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Acta Obstet Gynecol Scand 2000; 79: 598–603 Copyright C Acta Obstet Gynecol Scand 2000

Printed in Denmark ¡ All rights reserved


Acta Obstetricia et
Gynecologica Scandinavica
ISSN 0001-6349

ORIGINAL ARTICLE

Randomized controlled trial on the effect of


pelvic floor muscle training on quality of life
and sexual problems in genuine stress
incontinent women
KARI BØ1, TRYGVE TALSETH2 AND ANNE VINSNES3

From the 1Norwegian University of Sport and Physical Education, Ullevål 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: 598–603. C Acta Obstet Gynecol Scand 2000

Background. The purpose of the present study was to evaluate the effect of pelvic floor 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 inconti-
nence were randomized to either pelvic floor muscle exercise or an untreated control group.
The intervention group was asked to perform 8–12 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 floor muscle strength and motivation. Outcome measures were the Nor-
wegian 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 specific
questionnaire demonstrated that ability to participate in physical activity and some sex-life
variables were affected by the condition. There was a statistically significant (p⬍0.01) reduc-
tion in number of women having problems with sex-life, social life, and physical activity in
the exercise group after six months of pelvic floor muscle exercise.
Conclusion. Pelvic floor muscle exercise showed some effect on quality of life and sex-life
variables.

Key words: genuine stress incontinence; pelvic floor muscle exercise; quality of life; sex-life;
strength training

Submitted 25 October, 1999


Accepted 18 January, 2000

Randomized controlled trials (RCT) have demon- reported the results of such training on PFM func-
strated that pelvic floor muscle (PFM) training is tion and strength, urodynamic variables, and uri-
more effective than no treatment (1–4) and more nary leakage. After the 6 month intervention
effective than both electrical stimulation (1,2) and period 56% in the exercise group reported that the
vaginal cones (2) in treatment of genuine stress in- condition was unproblematic compared to 3.3% in
continence (GSI). In a former published RCT we the control group (2). The exercise group signifi-
cantly reduced urinary leakage from mean 38.6
grams (95% CI: 25.1–52.1) to 8.4 (95% CI: 3.9–
Abbreviations:
GSI: genuine stress incontinence; PFM: pelvic floor muscles; 12.9) (p⬍0.001). PFM strength was increased from
QoL: quality of life; UI: urinary incontinence; RCT: ran- 11 cm H2O (95% CI: 7.7–14.3) to 19.2 cm H2O
domized controlled trials. (95% CI.15.3–23.1) (p⬍0.001). There were no sig-
C Acta Obstet Gynecol Scand 79 (2000)
Pelvic floor muscle exercise, lifestyle and sex-life 599
nificant changes in the untreated control group (2). random numbers. Information for decoding ran-
The World Health Organization (WHO) has de- domization was kept locked in the statisticians’ of-
veloped a system for outcome measures in rehabili- fice. Inclusion criteria were history of stress uri-
tation interventions, named the International nary incontinence and ⬎4 grams of leakage meas-
Classification of Impairment, Disability, and ured by the pad test. Exclusion criteria were
Handicap/Participation (ICIDH) (5). According to urinary incontinence other than GSI, involuntary
this system pelvic floor muscle function and detrusor contractions exceeding 10 cm H2O on cy-
strength can be either at the patho-physiological stometry, residual urine ⬎50 ml , maximal uroflow
or the impairment level. Urinary leakage is at the ⬍15 ml/s, previous surgery for GSI, neurological
disability level. Interference with quality of life, or psychiatric disease, ongoing urinary tract infec-
lifestyle, and sexual matters can be classified at the tions, other diseases that could interfere with par-
