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Applied Psychophysiology and Biofeedback, Vol. 31, No. 3, September 2006 ( C 2006)DOI: 10.1007/s10484-006-9010-x Pelvic Floor Muscle Biofeedback in the Treatment
of Urinary Incontinence: A Literature Review
Howard I. Glazerand Carolyn D. Laine
Published online: 16 September 2006 Biofeedback is efficacious in the training of the pelvic floor musculature in order to en-hance continence. This article reviews the anatomy and physiology of micturition as theunderlying rationale for pelvic floor muscle biofeedback in the treatment of urinary incon-tinence. It critically reviews 28 studies published in peer reviewed journals from 1975 to2005 that were prospective, randomized studies with parametric statistical analyses, oper-ationally defined patient selection criteria, treatment protocols and outcome measures. Theoverall mean treatment improvement for patients undergoing biofeedback for urinary in-continence was 72.61%. In 21 of 35 (60%) paired comparisons, biofeedback demonstratedsuperior symptomatic outcome to control or alternate treatment groups. Larger studiesand a standardization of technology and methodology are required for more conclusivedeterminations. KEY WORDS: biofeedback; urinary incontinence; pelvic floor muscle.
INTRODUCTION
The International Continence Society has defined urinary incontinence as the in- voluntary loss of urine which is both objectively demonstrable and a social or hygienicproblem (Abrams, Blaivas, Stanton, & Andersen, The incidence in women has beenreported at over 50% (Harrison & Memel, Brown et al., with pregnancyincreasing the likelihood. The incontinence rate in men over 60 years has been found tobe 10% to 25% (Sueppel, Kreder, & See, Post-radical prostatectomy incontinenceranges from 6% to 87%, depending on the definition used (Wille, Sobottka, Heidenreich, &Hofmann, Factors contributing to incontinence include aging, childbirth, and surgery.
Urinary incontinence can have a serious impact on the quality of life, restricting social en-gagement, impacting the self-image, contributing to depression and other health problems(Fantl et al., Approaches to management include behavioral, such as strengtheningthe pelvic floor musculature with exercises and prompted voiding; pharmaceutical; andsurgical treatment options. Fantl et al. suggested the first choice, as a general rule, 1Joan and Sanford Weill Medical College of Cornell University, New York Presbyterian Hospital, New York, NY, 2Saybrook Graduate School and Research Center, San Francisco, CA, USA.
1090-0586/06/0900-0187/1 C 2006 Springer Science+Business Media, Inc.
Glazer and Laine
should be the least invasive treatment with the fewest potential adverse complications thatis appropriate for the patient; behavioral techniques meet these criteria for many formsof urinary incontinence. Kegel was the first to report the efficacy of pelvic floormuscle exercises in treating urinary incontinence in women. Since then, manometric pres-sure measures and surface electromyography (sEMG) instrumentation have been used asa biofeedback adjunct to pelvic muscle rehabilitation. This feedback helps to isolate thespecific muscles and can assist in motivation by visibly displaying pelvic floor muscleactivity and progress. sEMG electrodes placed on the abdomen can help prevent the inad-vertent overuse of the abdominal muscles when attempting pelvic floor contractions andhelp train abdominopelvic synergy in contracting the pelvic floor muscles while experi-encing intra-abdominal pressures, such as coughing (Brown, Although the actualmechanisms responsible for the therapeutic effect of pelvic floor muscle biofeedback, orfor the therapeutic effect of pharmacotherapy, have not yet been identified (Goode, Andersson & Wein, the behavioral approach of biofeedback-assisted pelvic floorrehabilitation focuses on the healthy functioning of the pelvic floor musculature which setsthe tone for the whole mictuation process.
ANATOMY AND PHYSIOLOGY OF MICTURITION
The anatomy and physiology of micturition underlies the rationale for biofeedback.
Knowledge of the structures, control systems and functions of the abdominal and uro-vesicular muscles are essential prerequisites to the clinical application of biofeedbackassisted rehabilitation. A thorough discussion can be found in DeLancey and Haab,Sebe, Mondet, and Ciofu The lower urinary tract controlling micturition is com-posed of the bladder and the urethra, forming one functional unit. This unit includes thedistal portions of the ureters and their ureterovesical junction at the detrusor muscle. Thedetrusor is smooth muscle and forms the bladder wall. It provides the propulsive force thatexpels urine through the urethra. The prostate in the male and the smooth and striated mus-cle of the urethra are also part of the lower urinary system. The pelvic floor muscles connectto and support the bladder neck, the vaginal and the anal canal. The pelvic floor musclesalso comprise the external urethral and anal sphincters and have significant influence onbladder control.
