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Electromyographic Assessment of Biofeedback Training for Fecal Incontinence and Chronic Constipation
Citation - 1996 Research Paper Presented at 95th Annual Meeting of the American Sociefy of Colon and Rectal
Surgeons, N.J. Espat MD, et al.
Methodology (U.S.) - 55 patients who underwent computerized EMG based biofeedback treatment between July
1993 and July 1995, Patients were divided into two groups, (1) 30 chronic constipation, 24 females and 6 males,
and (2) 25 fecal incontinent patients, 13 females and 12 males.
Results - Statistically significant sphincter endurance improves following BFT (biofeedback training) in both
chronic constipation and fecal incontinent patients. For the chronic constipation group, sphincter endurance as
measured by sustained contractions increased 69% from a mean of 6.4 to 10.8 seconds. For the fecal incontinent
group, sustained contractions increased 75% from a mean of 7.5 to 13.1 seconds.
Behavior vs. Drug Treatment for Urge Urinary Incontinence in Older Women
Citation - The Journal of the American Medical Association, December 16, 1998, Vol. 280, No. 23
Methodology (U.S.) - 197 women aged 55 to 92 years with urge UI or mixed UI with urge as the predominant
pattern. Subjects had to have urodynamic evidence of bladder dysfunction, be ambulatory and not have dementia.
Subjects were randomized into three groups, biofeedback-assisted behavior 4 sessions for 8 weeks, drug treatment
(oxybutynin chloride 2.5 mg daily to 5.0 mg 3 times daily) and a placebo group.
Results - For all 3 groups, reduction of UI was most pronounced early in treatment and progressed more gradually
thereafter. Behavior treatment, which yielded a mean 80.7% reduction of UI episodes was significantly more
effective than drug treatment, mean 68.5%, and both were more effective than the placebo group, mean 39.4%.
Patient-perceived improvement was greatest for behavior treatment, 74.1% indicating "much better" after
treatments vs. 50.9% for the drug group and 26.9% for the placebo group.
Comparative Efficacy of Behavioral Interventions in the Management of Female Urinary Incontinence
Citation - General Obstetrics and Gynecology 1998; 179:999-1007
Methodology (U.S.) - A randomized l2-week clinical trial with 3 treatment goups conducted in gynecologic
practices at 2 university medical centers. The sample size featured 204 women (mean age 61 years and 8 mean
number of urinary incontinent years) diagnosed with genuine stress UI and/or detrusor instability. The first
treatment group utilized bladder training, the second pelvic muscle exercises with biofeedback-assisted instruction
and the final group a combined intervention.
Results - Immediately after the clinical trial, cure rates were significantly higher in the combination group (31%)
than the bladder training (18%) and the pelvic-muscle group (13%). Improvement rates were also higher in the
combination group, 70% of the participants had a 50% or greater reduction in incontinent episodes in contrast to
56% for the pelvic muscle biofeedback assisted and 5l% bladder training groups. After 3 months of treatment no
differences were found among the groups in incontinent episodes. Cure rates increased 27% in the combination,
20% in the pelvic muscle and 16% in the bladder training groups.
Effectiveness of Behavioral Therapy to Treat Incontinence in Homebound Older Adults
Citation - Journal of the American Geriatrics Society 47:309-318, 1999
Methodology (U.S.) - 105 subjects were randomized into two goups. The first group's intervention consisted of
weekly in-home visits by a nurse practitioner to perform biofeedback-assisted pelvic muscle training for a period of
8 weeks. The second, a control group, received social interaction by a visiting nurse every 1 to 2 weeks.
Participants for both groups had to be at least 60 years of age, cognitively intact, meet Healthcare Financing
Administration criteria for being homebound, experience at least two urinary accidents per week, and report UI for
at least 3 months. After completion of the 8,week social interaction/observation period, control subjects crossed
over to the treatment protocol.
