Pamela
Downey, PT, DPT, WCS, BCB-PMD
Esther
Levy, SPT
Purpose:
To assess the efficacy of intravaginal electrical stimulation—using subjective
and objective outcome measures—in the management of female urinary
incontinence.
Study
Design: Multicenter prospective observational study.
Participants:
359 women with urinary incontinence (207 with stress UI [group A], 33 with urge
UI [group B], and 119 with mixed UI [group C]) were recruited between September
2010 and June 2011. No information regarding parity, BMI, and/or type of birth
delivery was provided in this article. Length of time/onset of UI was not
described for participants in this study.
Inclusion
Criteria: Women who presented with clinical or urodynamic symptoms of genuine
stress UI, urge UI, or mixed UI were included in this study.
Exclusion
Criteria: Women with neurogenic incontinences, associated urogenital prolapse
(stage 2), patients <18 and="" contraindications="" electrical="" pacemaker="" pregnancy="" span="" stimulation="" style="mso-spacerun: yes;" the="" to="" years="">
current or past genitourinary cancer, untreated urinary tract or vaginal
infection, non-investigated metrorrhagia, nickel allergy, pelvic anatomy
preventing placement of the stimulator, and difficulties understanding pelvic
floor muscle training technique).
Outcomes:
·
Primary:
Objective cure=absence of stress UI in voiding diary. Improvement= ≥50%
reduction of UI incidents. Failure=patients who did not meet the above
criteria.
·
Secondary:
Subjective cure=Contilife overall QOL score >7.
Standardized
Procedures: An initial visit with an MD consisted of a standard interview to
obtain the patient’s urinary symptoms, a voiding diary, and a complete
urological and gynecological physical exam in order to assess pelvic floor
muscle tone, strength of the levator ani, a urinary disability questionnaire
(MHU), and the Contilife quality of life questionnaire.
·
Mesure
du Handicap Urinaire (MHU): provides a quantitative measurement (score 0-4) for
7 classes of urinary symptoms: stress incontinence, frequency of stress
incontinence, urgency, urge incontinence, diurnal voiding frequency, nocturnal
voiding frequency, and dysuria.
·
Contilife
QOL Questionnaire: 28 items divided into 6 subgroups scored 0 to 5 (0-poor QOL,
5-excellent). The 6 subgroups consisted of daily activities, effort,
self-image, emotional consequences, sexuality, overall QOL.
Informed
consent was obtained prior to giving oral and written instructions for either
the Keat or Keat Pro electrical stimulators.
·
Keat
Pro, the latest model of the two stimulators, has each session already set at
30 minutes by the manufacturer. Depending on the type of incontinence,
participants set the stimulator at stress UI, urge UI, or mixed UI. They
completed five 30-minute sessions/week for a total of 10 weeks. Intensity was
gradually increased per the patient’s tolerance, with a total of 4 possible
levels.
·
Keat,
the older model of the two stimulators, allowed patients to program their
settings in a similar way to the Keat Pro, but sessions lasted only 20 minutes
max. Patients completed five 20-minute sessions/week, for a total of 10 weeks.
Intensity was also gradually increased for the patients who received this
stimulator.
After
the 10 weeks of pelvic floor muscle training were completed, patients were
given a follow-up assessment (identical to the initial assessment), as well as
a satisfaction questionnaire and a VAS.
Statistical
Analysis:
·
Qualitative
variables expressed as a number and percentage
o
Chi-Square
test or Fisher exact test performed depending on sample size
·
Quantitative
variables expressed as a number, mean, and standard deviation
o
Nonparametric
rank analysis performed for distribution was not normal.
·
Variations
of Contilife and MHU questionnaires tested by Student’s test on paired series
or Wilcoxon test on paired series for non-normal distribution.
·
Statistical
significance: P<.0001
·
Statistical
analysis performed with SAS version 9.2 by an independent statistician.
