Neurourology and Urodynamics 9:489-502 (1990) Pelvic Floor Muscle Exercise for the Treatment of Female Stress Urinary Incontinence: Ill. Effects of Two Different Degrees of Pelvic Floor Muscle Exercises Kari Bo, Rolf H. Hagen, Bernt Kvarstein, Jan Jorgensen, and Stig Larsen Norwegian University of Sport and Physical Education, Oslo (K.B.), Section of Urology, Department of Surgery, Akershus Central Hospital, Nordbyhagen (R.HH., B.K., JJ), Medstat, Center for Design, Administration, and Statistical Analysis in Medical Research, ‘Strommen (S.L.), Norway Fifty-two women, mean age 45.9 years (24~64) with clinically and urodynamically proven stress urinary incontinence (SUL) were randomly assigned to one of two different pelvic floor muscle (PFM) exercise groups. Both groups performed 8-12 maximal PFM contrac- tions 3 times a day for 6 months. In addition one group exercised with an instructor intensively 45 min once a week performing long-lasting contractions with the supplement ‘of 3-4 fast contractions at the end of each long-lasting contraction. Initially and after 6 months an examination was performed comprising history, urinary leakage index, pad test, maximum urethral closure pressure, functional urethral profile length. and recording of vaginal pressure during PFM contractions. The latter was per- formed monthly. ‘fier the treatment 60% of the intensive exercise (IE) group and 17.3% of the home exercise (HE) group reported to be continent or almost continent (P < .01). Only the IE group demonstrated significant reduction in urine loss; from mean 27 g 107.1 g (P< .01) and improvement in maximum resting urethral closure pressure (mean improvement 4.6 cm H,0, P = .02), PFM strength improved with mean 15.5 cm H,0 (P < .01) in the IE group while the HE group improved with 7.4 cm H,0 (P < .01) It is concluded that the results of PEM exercise for female SUI is highly dependent upon the degree and duration of treatment and frequent supervision by the therapist Key words: circumvs al muscles, strength training, stress urinary incontinence INTRODUCTION Kegel [1951] was the first to describe PFM exercise in treatment of stress urinary incontinence in women. He reported a cure rate of 84%. Very little activity Received for publication August 16, 1989; accepted February 14, 1990, Address reprint requests to Kari Ba, Norwe; 40, Kringsja, 0807 Oslo 8, Norway. in University of Sport and Physical Education, P.O. Box Abbreviations used: CI = confidence intervals; FPL. = functional profile length; MUCP = maximum urethral closure pressure; PFM = pelvic floor muscles; SUI = stress urinary incontinence. © 1990 Wiley-Liss, Inc.490 Bret al. in this field followed this first presentation. However, during the last decade it has been a renewed interest for this treatment method. The purpose of PFM exercise is to increase the muscle volume. Theoretically, hypertrophy of the PFM will result in increase of maximum urethral closure pressure and stronger reflex contractions following quick rise in intra-abdominal pressure. PFM activity is important for stabilisation of the proximal urethra in its intra-abdom- inal position [Staskin et al., 1985]. It has also been suggested that contraction of the m.levator ani moves the vesical neck anteriorly, compressing it against the precer- vical arc, favoring closure [DeLancey, 1988]. Previous published data of PFM exercise as treatment of SUI show cure and improvement rates from 32% to 76% [42% Klarskov et al., 1986; 76% Sandri et al., 1986; 32% Benvenuti et al., 1987; 66% Wilson et al., 1987}. These results are based on the patients own statements. ‘The great variation of success rates may partly be explained by the different duration of exercise periods which vary between 6 weeks [Wilson et al., 1987] and 4 months [Klarskov et al., 1986]. It may also be explained by lack of reliable and valid measurements of the degree of urinary leakage and PFM strength. Generally, the exercise regimens are sparsely described and very few au- thors have stated whether control of PFM contractions has been performed. The aim of the present investigation was to compare, after 6 months, the effects of two different degrees of PFM exercise on two similar groups of women with SUI, using reliable and valid methods to evaluate the results. MATERIALS AND METHODS: Fifty-seven women, mean age 45.4 years (24—64), with SUI participated in the study. The diagnosis was based on history and clinical and urodynamic assessment including pad test during physical exertion. Patients with detrusor instability and infections were excluded from the study. In order to obtain as equal groups as possible, the women were distributed in groups according to previous surgery and in relation to menopause. They were then stratified according to degree of leakage, whereafter they were randomly assigned to one of two exercise regimens: home exercise only (HE) or intensive exercise (IE). Two