Results - Including crossover participants, 85 out of 105, or 81% had complete post-treatment bladder diary data
(fully completed the treatment protocol). Among this group, the mean number of daily accidents decreased from
4.0 to 1.7, with a median 73.9% reduction in incontinent episodes. Of this group, 15.3% (13 in number) became
totally continent by the end of treatment.
Maximal Electrical Stimulation in Children with Unstable Bladder and Nocturnal Bnuresis and/or Daytime Incontinence: A Controlled Study
Citation - Neurourology and Urodynamics 15:133-142 (1996)
Methodology (Slovenia) - 73 girls, aged 5 to 17 years, mean age 9.7 years with cystometrically proven idiopathic
detrusor instability and nocturnal enuresis and/or daytime incontinence were treated by maximal electrical
stimulation (MES) 20 minutes daily for 1 to 2 months. Twenty-one girls, age 6 to 14 years, mean age 9.3 years,
with unstable bladder and micturition problems using only the anal plug without a battery for 1 month served as the
control group. Of the total 91 girls across both groups , 15% had received anticholinergic therapy with transitory or
no effect. Anticholinergic therapy was discontinued 1 month before the study. All parents of the studied children
gave informed consent.
Results - In the MES group , 23 or 3l% of girls were cured, 44% improved by at least 50% and 25% noticed no
evidence of change. In the control group none of the 21 girls were cure, l4% were improved and 86% noticed no
change. One month after the completion of anal MES, the median number of monthly nocturnal enuretic episodes
fell from 14 to 6.5 and the median number of daytime incontinence episodes diminished from 3 to 0. One month
after the termination of anal MES, the stimulated girls demonstrated significantly changed cystometrical parameters.
In the control group no significant cystometric changes were found, An average of 14.5 months after the first
recording of enuretic episodes, enuresis recurred in 20% of the girls.
A Predictive Score Index for the Outcome of Associated Biofeedback and Vaginal Electrical Stimulation in the Treatment of Female Incontinence
Citation - The Journal of Urology, Vol. 153, 1461-1466, May 1995
Methodology (U.S.) - 64 females presenting various degrees of urinary incontinence underwent treatment twice a
week for 6 weeks consisting of office-based biofeedback with alternate electrical stimulation through a vaginal
probe for a duration of 20 minutes. Patient age varied from 34 to 88. Of the women, 12 were nulliparous, 44 had 1
to 3 deliveries and 7 had 4 to 5 children.
Results - The overall results were classified into 3 groups, failure, 36%, sufficient recovery to allow for a normal
social life with no need for other forms of treatment,3l% and complete recovery 33%. OLS regression was used to
measure the effect to treatment outcome for 13 independent clinical parameters. Each of the 13 factors individually
did not allow for outcome prediction. However by analyzing a group of factors it was possible to generate a reliable
method of predicting success or failure of muscular reeducation. The most important factor was compliance. Other
factors, such as age, estrogen, presence or absence of detrusor instability, degree of initial intravaginal pressure,
degree of urethral hypermobility and presence of sphincter deficiency are significantly involved in the prognosis.
Obesity, type of incontinence and initial digital testing all appeared to have no impact on the treatment outcome.
Intravaginal Maximal Electrical Stimulation in the Treatment of Urinary Incontinence
Citation - The Journal of Reproductive Medicine, Vol. 38 No. 9, September 1993
Methodology (U.S.) - 76 females with urinary incontinence completed 6 weekly sessions of intermittent
intravaginal maximal electrical stimulation befween January 1991 and February 1992. Excluded from the study
were females with genital prolapse only if they were unable to retain the vaginal stimulation probe in the supine
position. Prior to the treatment protocol, all patients were evaluated with a standing stress test, cystourethroscopy
and multi-channel urodynamics, including urethral closure pressure profiles, pressure transmission ratios and
cystometry. All patients, regardless of their incontinence diagnosis, received the same electrical stimulation
protocol. 25% of the patients had genuine stress urinary incontinence (GSUI), 40% detrusor instability (DI) and
35% mixed (stress and urge) incontinence (MI).
