Professional Documents
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Clinical Practice Guidelines Rehabilitation.3
Clinical Practice Guidelines Rehabilitation.3
Medication
II Systematic review of high-quality cohort studies
High-quality cohort study Evidence quality: I
High-quality outcomes research Grade of recommendation: B
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218 © 2023 Academy of Pelvic Health Physical Therapy, APTA Volume 47 • Number 4 • October/December 2023
Copyright © 2023 Academy of Pelvic Health Physical Therapy, APTA. Unauthorized reproduction of this article is prohibited.
Clinical Practice Guideline
incontinence, urinary urgency, and/or urinary fre- Background and Rationale for the Need for a CPG
quency. Urinary incontinence (UI) is defined by the
International Continence Society (ICS) as “the com-
Fall Risk Management plaint of any involuntary loss of urine.”4 Urgency uri-
nary incontinence is “accompanied by or immediately
Evidence quality: V preceded by urgency.”4 The frequency and severity of
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Grade of recommendation: P (best practice) UUI symptoms can vary widely, from “frequent small
Health care providers should address fall risk losses between micturitions or as a catastrophic leak
management for patients with urgency urinary incon- with complete bladder emptying.”4 UUI can occur in
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tinence, urinary urgency, and/or urinary frequency. the absence of an underlying medical condition, or
as a result of urinary tract infections (UTIs), diabetic
INTRODUCTION polyuria, and bladder outlet obstructions or cancer
necessitating diagnostic workup to exclude these con-
Purpose/Aim of the Guideline ditions and identify UUI.4–6
The Academy of Pelvic Health Physical Therapy Bladder storage symptoms as defined by the joint
(APHPT) is committed to creating evidence-based report from the International Urogynecological
clinical practice guidelines (CPGs) for physical Association and the ICS7 are divided into 4 catego-
therapy management of patients with neuromus- ries: increased daytime urinary frequency, nocturia
culoskeletal impairments as described in the World (nighttime frequency), urinary urgency described as
Health Organization’s International Classification of a “sudden, compelling desire” to void that cannot be
Functioning, Disability, and Health (ICF).1 ignored, and overactive bladder. Overactive bladder
The purposes of this CPG are to: (OAB) is a bladder storage impairment that is usually
accompanied by increased daytime frequency and/or
1. Describe evidence-based physical therapy nocturia and can be with UI (OAB-wet) or without UI
interventions for urgency urinary incontinence (OAB-dry).7 Agreement regarding the medical diag-
(UUI), urinary urgency, and/or urinary frequen- nosis of OAB has been debated5; however, the cur-
cy among community-dwelling adult women. rent standard of practice is outlined in the American
2. Identify interventions supported by current Urological Association and Society of Urodynamics,
best evidence to address impairments of body Female Pelvic Medicine & Urogenital Reconstruction
function and structure, activity limitations, and Guideline Amendment.6
participation restrictions associated with UUI, UI is more common among women than among
urinary urgency, and/or urinary frequency. men, with more than 50% of women reporting UI.8
3. Provide information for payers and claims Among women, SUI is the most prevalent type fol-
reviewers regarding the practice of pelvic health lowed by mixed UI (MUI), characterized by symp-
physical therapy for women with UUI, urinary toms of SUI and UUI, and then UUI.9,10 Compared
urgency, and/or urinary frequency. with SUI, UUI is more common among women 60
4. Create a reference publication for health care years and older, and more common among Black
providers, educators, and students regarding women.11 Prevalence of OAB, in a study of more than
the best current practice of pelvic health physi- 122 000 women, was 4.41% among all participants,
cal therapy for women with UUI, urinary with prevalence among Black and Hispanic women
urgency, and/or urinary frequency. higher than among White women.10 Risk factors for
5. Provide information for health care consumers OAB included older age, high body mass index (BMI),
about effective treatments available to women with low socioeconomic status, diabetes, and smoking.10,11
UUI, urinary urgency, and/or urinary frequency. The report of prevalence varies widely depending on
This CPG does not provide information regard- how the symptom is defined and across what dura-
ing the examination and evaluation of women tion of time. The estimated worldwide prevalence of
with urinary incontinence. Readers seeking that urge and MUI is more than 20%, with women pre-
information are referred to the comprehensive dominately affected and prevalence increasing with
article by Berghmans et al entitled “Physiotherapy age.12 Ganz et al13 determined that the per capita cost
Assessment for Female Urinary Incontinence.”2 of OAB with UUI in the United States was $1925 in
Readers seeking evidence-based guidelines for 2007; extrapolating the projected cost and popula-
physical therapy interventions for women with tion, they estimated costs in 2020 to be $82.6 billion.
stress urinary incontinence (SUI) should consult The personal direct costs related to UI care are an
the “Dutch Guidelines for Physiotherapy in economic burden to many individuals.14
Patients with Stress Urinary Incontinence: An A recent systematic review of 23 articles reports
Update,” by Bernards et al.3 poor quality of life as measured by the Short Form-36
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Clinical Practice Guideline
among people with UI; participants were predomi- the IUS is a smooth muscle and is innervated by the
nately women 50 years and older.15 The National autonomic nervous system.23,24 Sympathetic input
Association for Continence reports “more than half from T10 to L2 causes IUS contraction and is critical
of all residents in nursing homes are incontinent for continence, while the parasympathetic input from
and it is the second leading cause of institution- S2 to S4 facilitates urination by causing IUS relax-
alization.”16 The secondary costs of UI resulting ation and detrusor contraction.23 The EUS is striated
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from decreased activity and participation are not skeletal muscle and thus under voluntary control.
