Complementary Therapies in Clinical Practice 49 (2022) 101624

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Complementary Therapies in Clinical Practice

journal homepage: www.elsevier.com/locate/ctcp

Intravaginal electrical stimulation as a monotherapy for female stress

urinary incontinence: A systematic review and meta-analysis
Magdalena Stania a, *, Barbara Niemiec b, Anna Kamieniarz a, Daria Chmielewska c
a
Institute of Sport Sciences, Academy of Physical Education, Mikołowska 72a, 40-065, Katowice, Poland
b
Department of Physiotherapy, Academy of Physical Education, Mikołowska 72a, 40-065, Katowice, Poland
c
Institute of Physiotherapy and Health Sciences, Electromyography and Pelvic Floor Muscles Laboratory, Department of Physical Medicine, Academy of Physical
Education, Mikołowska 72a, 40-065, Katowice, Poland

A R T I C L E I N F O A B S T R A C T

Keywords: Background and purpose: Since patients, physiotherapists and gynaecologists continue to seek effective conser­
Electric stimulation vative treatments for stress urinary incontinence (SUI), the aim of this systematic review and meta-analysis was
Female to determine the therapeutic efficacy of intravaginal electrical stimulation (ES) in women with SUI.
Therapeutics
Methods: We searched PubMed, Embase, EBSCOHost and Ovid for randomized controlled trials. For dichotomous
Urinary incontinence
data, we calculated the risk ratio (RR) and 95% confidence interval (CI). For continuous data, we calculated the
mean difference (MD) and 95% CI. Heterogeneity was assessed with I2 statistics.
Results: Of the 686 records identified, a total of 10 articles met the inclusion criteria. A meta-analysis revealed
significant differences between the ES and no active treatment groups in the pooled objective cure rates (RR:
4.20; 95% CI: 1.70 to 10.40; p = 0.001; I2 = 0%) and subjective cure or improvement rates (RR: 4.96; 95%: 1.01
to 24.37; p = 0.04; I2 = 0%). No significant differences were found in the pooled number of incontinence epi­
sodes per 24 h (MD: 0.16; 95% CI: 0.68 to 0.37; p = 0.56; I2 = 0%), the pooled Incontinence Quality of Life
Questionnaire scores (MD: 1.84; 95% CI: 2.11 to 5.80; p = 0.36; I2 = 0%) or the pooled number of adverse effects
(RR: 0.69; 95% CI: 0.38 to 1.27; p = 0.23; I2 = 0%) between the ES and other conservative treatment groups.
Conclusion: There was insufficient evidence for or against the use of intravaginal ES therapy for women with SUI,
partly due to the variability in the interventions of the included trials and the small number of trials included.

1. Introduction pelvic floor muscles (PFMs) was an effective conservative treatment for
female SUI. The treatment of SUI is primarily performed with intra­
It has been estimated that 25%–45% of all women suffer from uri­ vaginal electrodes [4–7], and less often, skin surface electrodes are
nary incontinence [1]. The magnitude of the problem cannot be ignored applied [8]. The trial by Correia et al. [8] compared the effectiveness of
due to its effect on quality of life and its socioeconomic impact. Ac­ two management strategies with different types of electrodes for female
cording to the recommendations of the International Continence Society SUI. Significant improvements in urinary loss and the pressure of con­
(ICS), physiotherapy management, as a conservative treatment, should tractions were demonstrated after treatment with both types of elec­
be a first-line approach in treating female stress urinary incontinence trodes. However, PFM strength increased only in the intravaginal ES
(SUI) [2]. Noninvasive treatments for SUI have been demonstrated to be group.
inexpensive for the patient/health care system and to have minimal side More than 30% of women are unable to contract their PFMs correctly
effects [3]. [9]. Patients with SUI receive intravaginal ES to activate the PFMs
Electrical stimulation (ES) of weakened muscles is a method of directly or indirectly via the pudendal nerve, the fibres of which arise
passive muscle activation through the direct stimulation of muscle or from the ventral rami of the sacral spinal nerves [10]. ES improves
nerve fibres. Chêne et al. [4] noted that electrical stimulation of the sensory and motor muscle functions. Intravaginal ES may therefore