Results:
30.1%
(108 patients) were treated with the Keat, and 69.9% (251 patients) were
treated with the Keat Pro pelvic floor muscle electrical stimulation. Of the
total number of patients in this study (359), there were three subgroups: 57.7%
with stress UI [group A], 9.2% with urge UI [group B], and 33.1% with mixed UI
[group C]. These groups showed the following results:
·
Overall
cohort (total 359 participants):
o
63.5%
(228 participants) objective cure rate
o
15.6%
(56 participants) improvement rate
o
20.9%
(75 participants) fail rate
o
83.6%
(275 participants) satisfaction rate
o
Mean
score on the VAS: 7.04 ±2.23
·
Group
A—Stress UI (207 participants):
o
65.7%
(136 participants) objective cure rate
o
14.6%
(30 participants) improvement rate
o
19.8%
(41 participants) fail rate
o
84.7%
(161 participants) satisfaction rate
o
Mean
score on the VAS: 7.17±2.3
·
Group
B—Urge UI (33 participants):
o
57.6%
(19 participants) objective cure rate
o
24.2%
(8 participants)
o
18.2%
(6 participants) fail rate
o
84.8%
(28 participants) satisfaction rate
o
Mean
score on the VAS: 7.6±2.1
·
Group
C—Mixed UI (119 participants):
o
61.3%
(73 participants) objective cure rate
o
15.1%
(18 participants) improvement rate
o
23.5%
(28 participants) fail rate
o
81.1%
(86 participants) satisfaction rate
o
Mean
score on the VAS: 6.66±2.09
·
MHU
Questionnaire: Statistically significant reduction (P<.0001) in stress UI
score, urge UI score, and frequency score observed for overall cohort and Group
C.
o
Stress
UI score significantly reduced for Group A.
o
Urge
UI score significantly reduced for Group B.
o
No
significant difference for objective efficacy based on the type of stimulator
was observed by the MHU (P=.4005).
·
All
groups had significant improvements in levator ani muscle testing after pelvic
floor muscle training.
·
Statistically
significant improvement noted in QOL (all items) as assessed by the Contilife
for all groups.
o
Group
C did not show marked improvement in sexuality following PFM training.
o
No
significant difference observed based on the type of stimulator used (P=.2875).
·
Mean
weekly sessions of pelvic floor muscle training: 4.23±1.13
·
Fourteen
participants (3.9%) discontinued pelvic floor muscle training.
Rationale:
Electrical stimulation was used to trigger reflex contraction of the pelvic
floor muscles, including the external urethral sphincter via the pudendal
nerve. Furthermore, this type of treatment attempted to activate three
simultaneous central actions (not normally activated during voluntary pelvic
floor contraction) via the deliverance of electrical impulses: activation of
hypogastric inhibitory fibers to the bladder; central inhibition of pelvic
outflow to the bladder; central inhibition of the ascending afferent pathway
from the bladder.
·
Type
of current: alternating/biphasic current to avoid overheating of tissues.
·
Stimulation
intensity: Stimulate nerve branches of interest without causing pain. Finding
an optimal threshold and the point of habituation are completed by starting at
the lowest intensity and gradually increasing to the patient’s tolerance.
·
Distance
between the stimulator and the nerve fibers: placement must be close to the
targeted fibers to avoid skin burns.
·
Stimulation
frequency: minimum of 50 Hz is necessary to activate motoneurons and reach
maximum urethral closure pressure. Sympathetic inhibition achieved at 5-20 Hz.
E-stim has also been shown to release endogenous catecholamines by hypogastric
fibers to induce direction inhibition of the detrusor muscle and decreased
parasympathetic neurotransmission.
·
Duration
of application: An intermittent stimulation current, i.e. 2-sec on, 5-sec off,
to achieve max efficacy and avoid muscle fatigability.
Limitations:
·
Methodological
issues prevented this research from being compared to other studies, e.g.
different stimulators, different treatment protocols, little or no assessment
of QOL or use of nonspecific scales used in other studies.
·
Dosage
parameters were unclear secondary to lack of research regarding training
guidelines.
·
Absence
of urodynamic data after pelvic floor muscle training.
·
Absence
of randomized controlled trial.
·
Pre-
and post-physical exams conducted by researchers who were not blinded to group
assignments.
Take
Home: Based on this study’s results, pelvic floor training via electrical
stimulation is an effective method in treating female urinary incontinence. The
authors of this study suggested that electrical stimulation should be combined
with a pelvic floor muscle training program to ensure long-term maintenance of
continence. Patients must be able to comprehend the verbal and written
instructions for electrical stimulation of the pelvic floor, and should be
advised to start at the lowest intensity before progressing to higher levels
over successive treatment sessions. The authors concluded that electrical
stimulation may be an effective first-line treatment for female urinary
incontinence based on the positive results of this study and effects on QOL.
Further studies are needed to assess long-term effects of this treatment, as
well as dosage and treatment parameters.
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