIS, Cleveland Clinic Incontinence Score; FIQL, Fecal Incontinence
Quality of Life questionnaire; ICIQ-OAB, International Consultation on Incontinence
Questionnaire Overactive Bladder; IQR, interquartile range; M, median.
Notes: a Kruskal-Wallis test. * Chi-squared test.
However, when comparing patients with FI and those with perfect continence regarding
the presence of LUTS and the FIQL and ICIQ-OAB scores, we observed that patients incontinent
to feces had a higher frequency of UI (p < 0.001) ([Table 2]).
Table 2
Comparison between patients with fecal incontinence and perfect continence for urinary
symptoms and FIQL and ICIQ-OAB scores
Variable
|
|
Fecal incontinence
|
Perfect continence
|
p-value
|
|
|
n = 25
|
n = 59
|
|
Pollakiuria
|
n (%)
|
9 (36.0)
|
15 (25.4)
|
0.32*
|
Nocturia
|
n (%)
|
16 (64.0)
|
42 (71.2)
|
0.51*
|
Voiding urgency
|
n (%)
|
12 (48.0)
|
18 (30.5)
|
0.12*
|
Urinary incontinence
|
n (%)
|
14 (56.0)
|
12 (20.3)
|
< 0.001*
|
FIQL
|
(M/IQR)
|
116 (112.0–117.0)
|
116 (115.0–117.0)
|
0.68+
|
ICIQ-OAB
|
(M/IQR)
|
7 (3.5–11.5)
|
4 (3.0–7.0)
|
0.08+
|
Abbreviations: FIQL, Fecal Incontinence Quality of Life questionnaire; ICIQ-OAB, International
Consultation on Incontinence Questionnaire Overactive Bladder; IQR, interquartile
range; M, median.
Notes: * Chi-squared test. + Mann-Whitney test.
Evaluating the treatment groups regarding the presence of FI, we observed that patients
submitted to RP presented an association between UI and FI (p < 0.001) and a greater impact of urinary symptoms on QOL, measured by the QOL section
of the ICIQ-OAB (p = 0.03). In addition, there was a greater impact of the presence of FI on QOL in
this group of patients (p < 0.001) ([Table 3]). However, when comparing the degrees of FI among the groups of patients, no difference
was found ([Table 4]).
Table 3
Intergroup comparison of patients (radiotherapy/radical prostatectomy/untreated) with/without
fecal incontinence regarding the presence of urinary incontinence and FIQL and ICIQ-OAB
quality of life scores
Variable
|
|
Radiotherapy
|
Radical prostatectomy
|
No treatment
|
|
|
No FI
|
With FI
|
p-value
|
No FI
|
With FI
|
p-value
|
No FI
|
With FI
|
p-value
|
|
|
n = 8
|
n = 5
|
|
n = 23
|
n = 8
|
|
n = 28
|
n = 12
|
|
Urinary incontinence
|
n (%)
|
3 (37.5)
|
3 (60.0)
|
0.59#
|
4 (17.4)
|
6 (75.0)
|
< 0.001#
|
5 (17.8)
|
5 (41.6)
|
0.11*
|
FIQL
|
(M/IQR)
|
116 (115.0–116.75)
|
116 (110.0–116.5)
|
0.76+
|
117 (116.0–117.0)
|
112 (88.5–116.25)
|
< 0.001+
|
116 (115.0–117.0)
|
116 (114.0–117.0)
|
0.77+
|
ICIQ-OAB (quality of life)
|
(M/IQR)
|
12.5 (1.0–23.75)
|
28 (14.5–40.0)
|
0.07+
|
0 (0.0–17.0)
|
18 (8.25–31.0)
|
0.03+
|
0 (0.0–12.25)
|
0 (0.0–25.5)
|
0.67+
|
Abbreviations: FI, fecal incontinence; FIQL, Fecal Incontinence Quality of Life questionnaire;
ICIQ-OAB, International Consultation on Incontinence Questionnaire Overactive Bladder;
IQR, interquartile range; M, median.
Notes: * Chi-squared test. + Mann-Whitney test. # Fisher test.
Table 4
Intergroup comparison of patients (radiotherapy/radical prostatectomy/untreated) regarding
the degrees of fecal incontinence
Variable
|
|
Radiotherapy
|
Radical prostatectomy
|
No treatment
|
p-value
|
|
|
n = 13
|
n = 31
|
n = 40
|
|
Degrees of incontinence:
|
|
|
|
|
0.58*
|
Perfect continence
|
n (%)
|
8 (61.5)
|
23 (74.2)
|
28(70.0)
|
|
Mild incontinence
|
n (%)
|
5 (38.5)
|
6 (19.4)
|
11(27.5)
|
|
Moderate incontinence
|
n (%)
|
0
|
2 (6.5)
|
1(2.5)
|
|
Severe incontinence
|
n (%)
|
0
|
0
|
0
|
|
Note:* Chi-squared test.
No correlations were found between age and the scores on the ICIQ-OAB (r = - 0.42;
p = 0.70), the CCIS (r = -0.23; p = 0.83), and the FIQL (r = -0.13; p= 0.90). In turn, there was a weak negative correlation between the CCIS and FIQL
scores (r = - 0.256; p = 0.01), and a strong positive correlation between the overall score on the ICIQ-OAB
and the score on its QOL section (r =0.75; p < 0.01).
