Barbara Woolner RN, CCN, CRNA, BCIA

EXPERT SERIES

When did you first become acquainted with biofeedback?

Woolner

Right at its inception in the early 70s, I attended a continuing education workshop for nurses. The idea lay dormant for a number of years until I retired from nurse anesthesia. My introduction to the field of biofeedback was general and not until I was certified did I really become interested in using it for incontinence. When I did pursue this very narrow field there was very little being done clinically, most of the early work on biofeedback and incontinence was done by researchers at the National Institute on Aging. So, at the time, I had no alternative but to be self-taught since training programs for this specific application were non-existent. After trying out the technique and having some amazingly successful outcomes. I began providing the service to a variety of physicians including urologists, colon rectal surgeons, uro-gynecologists.

I was fortunate to become associated with geriatrician Dr. Joseph Ouslander at the Jewish Home for the Aging of Greater Los Angeles. I was able to initiate a program for the independently living residents of the institution. In 1992 I presented the positive outcome of my work with this population before the International Continence Society in a paper called "Experience With Biofeedback in the Old Old".

EXPERT SERIES

Can you tell us about your work with biofeedback in the treatment of incontinence?

Woolner

I use surface electromyography (sEMG biofeedback) to treat both stress and urge incontinence as well as faecal incontinence. And of course, all the related irritative symptoms of the pelvic muscles and lower urinary tract such as urinary urgency and frequent voiding and some pain syndromes respond to this treatment as well.

I especially enjoy working with patients exhibiting symptoms of urge incontinence. This particular type of incontinence occurs when patients have sudden, strong impulses to urinate and have difficulty reaching the bathroom in time. So often one is able to help the patient gain improved control of the voluntary muscles of the pelvic floor and use those muscles to mediate an inhibitory response in the smooth muscle oaf the bladder. It is quite rewarding to see positive results in often very short periods of time.

Most of the current literature is focused on the use of this biofeedback enhanced pelvic muscle training in the treatment of stress incontinence, urinary leakage with increases in intra-abdominal pressure. This is certainly a good application and it works. I have found, however, that it often takes longer to see improvement in this population of patients since the actual strength, of bulking, of the muscle is so important. It can take up to 3-6 months of a good exercise program for muscles to reach their maximum performance levels. Patients with mild to moderate stress incontinence do quite well and one of the reasons not only to strengthen their pelvic floor but to use it at the appropriate time.

Patients with severe anatomical defects of the pelvic support system, however, are not the most appropriate candidates for biofeedback.

EXPERT SERIES

Can you describe your biofeedback protocol.

Woolner

I schedule patients initially for two 45 minute biofeedback visits, one week apart. I do this to make sure patients understand what they are to be doing and can do it correctly. On the second visit, the patient and I decide together when they need to be seen again and this is very dependent on their ability to follow through with their home exercise program as well as the other behavioral interventions that are prescribed.

All the visits include an assessment of pelvic muscle function which is performed in a standard fashion inasmuch as possible. This is about as close to "a protocol" as I come. All of the exercise instruction that I give to patients is specific to their ability to perform and varies considerably among individual patients.

Once the assessment is completed other business is taken care of such as fluid management (vital to good patient treatment), dietary concerns, evaluation of current symptoms, absorbent product use, and skin integrity to name a few.

Finally, biofeedback muscle re-education and training takes place in the session and the patient is guided into performing more and more skilled motor function.

Home work assignments are based on the muscle assessment as well as the learning that takes place within the visit. Most of the current literature recommends between 30-80 pelvic muscle contractions daily. My bias is toward the low end and my patients are having wonderful success.

EXPERT SERIES

We understand that you have been instrumental in the design of a vaginal and rectal sensor that is being marketed by Thought

Technology. Can you tell us about the process and the final design.

Woolner

I looked at the design of a new sensor from an ergonomics perspective. The major problem with the sensors on the market is that they are uncomfortable. It's been my experience that discomfort can lead to non-compliance and less positive outcomes. The problem was more pronounced with peri-and post-menopausal women because of changes in the uro-genital area. Most of the existing sensors were uncomfortable to sit on and would fall out when they stood up. In fact they could only be used in the prone position which limited the training opportunities.

I wanted a sensor that fit like an 'old shoe' and would not be noticeable. It was particularly important that the sensor function when the patient was ambulatory and in that way simulate normal activities when incontinent episodes occur.

I sketched out the design of a vaginal and a rectal sensor on a napkin while having dinner with Dr. Myers from Thought Technology. Dr. Myers took that original sketch and wiht their design and engineering team developed the final sensors. The final designs were very close to my original concept. We tested the vaginal sensor with 400 women, and 100 men with the rectal sensor. In certain cases with older

women, the anal sensor was an effective alternative. Our clinical tests revealed that our sensor was not only more comfortable, extended the number of positions that the sensor could be used, but that it was far less intimidating than the other sensors. All these factors contribute to more successful outcomes.

EXPERT SERIES

In addition to your contribution in the design of the vaginal and rectal sensors, you have also provided input on the software for Thought Technology's incontinence system.

Woolner

I have always been interested in the part instrumentation plays in providing the best feedback to patients. In my view, there were two critical areas that I felt were being overlooked by some of the instruments being used for continence. First, the pelvic floor muscles are often damaged or quite weak with corresponding signal frequencies falling into ranges below 80HZ. I suggested the bandpass filters be increased to encompass those frequencies. Instruments whose bandpass filters are in the 100-400HZ frequency range can miss subtle but critical muscle activity.

My second concern, though not affecting patient outcomes, was how the signals were being measured. Most instruments today have at least one protocol that calls for a patient to "work" and "rest" the muscles over a series of contractions. Quite often the signal amplitude is averaged over both the work and rest periods which provides little in the way of quantitative information. My suggestion related to having the software average work and rest periods separately, thus, providing the clinician with a more realistic measure of improvement.

There were other areas of instrument design that had to do with ease of operation for novice clinicians that make the instrument user friendly. The note page was originally set up to be Medicare proof by using subjective and objective data that could be entered during the visit. I do believe that area of the software and objective data that could be entered during the visit. I do believe that area of the software has been improved upon and now allows much greater freedom for the clinician to choose what they will report upon.

EXPERT SERIES

As a clinician who has been at the forefront of this modality in the treatment of incontinence, what obstacles do you see to its greater acceptance.

Woolner

In the past few years I have seen a significant improvement in the level of awareness for both incontinence and biofeedback, however I believe there still needs to be better education for all stakeholders: patients, health care professionalss and third-party insurers.