Results - were measured subjectively via respondent feedback and objectively. Objective improvement
was defined as a reduction in urinary incontinence episodes by 50% and reduction in voiding frequency by 50%, or
l0 or fewer voids per 24 hours. Objectively, the overall improvement rate was 76%. EighIy-nine percent of the
patients with GSUI, 73% with DI and 70% with MI met the criteria for objective improvement. Fifty-eight percent
of the patients who were potential surgical candidates (GSUI and MI) did not wish to pursue surgical correction of
their incontinence. Forty-six percent of the patients expressed a desire for fuither treatment for their incontinence.
Biofeedback in Colorectal Practice: A Multi-Center, Statewide, 3-Year Experience
Citation - From the 95th Annual Meeting of the American Society of Colon and Rectal Surgeons, A. Ferrara MD,
J.R. Levy MD, S.W. Larach, MD, M Kroecker, MD and P.R. Williamson, MD, Colon and Rectal Clinic of Orlando.
Methodology (U.S.) - Between October 1992 and October 1995, 188 patients completed a biofeedback treatment
pro$am in one of 5 coordinated centers within a 200 mile radius. A unified eommon database was established and
continuously updated. A colorectal surgeon served as the statewide director. Each local team included a medical
director, specially trained biofeedback therapist, dietitian and a nurse data coordinator. EMG biofeedback sessions
were given weekly and a home trainer program was established.
Results - 84% of constipated and 85% of fecal incontinent patients had significant improvement with biofeedback
treatment. Constipated patients increased the mean number of weekly-unassisted bowel movements from .8 to 6.5.
Fecal incontinent patients decreased the mean number of gross incontinence episodes from 11.8 to 2.
Maximal External Electrical Stimulation for Treatment of Neurogenic and Non-Neurogenic Urgency and/or Urge Incontinence
Citation - Neurourology and lJrodynamics, 15:187-194, 1996
Methodology (Germany) - Maximal electrical stimulation (MES) by intravaginal or intra-anal electrodes was used
for treatment of 75 patients with complaints of urgency and/or urge incontinence. The patient group consisted of 51
women and 24 men. A neurogenic background was present in 30 of the women who had a diagnosis of multiple
sclerosis. In the other 45 patients the pathology was idiopathic in nature. MES treatment consisted of 15 sessions
across a 3-week period with each session lasting 20 minutes.
Results - 59% of the patients had urodynamic and subjective improvement and an additional 40% only subjective
improvement. One patient found no benefit. The effect lasted for at least 2 years in 64% of the idiopathic goup.
In the multiple sclerosis group, relapse occurred within about two months. Re-treatment was again immediately
successful. The multiple sclerosis patients do need daily home stimulation treatments.
Efficacy of Biofeedback, When Included With Pelvic Floor Muscle Exercise Treatment, for Genuine Stress Incontinence
Citation - Neurourology and Urodynamics, 15:37-52,7996
Methodology (Netherlands) - 40 women, age range 18 - 70 years with grade 1 (mild) and grade 2 (moderate)
stress urinary incontinence, were referred by a general practitioner or urologist and randomized into an exercise and
biofeedback group (BF), or treated exclusively with pelvic floor muscle training (PFMT). After a diagnostic phase
of 1 week, every patient received a total of 12 treatment sessions, 3 times weekly for 4 weeks. The office-based
treatments lasted approximately 25 to 35 minutes.
Results - Before the first treatment, the mean quantity of involuntary urine loss per 48 hours was 29.0 grams for the
PFMT group and 26.6 for the BF group. At the start of week 3, the means dropped to 17.4 grams PFMT and I2.4
grams BF. Afterthe lasttreatment, the means were 12.5 grams PFMT and l2.2 grams BF. The results of the 48-
hour PAD (amount of involuntary urine loss) test for both the PFMT and BF showed significant improvement after
all 12 treatments. Although the difference in improvement at the conclusion of the study between both groups was
not statistically significant, the BF group achieved significant improvement after 6 treatments.
