Medicare Coverage Policy ~ Decisions
Pelvic Floor Electrical Stimulation for Treatment of Urinary
Incontinence (#CAG-00021)
Decision Memorandum
To: |
File: Pelvic Floor Electrical Stimulation for
Treatment of Urinary Incontinence CAG-00021 |
From: |
Sean R. Tunis, M.D., M.Sc. Director,
Coverage and Analysis Group
John J. Whyte, MD, MPH Medical Officer, Coverage and
Analysis Group
Perry Bridger, MHS Health Insurance Specialist, Coverage
and Analysis Group |
Re: |
National Coverage Decision |
Date: |
October 5, 2000 |
This memo serves four purposes: (1) outlines the description and
treatment of urinary incontinence (2) reviews the history of
Medicare's coverage policies on pelvic floor electrical stimulation
(PFES) (3) analyzes the relevant scientific data related to the use
of PFES for stress, urge, and post-prostatectomy urinary
incontinence, and (4) delineates the reasons (a) supporting a
positive national coverage decision for patients with stress and/or
urge incontinence who have already undergone and failed a trial of
pelvic muscle exercises (PME) and (b) continuing a national
noncoverage policy for those patients who have not yet undergone PME
as an initial treatment modality.
Pathophysiology of Urinary Incontinence
Urinary incontinence refers to the involuntary loss of urine.
Approximately 17 million adults in the US suffer from incontinence,
with nearly half of nursing home residents having some degree of
incontinence.1 Women
are twice as affected as men. Nearly 35% of female Medicare
beneficiaries and 25% of male beneficiaries are estimated to suffer
from urinary incontinence.
Although the prevalence of incontinence increases with age,
incontinence is not a normal consequence of aging. Incontinence can
be a distressing and often disabling state in the elderly. It can
have a tremendous effect on the quality of life, as well as other
health conditions. Nearly a third of all patients do not speak to
their doctor about incontinence, thereby increasing morbidity.
2
Types of Incontinence There are various types of
urinary incontinence. The two most common types are stress and urge.
Stress incontinence refers to involuntary loss of urine
due to inadequate urethral pressure. The patients experience urine
loss during coughing, sneezing, or physical exertion.
Urge incontinence refers to the involuntary loss of
urine due to abnormal bladder contractions (e.g. detrusor
instability). It is often associated with a sudden, strong desire to
urinate. The urge gives little warning and large amounts of urine
are lost.
Mixed incontinence is the term used when features of
both stress and urge incontinence coexist.
Post-prostacteomy incontinence is a common condition
among elderly Medicare patients, and is a result of the treatment of
prostate cancer or benign prostatic hypertrophy.3 It is
predominantly stress or urge.
There can also be functional incontinence, which occurs in a
normal urinary tract. Such causes can be multifactorial and can
include medications, infections, cancer, trauma, diverticuli, and
fistulas.4
The specific diagnosis can be made by either clinical or
urodynamic testing.
Treatment Options
Treatment options include behavioral modifications, medications,
vaginal cones, sacral nerve stimulation, electrical and magnetic
stimulation, as well as surgery. This decision memo focuses solely
on the use of pelvic floor electrical stimulation (PFES).5
For the purposes of this decision memorandum, PFES relates to the
use of a non-implantable electrical device that delivers variable
rates of current through the pelvic floor with the intent of
strengthening the pelvic floor musculature. The device used in PFES
generally includes an internal probe that delivers the electrical
current and an external device for controlling the electrical
stimulation. The intent of PFES is to stimulate the pudendal nerve
in order to improve urethral closure by activating the pelvic-floor
musculature. PFES is thought to improve partially denervated
urethral and pelvic floor musculature by enhancing the process of
reinnervation. PFES is also intended to exercise and strengthen the
pelvic floor muscles.6
The methods of PFES vary in location (vaginal, rectal), stimulus
frequency, stimulus and intensity, pulse duration, treatments per
day, number of treatment days per week, length of time for each
treatment session, overall time period for device use and between
clinic and home settings.7 For
urge incontinence, the objective is to reinforce the inhibitory
system; these inhibitory neurons operate at low frequencies, so
stimulation is generally administered at 5-20 Hz. For stress
incontinence, the objective is to activate the motor neurons, so
stimulation is generally administered at 20-50 Hz. For mixed
incontinence, the treatment sessions generally alternate between
those for urge and stress incontinence.