Abbreviations: SUI, stress urinary incontinence; UUI, urgency urinary incontinence; MUI, mixed urinary incontinence; ES, electrical stimulation; PFMs, pelvic floor
muscles; RCT, randomized controlled trial; PEDro, Physiotherapy Evidence Database; RR, risk ratio; D, mean difference; CI, confidence interval.
* Corresponding author.
E-mail address: [email protected] (M. Stania).

https://doi.org/10.1016/j.ctcp.2022.101624
Received 3 May 2021; Received in revised form 22 June 2022; Accepted 25 June 2022
Available online 2 July 2022
1744-3881/© 2022 Elsevier Ltd. All rights reserved.
M. Stania et al. Complementary Therapies in Clinical Practice 49 (2022) 101624

function as specific biofeedback to improve muscle proprioception, treatment, (2) pharmacological treatment, or (3) injection of bulking
especially in patients who have trouble identifying their PFMs [11]. The agents. Outcomes. The primary outcomes were the following: (1)
results of recent studies [12,13] indicate that a series of intravaginal ES women’s observations - self-reports of urinary incontinence; and (2)
treatments in women with extremely weak PFMs enhances the ability to objective cure rates - pad tests measuring grams of involuntary loss of
voluntarily contract those muscles in 32%–36% of those patients. The urine. The secondary outcome measures included the following: (1)
National Institute for Health and Care Excellence (NICE) recommends quantification of symptoms - incontinent episodes, frequency symptoms,
that ES should be considered for women who cannot actively contract pad changes (voiding diary); (2) PFM function and strength; (3) uro­
their PFMs to aid motivation and adherence to therapy [14]. dynamic measurements and studies; (4) quality of life; and (5) adverse
Physiotherapy for female SUI can be administered as individual or effects of ES (e.g., infection of the lower urinary tract, pain, discomfort,
group therapy at an outpatient clinic, but it can also be continued as a exhaustion of the stimulated muscles). We excluded trials assessing only
home-based treatment [15]. Home-based and outpatient clinic-based health economics (e.g., costs of interventions, resource implications).
intravaginal ES tend to demonstrate a significant and comparable Study design. The articles were included based on the following inclusion
therapeutic effect for urinary incontinence in women [16]. ES therapy at criteria: (1) randomized controlled trials; (2) full texts of peer-reviewed
home is usually provided with the use of a mini-stimulator equipped original research articles; and (3) articles with a comprehensive
with an intravaginal electrode. Previously published meta-analyses [17, description of the application parameters, such as the stimulation fre­
18] regarding the efficacy of ES in women with SUI did not differentiate quency, pulse duration, on time, off time, and duration of application.
between the route of administration (vaginal, rectal, skin, pretibial Retrospective studies, case series, conference abstracts, proceedings,
area). Systematic reviews and meta-analyses are considered the highest commentary articles, secondary analyses, systematic reviews, meta-
level of research design and bring together all of the available scientific analyses and narrative reviews were excluded.
evidence to answer a particular research question [19].
The research question was defined by the PICOS format: In women
with SUI, how effective is intravaginal ES as a monotherapy compared 2.2. Information sources
with no intervention, sham ES or any other conservative treatment with
respect to objective cure rates (≤2 g leakage on the pad test), subjective A search was conducted using the following databases: PubMed,
cure or improvement rates (number of women with self-reported Embase, EBSCOHost and Ovid. Databases were searched from their
improvement or continence), number of incontinence episodes per 24 h inception until the last entry, which was 8 May 2022 for PubMed,
(reported in 7-day voiding diaries), quality of life (according to the In­ EBSCOHost and OVID and 12 May 2022 for Embase. To minimize the
continence Quality of Life Questionnaire, I-QOL) and number of adverse risk of omitting relevant sources, the following complementary strate­
effects, confirmed in the randomized controlled trials. gies to explore grey literature were implemented: customized Google
search engines, targeted websites and consultation with clinical experts
2. Methods [21]. The reference lists of all retrieved articles were manually checked
for additional studies. The full search strategies for all the databases,
This systematic review and meta-analysis followed the Preferred including any filters and limits used, are presented in Appendix A
Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) (Table A.1.).
2020 guidelines [20].

