Acta Obstet Gynecol Scand 2000; 79: 598603 Printed in Denmark All rights reserved

Copyright C Acta Obstet Gynecol Scand 2000

Acta Obstetricia et Gynecologica Scandinavica

ISSN 0001-6349

ORIGINAL ARTICLE

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Randomized controlled trial on the effect of pelvic oor muscle training on quality of life and sexual problems in genuine stress incontinent women
KARI B1, TRYGVE TALSETH2 AND ANNE VINSNES3
From the 1Norwegian University of Sport and Physical Education, Ullevl stadium, Oslo, the 2National Hospital of Norway, Oslo, and the 3Institute of Nursing Science, Faculty of Medicine, University of Oslo, Norway

Acta Obstet Gynecol Scand 2000; 79: 598603. C Acta Obstet Gynecol Scand 2000 Background. The purpose of the present study was to evaluate the effect of pelvic oor muscle exercise on quality of life, lifestyle and sex-life variables in genuine stress incontinent women. Methods. Fifty-nine women with clinically and urodynamically proven genuine stress incontinence were randomized to either pelvic oor muscle exercise or an untreated control group. The intervention group was asked to perform 812 close to maximum contractions in 3 series per day. In addition they were exercising 45 minutes per week in groups. The intervention period was 6 months, and the women in the exercise group met once a month for individual assessment of pelvic oor muscle strength and motivation. Outcome measures were the Norwegian version of the Quality of Life Scale (QoLS-N) and the Bristol Female Lower Urinary Tract Symptoms (B-FLUTS) questionnaire. Results. The results showed that general quality of life measured by the generic quality of life questionnaire was not much affected by urinary incontinence. However, the disease specic questionnaire demonstrated that ability to participate in physical activity and some sex-life variables were affected by the condition. There was a statistically signicant (p 0.01) reduction in number of women having problems with sex-life, social life, and physical activity in the exercise group after six months of pelvic oor muscle exercise. Conclusion. Pelvic oor muscle exercise showed some effect on quality of life and sex-life variables. Key words: genuine stress incontinence; pelvic oor muscle exercise; quality of life; sex-life; strength training Submitted 25 October, 1999 Accepted 18 January, 2000

Randomized controlled trials (RCT) have demonstrated that pelvic oor muscle (PFM) training is more effective than no treatment (14) and more effective than both electrical stimulation (1,2) and vaginal cones (2) in treatment of genuine stress incontinence (GSI). In a former published RCT we
Abbreviations: GSI: genuine stress incontinence; PFM: pelvic oor muscles; QoL: quality of life; UI: urinary incontinence; RCT: randomized controlled trials. C Acta Obstet Gynecol Scand 79 (2000)

reported the results of such training on PFM function and strength, urodynamic variables, and urinary leakage. After the 6 month intervention period 56% in the exercise group reported that the condition was unproblematic compared to 3.3% in the control group (2). The exercise group signicantly reduced urinary leakage from mean 38.6 grams (95% CI: 25.152.1) to 8.4 (95% CI: 3.9 12.9) (p 0.001). PFM strength was increased from 11 cm H2O (95% CI: 7.714.3) to 19.2 cm H2O (95% CI.15.323.1) (p 0.001). There were no sig-