A complex set of learned and reflexive control mechanisms govern the functions of urine storage and micturation. These processes involve efferent and afferent activityfrom the sympathetic and parasympathetic branches of the autonomic nervous system.
When experiencing a need to urinate the sympathetic and somatic activities diminishand parasympathetic activity increases. This causes detrusor contractions. The brain stemand cortical centers mediate these peripheral processes. With learning, the cerebral andcerebellar influences become the predominant inhibitory control over bladder contrac-tions. At maturity, micturition is coordinated at several levels of the nervous systemextending from the frontal lobe and sensorimotor cortex to the peripheral nervous sys-tem. Normal bladder function depends upon the integrative functions of the frontal lobes,the sensorimotor cortex, the thalamus, the hypothalamus, the basal ganglia, the cerebel-lum, specific centers in the brain stem, the spinal cord, nerve roots and the peripheralnerves.
PFM Biofeedback in the Treatment of Urinary Incontinence
Several studies have reviewed the components that interact to maintain normal blad- der functioning (see Hald & Bradley, Chung, Peters, & Diokno, and Myers,These factors help understanding the pathophysiology of various types of voidingdysfunction. To maintain continence during filling the pressure within the bladder mustremain low compared to urethral pressure. Disruption of the low intravesical pressure bybladder noncompliance can lead to urine overflow. The base of the bladder is the bladderneck or trigone which is flat during urine storage and forms a funnel during voiding. Theintegrity of the vesicourethral angle during storage provides a barrier to urine loss whenpressure is transmitted to the bladder and the bladder neck through activities which in-crease intra abdominal pressure, such as laughing, coughing, sneezing, standing and lifting.
The proper functioning of the bladder neck depends on elastic tissues in the submucosa,the tone of the urethral muscles, and sufficient support of the levator ani muscle. Smoothmuscle comprises the innermost layers of the bladder neck and the proximal urethra. Appro-priate functioning of the urethra depends on the integrity of these smooth muscles. Striatedmuscles in the distal one third of the urethra, periurethral area and levator ani complexare critical for bladder support and urethral closure. Collagen and elastin connective tissuewithin the urethral tissue are critical in maintaining the compliance of the urethral lumen forpurposes of closure. Vascular, epithelial and hormonal factors also play an important rolein the compliance of the urethra. Finally, all of these peripheral factors are interdependentwith both central and peripheral nervous system factors that control their functions.
PELVIC FLOOR MUSCLE ANATOMY
The pelvic floor musculature is a key component in the mictuation function. Anatomy of the human pelvic floor musculature involved in urinary control has been extensivelystudied and described (Shafik, Ahmed, Shafik, El-Ghamrawy, & El-Sibai, Critchley,Dixon, & Gosling, Singh, Reid, & Berger, The bilateral muscles of the levatorani meet in the midline to form the pelvic diaphragm across the floor of the pelvis. Theurogenital hiatus and the anal hiatus pierce through the pelvic diaphragm. The levator animuscle includes the more anterior and inferior pubococcygeus and the more posterior andsuperior iliococcygeus. The pubococcygeus attaches to the dorsal surface of the pubic boneand laterally to the arcus tendonius levator ani, or muscle white line. It forms a sling aroundthe anus, prostate or vagina, and urethra. The most anterior fibers are the pubovaginalis,and the more posterior fibers are the puborectalis. The posterior of the levator ani, theiliococcygeus muscle, anchors above the tendinous arch of the levator ani muscle and tothe spine of the ischium and below attaches to the anococcygeal body and to the last twosegments of the coccyx. The coccygeus muscle, also referred to as the ischiococcygeus, liesadjacent to, and forms a continuous plane with, the iliococcygeus. Laterally the coccygeus isanchored to the spine of the ischium and the fibers of the sacrospinous ligament. Medially itfans out to end on the margin of the coccyx and on the side of the lowest piece of the sacrum.