2.1. Eligibility criteria 2.3. Search strategy

The papers were checked for relevant content and were included Keywords including ‘urinary incontinence’, ‘urinary stress inconti­
based on the following inclusion and exclusion criteria defined by the nence’, ‘stress incontinence’, ‘genuine stress incontinence’, ‘electrical
PICOS format. Participants. We included studies with (1) adult women stimulation’, ‘functional electrical stimulation’, ‘intravaginal’, ‘trans­
(18 years or older or according to the study authors’ definitions of vaginal’, ‘vaginal’, ‘women’, ‘therapy’ and ‘treatment’ were used. The
adults) with SUI; (2) women with stress-predominant mixed urinary full search strategy for PubMed was as follows: (((urinary incontinence
incontinence (MUI); and (3) women with mixed urinary incontinence, [tiab] or incontinence[tiab] or urinary stress incontinence[tiab] or stress
urgency urinary incontinence (UUI) and SUI only if the data for women incontinence[tiab] or genuine stress incontinence[tiab] or urinary stress
with SUI were presented separately. We excluded studies in women with incontinence[tw] or urinary incontinence[tw] or incontinence[tw])
the following: (1) women with detrusor overactivity associated with AND (stimulation [tiab] or electrical stimulation[tiab] or functional
urgency urinary incontinence or symptoms of urgency; (2) women with electrical stimulation[tiab]) AND (intravaginal[tw] or transvaginal[tw]
urgency urinary incontinence; (3) women with urgency-predominant or vaginal[tiab])) AND (therapy[tiab] or treatment))’.
mixed urinary incontinence (4) women with neurogenic or congenital
disorders (e.g., multiple sclerosis); resulting in urinary incontinence;
and (5) studies with men and women that did not report data separately 2.4. Selection and data collection processes
by sex. Interventions. ES (as a monotherapy) with intravaginal electrodes
of non-implanted devices was administered in the experimental groups. A 2-step study selection process was conducted. During the first
We also chose to exclude papers reporting (1) surface skin ES (in an stage, using the study titles and abstracts, decisions were made based on
experimental group); (2) transcutaneous stimulation of the tibial or the eligibility criteria to select retrieved articles for further assessment
sacral nerves; (3) intravaginal ES combined with another nonelectrical and to minimize the chance of including nonrelevant studies. During the
intervention (as an experimental group); (4) ES with intra-anal elec­ second stage, studies that passed the first stage were downloaded, and
trodes; (5) ES with electrodes that penetrated the skin or had to be the full texts were reviewed. The decision on the inclusion of the study
placed surgically; (6) ES with nonimplanted devices to provide stimu­ was then made based on the prespecified inclusion and exclusion
lation of the bladder; (7) electroacupuncture; and (8) implantable ES criteria. Two authors (MS and BN) independently searched for articles
systems. Comparisons. In patients in the control groups, there was (1) no and screened the studies in a blinded manner. Any disagreements be­
active treatment; (2) sham (placebo) ES; and (3) other conservative tween the authors were resolved through consensus, with other research
treatments (e.g., PFM training, vaginal cones, acupuncture, biofeed­ team members (AK and DC) acting as arbiters.
back, or different types of ES other than intravaginal). We excluded Data were extracted independently by two investigators (MS and BN)
studies in which the control participants had undergone (1) surgical for each study.

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M. Stania et al. Complementary Therapies in Clinical Practice 49 (2022) 101624

Fig. 1. PRISMA flow chart of study inclusion.