History of Medicare's Coverage Process for
Pelvic Floor Electrical Stimulation
Presently, the Medicare program has a national noncoverage
policy. The Coverage Issues Manual (CIM) 65-9C states:
Electronic Stimulators--Pelvic floor
electrical stimulators, whether inserted into the vaginal canal or
rectum or implanted in the pelvic area, used as a treatment for
urinary incontinence, e.g., as a bladder pacer or a retraining
mechanism, are not covered. The effectiveness of these devices is
unproven
The topic of electrical stimulation has been discussed for
several years. It was first discussed in 1994 at HCFA's Technical
Advisory Committee (TAC). The TAC reviewed an Agency for Health Care
Policy and Research (AHCPR) guideline on urinary incontinence, but
the TAC did not believe the data in the guideline supported
effectiveness. 8 The TAC
focused on the fact that the report stated "Research is needed to
determine the efficacy of electrical stimulation either when used
alone or in combination with other management strategies....Ideal
parameters for electrotherapies have not been established by
controlled clinical trials, and research needs to be conducted
before this technique becomes a standard treatment." Therefore, the
TAC recommended the CIM be revised to state that these devices are
noncovered. Previously, it had been left to carrier discretion. This
issue was readdressed in March, 1996 at the TAC. Earlier in the
year, AHCPR had published an update on urinary incontinence. TAC
members reviewed the update, as well as results of a multi-center
clinical trial, and concluded that PFES may be no better than no
treatment at all, and it offered less evidence of its effectiveness
than biofeedback. Therefore, the TAC voted not to revise the
noncoverage policy.
In addition, the Blue Cross Blue Shield Technology Evaluation
Center (TEC) performed a technology assessment on this topic in 1998
and concluded that this device did not meet the TEC criteria.9
Since the TAC recommendation and subsequent noncoverage decision,
the manufacturers of this product have been to HCFA's Central Office
several times to discuss reconsideration of the policy. Empi
contracted with MEDTAP International, Inc to provide an analysis of
the assessment, and provided it to the agency in 1998. 10
11 The
MEDTAP report asserted that the Blue Cross Blue Shield TEC
assessment (1) misinterpreted the studies reviewed (2) excluded
articles that showed effectiveness of PFES. HCFA staff reviewed this
report, and met with MEDTAP representatives to discuss the report.
Given the conflicting evidence and differences of opinion in the
scientific and clinical community, in early 1999, it was decided by
then-Director of the Coverage and Analysis Group Grant Bagley, MD,
JD that this topic would be presented to the Medicare Coverage
Advisory Panel (MCAC). HCFA subsequently generated an internal
request for a national coverage determination, and referred the
issue to the MCAC.
Technology Assessment
Prior to referral to the MCAC, HCFA ordered a technology
assessment from the Blue Cross Blue Shield Technology Evaluation
Center, one of the evidence-base practice centers (EPC's) of the
Agency for Health Research and Quality (AHRQ). 12 The
EPC's employ rigorous, up-to-date methodology for systematically
reviewing the literature on a clinical topic and forming
evidence-based conclusions. By following this generally-accepted
methodology for performing systematic reviews, the likelihood that
the conclusions are bias is minimized.
See Technology
Assessment
The focus of the assessment was to answer the following
questions:
- Compared to placebo, is the treatment
with PFES efficacious in reducing incontinence?
- What is the efficacy of PFES as compared to
pelvic muscle exercises (PME) or alternative nonsurgical
treatment?
- Does the addition of PFES to PME
result in improved outcomes above that obtained with PME alone?
It is important to note that the technology
assessment did not specifically address the
effectiveness of PFES in those patients who have failed pelvic
muscle exercises.
Selection of articles to be reviewed were as follows:
Full-length peer reviewed articles
Documented stress, urge, or mixed incontinence by physician
diagnosis and urodynamic testing
Concurrent comparison group
Valid health outcome measures
Adequate description of patient population
A total of 12 studies (11 published articles) were included in
the assessment.
6 trials compared PFES to placebo
5 trials compared PFES to alternative treatments
1 trial compared PFES + PME to PME alone
The comparisons
were done for stress, urge, and post-prostactectomy incontinence.
The breakdown of the studies can be seen in Table 1.
Table 1: Comparisons for interventions
and types of incontinence *
|
Stress Incontinence |
Urge Incontinence |
Post-prostactectomy incontinence |
PFES vs placebo |
5 studies (4 randomized) (n=243) |
1 study (randomized) (n=61) |
--
|
PFES vs alternative treatments |
5 studies (5 randomized) (n=260) |
1 study (randomized) (n=38) |
--
|
PFES + PME vs
PME alone |
1 study (randomized) (n=14) |
--
|
1 study (n=63) | n=number of
patients * this represents articles in technology assessment
only, and does not include articles in the exclusion tables, or
articles received after the Medicare Coverage Advisory Committee
(MCAC) meeting
PFES vs placebo
As noted above, the majority of studies were done on stress
incontinence. Of the 5 studies, 4 were randomized, and all 5 were
blinded. A total of 243 patients were studied with number of
patients ranging from 30-67 in each study.
Specific information on each study can be found in the technology
assessment. The main outcome measures were (a) change in leaks/day
as measured by a bladder diary, and (b) change in weight on a pad
test. These two measures are generally agreed upon as the most
appropriate outcome measures in studies on incontinence.