easily measured; however, the association with falls The EUS as well as other pelvic floor muscles (PFMs)
and related fractures, and limited participation in receives somatic innervation via the pudendal nerve
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activities of daily living may be an important link (S2-S4) and contributes to urethral closure pressure.22
between UUI and rates of nursing home admissions. Bladder filling and urine storage are mediated
A robust study of more than 6000 community- by sympathetic input from the spinal cord and
dwelling women in the United States found that UUI voiding is controlled primarily by parasympathetic
episodes were associated with increased risk of falls input. Voiding involves complex afferent and efferent
(26%) and osteoporotic fractures (34%).17 Likewise, communication between the detrusor and the central
Chiarelli et al18 reported that urge UUI, but not SUI, nervous system.24,25 Afferent messages originated by
is associated with a modest increase in falls. Studies bladder wall stretching on filling are received by the
related to the cost of nursing home admissions due to pontine micturition center in the brainstem, which
UI are estimated at $6 billion per year in the United then communicate to the thalamus and the prefrontal
States.19 To further complicate the costs associated cortex.25 Ultimately, the parasympathetic signal to
with long-term care (LTC), incontinence is among the void is amplified to initiate urination. Voluntary inhi-
top reasons for medical denial of LTC insurance.20 bition of the detrusor contraction is possible through
Accessible and effective treatment for UI can contraction of the EUS and PFMs until the opportune
improve quality of life, reduce cost burden, and delay social and environmental context for micturition.
or prevent nursing home admissions. Despite this,
in a survey of nearly 95,000 women with UI, only Clinical Presentations of UI
a third of participants discussed concerns about UI The complexity of successful urine storage and mic-
with their health care providers.21 This may be due turition involves intact cognition, central, peripheral,
to women believing that UI is a normal part of aging and autonomic nervous systems, smooth and skeletal
or that there are not acceptable treatment options muscle coordination, and connective tissue support.
available. In a community survey conducted by this The type of UI one experiences is directly related to
Guideline Development Group (GDG) in 2018, 88 of underlying mechanical or neurological impairments.
139 respondents (63%) reported UI symptoms, but SUI, for example, occurs when the intra-abdominal
only 23 (16.5%) of those had sought any treatment pressure on the bladder exceeds the urethral closure
(J. Gunderman-King, unpublished survey, July 2018). pressure such as during physical exertion, coughing,
Of those 88, 99.28% were women who were col- sneezing, or laughing.3,4 In the absence of structural
lege educated and had private health insurance. For defect (muscle, ligament, and IUS), pelvic floor mus-
comparison, nearly 70 (50.4%) had participated in cle training (PFMT) is a well-established, first-line,
physical therapy for other conditions. The majority evidence-based intervention for women with SUI pri-
of people responded that “if my health care provider marily to improve urethral closure pressure.4
talked to me about the benefits of physical therapy There are plentiful resources in the pelvic health
for urinary leakage” they would have been moti- rehabilitation literature related to evidence-based
vated to participate in pelvic health physical therapy interventions for SUI, but the body of evidence for
(J. Gunderman-King, unpublished survey, July 2018). UUI interventions is not as accessible to consumers or
health care providers. This CPG is presented to help
Lower Urinary Tract Anatomy and Neurophysiology inform readers of the current evidence for physical
To fully understand the mechanisms that contribute therapy intervention of UUI, urinary urgency, and/
to UI, it is helpful to review the anatomy, physiology, or urinary frequency, as well as identify the areas in
and neural control that maintain continence. The which further research is needed.
lower urinary tract is comprised of the bladder and
urethra. The urinary bladder is a hollow organ com- Scope of the Guideline
prised of smooth muscle, called the detrusor. There The scope of this CPG is to provide recommendations
are 2 sphincters that contribute to urethral closure for interventions administered by physical therapists
pressure: the internal urethral sphincter (IUS) and the and other rehabilitation professionals for women
external urethral sphincter (EUS).22 Like the detrusor, with UUI, urinary urgency, and/or urinary frequency.
220 © 2023 Academy of Pelvic Health Physical Therapy, APTA Volume 47 • Number 4 • October/December 2023
Copyright © 2023 Academy of Pelvic Health Physical Therapy, APTA. Unauthorized reproduction of this article is prohibited.
Clinical Practice Guideline
line will not ensure a successful clinical outcome in literature search was completed to ensure no new
every case, nor should the guideline be construed as evidence had emerged between 2017 and 2022 that
including all proper methods of care or excluding contradicted recommendations put forth by this CPG
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other acceptable methods of care. Clinical judgment for the treatment of UUI, urinary urgency, and/or
regarding use of a particular clinical procedure or urinary frequency.
treatment plan must be made considering the clinical
data presented by a given patient; the diagnostic and Population of Interest
treatment options available; and the patient’s values, The patient population of interest are women with
expectations, and preferences. Significant departures UUI, urinary urgency, and/or urinary frequency.
from accepted guidelines should be documented in Classifications related to these diagnoses according
the patient’s medical records at the time the relevant to The International Classification of Diseases (ICD)
clinical decision is made. 10th Revision27–Clinical Modification (ICD-10-CM)
are in Supplemental Digital Content Appendix C,
METHODOLOGY available at: http://links.lww.com/JWHPT/A118.