2.5. Data items and study quality conservative treatments.

The following data items were sought: basic publication character­ 2.6.2. Secondary outcomes
istics (first author, publication year, country), aim of the study, sample Secondary outcomes were the number of incontinence episodes per
size, groups, ES parameters, duration of intervention, outcome mea­ 24 h (reported in 7-day voiding diaries) and quality of life according to
sures, follow-up and study conclusions. the Incontinence Quality of Life Questionnaire (I-QOL). The secondary
The methodological quality of the randomized clinical studies was outcome measures also included adverse effects. A comparison of ES
rated with the Physiotherapy Evidence Database (PEDro) scale. The versus other conservative treatments was made with respect to the
PEDro (ranging from 1 to 10 points) is a valid measure of the method­ secondary outcomes.
ological quality of randomized clinical trials [22]. Based on the PEDro
score, the methodological quality of trials is rated as high (PEDro scores
2.7. Effect measures
≥7), medium (PEDro scores of 4–6), or low (PEDro scores ≤3) [23]. The
methodological quality of the included articles was assessed indepen­
For dichotomous data, we calculated the risk ratio (RR) and 95%
dently by three reviewers (MS, BN, AK). In cases of disagreement,
confidence interval (CI). For continuous data, we presented the mean
consensus was sought by involving a fourth researcher (DC).
difference (MD) with the 95% CI. Heterogeneity was assessed with I2
We applied the principles of the GRADE approach to assess the
statistics; 25% was considered low, 50% was considered moderate, and
quality of the body of evidence [24]. This approach uses four categories
75% was considered high. Statistical significance was set at p < 0.05.
(very low, low, moderate and high) to rate the quality of evidence
The random effects model was applied for the pooled effect estimates, as
available for selected outcomes. We used GRADEpro Guideline Devel­
a high level of clinical and methodological heterogeneity across the
opment Tool (McMaster University, 2015; developed by Evidence
study design, such as different interventions, intervention parameters
Prime, Inc.; available from gradepro. org.) to create the ‘Summary of
and outcome measures, was expected.
findings’ table (Table A.2.).
3. Results
2.6. Synthesis methods
3.1. Study selection
A meta-analysis was performed when data were available from more
A total of 686 articles were identified by the electronic search. The
than one study assessing the same outcome. The following outcomes
titles, abstracts and full texts revealed that only 10 met the inclusion
were taken into consideration:
criteria (Fig. 1) and included 700 women with SUI.
2.6.1. Primary outcomes
The primary outcomes were the number of women with objective 3.2. Study characteristics and quality assessment
cures, defined as a leakage of urine ≤2 g on the pad test, and the number
of women with subjective cures or improvement, defined as the number Most of the trials were single-centre studies [25,26,28–31]. The
of women with self-reported improvement or continence. included RCTs were performed in the following countries: four in the
The following comparisons for the primary outcomes were made: ES USA [5,27,29,30], three in Brazil [8,26,28], and one each in Norway
versus no active treatment; ES versus sham ES; and ES versus other [6], Poland [25], and Italy [31].

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M. Stania et al. Complementary Therapies in Clinical Practice 49 (2022) 101624

Table 1
Studies on the effectiveness of intravaginal electrical stimulation in women with urinary stress incontinence.
Reference Aim of the study Sample Groups Parameters of Duration of Outcome measures Follow-up Study conclusions
size electrical intervention
stimulation