Overall, the data trends toward an improved outcome, with the
majority of studies reporting benefit. Statistically significant
results favoring PFES were reported in three of the five trials.
Tables 2 and 3 show the particular results of each study. Of note,
the Brubaker study, which used urodynamic measurements, may not have
used the appropriate stimulation intensity to see the desired
effect.
The Sand and Yamanishi studies are two of the better designed
studies on PFES. The Sand study randomly assigned 52 women (on a 2:1
basis) with stress incontinence to either PFES or a sham device.
After 12 weeks of home treatment, the PFES group showed a reduction
in the number of leaks per week from 14.2 to 10.0, and leaks/day
from 3.1 to 1.8. Patients using the sham group actually got worse.
(Other studies did not show this worsening effect in a sham group.)
Sand also showed a 46% improvement by pad test in the experimental
group. There was a fair number of dropouts in the study, but an
intent-to-treat analysis was performed. The data was statistically
significant. The Yamanishi study was a randomized, double-blinded
controlled trial enrolling 33 patients (28 women, 5 men). After 4
weeks of treatment, 50% patients were cured with the device vs 8.3%
for the sham. 80% of patients in the PFES group showed 50%
improvement versus 18% in the control group. Data was statistically
significant.
Table 2: Percent change in continence
(leaks/day) for stress incontinence (Numbers represent percent
reduction)
Study |
PFES |
Sham PFES |
Sand 1995 |
42%* |
-26% |
Luber 1997 |
14% |
11% |
Laycock 1993 |
No difference |
No difference |
Brubaker 1997 |
NR |
NR |
Yamanishi 1997 |
33%* |
0% | *statistically
significant NR=not reported
Table 3: Percent change in standardized
pad test (gms) for stress incontinence (Number represent
percent reduction)
Study |
PFES |
Sham PFES |
Sand 1995 |
66%* |
-8% |
Luber 1997 |
NR |
NR |
Laycock 1993 |
66%* |
28% |
Brubaker 1997 |
NR |
NR |
Yamanishi 1997 |
56%* |
-45% | *statistically
significant
One trial (Brubaker et al 1997) studied
patients with urge incontinence. The results of this trial are
notable since outcome measures were pre/post-treatment urodynamic
testing. Urodynamic testing is the gold standard for diagnoses. The
percentage of patients with diagnosis of urge incontinence decreased
from 54% to 27% after treatment, whereas the change in pre/post
treatment diagnosis was 47% to 41% for the sham treatment group.
Data was statistically significant. Although there may be some
question of correlation between urodynamic measurements and clinical
symptoms, most data points to a positive correlation.
PFES vs alternative A total of 5
studies were conducted comparing PFES to an alternative treatment
for stress incontinence. One study was conducted relating to urge
incontinence. These alternatives included PME, vaginal cones, and no
treatment (waiting-list control). Of the 5 trials for stress
incontinence, all 5 were randomized, and blinded. A total of 260
patients were studied, with study sizes ranging from 18-107
subjects.
Specific information on each study can be found in the technology
assessment. Tables 3 and 4 show the particular results of each
study. Overall, some studies reported benefit, others did not. As
can be seen, only one study showed statistically significant
results, and this study (Bo, 1999) was in favor of PME. This study
randomized 107 patients to four groups: PFES, PME, vaginal cones,
and waiting-list control. All three treatment groups showed efficacy
on at least one outcome measure, but improvement was consistently
larger for those patients undergoing PME, sometimes twice as
efficacious.
Table 4: Percent change in continence
(leaks/day) for stress incontinence
Study |
PFES |
Alternative |
Bo 1999 |
30% |
PME 60%* Cones 30% |
Smith 1996 |
53% |
PME 20% |
Olah 1990 |
60% |
Cones 63% |
Laycock 1993 |
NR |
NR |
Hahn 1991 |
NR |
NR | *statistically
significant
Table 5: Percent change in standardized
pad test (gms) for stress incontinence
Study |
PFES |
Alternative |
Bo 1999 |
13% |
PME 78%* Cones 30% |
Smith 1996 |
NR |
NR |
Olah 1990 |
67% |
Cones 49% |
Laycock 1993 |
NR |
NR |
Hahn 1991 |
34% |
PME 61% | *statistically
significant
One trial (Smith 1996) compared PFES with an
alternative (i.e. anticholinergic drug) for urge incontinence. It
was randomized and enrolled 38 women. Percent of patients with at
least a 50% improvement in leaks per day as measured by diary was
50% for the PFES group, and 35% for the medication group. There was
no statistical difference between the groups.
PFES + PME vs PME alone
One trial compared PFES + PME to sham PFES for the treatment of
stress incontinence. This trial (Blowman et al 1991) was randomized,
and double-blinded. It did not show a statistical difference between
treatment groups.
One trial (Moore et al 1999) compared PFES + PME to sham PFES for
the treatment of post-prostatectomy incontinence. The study did not
show a statistical difference between the groups as measured by a
pad test.