women dropped out immediately after randomisation to the IE group because they were unable to attend the weekly exercise group regularly. One woman withdrew after | week due to psychiatric problems without connection to the SUI problems. Another woman withdrew because she had to be operated on for a myoma uteri, while one belonging to the IE group was excluded because she had attended less than 50%. The final material therefore consists of 52 women, mean age 45.9 years (24-64). The two exercise groups were similar concerning all observed background variables (Table 1). Exercise Regimen HE. The women were individually instructed in pelvic floor anatomy and in how to contract the PFM correctly. The ability to contract the PFM was controlled by vaginal and perineal palpation and observation of movement of a vaginal balloon catheter during PFM contraction [Bg et al., 1990a,b]. The patients were asked to perform 8-12 strong PFM contractions three times a day for 6 months. Frequency of exercise was notified in a training diary. yab.Pelvic Floor Muscle Exercise for SUL 491. ‘TABLE 1. Background Variables of the Patients in the Two Groups Before Treatment (Mean and Total Ranges) Intensive exercise Home exercise W= 2) (N = 29) P-values ‘Age (years) 44.9 (24-64) 45.9 (35-63) NS ‘Duration of SUI sympt. (years) 8.5 (2-27) 10.8 (1-30) NS Body mass index 22.9 (18.6-28.6) 23.6 (18.8-32.5) NS Mean No. of children 2.4 (0-4) 2.6 (0-7) NS Max. birthweight 3,671 (2,800-4,500)g 3,809 (2,270-4,880)g NS Max. weight gain during pregnancy 15 (9-24) ke 15.8 (7-30) kg NS Previous surgery for SUI (No.) 1 4 NS Postmenopausal (No.) 7 u NS Parous (No.) 24 28 NS TE. The patients followed the same regimen as the HE group, but in addition to the HE this group followed a special PFM exercise course, training with instructor in groups 45 min once a week for 6 months, Standing, sitting, lying, and kneeling positions with the legs apart were used to facilitate maximum or close to maximum contractions with simultaneous relaxation of other muscles. In order to try to induce muscular hypertrophy, the contractions were done in the following way: The instruc- tor encouraged the participants to contract as hard as possible and hold the contraction for 6-8 sec. At the end of each contraction, 3~4 fast contractions were added. Eight to twelve contractions with added fast contractions were done in each position. The women in this group were encouraged to keep the same intensity in each contraction when exercising at home. History and Clinical and Urodynamic Examination History. The patients were asked about congenital malformations, neurological disorders, or injuries including operations on the spine and pelvis, infections, and diabetes mellitus. Height and weight, menstrual cycles, and details of pregnancy and childbirths were evaluated in each woman. Furthermore they were thoroughly ques- tioned about micturition and type of incontinence. Urinary leakage index. The patients were asked to register on a 5 point scale (S = always, 4 = often, 3 = sometimes, 2 = seldom, 1 = never) the degree of SUI during sneezing, coughing, laughing, walking, walking downhill, running, jumping, and lifting. As an overall index for urinary leakage before and after treatment the mean was calculated, Pad test. To measure urine loss during heavy physical activity a new pad test was used. Before the test the bladder was filled with saline according to each wom- an’s cystometric capacity. Maximum cystometric capacity was determined by CO, filling at the rate of 50 ml/min, The pad test was performed in the urodynamic laboratory during controlled experimental conditions. The subjects were Running on the spot for 30 sec. Jumping with the legs in subsequent adduction and abduction for 30 sec. Lying down, doing repetitive sit ups for 30 sec, and finally rising up to standing position492 Byet This 90 sec pad test has been tested for reproducibility and compared to the Inter- national Continence Society (1.C.S.) 1 hour’s test [Hagen et al., 1988]. Residual urine. Residual urine determinations were performed by catheterisa- tion immediately after voiding. Urodynamic examinations. Uroflowmetry and medium filling cystometry with CO, were performed in all patients. Initially and after 6 months treatment, simultaneous urethrocystometry (SUCM) with determination of urethral closure pres- sure during rest and stress (cough) and the urethral pressure profile were performed using Tip-Transducer 21K62 (Dantec, Copenhagen, Denmark) Measurement of PFM strength. A vaginal balloon catheter (balloon size 6.7 X 1.7 cm) connected to a pressure transducer (Camtech Ltd., 1300 Sandvika, Nor- way) was used to measure vaginal pressure during PFM contractions. The balloon was placed with the middle of the balloon 3.5 cm inside the introitus vagina. The method has been found to be reliable and valid [Bg et al., 1990a,b). Because it is impossible to strain and