The Internal obturator muscle forms the muscular sidewalls of the pelvis and narrows downto a tendinous band which exits the pelvic below the ischial spines to attach to the greatertrochanter of the femurs. The bulbospongiosis, ischiocavernosus and transversus perineisuperficialis muscles on each side of the body form a traingle. The medial leg of the triangleis the bulbospongiosus, also known as the bulbocavernosus or the sphincter vagina whichsurrounds the vaginal opening. This muscle attaches anteriorly to the copora cavernosa Glazer and Laine
clitoridis with a muscular fasciculus that also crosses over the body of the clitoris andcompresses its deep dorsal vein. Posteriorly the bulbospongiosus anchors to the perinealbody where it interdigitates with the external anal sphincter and the transversus perineisuperficialis. The ischiocavernosus, also known as the erector clitoridis, is located alongthe lateral boundary of the perineum next to the bony ridge of the anterior pubic ramusbetween the pubic symphysis and the ischial tuberosity. The ischiocavernosus anteriorallyblends with the sides of the crus clitoridis and posteriorly it anchors to the surface of thecrus clitoridids and to the ischal tuberosity. The transversus perinei superficialis musclespans the perineum laterally between the ischail tuberosities joining the sphincter ani andthe bulbospongiosi in the midline at the perineal body. This complex anatomy contributesto the current lack of clarity as to the urodynamic mechanisms involved in achievingcontinence through various therapies (Goode, TYPES OF URINARY INCONTINENCE
Urge incontinence is the involuntary loss of urine associated with an abrupt and strong desire to void (Abrams et al., Urge incontinence is usually associated withthe urodynamic findings of involuntary detrusor contractions. Urgency in the absence ofdetrusor contractions is often referred to as sensory urge contrasted with detrusor hyperac-tivity or motor urge. Ideopathic detrusor hyperactivity is referred to as detrusor instabilitywhile detrusor contractions caused by neurologic deficits are referred to as detrusor hyper-flexia or neurogenic bladder (Abrams et al., 1988). In patients with neurogenic bladder,urge is often accompanied by external urethral sphincter dyssenergia or an inappropriatecontraction of the external sphincter which can cause some degree of urinary retention.
Urge may also result from involuntary urethral relaxation, known as urethral instabil-ity. Urgency can also occur with detrusor hyperactivity with impaired bladder contrac-tility (Resnick & Yalla, which leads to urge incontinence and elevated post voidresiduals.
Stress incontinence is the involuntary loss of urine associated with coughing, sneezing, laughing or other physical activities which increase abdominal pressure (Abrams et al.,This symptom may be confirmed by observing urine loss coincident with an increasein abdominal pressure, in the absence of a detrusor contraction or an overdistended bladder.
Most commonly, the abdominal pressure causes hypermobility or significant displacementof the urethra and bladder neck during exertion. Stress incontinence can also result fromurethral sphincter deficiency (ISD) due to congenital or acquired weakness, most oftenassociated with multiple anti-incontinence surgeries (Blaivas, Overflow incontinence is the involuntary loss of urine associated with overdistension of the bladder (Abrams et al., This may present as constant dribbling or may have urgeand stress incontinence symptoms. Overflow incontinence may result from an acontractilebladder due to drugs, spinal cord injury, neuropathy, or fecal impaction or may be due tobladder outlet or urethral obstruction leading to an overdistended bladder and overflow.
It is common for patients to present with a combination of both urge and stress incontinence. When symptoms of both types of incontinence are present it is referred to asmixed incontinence.
Finally it should be noted that male urinary incontinence is most often associated with prostate surgery, primarily a radical prostatectomy for prostate cancer (Wille et al., PFM Biofeedback in the Treatment of Urinary Incontinence
INTAKE PROCEDURES
Patient evaluation should start with a history of the patient’s urinary patterns and symptoms (Khullar & Cardozo, Any pertinent medical history should be reviewedincluding hospitalizations, surgeries, family history, chronic illness, medication and aller-gies. Urinary symptoms should be evaluated in the following areas: 1. Symptom onset, duration and course of symptoms.