Sand et al. [5] To determine the 52 I: transvaginal 50 Hz and 12.5 Hz; 12 weeks 7-day voiding diary; 24- After Significant
(USA) efficacy of ES (n = 35) 0.3-ms pulse width; h voiding diary; 20-min treatment improvements were
transvaginal ES in II: sham ES (n on/off: 5 s/10 s (1–2 pad test (250 ml); found in the ES group
treating SUI. = 17) weeks) for 15 min, 5 urodynamic testing; but not in the control
s/5 s (3–4 weeks) for PFM strength group. The ES group
15 min, 5 s/10 s (perineometry); VAS; exhibited significantly
(5–6 weeks) for 30 quality of life better therapy
min, 5 s/5 s (for the questionnaires (SF-36 outcomes (weekly and
remaining weeks) Health Survey) daily leakage
for 30 min, twice a episodes, pad testing,
day PFM strength, VAS,
subjective reporting of
urine loss) compared
with the control
group.
Bø et al. [6] To compare the 107 I: untreated 30 min per day; 6 months Pad test with After The pelvic floor
(Norway) effectiveness of control group biphasic standardized bladder treatment exercises group
pelvic floor (n = 30) intermittent current, volume (200 ml); self- exhibited significantly
exercises, ES, II: pelvic floor 50 Hz, 0.2-ms pulse reports of severity; better therapy
vaginal cones, and exercises (n = width, individually three-day leakage outcomes (PFM
no treatment. 25) adapted on-off episodes (voiding strength, reduction in
III: ES (n = 25) cycles: on time diary); 24-h pad test; leakage on pad test)
IV: vaginal ranged from 0.5 s to leakage index; social compared with the ES
cones (n = 27) 10 s, off time from 0 activity index; PFM group and vaginal
s to 30 s; max strength; cystometry cone group. Pelvic
current intensity floor exercises
comfortably appeared to be the
tolerated by the most beneficial in the
patient treatment of SUI.
Correia et al. To evaluate and 45 I: surface ES (n 20-min stimulation; Not known 1-h pad test; PFM After Both ES groups
[8] (Brazil) compare the effect = 15) 50 Hz; pulse strength using the treatment significantly improved
of surface ES with II: intravaginal duration 700 μs; on/ PERFECT scheme in urinary loss and
intravaginal ES. ES (n = 15) off: 4 s/8 s (rise: 2 s, (Oxford scale); quality pressure of
III: no fall: 2 s); intensity: of life (KHQ); contractions. PFM
treatment max level tolerable; perineometry strength increased
control group 12 individual only in Group II.
(n = 15) sessions
Terlikowski To determine the 102 I: active Frequency ranged 8 weeks Quality of life (I-QOL 8 and 16 The active
et al. [25] efficacy of ES with transvaginal from 10 to 40 Hz, Questionnaire); weeks transvaginal ES group
(Poland) sEMG-assisted ES with sEMG pulse width from 20-min pad test; 24-h from exhibited significantly
biofeedback in biofeedback (n 200 to 250 μs; on/ pad test; PFM strength baseline better therapy
women of = 68) off: 15 s/30 s; 20- (Oxford scale); outcomes at the end of
premenopausal II: placebo min stimulation; 2 cystometry the 8th and 16th
age. transvaginal sessions per day weeks compared with
ES with sEMG the control
biofeedback (n participants. No
= 34) significant difference
was found between
Groups I and II in
urodynamic data
before and after the
intervention.
Castro et al. To compare the 118 I: PFM 50 Hz, 0.5 ms pulse 6 months Quality of life (I-QOL After Statistically significant
[26] effectiveness of exercises (n = width, on/off: 5 s/ Questionnaire); treatment reductions in the pad
(Brazil) pelvic floor 31) 10 s bipolar square Pad test with a test, the number of
exercises, ES, II: ES (n = 30) wave, max current standardized bladder stress urinary
vaginal cones, and III: vaginal intensity volume (200 ml); episodes, and a
no treatment. cones (n = 27) comfortably Voiding diary recording significant
IV: no tolerated by the the number of improvement in the
treatment (n = patient, 20-min incontinence episodes quality of life in
30) stimulation for 7 days; vaginal Groups I, II and III
muscle strength compared with Group
assessment (Oxford III.
scale) No significant
intergroup (I vs. II vs.
III) differences.
Dmochowski To compare the 159 I: external ES 50 Hz; 300-μs pulse 12 weeks Provocative pad weight Weeks 4, Both groups of ES
et al. [27] efficacy of external (n = 79) width, 1-sec ramp- test following a 12 significantly improved
(USA) ES with II: intravaginal up and down, 5-sec standardized bladder- in pad tests, number of
intravaginal ES for ES (n = 80) plateau, and 10-sec filling protocol (>250 incontinence episodes,
the treatment of rest; 30 min once ml); 3-day 24-hour pad and pads used per day,
SUI. weight test; 7-day and incontinence
(continued on next page)