Classifications related to the function of persons
Selection of CPG Committee Members with these diagnoses according to the International
Committee members for this CPG were selected by Classification of Functioning, Disability and Health1
the APHPT based on content expertise. The commit- (ICF) are in Supplemental Digital Content Appendix
tee was charged with performing a systematic review D, available at: http://links.lww.com/JWHPT/A119.
and evaluation of the available literature and provid-
ing a comprehensive synthesis of the evidence for Inclusion and Exclusion Criteria
rehabilitation interventions for UI. The development Abstract screening resulted in 545 articles that quali-
of the CPG was guided by the APTA Clinical Practice fied for full-text appraisal. Articles that were reviewed
Guideline Process Manual26 including external review and included in the final CPG (n = 31) reported
by selected stakeholders (n = 10) with expertise in a on adult women with UUI, urinary urgency, and/
variety of health care professions, as well as posting or urinary frequency. Articles excluded during the
for public comment (n = 63) on the APHPT website full-text appraisal process were those that were
for a period of 30 days. not available in English, were reviews (not original
research), had a low appraisal score, did not measure
Search Strategy and Databases UI as an outcome, only addressed SUI, or provided
The search terms and strategy were developed by the an intervention not included in the search terms (see
committee members with input from medical librar- Supplemental Digital Content Appendix E, available
ians at Walter Reed National Military Medical Center at: http://links.lww.com/JWHPT/A120). An example
and The Johns Hopkins University. Literature search of this is percutaneous tibial nerve stimulation.
databases utilized were OVID Medline, EMBASE,
Cochrane Library, CINAHL, and ProQuest. The ini- Appraisal Process
tial search was performed in October 2016 and was Prior to the critical appraisal process, reliability test-
limited to articles published after January 1, 1995; ing was performed to ensure all reviewers were reli-
this yielded 17 0006 titles. An example of search able in using the APTA Critical Appraisal Tool for
terms used is available (see Supplemental Digital Experimental Interventions (CAT-EI).28 Reviewers
Content Appendix A, available at: http://links.lww. watch the CAT-EI tutorial and were assigned 2
com/JWHPT/A116). Full search strategies for all intervention studies to review as part of the training
databases used are available upon request. process. The CAT-EIs for the 2 articles were discussed
An updated search was conducted in June 2017 and a narrow range of difference was acceptable;
using a filter to exclude studies that focused on inter- there were no critical readers who were rejected.
ventions for SUI due to the volume of references gen- Critical readers formally assessed the procured arti-
erated by the initial search and the already existing cles. The critical appraisal process was conducted
“Dutch Guidelines for Physiotherapy in Patients with through the Covidence Systematic Review Software
Stress Urinary Incontinence: An Update.”3 This search (Veritas Health Innovation; Melbourne, Australia).
narrowed the number of articles to 2161; please see All articles considered for inclusion in the CPG
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Clinical Practice Guideline
were reviewed by 2 critical readers. The committee procedures utilized for updating the guideline will
addressed and resolved any discrepancies that arose follow those utilized in the writing of this guideline,
during the appraisal process. based on the recommended standards of the APTA
and APHPT.
Procedure for Assigning and Definitions of Levels of
Evidence and Grades of Recommendations Summary of Evidence and Recommendations
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Thirty-one articles were retained after the appraisal Recommendations and supporting evidence are pre-
process. Each of the articles was assigned a grade in sented for each of the action statements. The 7 action
accordance with the APTA Clinical Practice Guideline statements based on the available literature are fol-
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Process Manual26 (Table 1). Again, the committee lowed by tables that summarize each of the articles
addressed and resolved any conflicts such that we all cited.
agreed with the final level of evidence. The committee
met in person to confirm the levels of evidence assigned Action Statement 1: Behavioral Interventions
and to create the tables included in this CPG. This infor- Health care providers must prescribe behavioral
mation was then used to create grade assignments and interventions including bladder retraining, dietary
generate action statements using BridgeWiz software and fluid modification, and urge suppression tech-
(© Yale University 2011; developed by Christopher niques for symptoms of UUI, urinary urgency, and/or
Michael Shiffman et al, 2012). Final grades were urinary frequency.
determined by the committee consistent with the grad-
ing scheme adopted by the APTA Clinical Practice Grade of evidence: A
Guideline Process Manual26 (Table 2). Strength of recommendation: strong
effect size of 0.04. After a 6-month follow-up period months: (1) rehabilitation (REH) and (2) medication
(8 months after onset of study), effect size on UUI for (MED) (oxybutynin ER). The rehabilitation group
the intervention group was 0.96 compared with 0.39 participated in 5 sessions with individual instruction
in the control group. This study demonstrates that on PFMT and behavioral techniques. The medication
behavioral therapy was effective for treating UUI with group was prescribed oxybutynin chloride extended-
lasting results at 8 months. release, single 5-mg daily dose for 3 months. During
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behavioral modification program (BMP) to a control line (pretreatment) level at the end of follow-up (21
group among 359 women, 55 years and older, who months). For nighttime frequency, the REH patients
were followed up for 12 months. All participants showed an average decrease of 0.7 voids per night
underwent initial clinic evaluation of PFM strength. (mean value of 1.0 ± 0.9 frequency/night), while the
The control group received no intervention and was MED patients showed an increase of 0.7 voids per
contacted quarterly for phone screens and to complete night at the end of follow-up. At the end of follow-
outcome measures. Participants in the BMP group up, the mean number of side effects was significantly
participated in 1 group session of PFMT instruction greater in the MED group than in the REH group
(and provision of home audiotape for home guid- (3.3 ± 0.5 vs 2.4 ± 0.4; P < .05). In the long-term,
ance), behavioral training, and education in addition the REH patients maintained and even improved
to 1 individualized clinic visit to further guide PFMT the achievements of the intervention period while
and behavioral techniques. At 12 months, partici- the MED patients deteriorated to baseline values in
pants with absolute continence and those with only urinary frequency.