Assessment Conclusions
The assessment made the following conclusions:
1. Evidence is not adequate to determine the efficacy of PFES for
stress incontinence. 2. Evidence does not suggest that PFES is
superior to alternatives for stress incontinence. 3. Evidence for
PFES in urge incontinence, and post-prostatectomy incontinence is
sparse.
These conclusions relate solely to the studies reviewed, which
were well-designed scientific studies with a control group, that
were published in peer-reviewed literature. The assessment did not
state that this therapy was ineffective, but rather remarked that
the data was, in their opinion, inconclusive. Such conclusions may
have been different, if different studies were reviewed. Of note, at
least one other literature review (Berghmans et al is discussed
later in this document) arrived at a different conclusion for women
with stress incontinence.
The assessment did not make any conclusions about the
effectiveness of PFES in those patients who have failed PME.
Additional Articles Not Included as Part of the
Assessment
Twelve additional articles were included for the panel to review.
These studies are part of the "Exclusion articles" which were not
included as part of the assessment review by Blue Cross Blue Shied
TEC, but were reviewed by HCFA staff and sent to the MCAC for
consideration. These studies did not meet the inclusion criteria for
the technology assessment, but were frequently cited by proponents
of PFES as demonstrating effectiveness. Eleven of the twelve were
case series, and one was a questionnaire. See Exclusion Tables
for the specifics of these articles.
8 studies focused on stress incontinence. A variety of outcome
measures were used, with some looking at change in leaks/day or
leaks/week, or a standard pad test. Of the 4 studies that measured
leaks per some defined time frame, as record by a patient diary
(Dumoulin, Miller, Richardson, and Siegel), 2 showed a statistically
significant improvement. Of the 2 studies that measured pad test
weight as an outcome (Dumoulin and Richardson), one showed a
statistically significant improvement. The main concern with these
studies was that most lacked an adequate control group, thus
rendering causality difficult to determine. Uncontrolled case series
may be informative, but are prone to a range of biases, and
generally require confirmation by controlled trials.
Of note, there has been an additional article on urge
incontinence that was not reviewed by the panel. This study appeared
in March 2000 in Urology, prior to the MCAC meeting, but was not
included as part of the committee materials since materials had
already been distributed. 13 This
study enrolled 68 patients (average age, 70 years), 29 men and 39
women with detrusor overactivity. 32 patients in the active group,
and 28 in the sham group completed the study. They received 15
minutes of therapy twice a day for four weeks. Efficacy was
evaluated on the basis of a frequency/volume chart and urodynamic
study. At the end of the study, 7 patients (22%) were cured, and 26
(81%) improved. Thirteen patients remained cured/improved for 8.4
months. Data was statistically significant.
In addition, a systematic review on PFES in the treatment of
incontinence was published in 1998.14 This
was not included as part of the assessment since it was not a
clinical trial. This review included many of the same articles the
BCBS TEC included, although the articles selected were not exactly
the same. Berghmans concluded that there was strong evidence for
efficacy of PFES versus sham, but no clear evidence that PFES was
better than other therapies.
Medicare Coverage Advisory Panel
On April 13, the Medical/Surgical Procedures Panel of the MCAC
met to discuss the topic of PFES for the treatment of
incontinence.15 This
panel included nationally recognized experts in health services
research, a urologist and former president of the American
Urological Association, a urogynecologist, an
obstetrics/gynecologist, and a nurse expert in incontinence. The
panel was sent the technology assessment, the exclusion tables, all
articles, and a catalogue of additional materials received by the
agency for the panel to review. See Catalogue of
Materials (which included such items as the AHCPR Guidelines
on Urinary Incontinence, position statements by specialty
societies, letters by individual physicians and patients).
During the panel meeting, more than fifteen people spoke,
representing a wide range of interests, including professional
societies, physicians and other providers, device companies, and
patients.
During the final panel recommendations period, the panel was
asked to vote on a series of questions. If the panel was to vote
affirmatively on question number 1, they were to proceed to
questions 2, 3, and 4. If the panel voted not to affirm any part of
question 1, then they would not be able to proceed to answering
questions 2, 3, and 4.
1. Is the scientific evidence adequate to draw conclusions about
the effectiveness of:
PFES compared to placebo
PFES compared to pelvic muscle exercises (PME) or alternative
non-surgical techniques
PFES + PME compared to PME alone
in routine clinical use in the Medicare populations for the
following three indications: 1) stress incontinence, 2) urge
incontinence, and 3) post-prostatectomy incontinence?
The following points were to be considered when answering this
question:
Adequacy of study design: Is there evidence that the
studies do not over or underestimate the effect of the intervention?
For example, do the patients who received the intervention differ
systematically from those in the control group in ways that might
affect outcomes? Do the studies permit conclusions about the
health outcome of the technology?