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Table 1 (continued )
Reference Aim of the study Sample Groups Parameters of Duration of Outcome measures Follow-up Study conclusions
size electrical intervention
stimulation

daily for 5 days per voiding diary; I-QOL quality of life score.
week score; pelvic organ No significant
prolapse incontinence intergroup differences.
sexual questionnaire –
IUGA revised (PISQ-IR);
Patient Global
Assessment of
Improvement (PGI-I)
Fürst et al. To investigate the 35 I: isolated 30-min stimulation, 3 months 1-week voiding diary; 12 and 96 Both groups
[28] effectiveness of vaginal ES (n 2 sessions a week: 4 perineum strength test months significantly improved
(Brazil) adding PFM = 17) Hz (15 min, 1-ms (with the use of after over the study period.
training to ES and II: vaginal ES pulse) and 50 Hz intravaginal cones); treatment No significant
to report long-term + PFM training (15 min, 700-μs patient’s degree of intergroup differences.
follow-up. (n = 18) pulse); fixed satisfaction ES associated with
intensity (20 mA); PFM training did not
on/off: 4 s/8 s show better results
than ES alone.
Luber, Wolde- To determine the 44 I: transvaginal 50 Hz; 2-ms pulse 12 weeks 24-h voiding diary; After No statistically
Tsadik [29] efficacy of ES (n = 20) width; on/off: 2 s/4 incontinence treatment significant difference
(USA) functional ES for II: sham ES (n s; twice a day for 15 questionnaire; in the rates of
SUI. = 24) min urodynamic subjective
examination improvement,
subjective cures, or
objective cures
between the treatment
and control groups.
Smith [30] To compare the 18 I: Kegel 12.5 and 50 Hz; 4 months 24-h voiding diary After All groups
(USA) effect of ES and exercises (n = started with a 5-sec (episodes of UI and the treatment significantly improved
standard therapy in 9) contraction time number of pads used); over the study period.
the treatment of II: intravaginal (range 3–15), a duty urodynamic testing No significant
SUI and detrusor ES (n = 9) cycle of 1–2 (range 1 intergroup differences.
instability. to 1 to 1 to 2), and
an increasing
treatment time from
15, 30, 45 and 60
min twice a day.
Delneri and To compare two 20 I: functional ES 15 min of 2 weeks Perineal assessment; After Both groups improved
Benedetto methods of SUI (n = 10) stimulation at 20 Hz pad test; urodynamic treatment in all of the
[31] (Italy) treatment: vaginal II: vaginal + 15 min of examination; VAS for a parameters. The
cones vs. ES. cones (n = 10) stimulation at 50 subjective rating of the vaginal cone group
Hz; on/off: 4 s/8 s; overall discomfort exhibited significantly
intensity according caused by UI better changes in the
to the patient’s abdomino-urethral
sensations; 12 transmission rate
consecutive sessions compared with the ES
group.

ES – Electrical Stimulation; F-36 Health Survey - Short Form – 36 Health Survey; IGUA - International Urogynecological Association; I-QOL – Incontinence Quality of
Life Questionnaire; KHQ – King’s Health Questionnaire; PFM – Pelvic Floor Muscle; PGI-I - Patient Global Impression of Improvement; PISQ-IR - Pelvic Organ Prolapse/
Urinary Incontinence Sexual Questionnaire; SUI – Stress Urinary Incontinence; UI – Urinary Incontinence; VAS – Visual Analogue Scale.

Table 1 shows the main characteristics of each intervention and the and other conservative SUI treatment groups (RR: 1.09; 95% CI: 0.82 to
key conclusions of the authors studying the question of efficacy. 1.44; p = 0.54) (moderate-quality evidence) (Fig. 4) (Table A.2.). There
Table 2 summarizes the methodological quality of the randomized was no significant heterogeneity among the studies (I2 = 0%, p > 0.05).
clinical trials that were included in our review and rated with the PEDro
scale. The methodological quality of these trials was rated as high [6,8, 3.3.2. Subjective cure or improvement rates
25], medium [5,26–30] or low [31]. The research of Correia et al. [8], The low-quality evidence (Table A.2.) suggested that a significantly
Smith [30] and Delneri and Benedetto [31] was not included in the higher number of women reported being cured or having improvement
meta-analysis, as none of the primary or secondary outcomes were after ES compared with those who had undergone no active treatment
available. (RR: 4.96; 95%: 1.01 to 24.37; p = 0.04) (Fig. 5), and the between-study
heterogeneity was low (I2 = 0%, p = 0.06). A comparison of the sub­
jective cure or improvement rates did not reveal significant differences
3.3. Results of individual studies and syntheses between ES and sham ES (RR: 1.67; 95%: 0.51 to 5.49; p = 0.39) (Fig. 6)
or ES and other conservative treatments (RR: 0.80; 95% CI: 0.62 to 1.02;
3.3.1. Objective cure rates (≤2 g leakage on the pad test) p = 0.07) (Fig. 7). However, significant heterogeneity was found (I2 =
The low-quality evidence (Table A.2.) suggested that intravaginal ES 76%, p = 0.04 and I2 = 66%, p = 0.01, respectively).
was significantly more effective than no active treatment (RR: 4.20; 95%
CI: 1.70 to 10.40; p = 0.001) (Fig. 2), and the heterogeneity of the 3.3.3. Quantification of symptoms
included studies was low (I2 = 0%, p = 0.74). The objective cure rates The number of incontinence episodes per 24 h was comparable be­
were comparable for the ES and sham-ES groups (RR: 4.49; 95% CI: 0.32 tween the ES and other treatment groups (MD: 0.16; 95% CI: 0.68 to
to 63.06; p = 0.26) (low quality evidence) (Fig. 3), as well as for the ES