correctly lift in a cranial direction with the PFM at the same time, only contractions with observed inward movement of the balloon catheter were accepted [B# et al., 1990b]. No visible or palpable synergistic contraction of other muscles were allowed during PFM contractions. All women were tested once a month doing eight successive maximal contractions. Control interview. After the 6 month treatment period the patients were asked to register whether they were worse, unchanged, had some improvement, or were almost continent or continent. Methods, definitions, and units conform to the stan- dards recommended by the I.C.S. ‘Statistical Methods Except for frequencies all results are expressed as mean values with 95% CI and total ranges. For construction of the CI the Student procedure was used [Kendall and Stuart, 1978]. All tests used in this analysis are one-tailed. Differences were cot ered significant if the P-values were less or equal to a level of 5%. The ANOVA- model was used for comparison between groups [Kendall and Stuart, 1978]. RESULTS Before treatment there was no statistical significant difference between the two exercise groups concerning degree of SUI measured by the urinary leakage index and pad test. Neither residual urine, urodynamic measurements, nor PFM strength showed significant differences (Table II). The attendance rate for both groups to the home exercise program and for the IE group to the weekly group exercise was close to 100%. Neither the IE nor the HE group stopped or slowed down on the exercise program. Fourteen women (60.1%) in the IE and 5 (17.3%) in the HE group reported to be continent or almost continent after the 6 month exercise period (P < .01 Table III). ‘The mean score measured by the urinary leakage index decreased from 3.0 to 1.9 in the IE group (P < .01) and from 3.1 to 2.6 in the HE group (P < .01). The improvement, however, was significantly higher in the IE group (P < .01 Fig. 1). The pad test demonstrated a significant decrease from a mean of 27 g (95% Cl 8.8-45.1, range 0-168.0) to 7.1 g (95% CI0.8-13.4, range 0-58.3) in the IE groupPelvic Floor Muscle Exercise for SUL 493 TABLE Il. Urodynamic Assessment and Pelvic Floor Muscle Strength Before Treatment (Mean and Total Ranges) Intensive exercise Home exercise (N = 23) (N= 29) P-values Max. cystometric capacity (ml) 245.2 (140-439) 252.7 (121-404) NS Residual volume (ml) 6.6 (0-33) 17.6 (0-100) NS Max. flow rate (ml/s) 22.5 (12.9-38.2) 37.1 (8.4-44.0) NS Negative urethral closure pressure (cough) (No.) 2 25, NS Pelvic floor muscle strength 7.0 (0-24.3) 7.9 (027.0) NS TABLE IIL, Patients’ Own Assessment of Improvement of Stress Urinary Incontinence After Treatment Some Almost Worse Unchanged improvement continent _ Continent Intensive exercise 0 1 8 2 2 Home exercise 0 10 4 5 0 Leakage index 3.5 | IE 25: jally After 6 months Fig. 1. Urinary leakage index before and after treatment. Columns illustrate 95% confidence intervals of the means. Means are given as horizontal ines. fJ] = intensive exercise group; [) = home exercise ‘group. There was a significant decrease of urinary leakage in both groups (P < .01) and between the groups (P< .01) (see text). (P < .01). The HE group did not demonstrate significant improvement in this pa- rameter (Fig. 2). Maximum resting urethral closure pressure increased significantly only in the IE group (P < .02, Table IV). Functional profile length was not significantly changed in either group (Table IV). In 12 of 20 women in the IE group and 7 of 25 women in the HE group, a negative closure pressure during coughing was changed to a positive494 Beet al. gram 40 35 30 25 ee 20 15 10 $$ $s — ially After months Fig. 2. Pad test before and after treatment. Columns illustrate 95% confidence intervals of the means. ‘Means are given as horizontal lines. ff] = intensive exercise group; [] = home exercise group. Only the IE group reduced the leakage significantly (P < .O1) (see text), pressure after the 6 months of treatment. Significantly fewer women in the IE group had a negative closure pressure after treatment (P < .05). At the beginning of the study 9 women in the IE group and 7 in the HE group were not able to contract correctly. After 6 months these numbers were reduced to one and three, respectively. There was a significant increase in maximum PFM strength after 1 month of exercise in both groups (P < .01, Fig. 3). From I to 5 months the IE group continued to increase the muscle strength, while the HE group was unchanged. The difference between the two groups at 5 months was significant (P < .03). After 6 months the IE group had demonstrated a threefold increase in maximum strength, while the HE group still had the same values as after 1 month. The difference in maximum PFM strength between the two groups at 6 months was significant (P < .01, Fig. 3). DISCUSSION In the present study, after 6 months, significantly different results