Pelvic oor muscle exercise, lifestyle and sex-life nicant changes in the untreated control group (2). The World Health Organization (WHO) has developed a system for outcome measures in rehabilitation interventions, named the International Classication of Impairment, Disability, and Handicap/Participation (ICIDH) (5). According to this system pelvic oor muscle function and strength can be either at the patho-physiological or the impairment level. Urinary leakage is at the disability level. Interference with quality of life, lifestyle, and sexual matters can be classied at the Handicap/Participation level. Urinary incontinence has been shown to inuence quality of life issues (6, 7) and it has been recommended to add quality of life and life-style issues as outcome variables when evaluating the effect of all intervention trials for urinary incontinence (8,9). Several authors have found that urinary incontinence (UI) affects womens sexlife (1012). Hilton (12) reported that 24% of women referred to a gynecological urology clinic experienced urinary leakage during intercourse, and Clark and Romm (10) showed that 66% of urinary incontinent women experienced incontinence, urgency or frequency during sexual activity. On the other hand, other studies found that urinary incontinence did not severely inuence womens sexuality in a negative way (1315). Some authors have claimed that PFM strength training can be effective in improving womens sexlife (16, 17). However, methodological issues related to appropriate control groups have been requested (18). To our knowledge, to date, no RCT has been conducted to evaluate the effect of PFM strength training on reducing leakage during intercourse or sexual matters in GSI women. The aim of the present study was to compare the effect of a 6 month intensive PFM training program on quality of life, lifestyle, and sex-life variables in women with GSI and to compare it with a randomized untreated control group.
Material and methods

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random numbers. Information for decoding randomization was kept locked in the statisticians ofce. Inclusion criteria were history of stress urinary incontinence and 4 grams of leakage measured by the pad test. Exclusion criteria were urinary incontinence other than GSI, involuntary detrusor contractions exceeding 10 cm H2O on cystometry, residual urine 50 ml , maximal uroow 15 ml/s, previous surgery for GSI, neurological or psychiatric disease, ongoing urinary tract infections, other diseases that could interfere with participation, use of concomitant treatments during the trial, and inability to understand instructions given in Norwegian. The study was approved by the local ethics committee, and all women gave written consent. Background variables for the two groups are given in Table I. There were no statistically signicant differences between groups at baseline (2). Intervention The training group was asked to perform 812 close to maximum contractions in 3 series per day. In addition they were attending a 45 minute PFM strength training class once a week with an experienced physiotherapist. In the exercise class motivation for maximum contraction of the PFM during every attempt was emphasized. PFM exercise was performed in lying, standing, kneeling, and sitting positions with legs apart to emphasize specic strength training of the PFM. Participants aimed at holding each contraction for 68 seconds, 34 fast contractions were then added. The rest period between contractions was approximately 6 seconds. A total of 812 contractions were completed in each position. Body awareness, breathing, relaxation, exercises, and strength training for the abdominal, back, and thigh muscles were performed to music between positions. The participants were encouraged to perform equally intensive contractions at home, and an audiotape with verbal guidance was available for home training. A training diary was kept. The women met the physiotherapist once a month for individual assessment of PFM strength

Thirty women with clinically and urodynamically proven GSI were randomized to the control group and 29 to the training group after stratication on degree of leakage measured by a provocative pad test with standardized bladder volume (2). The power calculation of the study was based on the power estimation and the results of a previous RCT designed to detect differences of 1 s.d. with a power of 80% and an a of 5% (2, 19). Randomization schemes stratied by degree of incontinence (20 grams and 20 grams of leakage) were constructed by using computer generated

Table I. Background variables for the training and control groups before treatment. Mean and s.d. Non signicant differences between groups Training Mean age (years) BMI (kg/m2) Parity Duration of symptoms (years) Stress pad test (grams) 49.6 25.1 2.3 10.2 38.6 (10.0) (2.8) (0.8) (7.7) (34.7) Control 51.7 25.8 2.4 9.9 51.4 (8.8) (3.7) (0.9) (7.8) (48.2)

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Table II. Percentage of women with a little, some, and much problems in sex-life variables before and after 6 months intervention measured by B-FLUTS Difference between groups after treatment 0.54 0.01 0.01 0.1 0.1 0.02 0.01 0.02 0.03 Cochran-MantelHaenszel

PFM exercise Problems because of avoiding places and situations Problems with interference with social life Problem with interference with physical activity Overall interference with life Unsatised if you had to spend the rest of your life with symptoms as now Before After Before After Before After Before After Before After 37.5% 28.0% 28.6% 3.7% 87.5% 43.5% 61.9% 56.0% 20.8% 4.0%

