Burgio KL, Goode PS, Locher JL, Umlauf MG, Roth DL, Richter HE, Varner RE, Lloyd LK. Behavioral Training With and Without Biofeedback in the Treatment of Urge Incontinence in Older WomenA Randomized Controlled Trial. JAMA. 2002;288(18):2293-2299. doi:10.1001/jama.288.18.2293
Author Affiliations: Department of Veterans Affairs Medical Center, Birmingham/Atlanta Geriatric Research, Education, and Clinical Center, Birmingham, Ala (Drs Burgio and Goode); and School of Medicine (Drs Burgio, Goode, Locher, Richter, Varner, and Lloyd), Center for Aging (Drs Burgio, Goode, Locher, Umlauf, Roth, Richter, Varner, and Lloyd), School of Nursing (Dr Umlauf), and School of Public Health (Dr Roth), University of Alabama at Birmingham.
Context Previous research on urge urinary incontinence has demonstrated that
multicomponent behavioral training with biofeedback is safe and effective,
yet it has not been established whether biofeedback is an essential component
that heightens therapeutic efficacy.
Objective To examine the role of biofeedback in a multicomponent behavioral training
program for urge incontinence in community-dwelling older women.
Design Prospective, randomized controlled trial conducted from April 1, 1995,
to March 30, 2001.
Setting University-based outpatient continence clinic in the United States.
Patients A volunteer sample of 222 ambulatory, nondemented, community-dwelling
women aged 55 to 92 years with urge incontinence or mixed incontinence with
urge as the predominant pattern. Patients were stratified by race, type of
incontinence (urge only vs mixed), and severity (frequency of accidents).
Interventions Patients were randomly assigned to receive 8 weeks (4 visits) of biofeedback-assisted
behavioral training (n = 73), 8 weeks (4 visits) of behavioral training without
biofeedback (verbal feedback based on vaginal palpation; n = 74), or 8 weeks
of self-administered behavioral treatment using a self-help booklet (control
condition; n = 75).
Main Outcome Measures Reduction in the number of incontinence episodes as documented in bladder
diaries, patients' perceptions and satisfaction, and changes in quality of
Results Intention-to-treat analysis showed that behavioral training with biofeedback
yielded a mean 63.1% reduction (SD, 42.7%) in incontinence, verbal feedback
a mean 69.4% reduction (SD, 32.7%), and the self-help booklet a mean 58.6%
reduction (SD, 38.8%). The 3 groups were not significantly different from
each other (P = .23). The groups differed significantly
regarding patient satisfaction: 75.0% of the biofeedback group, 85.5% of the
verbal feedback group, and 55.7% of the self-help booklet group reported being
completely satisfied with treatment (P = .001). Significant
improvements were seen across all 3 groups on 3 quality-of-life instruments,
with no significant between-group differences.
Conclusions Biofeedback to teach pelvic floor muscle control, verbal feedback based
on vaginal palpation, and a self-help booklet in a first-line behavioral training
program all achieved comparable improvements in urge incontinence in community-dwelling
older women. Patients' perceptions of treatment were significantly better
for the 2 behavioral training interventions.