Consistency of results: Are the results of the
studies consistent or are they contradictory? Applicability
to the Medicare population: Are the results of the studies
applicable to the various Medicare
populations? Applicability beyond the research
setting: Are the results likely to apply in routine clinical
settings? 2. If the evidence is adequate to draw conclusions,
what is the size, if any, of the overall health effect of PFES
compared to placebo for the treatment of urinary incontinence?
Please place the size and direction of effectiveness into one of the
following seven categories:
Categories of Effectiveness
Breakthrough technology: The improvement in health
outcomes is so large that the intervention becomes standard of care.
More effective: The new intervention improves health
outcomes by a significant, albeit small, margin as compared with
established services or medical items.
As effective but with advantages: The intervention has
the same effect on health outcomes as established services or
medical items but has some advantages (convenience, rapidity of
effect, fewer side effects, other advantages) that some patients
will prefer.
As effective and with no advantages: The intervention
has the same effect on health outcomes as established alternatives
but with no advantages.
Less effective but with advantages: Although the
intervention is less effective than established alternatives (but
more effective than doing nothing), it has some advantages (such as
convenience, tolerability).
Less effective and with no advantages: The intervention
is less effective than established alternatives (but more effective
than doing nothing) and has no significant advantages.
Not effective: The intervention has no effect or has
deleterious effects on health outcomes when compared with "doing
nothing," (e.g., treatment with placebo or patient management
without the use of a diagnostic test).
3. If the evidence is adequate to draw conclusions, what is the
size, if any, of the overall health effect of PFES compared to
pelvic muscle exercises (PME) or alternative non-surgical techniques
for the treatment of urinary incontinence?
4. If the evidence is adequate to draw conclusions, what is the
size, if any, of the overall health effect of the addition of PFES
to PME compared to PME alone?
On questions #1, the panel voted:
8-1-1 (one negative, one abstention) that there was
insufficient evidence to determine the effectiveness of PFES
compared to placebo for the treatment of stress incontinence
in the Medicare populations. 10-0 that there was insufficient
evidence to determine the effectiveness of PFES compared to
placebo for the treatment of urge incontinence and
post-prostactetomy in the Medicare populations.
10-0 that there was insufficient evidence to determine the
effectiveness of PFES compared to alternative nonsurgical
techniques for the treatment of stress, urge, or
post-prostactectomy incontinence in the Medicare
populations.
10-0 that there was insufficient evidence to determine the
effectiveness of PFES + PME compared to PME alone for the
treatment of stress, urge, or post-prostactectomy incontinence
in the Medicare populations. |
The panel was not asked to address the question of adequacy of
evidence for the effectiveness of PFES in patients who have failed
PME.
Since the panel voted that there was insufficient evidence to
determine the effectiveness of PFES, they did not proceed to
Questions 2, 3, 4. The panel did not vote to say that PFES was
ineffective, but rather voted to say that they could not
definitively conclude, based on the type and presentation of
materials submitted, whether PFES was effective or ineffective. In
addition, several panel members did comment that if they were to
vote specifically on Medicare coverage, they would have voted "yes."
Some panelists noted that if they were to have considered coverage,
they would have placed greater emphasis on the testimony of
professional organizations, clinical experts, and the public.
On June 6, 2000 the MCAC Executive Committee met and ratified the
recommendations of the Medical/Surgical Procedures Panel. This
decision was submitted to HCFA by Dr. Harold Sox on July 25, 2000.
Since the MCAC meetings, HCFA has continued to meet with
physicians and other providers groups, manufacturers, and other
interested parties, providing additional information to help in the
decision-making process.
HCFA's Analysis In addressing the
issue of a national noncoverage policy for the use of PFES in the
treatment of urinary incontinence, the following questions arise:
Is the evidence adequate to determine the effectiveness of PFES
in the treatment of stress, urge, and post-prostatectomy
incontinence?
Is the evidence applicable to the Medicare population?
Are the outcomes clinically and functionally relevant?
Who is the appropriate patient population?
When evaluating the adequacy of the evidence, HCFA has examined
the entire body of clinical and scientific information. This body of
evidence included the AHCPR guideline, the technology assessment,
exclusion tables, recommendations of the MCAC, position statements
of specialty societies, and all other information received by the
agency on this topic. No one piece of information was exclusively
relied upon, but rather the entire breadth of information was
carefully considered.
As mentioned earlier in the text, a guideline on urinary
incontinence was published by the Agency for Health Care Policy and
Research. This guideline was initially written in 1992 with an
update in 1996. The guideline gave a Level B Recommendation to the
following two statements:
Pelvic floor electrical stimulation has been shown to
decrease incontinence in women with SUI. Pelvic floor electrical
stimulation may be useful for urge and mixed incontinence.
