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Abstract
Urinary stress incontinence is the most
common cause of female urinary incontinence
and the second factor for permanent incontinence
in old women which effects quality of life
and women's health. Cone therapy is an effective
intervention for prevention and treatment
of urinary incontinence.
Objective: To determine the effect
of cone therapy on urinary stress incontinence.
Design: This was a before-after clinical
trial without a control group. 60 incontinent
women were selected consecutively in Lolagar
and educational and medical center of Shahid
Akbarabadi of Tehran. They were instructed
they should use vaginal cones (20 - 70 grams)
twice a day, each 15 minutes for 3 months,
except during menstruation. Data were evaluated
by assessing the number and amount of leakage
during stress after cone therapy.
Results: A significant decrease in
urine leakage frequencies and volume after
therapy(p<0.0001)
Conclusion: Cone therapy is an effective
method for urinary stress incontinence .
It is recommended that cone therapy be used
as supportive treatment for this problem.
Key words:
Urinary stress incontinence, cone therapy.
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Introduction
Stress incontinence
occurs during periods of increased intra-abdominal
pressure (e. g., sneezing, coughing, or exercise)
and other physical activities.
It is the most common
form of urine loss in women and the second most
consistent incontinence in older women (Braunwald,
Fauci, Jasper, Hauser, Longo, Jameson Zool). Urinary
incontinence, as a major health-social problem
influences daily activities and social relationships
in women. It was an inevitable problem related
to aging in the past, but it can be prevented
or cured in most cases now.
Female urinary incontinence
prevalence is estimated at 45 % in one year. (Walters,
Karamu, 1999). In our setting, 10 to 20 % of patients
complain of various degrees of urine loss.
The most important risk factors for stress incontinence
are: age, race, delivery, menopause, obesity,
and smoking. (Walsh, Petik, Vaughan, Wein, 1992)
SI is an annoyance condition that effects the
health and psychosocial status of patients. For
instance, stress incontinence limits patients'
ability to do regular physical activities and
exercise. Because these play a significant role
in preventing osteoporosis, hypertension, coronary
heart disease, depression and anxiety, avoidance
of exercise by patients could threaten women's
general health. (Ingar, Kari, Trygre, 1999). Stress
urinary incontinence changes the lifestyle of
the incontinent. They often use a nappy for leakage
and depression of urine odour and some women feel
excluded. (Moore, Hegar 1377). Medically, they
may suffer from primal rashes; feeling pressure
in the lower genital tract and UTIs are more prevalent
(Walsh et al, 1992).
SI is cured by non-surgical
and surgical treatment, but basic treatment is
strengthening pelvic floor muscle (Ryan, Berknowtiz,
Barbien, Daunraif, 1999). Cure rate of pelvic
muscle exercise was reported from 24 to 84 percent
in literature. Kegel believed there are degrees
of lavator ani musculature weakness in SI patients
(Tranagho, Mc Aninch, 2000).
However, pelvic
muscle training could be performed as Kegel exercise
with or without aid instruments (Berek, Adashi,
Hillard, 1996). One of these instruments is the
vaginal cone. The great advantage of cones is
that they cover the spectrum of muscular contraction
mechanisms for example strength, frequency and
duration of each contraction (Fisher, Linde 1994).
Weighted vaginal cones are 6 cones, of the same
shape and different in weight.
While the women
exercise with cones step by step, from lighter
to heavier cones, the compliance and strength
of muscles would be increased. Incontinent women
may avoid complaining of urine loss because of
fear of surgery, therefore, providing non-surgical
methods of treatment like pelvic floor exercise
and aids to patients could help them, especially
those with mild and moderate stress incontinence.
(Ryan et al 1999).
This study's objective is determining effectiveness
of using vaginal cones in treatment of SI. Our
hypotheses are:
1. Cone therapy decreases urine loss frequency.
2. Cone therapy decreases the amount of leakage
following stress.
Materials and methods
This study was approved
by the Institutional Review Board at Medical Science
University, Iran. All women signed consent forms
before participation.