Urge urinary incontinence is a common condition that affects millions
of US individuals, especially older women.1,2 It
is usually treated with drugs that inhibit detrusor contractions,3 but adverse effects are common and behavioral treatments
have also proven effective by changing voiding habits or teaching new continence
skills.4- 11 Biofeedback-assisted
behavioral training uses biofeedback to teach patients how to control the
physiologic responses of the bladder and pelvic floor muscles that mediate
incontinence.5- 9,11 It
is effective for treating urge incontinence, producing improvements ranging
from 76% to 86%, is at least as effective as drug therapy, and in 1 trial,
it was more effective than immediate-release oxybutynin chloride.6- 9,11
Biofeedback-assisted behavioral training has multiple components. A
primary component is teaching patients how to identify and exercise pelvic
floor muscles, and most important, how to use them to prevent urine loss by
aborting detrusor contractions and occluding the urethra during contractions
that cannot be inhibited. Although biofeedback is clearly an effective technique
for teaching pelvic floor muscle control, it is not established whether it
is an essential component of training for urge incontinence or whether muscle
control can be taught adequately by other methods, such as verbal feedback
during pelvic examination or written instructions. One small study (n = 27)
found that biofeedback did not enhance outcomes.8
The role of biofeedback in the treatment of urge incontinence is an
important issue because biofeedback is more expensive and slightly more invasive
than other teaching methods in that it involves placement of electrodes. Medicare
reimburses for biofeedback used to treat urinary incontinence, based on studies
of stress incontinence, but very little is known about the role of biofeedback
in the treatment of urge incontinence.12,13
The present study used a randomized controlled trial to test whether
biofeedback enhances the outcome of behavioral training for urge incontinence
in older women. Specifically, it evaluated the relative effects of training
with and without biofeedback compared with a control condition consisting
of self-administered behavioral treatment.
Participants were older community-dwelling women with persistent urge
incontinence. They were recruited through local advertisements, community
outreach, and professional referrals and then screened by telephone to determine
eligibility. To be eligible, patients were at least 55 years old, ambulatory,
and had described a pattern of predominant urge incontinence that occurred
at least twice per week and persisted for at least 3 months. All participants
provided informed consent according to procedures approved by the University
Institutional Review Board for Human Use. The study was conducted between
April 1, 1995, and March 30, 2001.
Potential participants who met initial criteria were scheduled for evaluation
in an outpatient continence clinic. The evaluation consisted of a continence
and medical history, physical examination, postvoid catheterization for residual
urine, urodynamic evaluation, hemoglobin A1C in the presence of
diabetes, and urinalysis (urine dipstick on clean-catch specimen with microscopic
evaluation, if indicated). In addition, the Mini-Mental State Examination
was used to screen for dementia.14 If patients
had a urinary tract infection (urine colony count >10 000), fecal impaction,
severe atrophic vaginitis, or a correctable metabolic problem, they were offered
treatment for the condition and reconsidered for study participation at a
later date if the incontinence persisted.
Urodynamic testing was performed to document bladder dysfunction (for
inclusion) and to classify the type of incontinence for stratification (urge
only vs mixed stress and urge). Two-channel supine water cystometry was performed
using a 12F double lumen urodynamic catheter, a rectal balloon, and room temperature
sterile water at a continuous filling rate of 50 mL/min up to a maximum of
500 mL. Threshold volumes were recorded for first desire to void, strong desire
to void, cystometric capacity (the highest volume achieved), and detrusor
contraction. Strength of the external anal sphincter was assessed by using
manometry. The catheter was removed and several maneuvers were performed to
provoke urge or stress incontinence.
To measure pretreatment frequency of incontinence, patients were provided
with 2 weeks of bladder diary booklets.15 Patients
documented the time of every void and incontinent episode, the volume of each
episode of urine loss (large or small), and the circumstances of each episode.
The Hopkins Symptom Checklist (SCL-90-R, for psychological distress),16 Incontinence Impact Questionnaire,17 and
the Short-Form Health Survery (SF-36)18 were
completed by patients at home and returned with baseline diaries.
To be included, patients had to have at least 2 urge accidents per week
on average documented in the 2-week bladder diary, and urge incontinence had
to be the predominant pattern (the number of urge accidents had to exceed
the number of stress and other accidents). Also, there had to be urodynamic
evidence of bladder dysfunction (detrusor instability during filling or provocation
or maximal cystometric capacity of ≤400 mL). Patients were excluded if
they had continual leakage, postvoid residual urine volume greater than 150
mL, severe uterine prolapse past the vaginal introitus, decompensated congestive
heart failure, or impaired mental status (Mini-Mental State Examination score
Prior to randomization, participants were stratified by race (black
or white) because of possible differences in the pelvic floor,19,20 type
of incontinence, and severity of incontinence. Baseline bladder diaries and
urodynamic test results were used to classify incontinence as urge only or
mixed stress and urge. To be sure that the groups were similar on pretreatment
severity of incontinence, the bladder diaries were used to stratify participants
as having mild (<5 episodes per week), moderate (5-10 episodes per week),
or severe (>10 episodes per week) incontinence. Patients were randomized to
behavioral treatment with biofeedback, behavioral treatment without biofeedback
(verbal feedback based on vaginal palpation), or a control condition consisting
of self-administered behavioral training.