were obtained in two similar groups of women with SUI who performed PFM exercise either intensely or moderately. Results were evaluated from the patients’ own statements and with objective methods, including measurement of PFM strength. The material in the present study consists of women with SUI. As the mean maximum urethral closure pressure was as high as 38.8 cm HO, the vast majority suffered from pure genuine stress incontinence, a condition where reduced transmis- sion of abdominal pressure to the proximal urethra is the main factor causing thePelvic Floor Muscle Exet for SUL 495 TABLE IV. Maximum Resting Urethral Closure Pressure (MUCP) and the Functional Profile Length (FPL) Before and After Treatment Before After ‘Change MUCP (em H,0) Intensive exercise Mean 38.8 434 46 95% conf. int. (32.6-45.0)37.0-49.8) —(0.3-8.9) Range (20-66) 2-81) (16-2) Home exercise Mean 38.8 39.8 10 95% conf. int. (34.5-43.1)(35.4-44.2) (-1.8-3.8) Range (12-58) 20-60) (= 19-14) FPL (mm) Intensive exercise Mean ns 212 13 95% conf. int. (20.4-24.6)_(19.4-23.0)—(-0.7-3.3) Range (13-30) (12-28) (13-10) Home exercise Mean 23.2 27 0. 95% conf. int. (21.2-25.2) (20.9-24.5)_ (-0.9-1.9) Range 15-32) (15-30) 10) leakage. Accordingly, in 45 of the 52 patients leakage was observed when they coughed during simultaneous urethrocystometry. Before treatment there was no significant difference between the IE and HE groups concerning background variables, SUI symptoms and signs, and PFM strength. This is probably due to the method of randomisation used in the present study. It was considered of utmost importance to obtain as equal groups as possible when effects of two different treatments were to be studied. After 6 months of treatment both groups had obtained a significant increase of muscle strength. However, the increase was significantly larger in the IE group which also showed significant improvement of all leakage parameters. Of the IE group 60.1% were continent or almost continent against 17.3% of the HE group. Only the IE group obtained statistical significant improvement of pad test results and MUCP during rest. Furthermore, in the IE group the negative closure pressure during cough was converted to positive significantly more often than in the HE group. The combination in the IE group of only little increase in MUCP (4.6 cm H,0) with large increase (15.5 cm H,0) in vaginal pressure (muscle strength) indicates that improvement of genuine stress incontinence after PFM exercise is explained by stronger and faster contraction of PFM and not by a rise in maximum urethral pressure. ‘At the beginning of the treatment 16 of the 52 patients did not contract correctly. : However, the majority learned and after 6 months only 4 still performed incorrect contractions. This demonstrates the importance of not leaving the patients alone with the exercises, but performing regular evaluation by the instructor during the complete ; treatment period. In previous studies of PFM exercise as treatment for female SUI the intensity of contractions usually has been much less than in the present IE group and the treatment es .____496 Bo etal. cmH;0 30 25 10 a Initially 1 month 5months 6 months Fig. 3. Maximal pelvic floor muscle strength before, after 1 month, after 5 months, and after 6 months of treatment. Columns illustrate 95% confidence intervals of the means. Means are given as horizontal lines. {fl = intensive exercise group; [] = home exercise group. Both groups had increased the muscle strength significantly at 1 month (P <.01). At 6 months there was a significant difference in muscle strength between the two groups (P < .01) (see text). Note that there is no significant difference between the groups after 1 month. periods had been shorter. Klarskov et al. [1986] did not give details about the performance of exercises and the treatment period was 4 months. In a study of Sandri et al. [1986] the women exercised for 2 weeks with a physical therapist and then at home. The exercise technique is not described and the exercise period was 4 months. Wilson et al. [1987] instructed the patients to contract 10 times every half hour and to stop the urine stream. In addition one group of patients exercised twice a week with a physical therapist. The exercise period, however, was only 6 weeks. In a study of Henalla et al. [1988], the patients exercised every hour at home and held each contraction for 5 sec. They were weekly assessed by a physical therapist. The exer- cise petiod was 3 months. A study of Tschou et al. [1988} lasted for only 4 weeks and the patients were exercising with a physical therapist twice a week. Tapp et al. [1988] does not describe the exercise regimen. The women were assessed once a week and the exercise period was 3 months. Results obtained in the present study show the importance of well-instructed and intensively performed exercises during a long period. After 1 month both groups showed