2. Precipitating events3. Frequency and volume of voluntary and involuntary voids (voiding diary)4. Patterns of straining during voids, pain, and incomplete voids with incontinence 5. Food and fluid intake as a factor in voiding6. Occurrence of urgency and control of voids or flatus7. Timing of incontinence, e.g. nocturnal, diurnal, food/fluid ingestion, activities, 8. Type and number of protective pads used9. Medication being used such as bladder stabilizing medications or laxatives 10. Pelvic floor, penile/vaginal or rectal pain11. Suprapubic or abdominal cramping Physical Examination
Clinical practice recommendations for identifying and evaluating urinary incontinence have been made by Fantl et al. and Schick The physical examination shouldinclude andominal exam to detect masses, suprapubic tenderness or fullness and estimationof urinary flow and post void residuals. Genital examination in men to detect abnormalitiesof foreskin, glans penis and perineal skin. Pelvic exam in women to assess perineal skin,atrophy, prolapse, pelvic mass, paravaginal muscle tone, urethral hypermobility and bladderneck angle. A rectal exam should be conducted for perineal sensation, sphincter tone,bulbocavernosis reflex and prostate status in men. If indicated a general exam should beconducted to detect edemetous conditions and neurological abnormalities.
Additional Tests
Additional urinary testing may include post void residual (PVR) estimation, provoca- tive stress testing, urinalysis, urine cytology, testing for blood urea nitrogen (BUN), voidingrecord, evaluation of environmental and social factors and observation of urination to detecthesitancy and straining. Specialized testing may include uroflow, cystometry, urodynamics,urethral pressure profilometry (UPP), cystoscopy and upper and lower urinary tract imag-ing. In addition, pelvic floor muscle sEMG has been demonstrated to be clinically reliableand predictively valid in identifying subtypes of urinary incontinence (Glazer, Romanzi, &Polaneczky, Romanzi, Poleneczky, & Glazer, and therefore may be a standardpart of an initial evaluation for urinary voiding dysfunctions.
Glazer and Laine
In the office practice of biofeedback by non-physicians, it is essential that patients be fully medically evaluated prior to initiating treatment so that, by history and examination,all factors such as physiological, anatomical, pharmacological, neurological, infectious,hormonal, oncological can be identified and appropriately treated or ruled out beforeinitiating biofeedback. It could be asserted that external urethral and anal sphincter surfacebiofeedback is a noninvasive, benign intervention, and therefore is rarely contraindicatedand does not require prior medical consultation. However, these authors strongly believe inrequiring patients to undergo appropriate medical evaluation prior to initiating biofeedbackas failure to do so may lead to poor clinical outcomes and delay in the identification andappropriate treatment of medical conditions, including degenerative neurological diseasessuch as diabetic neuropathy or multiple sclerosis, a wide range of infectious diseases,or even the identification of potential malignancies, all of which may manifest as voidingdisorders. In the following literature review, therefore, only those studies employing medicalevaluation of the patients prior to the administration of biofeedback are included.
LITERATURE REVIEW
Selection Criteria
Medline was searched from 1975 to 2005 using the combined keywords of “biofeed- back” and “urinary incontinence.” Pediatric and adult studies were included. Additionalrequirements were the use of operationally defined independent and dependant variables,prospective randomized trials using parametric statistical analyses, and patient selectioncriteria including medical history and intake to rule out organic causation of urinary incon-tinence.
Study Inclusion/Exclusion
The Medline search using combined keywords of “biofeedback” and “urinary inconti- nence” yielded 326 studies. Twenty-eight studies met the selection criteria for inclusion inthe review. The remaining studies were review papers, meta-analyses, editorials, individualcase histories, single group with single or nonrandomized multiple treatments, and stud-ies not meeting criteria for patient evaluation or not using objective operationally definedindependent and dependant variables.
Study Designs and Subjects
Twenty-seven of the studies were prospective randomized between group studies and one was a biofeedback versus no treatment control, randomized crossover design(McDowell et al., The study sample sizes varied from 16 to 227 with a mean of 94.
There were no pediatric studies meeting selection criteria for inclusion. Eight of the studiesused male patients with an average age of 62 years (see Tables and for references). Sevenof these eight studies treated incontinence related to radical prostatectomy and one studytreated post-micturition dribble in men with erectile dysfunction. Twenty of the studies PFM Biofeedback in the Treatment of Urinary Incontinence
Glazer and Laine
Table II. Paired Comparisons of Biofeedback and Alternative Treatment Groups by Secondary Variables Showing
the Number of Studies Producing Different Statistical Outcomes aDorey et al., 2004; Parekh et al., Sueppel, 2001; Van Kampen et al., bBales et al., Floratos et al., Franke et al., Wille et al., cParekh et al., Sueppel, 2001; Van Kampen et al., d Bales et al., Floratos et al., Franke et al., Wille et al., 200.
eDorey et al., 2004.