Control 36.7% 34.4% 33.3% 40.7% 85.7% 79.3% 86.2% 82.1% 33.3% 37.9%

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Table III. Percentage of women with little, some, and much problems in sex-life variables before and after 6 months intervention measured by B-FLUTS Difference between groups after intervention Cochran-MantelHaenszel

PFM exercise Sex-life spoilt by urinary symptoms Problem with sex-life spoilt by urinary symptoms Problem with pain in intercourse UI with intercourse Before After Before After Before After Before After 40.0% 16.7% 33.3% 11.1% 33.4% 10.5% 20.0% 10.5%

Control 46.2% 50.0% 52.2% 50.0% 20% 33.3% 45.8% 41.7%

0.03 0.02 0.1 0.02

0.9 0.02 0.05

and motivation for training (2, 19). The intervention period was 6 months. The control group had no contact during the intervention period. However, they were offered the opportunity to use the Continence Guard (Coloplast A/S) (2). Outcome measures In order to relate the QoL-score in women diagnosed with GSI to other groups we decided to use a generic QoL instrument. Hence the Norwegian version of the Quality of Life Scale (QoLS-N) was used to assess general health and quality of life (20). The scale is a 16 item scale adapted and modied for use in chronic illness population by Burckhardt et al. (21). The Norwegian version uses a 7 point satisfaction scale (20, 21). We also wanted to specically assess the impact of GSI on QoL. Hence the Bristol Female Lower Urinary Tract Symptoms (B-FLUTS) questionnaire was used as a condition specic quality of life questionnaire before and after treatment (22, 23). This instrument has been specically designed to subjectively quantify urinary incontinence and to assess how degree of bother inuence the impact of quality of life. The instrument
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has been tested for reliability and validity and was found to have acceptable reproducibility and validity (23). It also correlates well with objective measures of uid loss (23). Only those questions related to lifestyle (question nos 2831, 33) and sex-life (question nos 2124) will be reported here. Those women using the Continence guard answered two questionnaires, one that applied for the condition without the guard and another with use of the guard. The present results are reported without the guard.

Statistical analysis Generic QoL scores using the QoLS-N are given as mean and SEM before and after the intervention. Results of the B-FLUTS are reported as frequencies and positive ndings are grouped together (a little, somewhat, a lot or a bit of a problem, quite a problem, a serious problem). Wilcoxon two-sample rank test corrected for ties was used to compare the groups before and after treatment. Cochran-Mantel-Haenszel test was used to adjust for pre-values. Signicance level was set to 5%.

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Results

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There were four drop-outs in the training group, two due to causes outside the intervention and two due to lack of motivation. There were no drop-outs in the control group. In the control group the score on the generic QoLS-N changed from 82.3 (SEM 2.6) to 85.2 (SEM 2.2). For the exercise group pretreatment score was 85.3 (SEM 1.6), and posttreatment 90.1 (SEM 1.9). Neither changes were statistically signicant. There was no signicant difference between groups either before (p0.57) or after (p0.16) the intervention. Differences between groups on B-FLUTS variables after the 6 months treatment period are shown in Tables II and III. There were no signicant differences in any variables before the treatment period. Five women in each group reported that they did not have a sex-life at present. Table II shows that there was signicantly fewer women reporting problems in all quality of life and lifestyle variables, except avoiding places and situations, in the training group compared to control after treatment. Table III shows that the number of women with sex related problems was signicantly lower in the training group compared to the control after treatment, except for the variable pain during intercourse. When controlling for pre-values the variables: sex-life spoilt by urinary incontinence, urinary incontinence with intercourse and having problems because of avoiding places and situations no longer reached statistical signicance.
Discussion