considerable increase in muscle strength, but the difference between them was not significant. However, during the next 5 months the strength of the IE group continued to increase, while the HE group stayed at the same level.Pelvic Floor Muscle Exercise for SUL 497 The effect of the first 8 weeks of strength exercise of striated muscle is supposed to be caused by increased numbers of activated motor units (Saltin, 1986]. However, development of muscular hypertrophy is a much slower process and therefore needs longer exercise periods. Maximum or close to maximum contractions are also im- portant to achieve hypertrophy. In the present study both subjective and objective evaluation methods were used. The patients were asked about the results of treatment, and in addition the urinary leakage index chart gave more detailed information about the degree of Teakage in various situations. The use of such a chart has not been previously men- tioned. It seems to be an advantage in subjective evaluation. In previous investigations only Sandri et al. [1986] and Henalla et al. [1988] have used pad tests for objective evaluation. The pad test used in the present inves- tigation is new. It has been shown to give reproducible results in one and the same patient before treatment (Hagen et al., 1988]. The test provides very strong physical stress during 90 sec and has shown to be more provocative than the I.C.S. 1 hour's test [Hagen et al., 1988]. Hence, the threshold of improvement measured by this test is high. Resting urethral closure pressure increased significantly in the IE group. This is in accordance with the results obtained by Benvenuti et al. {1987}. However, Wilson et al. [1987] did not find significant change after PFM treatment. Maximum urethral closure pressure during cough increased significantly more in the IE than in the HE group. This test has not been used by other investigators. In the present study 12 ‘women obtained positive closure pressure during cough while only two reported to have become continent. Thus, this test is probably not a good indicator of clinical results, as many women with SUI also leak in other situations than during cough. In contrast to the present study Benvenuti et al. [1987] found a significant increase in functional urethral profile length after treatment. It is difficult to have an opinion about the usefulness of this parameter in SUI. In the present study vaginal pressure measurements were used to evaluate the increase of PFM strength after treatment with the two exercise regimens. Standard- ized placement of the vaginal balloon in combination with observation of inward movement of the balloon catheter secured reliable and valid recordings of PFM strength before, during, and after treatment [Bg et al., 1990b]. Previous investigators have also used vaginal pressure recordings of PFM strength (Kegel, 1951; Shepherd et al., 1983; Castleden et al., 1984; Sandri et al., 1986; Wilson et al., 1987). However, the various techniques employed have been inaccurately described. It is difficult to see if standardized placement of the vaginal device has been used and the validity of the method for correct PFM contractions has not been controlled. It will be seen that the PFM exercise and evaluation methods used in the present investigation are so different from methods applied in previous studies that compar- ison of treatment results is difficult. The results presented herein show that success of PFM exercise for female SUI is highly dependent upon the degree and duration of treatment and frequent supervision by the therapist. ACKNOWLEDGMENTS, We are indebted to professor Bjgrn Klevmark, M.D., Ph.D., for valuable help with the manuscript; professor Svein Oseid, M.D., and professor Sverre Mahlum,498 Beet al. M.D., Ph.D., for research advice. Nurses Helga Hagenes Eide and Orvokki Kananen have assisted with the urodynamic measurements. Financial support has been given by the Foundation for Education and Research in Physical Therapy and The Research Council for Science and the Humanities. REFERENCES Benvenuti F, Caputo GM, Bandanelli S, Mayer F, Biagini C, Somavilla A (1987): Reeducative treatment Of female genuine stress incontinence. Am J Phys Med 66:155-168, Bo K, Kvarstein B, Hagen RR, Larsen S (1990a): Pelvic floor muscle exercise for the treatment of female stress urinary incontinence: I. Reliability of vaginal pressure measurements of pelvic floor muscle strength, Neuroural Urodyn 9:471-477. Bg K, Kvarstein B, Hagen RH, Larsen S (19906): Pelvic floor muscle exercise for the treatment of female stress urinary incontinence: II. Validity of vaginal pressure measurements of pelvic floor muscle strength. The necessity of supplementary methods for control of correct contraction. Neurourol Urodyn 9:479-487. Castleden CM, Duffin HM, Ageing 13:235-237, DeLancey JOL (1988): Anatomy and mechanics of structures around the vesical neck. How vesical