Transvaginal Electrical Stimulation for Female Urinary Incontinence
Citation - American Journal of Obstetrics and Gynecology, September, 1997
Methodology (U.S.) - 121 women with symptoms and urodynamic evidence of genuine stress incontinence,
detrusor over-activity, or both, participated in the study across 4 medical centers in Baltimore, Indianapolis,
Chicago and Portland. Sixty-one participants were randomized to receive treatment via a self-administered in-home
electrical stimulation unit. The balance received a sham device, externally identical to the treatment device,
including LED displays, except that a wire in the unit had been disconnected and no energy supplied for electrical
stimulation. After a 1-week baseline assessment, treatment began for 20 minutes twice daily. Study nurses provided
telephone contacts with patients at the second and sixth weeks of treatment. An office visit at 4 weeks was used to
assess compliance by reading an internal compliance meter of the machine. Treatment continued for 8 weeks.
Results - Subject compliance was acceptable for both groups with a mean compliance of 87% and 81% at 4 and 8
weeks of treatment respectively. There were no statistically significant differences between groups relative to
change in the rate of genuine stress incontinence, number of daily accidents and daily urination frequency. Unlike
the control group, a highly statistically significant drop (50%) did occur within the treatment group in the number of
patients with urodynamic diagnosis of detrusor over-activity. Cure of detrusor instability occurred equally in
women with or without co-existing genuine stress incontinence.
Intravaginal Stimulation Randomized Trial
Citation - The Urology Journal Vol. 155, 127 - 130, Jantary 1996
Methodology (U.S.) - 56 women 24 to 82 years old with grade 2 (moderate) genuine stress urinary incontinence
(GSUD or detrusor instability were enrolled in a randomized trial from October 1992 to January 1994. Of the 56,
18 had GSUI and 38 had detrusor instability. Of the 18 with GSUI,9 were treated with Kegel exercises and 9
received graduated intravaginal electrical stimulation. Of the 38 patients with detrusor instability, 20 received
propantheline bromide (anticholinergic agent) and 18 graduated intravaginal electrical stimulation. The therapy
period lasted 4 months.
Results - Objective improvement was 4 out of 9 in the GSUI Kegel group including 1 who was considered cured.
Five had no significant improvement. Of the 9 in the GSUI graduated intravaginal electrical stimulation group 4
improved, another 2 were cured and 3 showed no significant improvement. Of the anticholinergic patients with
detrusor instability, 50% improved, none were cured and 50% failed - no improvement or escalating side effects
requiring cessation of drug use. Of the detrusor instability group that received graduated intravaginal electrical
stimulation, 72% improved, including 4 cures. Resultsbetween the detrusor instability groups, anticholinergic
versus graduated intravaginal electrical stimulation, were not statistically significant.
Single Blind, Randomized Controlled Trial of Pelvic Floor Exercises, Electrical Stimulation, Vaginal Cones, and no Treatment in Management of Genuine Stress Incontinence in Women
Citation - British Medical Journal, Volume 318, February 20, 1999
Methodology (Norway) - Five centers in southeast Norway participated in the study. Participants included 107
women with clinically and urodynamically proven genuine stress urinary incontinence, mean age 49.5, and mean
duration of symptoms 10.8 years. Patients were randomized into 4 treatment groups. The first group, n=25,
consisted of pelvic floor exercises, 8-12 contractions 3 times daily and exercise groups with skilled physical
therapists once a week. The second group, n:25, used home-based vaginal intermittent stimulation 30 minutes a
day. The third group, n:27, used vaginal cones 20 minutes per day. The fourth treatment group, the control group,
n:30, used a continence guard. Physicians evaluating treatment effect were unaware of the treatment modality.