Level B: Recommendation is supported by scientific evidence from
properly designed and implemented clinical series that support the
guideline development.16
Again, AHCPR defines strength of evidence as level B if there is
fair research-based evidence to support the recommendation. Although
Level B evidence is slightly better than Level C, it falls short of
an A rating for strength of evidence which would require good
research-based evidence to support the recommendation. Of note, the
guideline specifically states that "further research is needed to
determine the efficacy of PFES used alone, or in combination with
other therapies", reflecting the expert group's recognition of the
limited scientific evidence to support the recommendation. Since the
development of this guideline, at least 10 new studies have been
published, and all were reviewed in the technology assessment. Prior
to that time, only 2 RCTs had been conducted. In addition, the
guideline states that treatment using stimulation requires
monitoring by a health care provider. Nowadays, this device is
primarily used as durable medical equipment, and as such, monitoring
would not be available.
Some persons at the panel meeting and through letters to the
agency, have suggested that since the AHCPR guideline had already
created a guideline, why doesn't HCFA just accept the AHCPR report?
AHCPR guidelines are an important consideration in coverage
determinations; however, they do not guarantee coverage. Rather,
when a guideline exists, it needs to be viewed along other
scientific data. A national coverage decision must not only be based
on evidence to support reasonable clinical benefit but must also be
based on evidence which allows coverage and non-coverage based on
the appropriate selection of modalities, clinical conditions, and
patient characteristics.
In addition, there has been a wealth of new information available
since the guideline. This assessment takes into account all of the
information that AHCPR considered when first issuing the guideline,
and also considers an expanded and more comprehensive body of
literature.
Position statements
Position statements by specialty societies are an important
consideration in determining a national coverage decision. Although
it is not possible to comment on all of these statements, the
following represents a summary of the national organization's
comments on the topic of PFES.
The American College of Obstetricians and
Gynecologists (ACOG)
ACOG recognizes that there is bias and many unanswered questions
regarding the effectiveness of PFES that most likely require better
designed and better executed studies. Nonetheless, their opinion is
that PFES may be efficacious for both stress and urge incontinence
in women in whom traditional treatment approaches have failed. They
do, however, state that it may be no better than other therapies
available, including PME, bladder retraining, and medications for
urge incontinence. ACOG supports the availability of PFES devices
for patients because they are convenient, have no side effects, and
can be used in the convenience of the home avoiding travel to the
physician's office and time away from work.
American Physical Therapy Association
(APTA)
APTA cites several studies which demonstrate that electrical
stimulation can significantly reduce UI, and they strongly support
its use, particularly in patients who are not capable of voluntary
muscle contractions. The APTA feels that PFES is a valuable
treatment that improves efficiency of incontinent care along with
pelvic floor muscle strengthening and behavioral techniques.
American Urologic Association (AUA)
The AUA based its position statement upon a literature review of
the evidentiary support for specific therapies for the treatment of
UI. AUA formed a committee to examine the scientific evidence; this
committee felt that there was not strong consensus about the
effectiveness of vaginal, suprapubic, and/or anal electrical
stimulation for stress, urge, or mixed incontinence. The committee
rated the evidence for isolated electrical stimulation as level 5
(less effective but with advantages) and for some data, level 4 (as
effective but with no advantages). Additionally, they urged further
randomized trials be done, including a comparison of electrical
stimulation to behavioral modification programs within various
populations.
American Urogynecologic Society (AUGS)
AUGS supports the use of PFES therapy as a unique, low risk
therapy which strengthens the body's natural continence mechanisms
by stimulating particular pudendal nerve reflexes. They state that
PFES is nonsurgical, provides a potential cure, and is of relatively
low cost. They recommend initial diagnostic screening to ensure
appropriate patient selection and defined patient selection
criteria, including intact cognitive function, for patients who may
be eligible to receive PFES.
Association for Applied Psychophysiology and
Biofeedback (AAPB)
The AAPB expressed concern that PFES and biofeedback were being
viewed as "equal topics." The association pointed out that there are
fundamental differences between the two, including the mechanisms of
operation, clinician education and training required, and relevant
clinical outcomes. The AAPB state that electrical stimulation
research has a considerably poorer track record than biofeedback,
and that the overwhelming majority of electrical stimulation studies
achieve considerably less symptom reduction than biofeedback.
Society of Urologic Nurses & Associates
(SUNA) and the Wound, Ostomy, and Continence Nurses Society (WOCN)
Continence Coalition
The Continence Coalition, consisting of members of SUNA &
WOCN, supports the use of transvaginal/transrectal electrical
stimulation in selective cases. They testified that based on the
available evidence, maximal electrical stimulation is indicated for
urge UI, frequency and urgency, and for selected patients undergoing
pelvic muscle rehabilitation with biofeedback. The coalition
recommends a cost effective, outcome oriented, step-wise approach
for treating UI, and feels that PFES is effective in reducing UI and
in decreasing associated costs. The coalition recognizes the
potential misuse of these devices, but maintains that these
procedures should be reimbursed when appropriately applied.