The results of the present study demonstrated a signicant improvement from PFM training in several life-style, QoL, and sex-life variables compared with an untreated control group. The sample size of 25 and 30 women, with ve women in each group not having a sex-life at present, may have contributed to non signicant results when correcting for pre-test values. The effect may therefore be underestimated, and the results should be interpreted with some caution. Although this sample of women had substantial GSI measured by stress pad test (2), it did not make many women avoid places and situations in general. Other studies have documented that, even though patients express some negative feelings about their UI, they use a variety of strategies to live their lives in a manner that enables them to feel normal (14, 24, 25). It has been documented that co-morbidity is not a determinant of UI (15), which leads to the conclusion that middle aged women with UI often

have good health. It is also documented that women between 2049 years of age have less QoL impairment, and they are more likely to seek treatment (11). Hence, relevant improvement in lower urinary tract symptomatology (disability level) may not produce signicant improvement in general health score (participation level). The overall QoL-score in our group was quite high at pre-test. Statistically signicant changes, by means of an overall QoL improvement, may therefore both be difcult to achieve and unrealistic to suppose. Also another study, using both generic and condition-specic instruments, found the same; the QoL improvement that was noted with a condition-specic instrument, was not supported with a generic QoL instrument (26). Previous studies have shown that GSI has less impact on generic QoL outcomes than urge incontinence (7, 27). Our results may reect the fact that we only included women with GSI. Participation in physical activity was greatly affected. This corresponds with former studies showing that women with GSI withdraw from physical activities and have problems especially during high impact activities (28, 29). Since participation in regular moderate physical activity is important to good health and in prevention of e.g. coronary heart disease, high blood pressure, obesity, osteoporosis, anxiety and depression, withdrawal from regular physical activity can be a threat to womens health (30). In general, GSI may be more noticeable in the active woman than in the sedentary, and therefore GSI may be more difcult to treat in physically active women. However, the results of the present study correspond with other studies demonstrating that it is possible to improve GSI womens ability to participate in physical activity by PFM strength training (19, 28). In the present study more than 40% of the women reported that their sex-life was spoilt by urinary leakage. This corresponds with results from other studies (1012). On the other hand, some research groups have not found such associations. Berglund & Fugl-Meyer found that neither the magnitude of the leakage nor the duration of the GSI inuenced the womens sexual experiences signicantly (13). Klemm & Creason found that none of the women they included in their study felt differently about themselves sexually, or as a woman, because of their UI (14). Samuelsson et al. did not nd a statistically signicant difference between continent and incontinent women on a generic QoL instrument (15). It has been claimed that PFM training is important for female sexuality, and PFM exercise are often recommended if women have sexual problems (16, 17). These recommendations seem to be
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kin D et al. Conservative treatment for women. In: Abrams P, Khory S, Wein A. Incontinence. WHO 1st consultation on incontinence. Plymbridge Distributors Ltd, 1999. Lagro-Janssen A, Debruyne F, Smiths A, Van Weel C. The effects of treatment of urinary incontinence in general practice. Fam Pract 1992; 9(3): 2849. International Classication of Impairment, Disability, and Handicap (ICIDH). Zeist, The Netherlands. WHO. 1997; ICIDH-2-Beta-1 Draft. Norton P, MacDonald LD, Sedgwick PM, Stanton SL. Distress and delay associated with urinary incontinence, frequency, and urgency in women. BMJ 1988; 297: 11879. Hunskaar S, Vinsnes A. The quality of life in women with urinary incontinence as measured by the sickness impact prole. JAGS 1991; 39: 37882. Fantl J, Newman D, Colling J et al. Urinary incontinence in adults: acute and chronic management 2, update. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research. 1996; 960682. Clinical Practice Guideline. Blaivas J, Appell R, Fantl J, Leach G, McGuire E, Resnick N et al. Standards of efcacy for evaluation of treatment outcomes in urinary incontinence: recommendations of the urodynamic society. Neurourol Urodyn 1997; 16(145): 147. Clark A, Romm J. Effect of urinary incontinence on sexual activity in women. J Reprod Med 1993; 38(9): 67983. Kelleher C, Cardozo L, Wise B et al. The impact of urinary incontinence on sexual function. [Abstract] Neurourol Urodyn 1992; 11(4): 35960. Hilton P. Urinary incontinence during sexual intercourse: a common, but rarely volunteered, symptom. Br J Obstet Gynaecol 1988; 95: 33781. Berglund A, Fugl-Meyer K. Some sexological characteristics of stress incontinent women. Scand J Urol Nephrol 1996; 30: 20712. Klemm L, Creason N. Self-care practices of women with urinary incontinence a preliminary study. Health Care Women Int 1991; 12(2): 199209. Samuelsson E, Victor A, Tibblin G. A population study of urinary incontinence and nocturia among women aged 20 59 years. Prevalence, well-being and wish for treatment. Acta Obstet Gynecol Scand 1997; 76(1): 7480. Kegel A. Sexual functions of the pubococcygeus muscle. W J Surg, Obstet Gynecol 1952; 60: 5214. Graber B, Kline-Graber G. Female orgasm : role of pubococcygeus muscle. J Clin Psychiatry 1979; 40: 34851. Wyman J. The psychiatric and emotional impact of female pelvic oor dysfunction. Curr Opin Obstet Gynecol 1994; 6(4): 33669. B K, Hagen RH, Kvarstein B, Jrgensen J, Larsen S. Pelvic oor muscle exercise for the treatment of female stress urinary incontinence: III. Effects of two different degrees of pelvic oor muscle exercise. Neurourol Urodyn 1990; 9: 489502. Wahl A, Burckhardt C, Wiklund I, Hanestad V. The Norwegian version of the quality of life scale (QoLS-N). Scand J Caring Sci 1998; 12: 21522. Burckhardt C, Woods S, Schultz A, Ziebarth D. Quality of life in adults with chronic illness: a psychometric study. Res Nurs Health 1989; 12: 34754. Jackson S, Shepherd A, Brookes S, Abrams P. The effect of oestrogen supplementation on post-menopausal urinary stress incontinence: a double-blind placebo-controlled trial. Br J Obstet Gynaecol 1999; 106: 71118. Jackson S, Donovan J, Brookes S, Eckford S, Swithinbank L, Abrams P. The Bristol female lower urinary tract symptoms questionnaire: development and psychometric testing. Br J Urol 1996; 77: 80512.