1 to 5 UI days were 41% for the control and 56% In a 2013 multicenter, single-blind RCT, Kafri
for the BMP group (P = .01). PFM strength, voiding et al35 compared the efficacy of behavioral train-
frequency, and void interval were all significant for ing (BT), PFMT, drug therapy (DT), and combined
the treatment group (P = .0003, P = .0001, and P pelvic floor rehabilitation (CPFR) on UUI at 3- and
< .0001). This study demonstrates effectiveness of 12-month follow-ups. BT was comprised of (1)
group BMP to improve continence, pelvic muscle patient education on bladder function and on how
strength, and voiding control at 1 year. continence is maintained; (2) scheduled voiding with
Hulbaek et al33 conducted a clinical, randomized, the aim of 3 to 4 hours between voids; and (3)
non-blinded study comparing group training to indi- positive reinforcement through psychological support
vidual bladder training (BT) for OAB in adult women. and encouragement. The PFMT protocol was based
All participants received the same BT intervention on the National Institute for Health and Clinical
over 3 sessions with a nurse specialist to educate on Excellence recommendations including endurance
BT, use of diary, instruction in PFM exercises, receive and fast twitch contractions in clinic and for home
coaching and support, and reinforce continuous use. Drug therapy participants received a 3-month
home-based BT. The only difference was individual supply of tolterodine SR 4 mg. The combined pelvic
visits versus group visits of 3 to 4 participants per floor rehabilitation protocol included BT, PFMT,
group. The group participants also engaged in more and behavioral advice, including bowel education
dynamic evaluation of each other’s diaries and sup- to avoid constipation, advising modification of fluid
ported each other on BT strategies. The number of intake, daily activity, and ergonomic consultation. A
UUI episodes was reduced from a median of 2 epi- significant improvement was found for all treatment
sodes per day to 1 per day after 1 month and remained groups at 3 and 12 months in urinary frequency, UUI
so after 2 months for group setting (P = .611) as well episodes, quality of life related to UUI, and number of
as individual setting (P = .320). This study showed daily pads; however, only CPFR showed a significant
no significant differences in end points of UUI, uri- decrease of 4 voids/24 hours and a significant increase
nary urgency, or urinary frequency between the BT in self-reported function with a moderate effect size
program performed in group settings compared with (0.35) compared with the DT group.
the BT program performed individually. In an RCT, Burgio et al36 compared the effective-
ness of BF-assisted behavioral treatment with drug
Behavioral Intervention Compared to Medication treatment for the treatment of UUI in community-
In 2008, Kafri et al34 compared the residual effect of dwelling women, ages 55 to 92 years. One hundred
a 3-month pelvic rehabilitation program and drug ninety-seven participants were randomized to 1 of 3
treatment for UUI 21 months post-intervention. groups: (1) 4 sessions (8 weeks) of BF-assisted behav-
Forty-four women (ages 27-68 years) diagnosed with ioral treatment inclusive of PFMT and urge sup-
OAB were divided into 2 treatment groups over 3 pression technique; (2) drug treatment (oxybutynin
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Clinical Practice Guideline
chloride, possible range of doses, 2.5 mg daily to 1.75 among women participants. This study also dem-
5.0 mg 3 times daily); or (3) a placebo medication onstrated 88% satisfaction rate and ease of use with the
control group. Assignment to drug treatment or the online program among all participants.
placebo control condition was double-blinded. At 8 Andrade et al39 performed an RCT with parallel
weeks, behavioral training resulted in a mean 80.7% group design to determine whether an avatar-based,
improvement of UUI, which was significantly more online, self-management program is an effective
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effective than drug treatment (mean, 68.5% improve- therapeutic approach for women (55 years and
ment; P = .04) and the control condition (mean, older) with OAB. The control group was provided 3
39.4% improvement; P = .009). The results of this self-paced online modules that addressed behavioral
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RCT demonstrate that BF-assisted behavioral training techniques, PFMT instruction, use of bladder diary,
is an effective treatment with high patient satisfaction and online quizzes. The intervention group received
for urge incontinence among older women. It was the same online modules and, in addition, viewed 2
more effective than oxybutynin, the pharmacological avatar coaches: a generic avatar coach and a self-
agent of choice for urge incontinence, and it is safe, avatar “peer” mentor developed from the front-face
yields high levels of patient satisfaction, and is practi- view of the participant who appeared during the
cal for older individuals. tutorials’ introductions, asking questions, as well as
Colombo et al37 performed a randomized trial of accompanying animations of the urinary bladder,
81 women with detrusor instability, low compliance, lifestyle suggestions, BT, and PFMEs. At 12 weeks,
or sensory bladder to compare the effects of oxybu- within-group analysis of covariance analysis revealed
tynin (5 mg 3 times per day) or BT for urge inconti- 57% improvement for the avatar group for urinary
nence. All participants had visits every 2 weeks for a frequency per 24 hours (mean difference = 5.77)
total of 6 weeks to monitor progress in BT or in the compared with 20% improvement in control (mean
medication group to monitor for side effects or adjust difference = 2.61; P < .001); a 52% improvement
dosing as needed. In the medication group, 10% for nighttime urination per day (mean difference =
of the 42 patients on oxybutynin discontinued the 2.45) compared with 24% improvement in control
therapy due to side effects and the cure rate decreased (mean difference = 1.16; P < .001); a 62% improve-
from 74% to 42% during the 6-month period fol- ment for urinary urgency per 24 hours (mean dif-
lowing the treatment (from 93% to 57% in case of ference = 4.29) compared with 29% improvement
detrusor instability). Comparatively, in the BT group, in control (mean difference = 1.75; P < .001); and
the cure rate remained quite high, being reduced only a 50% improvement for urge incontinence per 24
from 73% to 70% (from 81% to 75% in the case hours (mean difference = 2.61) compared with 5%
of sensory bladder) at 6 months. It was concluded improvement in control (mean difference = 0.2; P <
that oxybutynin was not well tolerated with reported .001). Evidence from this trial suggests that women
side effects of dry mouth and 1 instance of glaucoma with OAB demonstrate significant improvements in
onset, and gave only early good results with frequent health-related quality of life and symptoms when
clinical relapse over time. Bladder training was well receiving an online self-management intervention
accepted and provided persistent results. with embedded avatars.