For all patients, treatment was implemented for an 8-week period. Patients
completed a daily bladder diary throughout treatment.
Treatment consisted of 4 clinic visits at 2-week intervals during the
8-week period. At each visit, clinic staff reviewed bladder diaries to ensure
that entries were clear and interpretable. Interventions were implemented
by nurse practitioners. During clinic visits, patients in the biofeedback
group were taught skills and strategies for preventing incontinence and provided
with oral and written instructions for daily home practice.
In the first visit, anorectal biofeedback was used to help patients
identify pelvic floor muscles and teach them how to contract and relax these
muscles selectively while keeping abdominal muscles relaxed.6 A
3-balloon probe was inserted into the rectum and used to measure external
anal sphincter responses, simultaneously with rectal (abdominal) pressures.21 Tracings were displayed on a computer monitor. The
second visit was devoted to teaching patients how to respond adaptively to
the sensation of urgency (urge suppression strategies).6,8,22 Instead
of rushing to the toilet, which increases intra-abdominal pressure and exposes
patients to visual cues that can trigger incontinence, patients were encouraged
to pause, sit down if possible, relax the entire body, and contract pelvic
floor muscles repeatedly to diminish urgency, inhibit detrusor contraction,
and prevent urine loss. When urgency subsided, they were to proceed to the
toilet at a normal pace. Patients with mixed incontinence were also taught
stress strategies, which consisted of contracting pelvic floor muscles just
before and during any physical activities such as coughing or sneezing that
had triggered stress incontinence. In the third visit, patients who had not
achieved at least 50% improvement underwent combined bladder-sphincter biofeedback
to teach them to contract pelvic floor muscles against increasing volumes
of fluid, in the presence of increasing urgency, and during detrusor contraction.6 The fourth visit was used to review progress, "fine-tune"
home practice, and encourage persistence.
Recommendations for pelvic floor muscle exercises included 45 exercises
every day divided into manageable sessions, typically sets of 15 exercises,
3 times per day. The initial duration of each individual contraction was determined
based on the ability demonstrated by each patient in the original training
session. Across sessions, the duration was increased gradually to a maximum
of 10 seconds, with an equal period of relaxation between contractions. Patients
were advised to practice in various positions including lying, sitting, and
standing, and whenever possible to integrate the exercises into other daily
activities. They were instructed to actively contract pelvic floor muscles
during activities that had resulted in incontinence and to practice interruption
or slowing of the urinary stream during voiding once a day.
This treatment included all the components of behavioral training minus
the biofeedback. In lieu of biofeedback, verbal feedback based on vaginal
palpation was used in the first treatment session to help patients identify
and contract pelvic floor muscles. If, after several attempts, no contraction
could be detected vaginally, the examiner placed a finger just inside the
anal opening and gave verbal feedback of voluntary external anal sphincter
contraction. Home practice and all other instructions were the same as for
the biofeedback group. If patients did not improve by at least 50% by their
third visit, the teaching was repeated.