Results - Mean treatment adherence was 93% for pelvic floor muscle training, 75% for electrical stimulation, and
78Yo for vaginal cones. There was no significant change in pelvic floor muscle strength for the control group, but
significant improvement was seen after treatment in the other groups, although a statistically significant
improvement between the control and other groups was only present for the pelvic floor exercise group. There was
no difference in changes of strength between the electrical stimulation and the vaginal cone groups. There was
significant change between the pelvic floor exercise group and the control group according to the:
- PAD test - amount of involuntary leakage
- 3-day leakage episode test
- Leakage index - leakage while sneezing, coughing, laughing, walking downhill, running, jumping and lifting
- Social activity index - perceived problems in participating in nine social activities
The difference between electrical stimulation and the control group was significant for the 3-day episode leakage test, leakage index and social activity index. The difference between vaginal cones and the control was significant for the leakage index and the social activity index. There was no significant difference between the electrical stimulation and the vaginal cones group in any outcome variable.
Pelvic Floor Electrical Stimulation in the Treatment of Genuine Stress Incontinence: A Multi-Center Placebo-Controlled Trial
Citation - American Journal of Obstetrics and Gynecology, July, 1995
Methodology (U.S.) - 52 women, mean age 53.2 years, with urodynamically proven genuine stress incontinence, in
the absence of detrusor instability on standing cystometry were included in this 6-site clinical across the U.S.
Patients were randomized within blocks at a 2:1 rate in favor of active over placebo devices. The placebo device
was limited to a maximum 1 milliamp of current. To facilitate the blind component, patients were told they might
not feel sensation when using the device. Treatment time and the stimulation-to-rest ratio (duty cycle) progressed
through the study to allow for improvement in the resistance to fatigue of skeletal muscle as it is exercised over
time. For the first 2 weeks, patients used a S-seconds on and 1O-seconds off duty cycle for l5 minutes, twice daily,
progressing to 5-seconds on and 5-seconds off for 3 0 minutes for the final 6 weeks of the I 2-week regimen.
Results - Patients in both study groups had comparable gynecologic, cardiovascular, endocrine, pulmonary,
gastroenterologic, neurologic, renal and psychiatric histories. Of the 52 women initially enrolled, 85% completed
the full 12 weeks of the study period. Seven in the active and 1 in the placebo device group dropped out. Of those
that dropped out, 2 complained of persistent vaginal irritation after 6 and 7 weeks of device use. After 12 weeks of
device use, the group using the active stimulator showed significant changes from baseline in five outcome
parameters, including number of leakage episodes, reduction in lost urine during PAD test and paravaginal muscle
strength, whereas the group using the placebo stimulator did not show any significant changes.
Efficacy of Functional Electrical Stimulation in Treating Genuine Stress Incontinence: A Randomized Clinical Trial
Citation - Neurology and Urodynamics 16:543-551, (1997)
Methodology (U.S.) - The study was conducted as a prospective, double blind, randomized controlled trial using
subjective and objective outcome criteria. The study sample comprised 54 women at the outset, 44 (mean age 53.9)
who actually completed, with genuine stress incontinence, no evidence of detrusor instability and failed an attempt
or chose not to pursue pelvic floor muscle exercises. Diagnosis of genuine stress urinary incontinence was
consistent with International Continence Society criteria. Patients were randomized (first blind) into active vs.
control groups. Patients in both groups were introduced to electrical stimulation in an ofhce setting by a physical
therapist. A second blinding was then accomplished by having all patients use the same electrical stimulation
device and probe and running the same program and device. However, wiring from the unit to the probe was
covertly discontinuous for the control group. The stimulation regimen took place in two l5-minute treatment
sessions per day for 12 weeks.
Results - Of those patients completing the trial and evaluation, there was no observed statistically significant
differences in the rate of subjective improvement, subjective cure, or objective cure between the treatment and
control groups. It was quite possible that retention of the vaginal probe alone may have affected improvement of
pelvic muscle function as a result of feedback created by simply retaining the probe.