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M. Stania et al. Complementary Therapies in Clinical Practice 49 (2022) 101624

Table 2
Publications on the effectiveness of electrical stimulation for urinary incontinence rated with the Physiotherapy Evidence Database (PEDro).
Reference Eligibility Subjects Allocation Groups Blinding Blinding Blinding >85% Intention- Between- Point and Score*
criteria randomly concealed similar of all of all assessors follow to-treat group variability
specified allocated at subjects therapists up analysis statistical measures
to groups baseline comparison

Sand et al. [5] + + – + – – – – – + + 4/10

Bø et al. [6] + + + + – – + + + + + 8/10
Correia et al. – + + + – – + + – + + 7/10
[8]
Terlikowski + + + + – – + + – + + 7/10
et al. [25]
Castro et al. + + – + – – + + – + + 6/10
[26]
Dmochowski – + – + – – + – + + + 6/10
et al. [27]
Fürst et al. – + – + – – – – – + + 4/10
[28]
Luber, + + + + – – + – – + + 6/10
Wolde-
Tsadik [29]
Smith [30] + + – + – – – + – + + 5/10
Delneri and + + _ _ _ _ _ _ _ + _ 2/10
Benedetto
[31]

*Eligibility criteria item is not included in the PEDro score calculations.

Fig. 2. Forest plot of objective cure rates assessed with the pad test between the ES and no treatment groups.

0.37; p = 0.56) (Fig. 8), but the quality of evidence was moderate significant heterogeneity among the studies (I2 = 0%, p = 0.88).
(Table A.2.). There was no significant between-study heterogeneity (I2
= 0%, p = 0.85). 3.3.5. Adverse effects
Low-quality evidence (Table A.2.) suggested that there were no
3.3.4. Quality of life significant differences between the ES and other conservative SUI
Low-quality evidence (Table A.2.) showed no significant difference treatment groups in the number of women with adverse effects (RR:
in the I-QOL questionnaire scores between the ES and other therapy 0.69; 95% CI: 0.38 to 1.27; p = 0.23; I2 = 0%) (Fig. 10). Adverse effects
groups (MD: 1.84; 95% CI: 2.11 to 5.80; p = 0.36) (Fig. 9). There was no in the ES groups included urinary tract infection, vaginal infection,

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M. Stania et al. Complementary Therapies in Clinical Practice 49 (2022) 101624

Fig. 3. Forest plot of objective cure rates assessed with the pad test between the ES and sham ES groups.