The control group received written instructions for an 8-week self-help
behavioral program, with the same content as the behavioral training program
described above, but completely self-administered without benefit of professional
expertise or equipment. It was a step-by-step self-help program written for
incontinent individuals who do not have access to a professional with this
expertise or who simply wish to try such a program on their own. In language
geared to a fifth-grade reading level, it presents basic information about
urge and stress incontinence, how to complete bladder diaries, how to locate
their pelvic floor muscles (including vaginal palpation), how to do daily
pelvic floor muscle exercises, how to use their muscles to prevent accidents,
and how to respond to urgency. The complete text is published in Staying Dry: A Practical Guide to Bladder Control.22 Patients
were given an instruction booklet and an appointment for a return visit in
8 weeks. They were also given a supply of bladder diaries and stamped envelopes
for returning completed diaries biweekly.
Following the last intervention visit, patients completed 2 weeks of
posttreatment bladder diaries and a patient satisfaction questionnaire, and
repeated the 3 quality-of-life measures. When they returned for their posttreatment
visit, these materials were collected and patients were asked to repeat urodynamic
The sample size was calculated to allow detection of 15% differences
in improvement between groups with 85% power and a significance level of .05,
assuming a 2-sided hypothesis test and a pooled within-group SD of 20%. The
3 treatment groups were first compared using χ2 analysis and
analysis of variance to determine whether there were any group differences
before treatment on key variables. After treatment, the bladder diaries were
used to calculate change in the frequency of incontinence episodes, which
was the primary outcome measure. The pretreatment and posttreatment frequency
of incontinence were used to calculate a percentage reduction for each patient
([pretreatment frequency − posttreatment frequency]/[pretreatment frequency]
× 100%).6,11 Thus, 100%
represented total continence, 0% represented no improvement, and a negative
percentage indicated regression. One-way analysis of variance was used to
test for differences among the 3 groups on reduction of incontinence. The
analysis was based on intention-to-treat. When patients did not complete treatment,
the most recent bladder diaries were used to calculate outcome, including
baseline diaries when no data were available postbaseline.
Differences between the groups on patient satisfaction and perceptions
were tested using the χ2 statistic for categorical variables
or the Kruskal-Wallis test for ordinal variables. Other outcomes measures,
including the Hopkins Symptom Checklist, the Incontinence Impact Questionnaire,
the SF-36, and bladder capacity, were examined using 3 (treatment group) ×
2 (pretreatment vs posttreatment) repeated measures analyses of variance.
SPSS version 10.0.5 (SPSS Inc, Chicago, Ill) was used for all statistical
Of 474 women who were evaluated clinically, 252 were ineligible or did
not participate and 222, aged 55 to 92 years, were randomized (Figure 1). The attrition rate was 15.1% in the biofeedback group,
12.2% in the verbal feedback group, and 9.3% in the self-help booklet group.
Twenty-seven patients did not complete treatment. All were included in the
intention-to-treat analysis. Characteristics of the participants are presented
in Table 1. Before treatment,
there were no significant differences among the 3 treatment groups on the
key parameters, with the exception of bladder capacity. Therefore, this variable
was included as a covariate in the primary analysis of treatment outcome.
Before treatment, the weekly frequency of incontinence was similar across
the 3 groups, although the verbal feedback group had slightly more accidents
than the other 2 groups (mean [SD], 17.3 [16.3] per week compared with 15.4
[14.2] and 15.1 [13.5] per week, Table 2). After treatment, the biofeedback and verbal feedback groups were
almost identical (6.1 [10.3] and 6.0 [10.7] accidents per week) and 6.7 (11.4)
accidents per week were reported in the self-help group.
Behavioral treatment with biofeedback resulted in a mean (SD) 63.1%
(42.7%) reduction in frequency of accidents, 69.4% (32.7%) reduction in treatment
with verbal feedback, and 58.6% (38.8%) reduction in treatment with the self-help
booklet. The analysis of covariance indicated that the 3 groups were not significantly
different from each other (P = .23). Similarly, a
larger proportion of participants in the verbal feedback group achieved at
least 50% and 75% reductions of incontinence, but differences were small and
nonsignificant (Figure 2).