National Association for Continence
(NAFC)
NAFC supports the Society of Urologic Nurses & Associates
(SUNA) and the Wound, Ostomy, and Continence Nurses Society (WOCN)
Continence Coalition position statement supporting coverage of PFES.
Furthermore, NAFC supports the development of uniform clinical
criteria which would be consistent with national policy and include
access to clinical services regardless of type of residence, e.g.
home health, nursing, home, assisted living, rehabilitation and
outpatient settings.
Summary of Position Statements In general, the
position statements are supportive of PFES, particularly for those
women who fail PME. At the same time, the majority of societies
acknowledge that it is unclear whether PFES has any added benefit
over PME or other therapies. Almost all association representatives
acknowledge that patients should have a choice of therapeutic
options, especially noninvasive, since the alternative is surgery.
Summary of Evidence To summarize the
literature, a total of 25 studies were evaluated; 13 were randomized
control trials, 12 were case series. Over 80% of the studies
evaluated the effectiveness of PFES in stress incontinence. Of the
13 randomized studies, 5 showed benefit of PFES that was
statistically significant. The others either showed no difference
(or difference was not statistically significant), or greater
benefit of PME over PFES. Of the 12 case series, 9 showed some
benefit. The majority of other studies had no comparison group, so
it is difficult to determine if these patients would have improved
without the use of PFES.
The main outcome measures have been discussed earlier and are
listed in Tables 2-5. When evaluating these outcome measures such as
reduction in leaks/day, it is important to determine whether they
are functionally and clinically relevant. It is also useful to look
at the cure rates, and > 50% improvement rate for this therapy.
Table 6 lists the cure rates for those studies that listed one of
the main outcome measures discussed earlier. Cure was generally
defined as 100% decrease in incontinence (i.e. no incontinent
episodes over a defined time period). 50% improvement was generally
defined as 50% decrease in incontinent episodes, or reduction by 50%
in the weight on a pad test.
Table 6: Cure Rates/Improvement
Rates
Study |
% cure |
> 50% improvement |
Bent |
4 % (2/45) (subjective) |
58% (26/45) (subjective) |
Blowman |
100% (7/7) 52% cure rate in 6 control patients doing
PME |
NR |
Bo |
28% (n=32) PFES 44% (n=29) for PME |
30% PFES group 60% PME |
Caputo |
NR |
76% (58/76) |
Eriksen |
36% 2- yr followup 20/55 |
20% (11/55) |
Hahn |
10% cure PFES 40% cure PME |
50% PFES (n=10) 80% PME (n=10) |
Kralj |
50.5% (56/111) |
23.4% (26/111) |
Laycock |
4.3 % cure PFES (n=23) 17.6% cure PME (n=23) |
|
Luber |
10% cure PFES (n=26) 17% cure sham (n=28) |
|
Moore |
NR |
66% PFES + PME (n=22) 85% PME (n=20) 73% control
(n=21) |
Olah |
11.1% (n=36) PFES 12.2% (n=23) PME |
|
Richardson |
23% (n=13) |
|
Sand |
20% cure PFES 12% cure sham |
46% PFES 18% sham |
Siegel |
28% (19/68) |
69% (46/76) |
Smith |
22%(n=9) PFES 11% (n=9) PME |
44% PFES 33% PME |
Yamanishi |
50% PFES (n=20) 8.3% Sham (n=13) |
80% PFES 18% Sham |
The majority of patients experienced a reduction of a few leak
episodes per day. Although the majority of patients remained
incontinent, a reduction in a few episodes per day can have enormous
functional relevance.
It is important to acknowledge that not all studies are given
equal weight in considering coverage. Rather, there is a hierarchy
of evidence; well-designed are given more consideration than less
rigorous studies. In this particular example, there have been 25
studies with over 700 patients studied. Although there are
conflicting studies on the effectiveness of PFES for stress
incontinence, the better-designed studies appear to show benefit.
The majority of studies also showed statistical significance when
compared to placebo. Studies comparing PFES to alternative therapies
did not show superiority of PFES, with one study showing PME nearly
twice as effective as PFES. However, the studies did show PFES was
effective.
There is also reasonable data on urge incontinence. Both
Yaminishi and Brubaker were well-designed studies that showed
effectiveness. Combined with the Smith study and several studies
from the exclusion tables, one can conclude that PFES works for urge
incontinence as well. In addition, there is biologic plausibility
that if this device works for stress incontinence, it should also
work for urge, albeit at a different frequency. As with the studies
for stress incontinence, we would have preferred to see studies with
a larger number of patients, longer followup and more rigorous data
analysis.