(23% in control). This study shows promising initial consisting of 20 to 60, 10-second contractions per day
results of caffeine reduction on UUI symptoms at 4 and combined with behavioral therapy appears to pro-
weeks; however, long-term data are needed to show vide the greatest outcomes for women with symptoms
long-term results and adherence to caffeine reduction of UUI, urinary urgency, and/or urinary frequency.
(Table 3). Higher doses of PFMT may be more appropriate for
women with stress UI, but not for urge UI.
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Action Statement 2: Pelvic Floor Muscle Training Burgio et al30,36 studied PFMT in women with
Health care providers should prescribe PFMT pro- urge- or urge-dominant UI. One RCT included PFMT
grams when contraction quality has been confirmed, as part of the behavioral treatment group; the other
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with or without surface electromyography (sEMG) groups were drug treatment and placebo control.36
BF, for symptoms of UUI, urinary urgency, and/or The behavioral treatment group (n = 63) had a mean
urinary frequency. improvement of 80.7%, which was statistically sig-
nificant (P = .04) compared with the drug treatment
Grade of evidence: A
group and the control group (P < .001). A later study
Strength of recommendation: strong
employed the same behavioral intervention with
In order for a study of PFMT intervention to PFMT compared with the same intervention with
be included in this CPG, confirmation of the PFM no BF and to an education only (no confirmation of
contraction needed to be reported. This resulted in contraction) group.30 All 3 groups had pre-to-post-
5 articles. The methods of confirmation varied and intervention improvements in symptoms (episodes of
are described along with the parameters of exercise UI), but there were no significant differences between
prescription. In general, PFMT of 8 weeks or longer the groups (P = .78).
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Copyright © 2023 Academy of Pelvic Health Physical Therapy, APTA. Unauthorized reproduction of this article is prohibited.
Clinical Practice Guideline
months. A significant improvement was found for reflexes or alter neurotransmission processes. Sacral
all treatment groups at 3 and 12 months in urinary neuromodulation has been shown to be effective in
frequency, UUI episodes, quality of life related to the treatment of OAB, UUI, urinary retention, fecal
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UUI, and number of daily pads; however, only CPFR incontinence, constipation, and pelvic pain among
showed a significant decrease of 4 voids/24 hours neurogenic and nonneurogenic causes of pelvic floor
and a significant increase in self-reported function dysfunction.43–45 The exact mechanism of action for
with a moderate effect size (0.35) compared with sacral neuromodulation is unclear. The prevailing
the DT group. theory is that sacral stimulation targets the pudendal
Kaya et al41 assessed whether BT combined with and pelvic nerve reflex loops, facilitating neuroplastic
high-intensity PFMT (BT+PFMT) results in better changes that result in improved bladder sensation,
outcomes in the short term than BT alone. Women filling, and emptying.46
with diagnoses of stress UI (SUI, n = 50), urgency
UI (UUI, n = 16), or MUI (n = 42) were randomly Action Statement 3: Transcutaneous Tibial Nerve
assigned to 6 weeks of BT+PFMT or BT alone Neuromodulation
(control group). Baseline and outcome data were Health care providers should use low-frequency
reported separately for the different diagnoses. A transcutaneous tibial nerve ES for symptoms of UUI,
standardized 6-week treatment protocol was imple- urinary urgency, and/or urinary frequency in the
mented for both groups by an experienced physical absence of contraindications for ES.
therapist for 4 visits. All patients were supplied with Grade of evidence: B
a brief instruction sheet on BT and/or PFMT. For Strength of recommendation: moderate
PFMT, an exercise diary was used to facilitate adher-
ence. For BT, patients completed a voiding diary Some literature and some clinicians use posterior
every other week to chart progress. Both groups, tibial nerve and tibial nerve interchangeably. For the
behavioral therapy and behavioral therapy plus purposes of this CPG, it is consistently termed tibial
PFMT, improved from pre- to postintervention for nerve. This is consistent with recent recommenda-
women with SUI and MUI, and the rate of improve- tions.47 In a prospective, RCT, Manriquez et al48
ment was greater for the PFMT group; 100% com- compared the use of transcutaneous tibial nerve
pared with 82.7% (P = .001). The only outcome stimulation (TTNS) with extended-release oxybutynin
showing significant improvement in patients with for 12 weeks. Seventy participants initiated the trial
UUI was quality of life (P = .045) as measured by and 64 completed the protocols. The oxybutynin
the Incontinence Impact Questionnaire–Short Form; group (n = 34) received 10 mg daily for 12 weeks.