We also investigated whether baseline characteristics were associated
with treatment outcomes. Treatment outcome was not related to diuretic use
(P = .40), previous surgery (P = .87), or uterine prolapse (P = .69). Furthermore,
no interaction was found by therapist. Results did not differ substantially
when we excluded patients lost to follow-up after baseline only.
A total of 48% of patients completed a posttreatment cystometrogram
(30 in biofeedback, 35 in verbal feedback, and 42 in self-help booklet group).
This subsample who completed pretreatment and posttreatment urodynamics was
compared with the remaining patients on outcome (reduction of incontinence)
and the baseline characteristics. Patients who completed a posttreatment cystometrogram
had significantly shorter durations of incontinence (P =
.006), were more likely to have a urethrocele (P =
.03), and had greater reductions of incontinence with treatment (P = .005) than those who did not complete posttreatment urodynamics.
These 2 groups did not differ significantly on the remaining variables. Bladder
capacity increased by a mean 47.8 mL in the biofeedback group, 63.2 mL in
the verbal feedback group, and 37.0 mL in the self-help booklet group. The
improvements across all 3 groups were statistically significant (overall, P = .001), but the increases did not differ among the 3
interventions (P = .54).
Several aspects of the patient's perspective were assessed by a questionnaire
(Table 3). After completing treatment,
the biofeedback and verbal feedback groups were very similar in their descriptions
of progress in therapy and comfort level for continuing treatment. For example,
62.3% and 63.2% described their condition as "much better," respectively,
whereas only 30.8% of patients in the self-help group considered themselves
"much better" (overall, P = .002). On all 5 measures
with significant group differences, the verbal feedback group was found to
be significantly better than the self-help booklet group (description of progress, P<.001; accidents are smaller, P =
.006; comfortable with treatment, P = .01; satisfaction
with progress, P<.001; and restriction of activities, P = .002), and on 3 of the 5 measures (description of progress,
satisfaction with progress, and restriction of activities), the biofeedback
group was also found to be superior to the self-help group (P<.001, P = .03, and P = .047, respectively). The verbal feedback group did not differ from
the biofeedback group on any measure. Thus, from the patients' point of view,
both verbal feedback and biofeedback led to better outcomes on important measures
of progress and patient satisfaction compared with the self-help group.
Repeated measures analyses of treatment effects revealed statistically
significant main effects for pretreatment vs posttreatment on 9 of 10 scales
of the Hopkins Symptom Checklist (P<.05; not hostility, P = .13), on all 4 subscales of the Incontinence Impact
Questionnaire (all P<.001), and on 5 of 8 scales
of the SF-36 (all P<.05). These effects indicated
significant improvements across all 3 treatment groups. One significant group
× time interaction effect was found on the vitality subscale, indicating
that vitality scores increased more for the verbal feedback group (P = .01). Otherwise, no differential treatment effects were observed.
This study demonstrates that all 3 behavioral interventions were effective
for helping patients identify the pelvic floor muscles and use them to prevent
episodes of urge incontinence. The use of biofeedback did not enhance efficacy
more than what was achieved using careful training with verbal feedback or
a detailed self-help program. In fact, the biofeedback and verbal feedback
groups had almost identical rates of incontinence after treatment. The verbal
feedback training did not consist merely of a cursory pelvic floor muscle
contraction during a pelvic examination, but involved a more comprehensive
session in which exercises were carefully and thoroughly taught, with time
devoted to guiding patients through a series of exercises. Furthermore, the
training was done in the context of an 8-week program in which patients were
taught other continence skills and encouraged to persist in their efforts.
In this study, the self-administered behavioral treatment program was
also very effective. The practitioner should note that this self-help program
included keeping continuous bladder diaries that were mailed in biweekly,
and patients were called if the diaries were not received. Furthermore, when
patients were given the self-help booklet, they were also given an appointment
to return after 8 weeks, which could have helped sustain their motivation.
It is possible that the highly motivated volunteers who participated in this
clinical trial may not be representative of the general clinical population.
