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					                                      Statement on
                                      Biofeedback

                          Testimony of Alfred Bent MD
       On behalf of the American College of Obstetricians and Gynecologists
             Before the Medical and Surgical Procedures Panel of the
                      Medicare Coverage Advisory Committee
                                April 12-13, 2000

Good morning. I am Alfred Bent, MD, a practicing obstetrician-gynecologist, director of
residency training program in obstetrics and gynecology at the Greater Baltimore
Medical Center, Baltimore, Maryland, and program director for fellowship training in
urogynecology/reconstructive pelvic surgery at the Greater Baltimore Medical
Center/University of Maryland Program. I am a program director of postgraduate courses
on the management of urinary incontinence for the American College of Obstetricians
and Gynecologists (ACOG). On behalf of ACOG, an organization representing more than
39,000 physicians dedicated to women's health, I appreciate the opportunity to address
the Medical and Surgical Procedures Panel of the Medicare Coverage Advisory
Committee on the subject of coverage for biofeedback.

The summary of technology assessments provided by Dr. Frank Lefevre, Director of
Special Assessments, Technology Evaluation Center, Blue Cross and Blue Shield
Association was received by myself last week, along with the directive from HCFA that
we minimize background on incontinence and spend more time with the substance of the
treatment modalities. It would appear that the assessment provided by the above
summary has concluded that biofeedback does not provide additional benefit to pelvic
muscle exercises alone.

Both the AHCPR (Agency for Health Care Policy and Research) guidelines (1996) and
the 1st International Consultation on Incontinence (co-sponsored by WHO in Monaco
1998) have recommended behavioral techniques as first line management for stress, urge,
and mixed urinary incontinence. The Monaco conference recommended a protocol for
pelvic muscle exercises consisting of 3 sets of 8 to 12 slow velocity maximal contractions
sustained for 6 to 8 seconds each, performed 3 to 4 times per week, and continued 15 to
20 weeks. A person with specialist training should assess the patient to be sure a correct
voluntary pelvic floor contraction is being performed. The AHCPR guidelines also stated
that the intensity of the exercise program influenced functional and physiological
outcomes, and multimeasurement biofeedback protocols seemed to yield the greatest and
most consistent reductions in urinary incontinence. The Monaco conference consensus
was that biofeedback or intravaginal resistance devices made no apparent difference,
although clinicians may find occasions when these would be useful adjuncts.

Weatherall (1999) performed a quantitative meta-analysis of five trials comparing pelvic
floor exercises (PFE) with biofeedback to PFE alone, and concluded that the odds ratio
for biofeedback combined with PFE, compared with PFE alone was 2.1. Berghmans
(1998) also analyzed the same five studies and concluded that there was no strong
evidence to support that the addition of biofeedback to PFE added any additional benefit
to PFE alone. One of the analyzed studies, Glavind (1996) showed a significant
improvement in the biofeedback group, while Berghmans (1996) in his own study on the
problem found no difference in treatment with PFE and biofeedback compared to PFE
alone. It is interesting that the analysis provided from Blue Cross/Blue Shield decided to
use the conclusions of the Berghmans study and consider the other studies to be flawed.
Berghmans had already shown no additional benefit to biofeedback in the 1996 study,
and it is hardly surprising than in the 1998 Berghmans study, that he should again find no
improvement with additional biofeedback. One of the co-authors on the 1998 Berghmans
study is Professor Kari Bo, who is well published in PFE for stress incontinence, but who
many times has refuted the use of any biofeedback modalities other than one on one
instruction or group instruction. A more recent publication by Berghmans (2000) is
another systematic review of randomized clinical trials, and the conclusion in this study
was that there were too few studies to evaluate the effectiveness of PFE with or without
biofeedback. The old studies by Burgio (1986) and Shepherd (1983) were also excluded
from consideration. The bias in selection of studies to believe is obviously biased to
exclude those studies which show benefit.

There was only one study on urge incontinence (Burton 1988) and it showed no benefit to
adding biofeedback to PFE. However the report to HCFA did not mention that there was
a strong selection bias in this study, and that the AHCPR noted this study as having
groups that differed in severity prior to treatment.