In this study, the subjects were selected from
patients refered to the gynecology and health
clinics in Lolagar and Shahid Akbar Abadi Hospital
of Tehran in 1380 _ 81.
Inclusion criteria were being literate, having
telephone contact, Iranian nationality, and a
history of one recurring SI episode in a month.
Inclusion criteria included indication for surgical
management, severe pelvic organ prolapse, infectious
disease, neuralgic disease, antihypertensive and
diuretics drug users, smokers, pregnancy and women
6 weeks after delivery, virgins, having a history
of pelvic surgery in recent years and having contraindications
for using vaginal cones.
Current study was an after-before
clinical trial without a control group and consecutive
sampling occurred for a month. The sample number
was 60 women. However 7 patients were excluded
for some reasons (e.g., senility and allergy to
plastic cones, virginity, etc) during the study.
All subjects should undergo urine analysis and
culture and pap smear before introducing them
to the study. Subjects must attend 3 educational
and clinical sessions prior to commencement of
cone therapy. This practice was done with a midwife.
In the first session, a summary of cone therapy
and stress incontinence was delivered by the midwife.
Also, cones were shown to participants. In the
second session, a summary of the physiology and
anatomy of the female lower urinary tract and
pelvic organs and structure, and vagina ,were
explained by that midwife with the aid of molage,
pamphlets, posters and cones.
In the third session,
cone therapy was explained to the subjects, then
the patients received it and used it in the clinic,
assisted by a midwife.
The subject should be
filling a stress leakage/frequency chart in one
week before cone therapy and one week after termination
of it.
The stress leakage was
categorized in 3 levels: If the amount of urine
leakage following stress in one week, usually
was wetting, it was classified as mild. If it
was a soaking and overflowing, it was referred
to as moderate and severe respectively.
The stress frequency,
was also categorized in 3 levels: If the amount
of urine lost during stress was 1 to 9 times in
one week, it was mild, 10 to 25 times in a week
was moderate and more than 25 was severe.
The cones consisted of
6 white plastic cones in different weights and
similar shape, with a blue nylon thread from 20
to 70 gram.
Duration of cone therapy
was 3 months. The subject must use them two times
daily, with each duration 15 to 20 minutes, except
during menstruation.
The management commenced
with the lightest cone (20 gram).
The woman had to insert
the cone in the vagina totally and had to contract
the levator ani muscle to avoid cone expulsion
from the vagina for 2 minutes. If she was successful,
thenext cone was tried. This was sone until she
could not keep a cone in her vagina. Then, this
cone was suitable for therapy.
Results
The results of this study
are demonstrated in tables 1 - 3
Table 1: demographic characteristic
of subjects
|
Characteristics |
Mean |
SD |
Range |
|
Age (yr) |
43.02 |
9.99 |
19-75 |
|
BMI (kg/m2) |
24.40 |
4.45 |
20.3-44.4 |
|
Parity |
4.02 |
2.04 |
0-10 |
Table
2: comparison of mean and SD of SI frequencies
changes:
| |
Mean +_ SD |
Changes |
|
Frequency / week
|
|
Before
|
After
|
|
8.77+_10.63
|
4.04+_8.42
|
|
_ 4.73 +_ 7.52
|
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Wilkaxon test
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P< 0.0001
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Z= 5.496
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Table
3: comparison of leakage amount following
stress before conetherapy and 3 months after it.
|
Before
|
Mild
|
Moderate
|
Severe
|
Total
|
| After
|
|
Cure
|
|
|
|
|
|
Mild
|
|
|
|
|
|
Moderate
|
|
|
|
|
|
Severe
|
|
|
|
|
|
Total
|
|
|
|
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X2 test p<0.0001
X2 = 11.44
Discussion
In this study, the most
significant finding was relative cure in SI frequencies
and urine leakage, reduction in complaint of SI
disorders and symptoms. In general, the patients
suffering from SI were reduced significantly 3
months after cone therapy (p< 0.0001).