this may be related to the low number of partici- The TTNS group (n = 36) received transcutaneous
pants in the UUI group. stimulation twice a week for 30 minutes at 20 Hz
Arruda et al42 conducted a 3-arm randomized and 200 µsec voltage set to create flexion of the great
clinical trial comparing oxybutynin (n = 22), electri- toe. Four of the women in the medication group were
cal stimulation (ES) (n = 21), and PFMT (n = 21)
for the treatment of detrusor overactivity in women. Sacral neuromodulation can be administered through a surgically
The intervention period was 12 weeks in duration. All implanted sacral nerve stimulation device, percutaneous nerve
stimulation of S2-4 nerve roots or at the tibial nerve, transcutane-
groups had significant decreases (P < .05) in episodes
ous nerve stimulation at S2-4 nerve roots or at the tibial nerve, and
of UI and number of pads per day, yet between the transvaginal stimulation of the pudendal nerve. Based on the search
groups, these measures were not statistically different. terms and levels of evidence, transcutaneous stimulation of the
Post-intervention, the PFMT group (1) experienced tibial nerve and transvaginal stimulation of the pudendal nerve are
fewer episodes of UI with a modest effect size of included in this CPG. All methods of neuromodulation for treatment
of UUI follow similar parameters.
0.53, (2) reported subjective resolution of symptoms
• Low frequency: 5-20 Hz (10 Hz most common)
for 57.1% of participants, and (3) had documented • Pulse width: variable depending on type of device (150-700 μs)
urodynamic cure among 52.4% of participants. The • Intensity: sensory only (submotor)
wide confidence interval for episodes of UI (pre- and • Duration: variable; 20 min once per week to continuous for the
post-) within the PFMT group was not specifically implanted sacral stimulator
• Treatment period: variable; 4 weeks to indefinite for the implanted
addressed by the authors and was similar in the other
sacral stimulator
2 groups (Table 4).
226 © 2023 Academy of Pelvic Health Physical Therapy, APTA Volume 47 • Number 4 • October/December 2023
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Clinical Practice Guideline
lost to follow-up due to medication side effects and sham treatment had the electrodes placed, but with no
pregnancy and 2 women in the TTNS group were lost current delivered. There was a significant reduction in
due to pregnancy and moving. Nine participants in the urinary frequency when comparing pre- and posttreat-
medication group reported a side effect of dry mouth, ment in the TTNS group (P = .003) and in the TTNS
while no side effects were reported in the TTNS group. group when compared with placebo following treat-
Successful response to treatment was considered a ment (P = .009). There were also significant differences
50% or more reduction in urinary frequency. Seventy in nocturia in the pre- and posttreatment in the TTNS
percent of those in the TTNS group had a successful group (P = .001). There was a moderate effect size of
response compared with 60% in the medication group. 0.746 for posttreatment OAB-q with TTNS (Table 5).
There was significant improvement in all bladder diary
aspects (frequency, urgency, urge incontinence, and Action Statement 4: Transvaginal Neuromodulation
daily pad use) and OAB-q (all domains) when compar- Health care providers should consider low-frequency
ing pre- and posttreatment for each group separately. transvaginal ES for symptoms of UUI, urinary urgen-
When comparing between groups post-treatment, the cy, and/or urinary frequency.
only significant difference was in TTNS for domain 2
Grade of evidence: B
(sleep) of OAB-q (P = .036).
Strength of recommendation: moderate
Bellette et al49 compared the TTNS (n = 21) to
sham (n = 16) in 37 female participants in a prospec- All of the articles that informed this recommenda-
tive RCT. Participants in the treatment group under- tion use low-frequency ES delivered transvaginally. In
went tibial nerve ES for 30 minutes for 8 sessions with a randomized controlled clinical trial, Barroso et al50
the Dualpex 961 device. The settings for this device compared the use of home-based vaginal ES to place-
are 250-ms pulse width, 12 Hz, and 5 to 30 mA. The bo (sensor with no current) in women with primarily
Journal of Women’s & Pelvic Health Physical Therapy © 2023 Academy of Pelvic Health Physical Therapy, APTA 227
Copyright © 2023 Academy of Pelvic Health Physical Therapy, APTA. Unauthorized reproduction of this article is prohibited.