A Comparison of Effectiveness of Biofeedback and Pelvic Muscle Exercise Treatment of Stress Incontinence in Older Community Dwelling Women
Citation - Journal of Gerontology: Medical Sciences, Vol. 48, No 4, M167-M174, 1993
Methodology (U.S.) - Subjects were 135 community-dwelling female volunteers aged 55 and older recruited
through newspaper advertisements and a poster campaign. A range of selection criteria was established to obtain a
homogeneous sample of cognitively intact subjects with predominantly stress incontinence. Single blind
randomization was used to develop three groups: biofeedback, pelvic muscle exercise only and control (nontreatment
diary completion and regular contact with study personnel.), Biofeedback treatment was accomplished
through the use of a vaginal probe attached to an electromyograph and digital integrator. A nurse, using visual
feedback ofthe subject's performance, coached the subjects to properly relax and contract the pelvic muscle.
Results - Throughout the 3.5-year clinical trial, ten women withdrew and two lacked complete urinary diaries.
Reported data was a function of 123 subjects. The number of incontinent episodes decreased significantly in the
biofeedback and pelvic muscle exercise subjects but not in the control subjects for all severity of incontinence
frequency subgroups. Improvement was maintained within the moderate and severe symptom subgroups for both
treatments for at least 6 months but declined in subjects with mild incontinence frequency. Pelvic muscle
electromyograph (EMG) measures were significantly correlated with decreases in incontinent episodes, and only the
biofeedback subjects showed significant improvement in EMGs.
Assessment of Kegel Pelvic Muscle Exercise Performance after Brief Verbal Instruction
Citation - American Journal of Obstetrics and Gynecology, 165:322-9, 1991
Methodology (U.S.) - The study subjects included 47 women, mean age 53.6 years. Twenty-eight (60%) of the
subjects had urinary incontinence, five had vaginal vault prolapse, four had emptying phase defects, five sensory
urgency without incontinence or motor instability and five were being evaluated six months after successful
incontinence surgery. Subjects underwent standardized urodynamic evaluations. After brief standardized verbal
instructions urethral pressure profile determinations were performed at rest and during Kegel pelvic muscle
contractions.
Results - Twenty-eight (60%) had an effective Kegel effort by demonstrating the ability to generate a sufficient
increase in the force of urethral closure. Nineteen (40%) had an ineffective effort, Twelve subjects, 5 from the
effective and 7 from the ineffective group displayed a Kegel technique that could potentially promote incontinence.
Thus, using just verbal instruction, only 23 (49%) had an ideal Kegel effort - a sufficient increase in the force of
urethral closure without an appreciable increase in abdominal and vaginal pressure, Age, parity, weight, estrogen
deprivation, prior continence surgery or hysterectomy, and passive urethral function did not predict successful
effort.
Biofeedback and Physiotherapy versus Physiotherapy Alone in the Treatment of Genuine Stress Urinary incontinence
Citation - International Uro gynecology Journal 7:339-343, 1996
Methodology (Denmark) - Forty women with genuine stress urinary incontinence were randomized into two
groups to compare the efficacy of physiotherapy alone (group 1) and physiotherapy in combination with
biofeedback (group 2). All patients had a thorough history taken, stating incontinence when coughing, laughing,
lifting and during physical exercise. Patients with detrusor instability were excluded from the study. All patients
included had normal cystometrograms. Urinary incontinence was verified by positive 1-hour pad-weighting test
(greater than 2 grams) with a bladder volume of three-quarters of cystometric capacity. Patients with severe
incontinence were not excluded, but were excluded if previous surgery for urinary incontinence had been
performed. Study outcome was measured by performing a standardized pad-weighting test 1 and 3 months after the
treatment and comparing values to baseline values. The patient was considered cured when the pad test showed a
result of 0 or 1 gram. After a median 2.5 years a questionnaire was sent to each patient conceming the degree of
incontinence and the amount of pelvic floor exercises being presently performed.