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based more on anecdotal stories than scientic evidence, and the theoretical background for how and why the training should improve womens sexual function is rather vague. It is not easy to understand whether the authors are referring to womens ability to achieve orgasm, length and strength of orgasm, number of orgasms, perception in the vagina during intercourse, a more general feeling of well-being and self-esteem, or even whether it is referred to male or female perception. Some authors have shown that there is no link with PFM strength and female orgasm (31, 32). In the present study fewer women in the PFM exercise group reported their sex-life to be spoilt by urinary leakage than in the control group after treatment. However, this signicance disappeared when corrected for pre-values. Larger sample sizes may change this in favor of training. The number of women reporting this to be a problem for them was, however, signicantly fewer in the exercise group. This is different from the ndings of Wilson and Herbison (33). However, they used another questionnaire and were investigating a population of postnatal women. A direct comparison of results cannot, therefore, be done. Our results point to the value of PFM exercise on some sex-life issues. However, the results of the present study should be interpreted with caution. The small number of women having a sex-life bias the interpretation of the results. A more in-depth information about dysfunction related to the sexual response cycle is necessary in order to understand the complexity of womens sexuality. We need further information about the occurrence of UI during intercourse, e.g. whether the leakage occurs during the penetration movements or whether the occurrence of UI during intercourse is related to one of the phases: desire, excitement, orgasm or resolution phases.
Acknowledgments
We thank Ingar Holme, Professor in Biostatistics, for valuable help with the statistical analyses. This research was funded by The Norwegian Fund for Postgraduate Studies in Physiotherapy and The Norwegian Research Council. In addition, Coloplast AS gave nancial support to the study.

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