Clinical Practice Guideline
urge and mixed incontinence (71% of participants). group (50%) and PFMT alone (38.2%). Each group
The home-based vaginal stimulation for those with had withdrawal during treatment, 6 from the PFMT
UUI was set at a frequency of 20 Hz. This treatment group, 7 from the ES group, and 4 from the BF group.
was completed twice a day for 20-minute sessions for Five out of the 7 withdrew from the ES group due to
12 weeks, while gradually increasing the intensity of discomfort. Notably, BF showed a statistical improve-
the stimulation. Eighty-eight percent of participants ment for the elements of the PERFECT score. The
were cured or improved at the end of the treatment ES group had statistically significant improvements
sessions with one-third of patients requiring further in the quality of life domains of the Kings Health
intervention at 6 months post-treatment. With respect Questionnaire.
to urgency symptoms, participants voiding urgency Wang et al53 conducted an RCT of 68 women com-
decreased significantly as well as the total number of paring the effects of transvaginal ES, oxybutynin, and
voids with increased bladder capacity. placebo. All 3 treatment arms were carried out over
Franzén et al51 compared the use of ES delivered 12 weeks. Oxybutynin and the placebo were given
vaginally and/or transanally to tolterodine SR 4 mg 3 times per day. ES was delivered with a frequency
once daily in 72 women. Those in the ES treatment of 10 Hz, pulse width of 400 μs, and duty cycle of
arm completed 20-minute treatments with a frequen- 10 seconds on and 5 seconds off to patient tolerance
cy of 5 to 10 Hz at the maximum tolerable intensity for 20 minutes twice a week. One participant in the
for 10 sessions over 5 to 7 weeks. Both groups had ES group withdrew due to fear, 3 withdrew from the
statistically significant improvement in mean volume oxybutynin group due to dry mouth, and 2 women
of urine and number of voids per day compared withdrew from the placebo group due to no effect.
with baseline, but did not differ between each other. Participants in the ES group had a statistically sig-
Continued benefits were maintained at 12 and 24 nificant improvement in all parameters except for
months, although there were a number of them who UI. These included warning time (P = .002), maxi-
were lost to follow-up. Negative side effects were not mal voided volume (P = .018), daily voided volume
reported in the ES group, but dry mouth and muscular (P = .024), pad count (P = .010), subjective urgency
pain were side effects in the medication group. Effect (P < .001), frequency (P <.001), nocturia (P = .001),
size was 1.76 when comparing the baseline ES group and UI (P = .814). Oxybutynin had a significant dif-
to the 6-month follow-up for the same group, but this ference in warning time (P = .001), maximal voided
did not differ greatly from the medication group. volume (P = .004), subjective urgency (P < .001), and
In an RCT, Wang et al52 compared personalized frequency (P <.001). Participants in the ES group had
PFMT programs, PFMT with BF, and ES with an a 58.4% reduction in OAB compared with 39.1% in
intravaginal electrode in 103 women. The PFMT was the oxybutynin group and 9.5% in the placebo group.
determined based on participants’ PERFECT scores Arruda et al42 compared ES to oxybutynin to
and were to practice 3 times per day in multiple pelvic floor training (PFT) in 64 women with detru-
positions. BF was completed twice per week with an sor overactivity over a 12-week period. The oxybu-
intravaginal sensor with visual feedback combined tynin group (n = 22) took 5-mg dose twice a day
with a home regimen based on their PERFECT with an interview every 4 weeks. The PFT group (n
score. Intravaginal ES was used twice a week for 20 = 21) completed in-person sessions twice a week
minutes per session with a frequency of 10 Hz, pulse for 12 weeks for 45 minutes. The exercise regimen
width of 400 μs, duty cycle with 10 seconds on and consisted of 40 fast (2 and 5 seconds) and 20 sus-
5 seconds off. The intensity of the stimulation was set tained (10 seconds) contractions with equal rest time
to patient tolerance. The ES group had the highest between performed in orthostatic, sitting, and supine.
subjective cure rate at 51.4% compared with the BF Participants also completed exercises at home. ES
228 © 2023 Academy of Pelvic Health Physical Therapy, APTA Volume 47 • Number 4 • October/December 2023
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Clinical Practice Guideline
was performed twice a week for 20 minutes using an There were no significant differences between groups,
intravaginal electrode 1 μs of intermittent biphasic but both groups improved significantly with frequen-
waves at a frequency of 10 Hz. There was no sig- cy of urgency, incontinence episodes, and voiding.
nificant difference between groups for bladder diary When considering the long-term effects at 18 weeks,
measures; however, significant change in urge inconti- the ES group maintained improvement in decreased
nence episodes (Oxy P = .007, ES P = .039, and PFT number of incontinence episodes, but the frequency
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P = .035) and total number of daily pads decreased of urgency decreased at week 10 (P < .05).
in each group (Oxy P = .000, ES P = .04, and (PFT In a multicenter, prospective, nonrandomized trial,
P = .000). Urinary frequency only decreased in the Siegel et al56 compared daily stimulation to every-
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oxybutynin group (P = .014). Subjectively urgency other-day stimulation over a 20-week period in 72
resolved in 63.6% of the medication group, 57.1% participants, 36 with urge UI and 36 with MUI. Four
in the PFT group, and 52.4% in the ES group. The participants withdrew from the study, 3 from undesir-
number of urge incontinence episodes correlated able effects and 1 because of the time commitment.