Results - Of the 40 women, six failed to complete the treatment period, 1 in the combination and 5 in the
physiotherapy alone group. There was no statistical difference in age or degree of incontinence between patients
who dropped out and those who completed the study. The study showed a statistically significant short-term
improvement in the group with combination physiotherapy and biofeedback. The estimated relative change in the
pad-weighting test after 3 months in relation to the baseline level was mean 88.4% for the biofeedback group and
53.9% for the other group. In the biofeedback group, 58% were cured compared to 20% physiotherapy alone
group. The long-term effect in the biofeedback group was also superior as patients exhibited increased motivation
to continue haining after the study period.
The Role of Biofeedback in Kegel Exercise Training for Stress Urinary Incontinence
Citation - American Joumal of Obstetrics and Gynecology, 154:58-64, 1986
Methodology (U.S.) - This study examined the effectiveness of teaching pelvic floor exercises with use of bladdersphincter
biofeedback compared to training with verbal feedback based on vaginal palpation in 24 women, ages 29
to 64, with stress urinary incontinence. Verbal feedback (n:11) training consisted of instructing the patient to
squeeze the vaginal muscles around the examiner's fingers and providing her with verbal performance feedback.
Biofeedback patients (n:13) received visual feedback of bladder pressure, abdominal (rectal) pressure, and
external anal sphincter activity. All subjects complained of involuntary loss of urine associated with coughing,
sneezing, lifting, or other physical activity. Patients with detrusor hyperreflexia were excluded and those with
urinary tract infection were deferred until treated medically. Training in each group included four bi-weekly
training sessions approximately t hour in duration. A home training program was also put in place for both groups.
Results - The biofeedback group improved the strength and selective control of pelvic muscles while the verbal
feedback group did not. Both goups significantly reduced the frequency of incontinence. The biofeedback group
averaged 75.9% reduction in incontinence, significantly greater than the 5l% reduction shown by the verbal
feedback group. Twelve of 13 patients in the biofeedback group improved by 60% or better. Six out of 11 in the
verbal feedback group improved by 68% or better. Five out of 11 in the verbal feedback group were less than 30%
improved. Each of the 5 verbal feedback failures was subsequently offered biofeedback training, and each refused.
Because of their initial failure, they expressed discouragement with physiotherapy. Therefore, the effects of a
crossover could not be evaluated.
Biofeedback: A Noninvasive Treatment for Incontinence After Radical Prostatectomy
Citation - Urologic Nursing, Volume 16, Number 2, June 1996
Methodology (Canada) - 28 patients who became incontinent after a radical prostatectomy for treatment of cancer
were treated at Kingston General Hospital (Ontario) between 1991 and 1994. The interval between surgery and
referral varied from 1 month to 5 years, median 7 months. Two patients had failure with other modalities (collagen
injections and artificial sphincter). Initial evaluation before treatment included urinalysis, urine culture,
urodynamic studies, documentation of medical history and a physical examination. There were no exclusion
criteria for entry to the program. An electromyographic probe was inserted rectally and connected to a
computerized biofeedback unit. Patients were instructed to contract the pelvic floor muscles, and the physiological
response was monitored. That response was then altered with a new response displayed and monitored. The
patient was subsequently instructed to practice the technique at home 3 times a day for 10 to 15 minutes. During
the 10-week program, 10 weekly sessions of 15 minutes duration were scheduled for an objective assessment using
visual biofeedback. Patients then received further reeducation ifneeded.
Results - 27 patients completed the full course of biofeedback, with 13 (48%) attaining complete success. Seven
(28%) had significant improvement. The total improvement rate was 74%. Criteria for evaluation included:
- Using digital rectal assessment, comparison of pre-and post-treatment grading for muscle tonicity and voluntary contractility.
- Comparison of pre-and post-treatment subjective symptoms of bladder behavior relating to frequency, urgency, nocturia and circumstances causing incontinence.
- Determination of pad protection required before and after treatment.
- Comparison of pre-tracings and post-tracings of the physiological responses.