vulvovaginal mycotic infection, tenderness, bleeding and discomfort. women with different types of urinary incontinence and presented their
overall results, which does not allow the determination of the ES effect
4. Discussion on SUI. Additionally, the papers analysed did not provide information
on whether the patients who qualified for ES were capable of correct
Pooled data from published trials reporting objective cure rates in PFM contraction [5,29,31].
women with SUI suggested that ES was significantly more effective than It has been indicated that ES-associated alleviation of UI symptoms
no active therapy. Similarly, ES was more effective than no active may result from the strengthening of the PFM [5] and anatomical
treatment when we considered self-reported improvement or cures. structures supporting the urethra and bladder neck [35]. Therefore, the
However, intravaginal ES failed to yield statistically significant im­ major aim of ES for SUI is to increase the urethral closure pressure and
provements in the number of incontinence episodes per 24 h, quality of stimulation of the external urethral sphincter muscle [5]. Three factors,
life or objective cures between the ES and other conservative treatment i.e., local striated and smooth muscles and their surrounding tissues,
groups. Additionally, there was no significant difference in adverse ef­ connective tissue, and local vasculature, are involved in the regulation
fects between the ES and other conservative treatment groups. Overall, of urethral closure pressure. The benefits of ES include enhanced cir­
the quality of the evidence was too low to provide reliable results culation and trophic magnification around the urethra and bladder neck
(Table A.2.). [35]. Long-term electrical PFM stimulation has increased the number of
This meta-analysis did not confirm the advantage of ES therapy over slow-twitch muscle fibres in the periurethral area [36].
other forms of conservative SUI treatment, which limits its use as a This study has some limitations. First, our analysis included a limited
monotherapy in patients with SUI. Stewart et al. [17] also concluded number of studies investigating the therapeutic efficacy of intravaginal
that ES may prove no better than other conservative treatments in terms ES in women with SUI. Because of the great heterogeneity in the diag­
of clinical effectiveness or the risk of adverse effects in the population of nostic instruments used among the different RCTs in assessing subjective
women with SUI. However, the meta-analysis performed by these re­ and/or objective cure or improvement rates (Table 1), we included only
searchers included all trials with ES with nonimplanted devices that trials addressing the same individual outcome in the meta-analysis.
could be placed in the vagina or anus or on the skin surface. Second, excluding studies published in languages other than English
Due to the small number of randomized clinical trials with high could lead to language bias. Additionally, we may have missed ran­
methodological quality (based on the PEDro scale), the assessment of domized clinical trials published in different languages. Finally, the re­
whether intravaginal ES as a monotherapy is more effective than no view was not registered.
treatment, sham ES, or any other conservative treatment is difficult.
Additionally, considerable discrepancies were found regarding the in­ 5. Conclusion
terventions used, study protocols, ES parameters, evaluation of therapy
outcomes and outcome measures. It was not possible to perform a sub­ The conclusions should be considered carefully because of the
group analysis to explore the possible causes of significant clinical and limited evidence level of the outcomes and the quantity of included
methodological heterogeneity due to the limited number of studies RCTs. There was insufficient evidence for or against the use of intra­
included in the meta-analysis. Several researchers [32–34] recruited vaginal ES therapy in women with SUI, partly due to the variability in

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M. Stania et al. Complementary Therapies in Clinical Practice 49 (2022) 101624

Fig. 4. Forest plot of objective cure rates assessed with the pad test between the ES and other conservative treatment groups.

Fig. 5. Forest plot of subjective cure or improvement rates between the ES and no treatment groups.

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M. Stania et al. Complementary Therapies in Clinical Practice 49 (2022) 101624

Fig. 6. Forest plot of subjective cure or improvement rates between the ES and sham ES groups.

Fig. 7. Forest plot of subjective cure or improvement rates between the ES and other conservative treatment groups.

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M. Stania et al. Complementary Therapies in Clinical Practice 49 (2022) 101624

Fig. 8. Forest plot of the number of incontinence episodes per 24 h reported in 7-day voiding diaries between the ES and other conservative treatment groups.

Fig. 9. Forest plot of quality of life scores according to the Incontinence Quality of Life Questionnaire between the ES and other conservative treatment groups.

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M. Stania et al. Complementary Therapies in Clinical Practice 49 (2022) 101624

Fig. 10. Forest plot of adverse effects between the ES and other conservative treatment groups.

the interventions of the included trials and the small number of trials Appendix A. Supplementary data
included. Hence, there is a need for further multidirectional and mul­
ticentre randomized controlled studies on the effectiveness of intra­ Supplementary data to this article can be found online at https://doi.
vaginal ES for SUI that would fulfil the criteria of evidence-based org/10.1016/j.ctcp.2022.101624.
medicine.
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