Discussion
In the present study, we observed that the group of patients submitted to RT presented
more intense LUTS, characterized by higher ICIQ-OAB scores. Moreover, in the evaluation
of the entire sample, the presence of FI was associated with the presence of UI. It
is also noteworthy that, in the evaluation of FI, the patients incontinent to feces
submitted to RP presented a greater association with UI, and there was also impairment
of QOL related to fecal and urinary loss. Finally, a correlation was identified between
the CCIS and FIQL scores and between the overall ICIQ-OAB score and the score on its
QOL section, which demonstrates the impact of FI and LUTS on patient well-being, with
urinary complaints having a more intense impact.
The most intense urinary complaints among the patients submitted to RT are possibly
related to the presence of actinic lesions, and actinic cystitis is responsible for
symptoms such as urgency, dysuria, and pollakiuria and, consequently, higher scores
among this group of patients.[3] Unlike the results obtained in the present study, the study by Potosky et al.[8] identified that patients submitted to RP had a higher frequency of urinary complications
(9.6%) when compared to those submitted to RT (3.5%). Still in divergence to our findings,
Sanda et al.,[2] found that, compared to postradiotherapy UI, postsurgery UI had a greater impact
on QOL. According to the same authors,[2] the effects of RT on urinary symptoms usually resolve 12 months after the end of
treatment, improving in relation to symptoms prior to 24 months of RT. Also studying
patients with irradiated PC, Fonteyne et al.[9] observed that the urinary symptoms present before treatment intensified during RT
sessions, from grade 1 to grade 2, in 48% of the cases, and that, after 1 and 2 years,
60% to 70% of the patients presented symptoms less intense than those felt before
the treatment. The dissonant result of the present study can be explained by the fact
that the date of the end of RT was not taken into account, although only patients
undergoing treatment in the last 5 years were included, and the presence of recently-irradiated
patients may have influenced the analysis. It is worth noting that Pinezi,[10] in a study evaluating women submitted to RT for cervical neoplasia, observed that
the diagnosis of actinic cystitis with intensity ≥ 2 was more performed when to assess
simulated symptoms by specific questionary. Thus, although the duration of the RT
was not determined, the application of a specific questionnaire (the ICIQ-OAB) to
evaluate the LUTS, may have enabled a better identification and analysis of these
symptoms.
The physiological explanation for the concomitant occurrence of FI and UI is mainly
due to advancing age and its consequences, such as increased prevalence of mental
confusion, detrusor instability, poor mobility, cognitive decline, use of diuretics,
and loss of pelvic support.[11] In the study by Roberts et al.,[7] the prevalence of FI combined with UI was of 5.9% among men, with increased incidence
with advancing age. In their cross-sectional study, Silva et al.[12] identified that, of the 324 elderly patients evaluated, 33 (10.25%) had UI, only
1 had isolated FI (0.31%), and 120 (37.27%) had double incontinence. Thus, it is possible
to verify that there is still no consensus regarding the prevalence of this association.
The difference between the studies may stem from the different definitions of incontinence
proposed and the variability in the age of the patients involved.
In patients incontinent to stool submitted to RP, a higher incidence of UI and a negative
impact on QOL were observed due to the presence of urinary and fecal losses. Several
factors such as deficiency of the internal and external sphincters of the urethra,
bladder dysfunction, and weakness of pelvic floor muscles may be implicated in the
occurrence of UI in patients submitted to RP.[13] During surgery, the sphincters may be injured; in addition, the external urethral
sphincter may already be weakened due to the period in which the urethra was compressed
by the enlarged prostate.[13] The incidence of UI-associated FI, called double incontinence, may justify the impact
on the patient's QOL, because the presence of double incontinence is related to depressive
symptoms in men.[11]
Since the scores that assess LUTS and FI correlate with the scores that measure QOL,
it has been demonstrated that the intensity of both directly affects the patient's
life, but there is a greater impact on QOL related to the intensity of urinary symptoms.
Changes in lifestyle occur in an attempt to adapt to the new reality, because urinary
loss may cause anxiety, social/family distancing, and feeling of loss of control of
one's own life.[14] It is important to point out that the weak correlation found between the CCIS and
FIQL scores in the present study can be explained by the fact that most (88%) of the
incontinent patients presented mild incontinence.
We also observed that 30% of the patients who had not yet been treated for PC already
had FI. Since some treatments for PC may aggravate the patient's defecation complaints,
previous knowledge about fecal loss is fundamental when choosing the best approach.
Radiotherapy, for example, can cause intestinal discomfort, such as rectal urgency,
increased frequency, pain, FI, and hematochezia within one year of treatment, which
could intensify the intestinal complaint that already existed before the treatment.[2] In turn, RP could cause, above all, LUTS, such as dysuria, voiding urgency, and
urethritis, thus adding urinary complaints in patients with previous fecal symptoms,
significantly reducing QOL.[9] Therefore, the presence of FI prior to treatment should be considered when defining
the therapeutic approach for PC.
One of the limitations of the present study is the lack of information about the time
elapsed after each type of treatment, which could better explain some of the results
found. Moreover, the fact that the study is observational makes it impossible to determine
the causality involving the variables.
Therefore, the present study, with the evaluation of LUTS, FI and the association
between them, provides more information about the presence of these symptoms in men
with PC and how they interfere with QOL. Thus, the broad and individualized evaluation
of men with PC can help in the choice of treatment, which should be defined according
to the clinical picture and the desires of the patient, always considering the associated
symptoms that may impact QOL.
Conclusion
In men with PC, LUTS are more intense in those submitted to RT. The presence of FI
in men with PC is associated with the presence of UI, with QOL impairment, particularly
in patients with FI undergoing RP.