Considering the total body of scientific literature which at
times was conflicting either because of study design or low power to
detect differences, the MCAC panel believed that the empirical
evidence presented was inadequate, to determine conclusively, the
effectiveness as a primary treatment modality. At the same time,
professional societies' consensus statements, expert opinions, and
additional analysis strongly suggests the value of PFES,
particularly for those patients who have undergone and failed a
trial of PME. Therefore, we will cover this therapy for those
patients who have undergone and failed PME, and noncover PFES as a
primary (i.e. initial) treatment modality.
We encourage physicians, patients, manufacturers, and other
interested parties to review the recent National Coverage
Determination on Clinical Trials. This policy details the
implementation of President Clinton's Executive Memorandum on
covering routine patient care costs for Medicare patients enrolled
in clinical trials.17 Such
provision of Medicare funding is designed to help the Medicare
program answer questions about the effectiveness of therapies on
Medicare patients. It would be particularly interesting to see a
clinical trial comparing the multiple behavioral therapies against
each other, as well as to surgery. We would be interested in looking
at this therapy again within the next three years, with the hope of
possibly expanding coverage for patients as an initial therapy based
on high-quality, rigorously designed studies.
Summary Urinary incontinence remains a significant
medical problem for a large number of beneficiaries. After reviewing
the entire body of scientific and clinical literature, the position
statement by specialty societies, discussion at the MCAC, and
numerous letters from individual patients and physicians, we can
conclude that PFES is effective for those patients with stress
and/or urge incontinence. Such patients must undergo a trial of
pelvic muscle exercise training prior to use of the device.18
Patients with post-prostactectomy incontinence may receive this
therapy as long as they have undergone and failed a trial of PME,
and have their condition diagnosed as stress/urge. We encourage
additional clinical trials to determine the exact role of this
therapy, especially in relation to other incontinence treatments.
Amend Coverage Issues Manual 65-9C to state:
Electronic Stimulators--Pelvic floor electrical stimulators,
inserted into the vaginal canal or rectum, are covered as reasonable
and necessary as a treatment for stress and/or urge urinary
incontinence. The patient must have first undergone and failed a
documented trial of pelvic muscle exercise training. These devices
are not covered as initial treatment modality for stress or urge
incontinence. Implanted stimulators remain noncovered.
1 Urinary incontinence is a leading cause of admission
to nursing homes.
2 In a recent study, although 75% of incontinent
men expressed interest in being evaluated and treated, only 32% had
brought up the problem with their primary care provider. Smoger SH,
et al. Annals of Internal Medicine 2000;132:547-551
3 Approximately 8% of patients who undergo
transurethral resection of the prostate suffer from some degree of
post-prostactectomy incontinence.
4 The classic mnemonic is DIAPPERS: delirium,
infection, atrophic urethritis, pharmacologics, psychologic,
endocrine, restricted mobility, stool impaction. See Resnick NM,
Yalla SV. Management of urinary incontinence in the elderly. New
England Journal of Medicine 1985;313:800-805.
5 Decision
Memorandum on Biofeedback for Treatment of Urinary Incontinence
(CAG-00020) can be found at http://www.hcfa.gov/quality/8b.htm
6 Current PFES devices have 510 (k) clearance from
the Food and Drug Administration (FDA)
7 Although PFES is primarily used as Durable
Medical Equipment, this document addresses the use of PFES in any
setting.
8 Urinary Incontinence Guideline Panel. Urinary
incontinence in adults: clinical practice guideline. Rockville, MD:
Agency for Health Care Policy and Research, Public Health Service,
US Department of Health and Human Services, 1992.
9 The five criteria are: (A) The technology must
have final approval from the appropriate government regulatory
bodies. (B) The scientific evidence must permit conclusion
concerning the effect of the technology on health outcomes. (C) The
technology must improve the net health outcome. (D) The technology
must be as beneficial as any established alternative. (E) The
improvement must be attainable outside the investigational settings
10 Empi, St. Paul Minnesota is a major
manufacturer of the pelvic floor electrical stimulators.
11 MEDTAP International, Inc is a technology
assessment firm located in Bethesda, MD.
12 AHRQ was formerly AHCPR. There are 12 EPC's.
13 Yamanishi T, Yasuda K, et al. Randomized,
double-blind study of electrical stimulation for urinary
incontinence due to detrusor overactivity Urology 55:353-357, 2000.
14 Berghmans LC, Hendriks HJ, Bo K, et al.
Conservative treatment of stress urinary incontinence in women: a
systematic review of randomized clinical trials. British Journal of
Urology, 82:181-191, 1998.
15 On April 12, the same panel met to discuss the
effectiveness of biofeedback for the treatment of incontinence.
16 Level A: Recommendation is supported by
scientific evidence from properly designed and implemented
controlled trials providing statistical results that consistently
support the guideline.
Level C: Recommendation is supported by expert opinion.
The ratings represent the strength of the supporting research
evidence, not the strength of the recommendation itself.
17 This memo can be
found at http:/www.hcfa.gov/quality/8d.htm
18 Adequate trial of PME will be defined in an
upcoming coverage instruction to Medicare contractors.
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