Handicap/Participation level. ticipation, use of concomitant treatments during
Urinary incontinence has been shown to in- the trial, and inability to understand instructions
fluence quality of life issues (6, 7) and it has given in Norwegian. The study was approved by
been recommended to add quality of life and the local ethics committee, and all women gave
life-style issues as outcome variables when evalu- written consent. Background variables for the two
ating the effect of all intervention trials for uri- groups are given in Table I. There were no statisti-
nary incontinence (8,9). Several authors have cally significant differences between groups at
found that urinary incontinence (UI) affects baseline (2).
women’s sexlife (10–12). Hilton (12) reported that
24% of women referred to a gynecological urol- Intervention
ogy clinic experienced urinary leakage during in-
tercourse, and Clark and Romm (10) showed The training group was asked to perform 8–12
that 66% of urinary incontinent women experi- close to maximum contractions in 3 series per day.
enced incontinence, urgency or frequency during In addition they were attending a 45 minute PFM
sexual activity. On the other hand, other studies strength training class once a week with an experi-
found that urinary incontinence did not severely enced physiotherapist. In the exercise class motiva-
influence women’s sexuality in a negative way tion for maximum contraction of the PFM during
(13–15). every attempt was emphasized. PFM exercise was
Some authors have claimed that PFM strength performed in lying, standing, kneeling, and sitting
training can be effective in improving women’s sex- positions with legs apart to emphasize specific
life (16, 17). However, methodological issues re- strength training of the PFM. Participants aimed
lated to appropriate control groups have been re- at holding each contraction for 6–8 seconds, 3–4
quested (18). To our knowledge, to date, no RCT fast contractions were then added. The rest period
has been conducted to evaluate the effect of PFM between contractions was approximately 6 sec-
strength training on reducing leakage during inter- onds. A total of 8–12 contractions were completed
course or sexual matters in GSI women. in each position. Body awareness, breathing, relax-
The aim of the present study was to compare the ation, exercises, and strength training for the ab-
effect of a 6 month intensive PFM training pro- dominal, back, and thigh muscles were performed
gram on quality of life, lifestyle, and sex-life vari- to music between positions. The participants were
ables in women with GSI and to compare it with encouraged to perform equally intensive contrac-
a randomized untreated control group. tions at home, and an audiotape with verbal guid-
ance was available for home training. A training
diary was kept.
Material and methods
The women met the physiotherapist once a
Thirty women with clinically and urodynamically month for individual assessment of PFM strength
proven GSI were randomized to the control group
and 29 to the training group after stratification on
degree of leakage measured by a provocative pad Table I. Background variables for the training and control groups before treat-
test with standardized bladder volume (2). The ment. Mean and s.d. Non significant differences between groups
power calculation of the study was based on the
Training Control
power estimation and the results of a previous
RCT designed to detect differences of 1 s.d. with Mean age (years) 49.6 (10.0) 51.7 (8.8)
a power of 80% and an a of 5% (2, 19). BMI (kg/m2) 25.1 (2.8) 25.8 (3.7)
Randomization schemes stratified by degree of Parity 2.3 (0.8) 2.4 (0.9)
incontinence (Æ20 grams and ⬎20 grams of leak- Duration of symptoms (years)
Stress pad test (grams)
10.2
38.6
(7.7)
(34.7)
9.9
51.4
(7.8)
(48.2)
age) were constructed by using computer generated
C Acta Obstet Gynecol Scand 79 (2000)
600 K. Bø et al.