with subjective improvement. No side effects were Stimulation was delivered transvaginally twice a day
reported in the ES or the PFT group, but side effects (n = 17) or twice every-other-day (n = 19) with a
occurred in the oxybutynin group. These included dry symmetrical biphasic wave form with a pulse duration
mouth, difficulty with micturition dizziness, blurred of 0.3 μs at a constant current from 0 to 100 mA,
vision, and constipation. At 1-year follow-up with with a 5-second on and 10-second off period. Those
those with symptomatic improvement, 10/17 in the with urgency had the frequency set to 12.5 Hz for
oxybutynin group maintained improvement. Four out both sessions and those with mixed used 50 Hz in the
of 11 in the ES group maintained improvement. Nine morning and 12.5 Hz in the evening for 15 minutes
out of 16 in the PFT group maintained improvement. each session. There were no significant differences in
Gungor Ugurlucan et al54 compared the effects the primary outcome measures between the daily and
of transvaginal ES with TTNS in 52 participants. every-other-day users. In those with UUI, there was
Transvaginal ES (n = 35) was delivered for 30 min- a significant decrease in leakage (P < .001) and sig-
utes 3 times a week over 6 to 8 weeks. For those with nificant improvement in all other subjective measures
UUI, frequency was 5 to 10 Hz at 300-μs or 1-ms related to quality of life and self-assessment. Sixty-nine
pulse duration and a maximally tolerable intensity. percent of the total participants (UUI and MUI) were
Tibial nerve stimulation was delivered for 30 minutes cured or had at least 50% reduction in UI episodes.
one time per week for 12 weeks at a set pulse width Elgamasy et al57 completed a case series of 15
of 20 μs and a frequency of 20 Hz. Placement was women utilizing transvaginal ES in the office and at
confirmed with activation of great toe flexion and home. In-office treatments occurred twice a week for
intensity was adjusted to be pain free. Both the ES 6 to 10 visits and home use occurred twice daily for
and TTNS groups had significant improvement in the an average of 6 weeks. ES settings were 10 Hz with
number of urge incontinence episodes; however, there a pulse width of 3 μs, with 2 seconds on and 4 sec-
were no between-group differences. Daytime micturi- onds off for 15 minutes. Three participants required
tion decreased more significantly in the ES group than additional treatment due to recurrence within 1 to 3
in the TTNS group (P = .03). Subjective cure rate was months after the initial sessions. The only side effects
also higher in the ES group. reported were mild vaginal discomfort in 2 par-
Ozdedeli et al55 compared the use of trospium ticipants. Urinary frequency and nocturia decreased
hydrochloride (n = 17) and ES (n = 18) in 35 female significantly (P < .05 for both). Eleven of the 15
participants. Two patients from the medication group participants (73%) were satisfied with the treatment.
and 2 patients from the ES group did not complete Eighty percent of participants had improvement in
the study. Patients were evaluated pre-treatment, 6 urgency and urge incontinence.
weeks at the stop of treatment, and at 10 weeks and In a prospective, cohort study, Yaşar et al58
18 weeks. Forty-five mg of trospium hydrochloride observed the long-term results of 6 weeks of ES
(Spasmex 30-mg tablet) was given daily for 6 weeks, treatment on 67 participants. ES was delivered with
with 30 mg in the morning and 15 mg in the evening. a biphasic current at 12.5 Hz with a 5-second on
Transvaginal ES was provided for 20 minutes per ses- and 5-second off duty cycle with intensity to have
sion, 3 times per week for 6 weeks. The current was a muscular contraction or discomfort. Fifty-two out of
biphasic rectangular pulse at 5 Hz with a pulse width the original 67 participants completed 3-year follow-
of 100 μs at the maximally tolerated intensity (0-80 up. The quality of life measurement in this study
mA). Side effects for the medication group included was the Stress, Emptying, Anatomy, Protection, and
dry mouth, constipation, hematuria due to nephroli- Inhibition (SEAPI) quality of life score. There was
thiasis, and UTI. Side effects for the ES group includ- statistically significant improvement in the SEAPI
ed vaginal discomfort, UTI, and vaginal hemorrhage. initially following treatment and this was maintained
Journal of Women’s & Pelvic Health Physical Therapy © 2023 Academy of Pelvic Health Physical Therapy, APTA 229
Copyright © 2023 Academy of Pelvic Health Physical Therapy, APTA. Unauthorized reproduction of this article is prohibited.
Clinical Practice Guideline
at 3-year follow-up. The mean volume of urine per differences in these measures in the pharmacotherapy
void increased significantly initially following treat- alone group. Adverse effects of dry mouth were
ment and was also maintained at 3-year follow-up. reported in the medication and combined groups
Improvement in nocturia was significant initially (28%), and 1 report of visual disturbances in the
post-treatment and at the 1-year follow-up, but was medication group was reported.
not maintained at the 3-year follow-up and was simi- The literature includes evidence for self-care strate-
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lar to pretreatment numbers (Table 6). gies for the treatment of UUI, urinary urgency, and/
or urinary frequency. These strategies are weight
Action Statement 5: Medication Combined With loss and mindfulness-based stress reduction (MBSR).
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Clinical Practice Guideline
treatment of idiopathic and physical therapy + medica- each dose and totaling
detrusor overactivity: a tion were compared over 8 wk. 45 mg/d) for 8 wk
randomized controlled Physical therapy interventions
trial. included pelvic floor exercises
with sEMG, bladder training, and
electrical stimulation.
Abbreviation: sEMG, surface electromyography.
232 © 2023 Academy of Pelvic Health Physical Therapy, APTA Volume 47 • Number 4 • October/December 2023
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Clinical Practice Guideline
day reduced an average of 2.91 (P = .0005 and effect Providers considering an anticholinergic medica-
size 1.90; Table 9). tion prescription for a patient should complete a
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has urinary urgency with underactive PFMs. Future J Am Geriatr Soc. 2000;48(7):721–725. doi:10.1111/j.1532-5415.2000.
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Clinical Practice Guideline
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Copyright © 2023 Academy of Pelvic Health Physical Therapy, APTA. Unauthorized reproduction of this article is prohibited.