f Aksac et al., Aukee et al., Berghmans et al., Burgio et al., Burgio et al., Burnset al., Dougherty et al., Johnson et al., McDowell et al., Pages et al., Sung et al.,Wang et al., gAukee et al., Burgio et al., Burton et al., Laycock et al., Morkved et al., Seo et al.,2004; Sherman et al., Wyman et al., 1998.
hAksac et al., Aukee et al., Berghmans et al., Burgio et al., Burns et al., McDowellet al., Pages et al., Sung et al., iAukee et al., Burton et al., Laycock et al., Seo et al., 2004.
jJohnson et al., Wang et al., k Burgio et al., lBurgio et al., Dougherty et al., mMorkved et al., Sherman et al., Wyman et al., 1998.
nBurgio et al., Burgio et al., Dorey et al., 2004; Pages et al., Sueppel, 2001; Sung et al., oBurgio et al., Burton et al., Laycock et al., Morkved et al., Seo et al., 2004; Wille et al.,Wyman et al., 1998.
pAksac et al., Aukee et al., Berghmans et al., Burns et al., Dougherty et al., Johnsonet al., McDowell et al., Parekh et al., Van Kampen et al., Wang et al., .
qAukee et al., Bales et al., Floratos et al., Franke et al., Sherman et al., .
r Berghmans et al., Burgio et al., Burns et al., Wang et al., sBurton et al., Seo et al., 2004.
t Aksac et al., Burgio et al., Dorey et al., 2004; Dougherty et al., Johnson et al., McDowellet al., Pages et al., Parekh et al., Sueppel et al., Sung et al., Van Kampen et al.,uAukee et al., Bales et al., Burgio et al., Floratos et al., Franke et al., Morkvedet al., Wille et al., Wyman et al.,1998.
vAukee et al., wLaycock et al., Sherman et al., PFM Biofeedback in the Treatment of Urinary Incontinence
used female patients. Of these 20 studies, 12 used patients with stress urinary incontinencewith an average age of 60 years. Three studies used patients with urge urinary incontinencewith an average age of 57 years, and five studies used patients with mixed or both stressand urge urinary incontinence with an average age of 59 years.
Operational Definitions of Variables
Studies varied in their operational definitions of incontinence subtypes. All studies employed history and medical exams to rule out organic causes of urinary incontinence.
Additionally, 15 studies employed urodynamics, 11 studies employed the pad test, ninestudies employed voiding diaries, and nine studies employed standardized questionnairesin defining the incontinence subtype under study. Outcome variables also covered a widerange of measures including 20 studies using voiding diaries, 17 using pad tests, six usingphysical examinations, eight using pelvic floor muscle measurements by manometry orelectromyography, four using urodynamics or cystometry, and 13 using patient self-reportstandardized scales.
Independent, or treatment, variables also showed a wide range of operational defi- nitions. While all twenty-eight studies included a pelvic floor muscle biofeedback group,13 studies employed manometric biofeedback, anal in males and vaginal in females, and15 studies employed surface electromyographic biofeedback, anal in males and vaginal infemales. Six of the studies did not use any home training of pelvic floor muscles in thebiofeedback group, while 19 of the studies used unassisted pelvic floor muscle home train-ing along with office biofeedback, and three studies used pelvic floor muscle biofeedbackassisted home training.
Biofeedback protocols varied widely using different patient education, contraction parameters, numbers of training sessions, numbers of repetitions, duration of training,use of accessory muscles, patient positioning, and so forth. Nineteen studies comparedbiofeedback to unassisted pelvic floor muscle training. Like biofeedback, unassisted pelvicfloor muscle training protocols were highly variable between studies. Seven of the studiescompared biofeedback to an untreated control group. Two studies compared biofeedback,drug therapy with oxybutynin, and placebo in the treatment of urge incontinence. Onestudy compared biofeedback administered before versus after surgery in post prostatectomyincontinence, and two studies compared biofeedback, electrical stimulation and unassistedpelvic floor muscle training. Of the four remaining studies one compared biofeedback tovaginal cones, one compared biofeedback to vaginal cones and to unassisted pelvic floormuscle training, one compared biofeedback to unassisted pelvic floor muscle training andto a no treatment control group, and the final study compared biofeedback to bladderretraining and to a combined biofeedback and bladder retraining group.