neck position might affect its closure. Neurourol Urodny 7:161,162. Hagen RH, Kvarstein B, Bg K, Larsen S (1988): A simple pad test with fixed bladder volume to measure urine toss during physical activity. International Continence Society 18th Annual Meeting, Oslo, Papers to be read by title, pp 88,89. Henalla SM, Kirwan P, Castleden CM, Hutchins CJ, Breeson AJ (1988): The effect of pelvic floor exercises in the treatment of genuine urinary stress incontinence in women at two hospitals. Br J Obstet Gynecol 95:602-606. Kegel A (1951): Physiologic therapy for urinary stress incontinence. JAMA 146:915-917. Kendall M, Stuart A (1978): “"The Advanced Theory of Statistics,"” Vol 2. London: Charles Griffin et Co LD. Klarskov P, Belving D, Bischoff N, Doysh S, Gerstenberg T, Okholm B, Pedersen PH, Tikjop G, ‘Wormslev M, Hald T (1986): Pelvic floor exercise versus surgery for female urinary stress inconti- rence. Urol Int 41:129-132. Saltin B (1986): Muskulara anpassningen til styrketrening. In “‘Styrketrening,” Idrottens forskningsrid. Folksam: Sveriges Riksidrottsforbund (Swedish) pp 74-81. Sandri SD, Magnaghi C, Fanciullacei F, Zanollo A (1986): Pad controlled results of pelvic floor phys- iotherapy in female stress incontinence. Proceedings of Third Joint Meeting, International Continence Society 16th Annual Meeting, Boston, pp 233-235. Shepherd A, Montgomery E, Anderson RS (1983): A pilot study of a pelvic exerciser in women with stress incontinence. J Obstet Gynecot 3:201,202. Staskin DR, Zimmern PE, Hadley HR, Raz $ (1985): The pathophysiology of stress incontinence. ‘Symposium on female urology. Urol Clin North Am 1:271-278. ‘Tapp AIS, Cardozo L, Hills B, Barnic C (1988): Who benefits from physiotherapy? Neurourol Urodyn 7:260-261. ‘Tschou DCH, Adams C, Varner RE, Denton B (1988): Pelvic-floor musculature exercises in treatment of anatomical urinary stress incontinence. Phys Ther 68:652-655. Wilson PD, Sammarai TAL, Deakin M, Kolbe E, Brown ADG (1987): An objective assessment of physiotherapy for female genuine stress incontinence. Br J Obstet Gynecol 94:575~582. itchell EP (1984): The effect of physiotherapy on stress incontinence. Age EDITORIAL COMMENTS ‘This series of articles on pelvic floor muscle training investigates the value of vaginal pressure measurement with refreshing concern for the issues of reliability and validity. The authors have explored details of technique that are often overlooked, and clearly, they have preserved the goal of improving the efficacy of this treatment modality.“ Pelvic Floor Muscle Exercise for SUL 499. Part I of this series evaluates the test-retest reliability of maximal pelvic floor muscle (PFM) contraction as measured by air- filled vaginal balloon. The authors conclude that the methods are reproducible based on small differences between the median values. The test-retest reliability is not high (¢ = .48), but the task of determining reliability in this context is complicated. Variability in the dependent measure can be attributed not only to measurement technique (such as slight differ- ences in balloon placement), but to erratic performance of an unpracticed skill. By measuring PFM contractions at time 1 and time 2, one is measuring different behav- iors, as opposed to measuring the same entity at two different times. One might find higher reliability if variation due to measurement technique were more isolated, for instance by reducing variability in performance. This might be accomplished by training subjects first or by using subjects who are more practiced and whose per- formance is therefore more consistent. Part Il investigates a very important issue, the validity of measuring PFM contractions using the vaginal balloon. The authors conclude that vaginal pressure rise per se is not a valid parameter in evaluation of PFM contraction, because the balloon registers pressure rises resulting from contraction of abdominal, gluteal, and adductor muscles, as well as total body muscle contraction, forced inspiration, and forced expiration. They comment further that vaginal pressure measurement of PFM strength is valid, however, with simultaneous observation of inward movement of the catheter. This is a rational stance, based on the original assumption that inward movement is the gold standard. Although it is not a valid parameter by itself, the authors suggest that vaginal pressure can be used to measure degree of strength on the basis that it is impossible to strain and obtain inward movement of the catheter at the same time. However, the data do not rule out the possibility that PFM pressure can occur concomitantly with and yet exceed abdominal pressure resulting in inward movement. In fact it is highly likely that the vaginal balloon pressure reflects a sum of PFM and abdominal muscle pressure: especially in light of Study III in which experienced trainers exhibited increased EMG activity in abdominal muscles