Hirsch (1999) studied 33 patients treated with EMG-controlled biofeedback home
training for 6 months and showed improvement in 85%, although urodynamic parameters
did not change. The number of patients asked to enroll for treatment was 67. This last
reference reflects the difficulty in providing conservative therapy to the population that is
most deserving: there is difficulty enrolling patients, and there is a high drop-out. The
real-world practice is a far cry from randomized controls, or blinded study protocols
where highly trained and motivated individuals are instructing and interacting with
patients. The patient most often is to be managed by a clinician with minimal back-up
nursing support services. Someone has to show the patient how to do the exercises, and
must provide a positive reinforcement by reaffirming progress. This some one is not the
physician, and usually it is left to allied health personnel. Study personnel have protocols
to follow, and have assigned time to spend with patients, and a detailed script on what to
say and how to say it. Unless we can provide trained personnel to handle patients, it will
be difficult to provide any more than hand-out instructions on PFE.

One of the great difficulties in hiring personnel to look after incontinence services is the
lack of reimbursement provided by many carriers for these types of services. The greatest
and most consistent reduction in incontinent episodes is provided by multimeasurement
biofeedback protocols (AHCPR 1996). The correct amount of intervention for maximum
benefit is not known. The patient must be seen at frequent enough intervals to provide
appropriate reinforcement. Where benefit from PFE may extend 12 to 20 weeks (Monaco
1998), there should be expected to be an appropriate learning time of 6 weekly visits with
biofeedback, and then continued PFE at home while being monitored with office visits at
4-week intervals, including two more biofeedback sessions. The normal physician office
cannot provide this service. Patients can be markedly improved or even cured of stress
incontinence, but need a place to have therapy delivered in a comprehensive fashion. The
teaching of correct methods of pelvic floor contractions requires advance training,
although it can be performed by a nurse under physician supervision.


References

Fantl JA, Newman DK, Colling J, et al. Urinary incontinence in adults: acute and chronic
management. Clinical practice guideline #2, 1996 update. Rockville, Maryland: US
Department of Health and Human Services Public Health Service, Agency for Health
Care Policy and Research, AHCPR publication no. 96-0682, March 1996

Abrams A, Khour S, Wein A. Incontinence. Health Publication Ltd, United Kingdom,
1999

Weatherall M. Biofeedback or pelvic floor muscle exercises for genuine stress
incontinence: a meta-analysis of trials identified in a systematic review. BJU
International. 1999; 89: 1015-1016

Berghmans LCM, Hendriks HJM, Bo K. Conservative treatment of stress urinary
incontinence in women: a systematic review of randomized clinical trials. Br J Urol 1998;
82: 181-191

Glavind K, Nohr SB, Walter S. Biofeedback and physiotherapy versus physiotherapy
alone in the treatment of genuine stress urinary incontinence. Int Urogynecol 1996; 7:
339-343

Berghmans LCM, Frederiks CMA, de Bie RA. Efficacy of biofeedback, when included
with pelvic floor muscle exercise treatment, for genuine stress incontinence. Neurourol
Urodynam 1996; 15: 37-52

Berghmans LCM, Hendriks HJ, De Bie RA, VanWaalwijk van Doorn ES, Bo K, van
Kerrebroeck PE. Conservative treatment of urge urinary incontinence in women: a
systematic review of randomized clinical trials. BJU International 2000; 85: 254-263.

Burgio KL, Robinson JC, Engel BT. The role of biofeedback in Kegel exercise training
for stress urinary incontinence. Am J Obstet Gynecol 1986; 154: 58-64

Shepherd AM, Montgomery E, Anderson RS. Treatment of genuine stress incontinence
with a new perineometer. Physiotherapy 1983; 69: 113

Burton JR, Pearce KL, Burgio KL, et al. Behavioral training for urinary incontinence in
elderly ambulatory patients. J Am Geriatr Soc 1988; 36: 693-698
Hirsch A, Weirauch G, Steimer B et al. Treatment of female urinary incontinence with
EMG-controlled biofeedback home training. Int Urogynecol J 1999; 10: 7-10

				
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