Paired Comparisons of Biofeedback vs. Comparative Treatment
and Control Groups
Paired comparisons of biofeedback groups to all other groups, and paired compar- isons of biofeedback groups to other treatment groups by secondary variables are presentedin Tables 1 and 2, respectively. The total number of biofeedback, comparative treatment Glazer and Laine
and control groups in the 28 studies is 61 and the total number of paired comparisonsof the biofeedback groups compared to each other group within each study is 35. All 28biofeedback groups showed statistically significant symptom reduction over the courseof treatment. In 21 of the 35 paired group comparisons, the biofeedback group showedstatistically significant greater symptomatic improvement. In 14 of the 35 paired groupcomparisons, the biofeedback group and the comparison group showed no statistical dif-ferences in symptomatic improvement. In no comparison was biofeedback less effectivethan no-treatment controls or comparative treatments, including unassisted pelvic muscleexercises, medication, electrical stimulation, vaginal cones or behavioral bladder training.
Biofeedback vs. No Treatment Controls In the seven studies which included both biofeedback and no-treatment control groups, the biofeedback groups all showed statistically significant improvement, and in six ofthe seven studies the biofeedback treatment resulted in statistically significant superioroutcomes compared to the no-treatment control groups. Of the no-treatment control groups,six of the seven showed no statistically significant symptomatic improvement, and oneno-treatment control group did show statistically significant improvement. The study inwhich both biofeedback and no-treatment controls showed statistically significant and equalimprovement compares post-prostatectomy biofeedback to no-treatment controls (Frankeet al., Both groups achieved in excess of 85% improvement. Notably the authors statethat control subjects were provided detailed literature including postoperative instructionsand may have performed pelvic floor muscle exercises without being directed to do so.
Biofeedback vs. Unassisted Pelvic Floor Muscle Exercises
A total of 18 studies included both biofeedback and unassisted pelvic floor muscle exercise groups. All biofeedback and unassisted pelvic floor muscle exercise groups showedstatistically significant improvement. In nine of the 18 studies, biofeedback demonstratedstatistically significant superior outcomes; and in the remaining nine studies, biofeedbackand unassisted pelvic floor muscle exercises demonstrated no statistical difference in degreeof improvement. In no studies did pelvic floor muscle exercises produce statistically superiorimprovement to biofeedback.
Biofeedback vs. Oxybutyinin vs. Placebo Two studies compared biofeedback, oxybutynin, and placebo groups for the treatment of urge incontinence. In both studies, all three groups showed statistically significantimprovement. In both studies, biofeedback was statistically superior to both oxybutyninand placebo, and oxybutynin was statistically superior to placebo.
Two studies compare biofeedback to vaginal cones. One study shows statistically significant symptomatic improvement in both treatment groups and no statistical difference PFM Biofeedback in the Treatment of Urinary Incontinence
between the treatment modalities, and the second study shows statistically greater symptombenefit for biofeedback over vaginal cones.
Biofeedback vs. Electrical Stimulation Two studies compared biofeedback to both electrical stimulation and unassisted pelvic floor muscle exercises, showing statistically significant symptomatic improvement in allgroups. Both the biofeedback and electrical stimulation groups were statistically superiorto the unassisted pelvic floor muscle exercise group but showed no statistical differencebetween each other.
Paired Comparisons of Biofeedback vs. Alternative Treatments
by Secondary Variables
Eight studies employed male subjects. Seven of the eight studies employed pelvic floor biofeedback and one or more comparison groups in the treatment of urinary incontinence as-sociated with radical prostatectomy. Of these seven studies, three demonstrated biofeedbackto be statistically superior to a no treatment control group, a placebo electrotherapy group,and an unassisted pelvic floor muscle exercise group. One study demonstrated biofeedbackadministered both before and after surgery to be statistically superior to biofeedback admin-istered only after surgery. Two of the seven studies on prostatectomy patients demonstratedstatistically successful outcomes using biofeedback, but equally successful outcomes usingunassisted pelvic floor muscle exercises. One study demonstrated statistically significantsuccessful outcomes for both biofeedback and a no treatment control group. The finalstudy employing male subjects demonstrates biofeedback to be effective in the treatmentof post void dribble in men with erectile dysfunction while a no-treatment control showedno improvement. In summary, four of the eight male studies demonstrated statistically bothefficacy and superiority of biofeedback, and four of the studies demonstrated efficacy.