during efforts at selective PFM contraction. Study III indicates that abdominal muscle activity can frequently occur with “‘correct”” PFM activity. Our data are similar. We often see inward movement of the measurement device with contraction of vaginal muscles or the external anal sphincter while, at the same time, the patient is bearing down. Finally, although rectus abdominis muscle EMG activity was found to accom- pany maximal PFM contraction in Study III, the data do not support the conclusion that a rise in EMG activity of the lower part of rectus abdominis is ‘‘unavoidable if efficient PFM training shall be obtained.”” These women had extensive experience in PFM training, but apparently they did not have training, with accurate feedback, to Jearn abdominal relaxation. It is entirely possible that with specific feedback and training a selective PFM contraction accompanied by abdominal relaxation could be learned. The measurement techniques used in this study have the same difficulty as other vaginal pressure techniques. They are not specific for pelvic floor muscles, and this has potential for interfering with PFM training. Even if they were specific, we still face the problem that most women tend to use abdominal and other muscle groups simultaneously, which can be counterproductive to their attempts to avoid urine loss. One solution to this problem is to measure abdominal activity independently as the500 Beet al. during PFM contraction (Burgio et al., 1985, 1986). Despite the limitations of vag- inal pressure measurement, the technique has proven especially valuable in the treat- ment of urinary incontinence as demonstrated in Part III. Part III in this series is a small, but nicely designed clinical trial comparing two PFM exercise programs for treatment of stress urinary incontinence. One group participated in PFM training and home practice. The second group received, in addition, intensive weekly training with an instructor and produced better results. The findings of the study are predictable and underscore the importance of following and encouraging the efforts of patients who are involved in a program of PFM exercise. Further, it sheds light on the possible reasons for failure when PFM exercises are merely described or taught only briefly. Because of many differences between the two treatment groups, one cannot tell whether the differences are due to the effects of group contact, therapist contact, the addition of more (fast) contractions to the programs, practicing in various positions, feedback, improved compliance, or some combination. Nevertheless, the results are important and constitute a significant contribution to the literature. The results send an important message to trainers: “Don’t leave your patients alone with pelvic floor muscle exercises.”” Kathryn L. Burgio, Ph.D. School of Medicine University of Pittsburgh REFERENCES Burgio KL, Whitehead WE, Engel BT (1985): Urinary incontinence in the elderly; bladder-sphincter feedback and toileting skills raining. Ann Intern Med 104:507-515. Burgio KL, Robinson JC, Engel! BT (1986): The role of biofeedback in Kegel exercise training for stress urinary incontinence. Am J Obstet Gynecol 154:58-64. AUTHOR'S REPLY We agree with the editorial comment that a test-retest to determine reliability of vaginal pressure measurements of pelvic floor muscle (PFM) strength is complicated and that the variability can be attributed to erratic performance and unpracticed skill of the participants. In fact this was demonstrated in our results during the clinical trial period. As soon as the women had learned how to perform a correct contraction and had exercised regularly for a few days, the peak pressure rises during ten successive contractions became consistant. The main reason for the low correlation coefficient is that the correlation anal- ysis makes a comparison between subjects (intervariation) as well as a comparison among the actual tests performed by the same subject. When the intervariation is large, as in pelvic floor muscle strength, and the number of subjects is small, the correlation coefficient accordingly will be small. We consider the true variability between the tests to be properly demonstrated in Figures 2 and 3 in addition to Table I. Inward movement of the PFM and the perineum during a PEM contraction is the gold standard of a correct contraction. This standard is based on clinical observationPelvic Floor Muscle Exer for SUL SOI of the catheter movement and vaginal and perineal palpation. In addition, it can be visualized by ultrasound scanning [Beco et al., 1987] In clinical tests we never witness an inward movement of the catheter while the women are bearing down. Such observations, as reported by Burgio, may be based on the misinterpretation that bearing down and abdominal muscle contraction is the same. By bearing down, the respiratory diaphragm presses the abdominal wall in a frontal