Like any intervention, each of these teaching methods may not be the
best approach for every patient. Some may learn more readily by interacting
closely with the therapist; others may be more comfortable with the instrumented
biofeedback and the more intricate variations the biofeedback provides. While
many patients may prefer verbal feedback over being instrumented, clearly
there are those who cannot identify the pelvic floor muscles because of extreme
weakness, who lack the proprioceptive feedback that allows them to control
pelvic floor muscles, and who may do better with biofeedback. Many clinicians
have observed patients who cannot identify or adequately control pelvic floor
muscles without biofeedback but subsequently are able to gain control through
biofeedback. After completion of this trial, patients were offered the opportunity
to crossover to these treatments. Five patients who completed treatment with
verbal feedback elected to crossover into the treatment with biofeedback.
These patients showed a mean 54.2% reduction of incontinence after the first
treatment and 73.4% mean reduction after treatment with biofeedback. Patients
who received biofeedback first were not offered the option of a second intervention
in this trial.
Although the biofeedback and verbal feedback interventions were not
significantly more effective than the self-help condition for reducing accidents
as documented in bladder diaries, they did result in better outcomes in the
patients' perceptions of and satisfaction with progress. Patient satisfaction
with their progress is likely to be highly related to accident reduction;
therefore, it could be that they were less satisfied because they did not
reduce accidents to a critical threshold. However, other aspects of patient
satisfaction might have been affected by their having had less contact with
clinical staff. Personal interactions with care providers may contribute to
patient satisfaction through encouragement and support, which are often critical
to sustain a patient's motivation in a behavioral program.
Because all 3 treatment approaches appear to be clinically useful and
acceptable, a practical strategy would be to initiate training with an instruction
booklet or verbal feedback and reserve biofeedback for those who have difficulty
learning pelvic floor muscle control in this way or who do not progress adequately
in their attempts to reduce incontinence in their daily lives. This approach
is consistent with the current reimbursement policies issued by the Centers
for Medicare and Medicaid Services, which state that biofeedback is reimbursable
after patients have failed a course of pelvic floor muscle training. However,
patients whose efforts are not producing results may lose motivation and these
patients are likely to reject alternative behavioral training.13
This study was specific to the treatment of urge incontinence and results
should not be generalized to stress incontinence. Previous studies are inconsistent
in determining the role of biofeedback in treatment of stress incontinence.12,13,23,24 Although
some research provides evidence that biofeedback results in higher success
rates than training without biofeedback,12,13 other
studies are equivocal.23,24 Thus,
conclusions regarding the treatment of stress incontinence should be reserved
for more definitive studies.
Furthermore, there is reason to believe that biofeedback may play different
roles in the treatment of urge vs stress incontinence. It is clear that biofeedback
makes it possible for patients to gain better control over pelvic floor muscle
contraction, especially in the ability to maximize force and to sustain contractions,
which is important for building strength. Treating stress incontinence relies
on voluntary periurethral contractions to occlude the urethra. Thus, strength,
the ability to sustain contractions, and a higher degree of muscle control
would seem to be important for preventing stress accidents. In treating urge
incontinence, mechanical occlusion of the urethra may be a less important
function of pelvic floor muscle contraction than the fact that it inhibits
detrusor contractions. It may not be necessary to achieve such a high degree
of control or strength or to sustain a contraction, but only to activate the
reflex pathway. The urge suppression strategy, consisting of pelvic floor
muscle contraction adequate to inhibit the detrusor, may be the most essential
component of this therapy.
The finding that biofeedback did not enhance the effectiveness of behavioral
training for reducing urge incontinence indicates that behavioral training
has excellent potential for becoming more widely disseminated and may be implemented
using existing coding using time spent in patient education and counseling
as the key factor for determining the specific level of service provided.
Because verbal feedback and the self-help program can be implemented without
the equipment and expertise needed to perform biofeedback, they are both appropriate
and practical for use in most any outpatient clinical practice.