Twenty studies employed females. Twelve of the 20 studies employed subjects with stress urinary incontinence, three studies employed urge incontinence subjects and fivestudies employed subjects with mixed incontinence. Biofeedback produced statisticallysignificant symptom improvement in all 12 studies of stress incontinence. In eight of the 12studies, biofeedback produced statistically superior results to comparison treatment groupsand statistically non-differential results in the remaining four studies. Two of the threestudies on urge incontinent patients showed efficacy and superiority of biofeedback overoxybutynin and placebo and over electrical stimulation and exercises. The other study onurge incontinent patients showed non-differential efficacy over unassisted exercises. Ofthe five studies on mixed incontinence subjects, biofeedback showed statistical efficacyin all studies and statistical superiority in two of the five studies. Over all female incon-tinence subtypes, biofeedback demonstrated statistically significant clinical efficacy in all Glazer and Laine
20 studies and statistically significant superiority in 12 of the 20 studies and statisticallynon-differential efficacy in eight of the 20 studies.
Manometry vs. Surface Electromyography (sEMG) Thirteen of the 28 studies employed manometric biofeedback, and 15 studies em- ployed surface electromyographic biofeedback. Of the 13 studies employing manometricbiofeedback, six studies demonstrated statistical superiority of biofeedback over the com-parison group(s) with no statistical difference demonstrated in the remaining seven studies.
Of the 15 studies employing surface electromyographic biofeedback, 10 studies demon-strated statistical superiority of biofeedback over the comparison group(s) with no statisticaldifference demonstrated in the remaining five studies.
Six of the 28 studies employed in-office biofeedback treatments only and prescribed no home training, 19 studies employed in-office biofeedback and prescribed unassistedpelvic floor muscle home training and three studies employed in-office biofeedback andprescribed biofeedback assisted home training. In four of the six studies using no hometraining, the biofeedback groups were statistically superior in symptom reduction to thecomparison treatment group(s); and in the remaining two studies, biofeedback groups werenot statistically different from their comparison treatment group(s). In 11 of the 19 stud-ies using unassisted home training, the biofeedback groups were statistically superior insymptom reduction to the comparison treatment group(s); and in the remaining eight stud-ies, biofeedback groups were not statistically different from their comparison treatmentgroup(s). In two of the studies employing biofeedback assisted home training, the biofeed-back groups were not statistically different from their comparison treatment group(s) insymptomatic outcomes.
Protocols/Researchers/Biofeedback Equipment
Biofeedback protocols and equipment employed were consistent over studies only within researchers having multiple studies included in this review. Of the 28 studies re-viewed, two researchers (Aukee and Burgio) have two and three studies, respectively, in-cluded; and the remaining 23 studies are each by different researchers and employ differentbiofeedback assessment and treatment protocols and equipment.
Summary of Findings
In summary, all biofeedback groups included in this review showed statistically sig- nificant symptomatic improvement. Biofeedback was superior to controls and/or alternatetreatments in the majority of studies and demonstrated statistical superiority over no treat-ment, unassisted pelvic muscle exercises, oxybutynin, placebo, intravaginal electrical stim-ulation, and equal efficacy to vaginal cones. Biofeedback demonstrated statistically superior PFM Biofeedback in the Treatment of Urinary Incontinence
efficacy in post prostatectomy incontinence as well as in female stress, urge and mixed in-continence. Surface electromyographic biofeedback more frequently showed statisticallygreater efficacy than manometric biofeedback, and neither unassisted nor biofeedback as-sisted home training improved the outcomes of office administered biofeedback.
CONCLUSION
It is notable that the Medline review yielded only 28 studies in the span of 30 years which met traditional scientific criteria for research design and data analysis. Equallynotable and likely related is the complete absence of standardization of both biofeedbacktechnology and the methodology for its application to pelvic floor muscle assessment andrehabilitation. Both the small number of studies and the lack of standardized technologyand protocols are limiting factors in generalizing our findings. It must also be noted thatto date, the mechanisms responsible for therapeutic efficacy have not been identified,making more difficult a focused approach to intervention. In spite of these difficulties, thisreview consistently demonstrates that pelvic floor muscle biofeedback is efficacious in thetreatment of urinary incontinence. In the majority of studies, biofeedback is statisticallysuperior to comparison treatments and controls; and in no studies were any other treatmentssuperior to biofeedback. A more conclusive determination of the role of pelvic floor musclebiofeedback in the medically integrated diagnosis and treatment of urinary incontinencerequires further scientifically sound investigations and standardization of technology andprocedures.
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