direction. This distention is not due to an active abdominal muscle contrac- tion, but to a passive push of the abdominal wall. If movement is allowed, a con- traction of the lower m.rectus abdominis will curve the lower back. If movement is not allowed, there will be an inward movement of abdominal wall. These two forms of abdominal contractions were not allowed in our study. The women were taught nor to contract other muscles. However, we have observed that in thin women, a very small “tucking in"” with the lower part of the m. rectus abdominis simultaneous with attempts of maximal contraction can be ob- served. This “tucking in’ is almost invisible, but women with a high degree of body awareness have recognized this small contraction. The small contraction can be done simultaneous with normal breathing. In Study III Part II, which indeed is a very small study, we suggest that during a maximal or close 10 maximal contraction there is a small synergistic contraction of the very lower part of the m. rectus abdominis. We agree with the editorial comment that a PFM contraction can be performed without contraction of the abdominal muscles. In our experience it is not difficult to teach how to perform a PFM contraction without use of these other muscles. Indeed, this was demonstrated in Study II Part II. In this study there was no EMG activation during SUBMAXIMAL contractions. So what we are measuring with no activation on the EMG is not a contraction that reaches maximum strength. We have aimed to teach very strong PFM contractions in order to get significant effect on PFM strength and stress urinary incontinence (SUI). The main results of Part It demonstrate that simultaneously adding maximum force from abdominal, hip adductor, and gluteal muscles with a correct pelvic floor muscle contraction, does not add significant pressure rise above that registered from pelvic floor muscle contraction ‘‘alone.”* In the editorial comment it is suggested that the use of abdominal muscles and other muscle groups simultaneously with the PFM can be counterproductive in at- tempting to avoid urine loss. Again, there should be a differentiation between an abdominal muscle contraction and a bearing down. Bearing down/straining has shown to press a hypermobile bladder and urethra downward [Koelbl et al., 1988]. Bearing down may be counterproductive, but we do not know whether a small synergistic contraction of the lower rectus abdominis during PFM contraction is. This needs further investigation. ‘The aim of our study was to design a PFM exercise program based on the science of work physiology and the mechanisms to increase muscle strength, and to compare this to a control group performing PFM exercise as they often are taught. In order to recruit as many motor units as possible and in order to produce muscle hypertrophy, we have used Positions that made it difficult to contract other muscles than the PFM Sustained contraction with 3-4 fast contractions on the top Strong verbal encouragement502 Bo et al. These three factors should not be separated because they all aim at the same goal: maximum contraction. We agree with the editorial comment that the significant improvement, mea- sured by the women’s own judgement, could be influenced by the effect of group or therapist contact. Nevertheless, there were significant differences in muscle strength, pad test, and urodynamic assessments between the two groups. We do not agree with the characterization of Part III as a small study. The number of participants in this study was statistically adequate, and this study is one of the largest published studies that evaluates the effect of PFM exercise on female SUI. We agree that vaginal pressure measurements of PFM strength are difficult. However, these studies have demonstrated that some of the problems can be solved with the use of other methods, such as palpation and simultaneous observation of the vaginal catheter. Compared to other studies of PFM strength we are sure that the present study: Did not involve measurements of women who were straining/bearing down Obtained measurements from an anatomical reproducible placement of the balloon Avoided movement of the pelvis or other parts of the body simultaneous with attempts of MAXIMUM contraction. In the future, ultrasound scanning and MRI may reveal more of the function of the PFM in maintenance of female continence and may also help explain more of the physiological effects of PFM exercise. Such studies are now in progress. REFERENCES Beco J, Sulu M, Schaaps JP, Lambotte R (1987): A new approach to the troubles of urinary incontinence in women: Urodynamic ultrasound examination by the vaginal route. J Gynecol Obstet Biol Reprod 16:987-998 (French). Koelbl H, Bemaschek G, Wolf G (1988): A comparative study of perineal ultrasound scanning and urethro cystography in patients with genuine stress incontinence. Arch Gynecol Obstet 244:39-45.