For example, 75% of women
with mild SI became healthy after cone therapy.
Also 31% of women with moderate SI became healthy.
In contrast, no patients
with severe urine leakage were cured. Nylen and
Cammue (1998) in 60 patients with genuine SI made
similar findings.
In our study, about 75% of women were statistical
with cone therapy and had good results.
The patients inserted
a suitable cone to initiate treatment. If she
could not retain it in her vagina without pelvic
muscle contraction, she selected I for exercise.
She must continue exercising with the same cone
until she could hold it by contraction. If she
could retain it, she should change to a heavier
cone. For example cone 2 to cone 3.
These activities
should be done in 3 months except during the menstrual
period.
Each subject completed a questionnaire showing
SI leakage and frequency during one week after
cone therapy .
The comparison of
the continuous variables in the study group was
carried out using the Chi-square and Wilcoxon
tests to evaluate leakage and frequency changes,
respectively. The level of statistical significance
was set at P= 0.05. Data analysis was performed
by SPSS software.
Results:
Of 60 patients who commenced treatment, 53 completed
the course of therapy and several failed to attend
because of vaginitis (3 cases), severe buring
(2 cases) and others were disinterested in applying
cones.
Demographic data
shown in Table -1 revealed that women with SI
were significantly older than the other sample
(68.3 women older than 40 yrs vs 31.7 %) only
3.3 % of samples had academic education and 95%
were housewifes and 88.1% of patients never practiced
pelvic muscle exercise.
In Table 2, the
clinical findings of gynecological examination
are shown.
The frequencies of pelvic organ prolapse is 96.7
%. Most of cases stated therapy with cone 1 (20
gram weighted) which was the lightest one and
only 3.3 % started with the 70 gram weighted cone.
The percentage improvement
for the primary outcome measures is shown in Table
3. For the entire group the number of incontinent
episodes decreased.
The percentage of
complete improvement in urinary leakage was 45.3
%, while mild, moderate and severe levels of urinary
leakage were 20.8, 16.4 and 7.5 percent, respectively
after 3 months.
Discussion
Ageing and menopause are two tisk important
factors of SI. Prevalence of SI increases with
aging. In more than five years, it increases up
to 30 %. Ageing is associated with bladder capacity,
urethral sphincter muscle cells volume and numbers
reduction and residual volume of urine increasing.
It seems these factors predispose older women
to suffer from SI.
Cone therapy is less invasive
than surgery; could be performed by the patient
at home without disrupting home life, and is considerably
less expensive and may be as effective as surgical
correction especially in old women.
In our study the majority
of cases were premenopausal and menopausal women.
This innovative approach to pelvic floor exercises
by cone therapy is an advance in our management
of stress incontinence in the premenopausal and
menopausal women who are aged patients, which
we have assumed to represent. In the present study
the main findings were relatively important and
in some cases completely cured patients suffering
SI signs and symptoms. Generally, frequency of
sufferers from SI after conetherapy were reduced.
The cone test results showed, (4.03 +- 8.42) of
stress incontinence reduced significantly. (p<
0.0001, Z= 5.496).
Otherwise, leakage amount was reduced significantly.
(P<0.0001, X=11.44). 45.3 % of patients.
Hendrickson reported that
89% of women were subjectively improved and Castledon
et al noted improvement in 74% of 19 incontinent
women who practiced pelvic muscle exercise.
Pelvic floor physiotherapy is an important part
in stress incontinence management.
Acknowledgement
This study was a registered
proposal of Midwifery and Nursing Faculty of Medical
science of Iran. We acknowledge :
Dr. Heidari Kohan and
Dr. Derakhshan - Dean of Lolagar and educational
and medical center of Shahid Akbarabadi of Tehran.
Dr. Shah hosseini - Dean of Iran University of
Medical Science and Health Services. Dr. Oscuei-Dean
of Midwifery and Nursing Faculty and all of women
accepted cone therapy.