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 Cochran-Mantel-


PFM exercise Control after treatment Haenszel

Problems because of avoiding places and situations Before 37.5% 36.7% ⬍0.54
After 28.0% 34.4%
Problems with interference with social life Before 28.6% 33.3% ⬍0.01 ⬍0.02
After 3.7% 40.7%
Problem with interference with physical activity Before 87.5% 85.7% ⬍0.01 ⬍0.01
After 43.5% 79.3%
Overall interference with life Before 61.9% 86.2% ⬍0.1 ⬍0.02
After 56.0% 82.1%
Unsatisfied if you had to spend the rest of your Before 20.8% 33.3% ⬍0.1 ⬍0.03
life with symptoms as now After 4.0% 37.9%

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 Cochran-Mantel-


PFM exercise Control after intervention Haenszel

Sex-life spoilt by urinary symptoms Before 40.0% 46.2%


After 16.7% 50.0% 0.03 0.9
Problem with sex-life spoilt by urinary symptoms Before 33.3% 52.2%
After 11.1% 50.0% 0.02 0.02
Problem with pain in intercourse Before 33.4% 20%
After 10.5% 33.3% 0.1 ⬍0.05
UI with intercourse Before 20.0% 45.8%
After 10.5% 41.7% 0.02

and motivation for training (2, 19). The inter- has been tested for reliability and validity and was
vention period was 6 months. The control group found to have acceptable reproducibility and valid-
had no contact during the intervention period. ity (23). It also correlates well with objective meas-
However, they were offered the opportunity to use ures of fluid loss (23). Only those questions related
the Continence Guard (Coloplast A/S) (2). to lifestyle (question nos 28–31, 33) and sex-life
(question nos 21–24) will be reported here.
Outcome measures Those women using the Continence guard
answered two questionnaires, one that applied for
In order to relate the QoL-score in women diag- the condition without the guard and another with
nosed with GSI to other groups we decided to use use of the guard. The present results are reported
a generic QoL instrument. Hence the Norwegian without the guard.
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 Statistical analysis
modified for use in chronic illness population by
Burckhardt et al. (21). The Norwegian version uses Generic QoL scores using the QoLS-N are given as
a 7 point satisfaction scale (20, 21). mean and SEM before and after the intervention.
We also wanted to specifically assess the impact Results of the B-FLUTS are reported as frequen-
of GSI on QoL. Hence the Bristol Female Lower cies and positive findings are grouped together (‘a
Urinary Tract Symptoms (B-FLUTS) ques- little, somewhat, a lot’ or ‘a bit of a problem, quite
tionnaire was used as a condition specific quality a problem, a serious problem’).
of life questionnaire before and after treatment Wilcoxon two-sample rank test corrected for ties
(22, 23). This instrument has been specifically de- was used to compare the groups before and after
signed to subjectively quantify urinary inconti- treatment. Cochran-Mantel-Haenszel test was
nence and to assess how degree of ‘bother’ influ- used to adjust for pre-values. Significance level was
ence the impact of quality of life. The instrument set to 5%.
C Acta Obstet Gynecol Scand 79 (2000)
Pelvic floor muscle exercise, lifestyle and sex-life 601

have good health. It is also documented that


Results
women between 20–49 years of age have less QoL
There were four drop-outs in the training group, impairment, and they are more likely to seek treat-
two due to causes outside the intervention and two ment (11). Hence, relevant improvement in lower
due to lack of motivation. There were no drop-outs urinary tract symptomatology (disability level)
in the control group. In the control group the score may not produce significant improvement in gen-
on the generic QoLS-N changed from 82.3 (SEM eral health score (participation level).
2.6) to 85.2 (SEM 2.2). For the exercise group pre- The overall QoL-score in our group was quite
treatment score was 85.3 (SEM 1.6), and post- high at pre-test. Statistically significant changes, by
treatment 90.1 (SEM 1.9). Neither changes were means of an overall QoL improvement, may there-
statistically significant. There was no significant fore both be difficult to achieve and unrealistic to
difference between groups either before (pΩ0.57) suppose. Also another study, using both generic
or after (pΩ0.16) the intervention. and condition-specific instruments, found the
Differences between groups on B-FLUTS vari- same; the QoL improvement that was noted with
ables after the 6 months treatment period are a condition-specific instrument, was not supported
shown in Tables II and III. There were no signifi- with a generic QoL instrument (26). Previous
cant differences in any variables before the treat- studies have shown that GSI has less impact on
ment period. Five women in each group reported generic QoL outcomes than urge incontinence (7,
that they did not have a sex-life at present. Table 27). Our results may reflect the fact that we only
II shows that there was significantly fewer women included women with GSI.
reporting problems in all quality of life and life- Participation in physical activity was greatly
style variables, except avoiding places and situ- affected. This corresponds with former studies
ations, in the training group compared to control showing that women with GSI withdraw from
after treatment. Table III shows that the number of physical activities and have problems especially
women with sex related problems was significantly during high impact activities (28, 29). Since partici-
lower in the training group compared to the con- pation in regular moderate physical activity is im-
trol after treatment, except for the variable pain portant to good health and in prevention of e.g.
during intercourse. coronary heart disease, high blood pressure, obes-
When controlling for pre-values the variables: ity, osteoporosis, anxiety and depression, with-
‘sex-life spoilt by urinary incontinence’, ‘urinary drawal from regular physical activity can be a
incontinence with intercourse’ and ‘having prob- threat to women’s health (30). In general, GSI may
lems because of avoiding places and situations’ no be more noticeable in the active woman than in the
longer reached ‘statistical significance’. sedentary, and therefore GSI may be more difficult
to treat in physically active women. However, the
results of the present study correspond with other
Discussion
studies demonstrating that it is possible to improve
The results of the present study demonstrated a GSI women’s ability to participate in physical ac-
significant improvement from PFM training in sev- tivity by PFM strength training (19, 28).
eral life-style, QoL, and sex-life variables com- In the present study more than 40% of the
pared with an untreated control group. women reported that their sex-life was spoilt by
The sample size of 25 and 30 women, with five urinary leakage. This corresponds with results
women in each group not having a sex-life at pres- from other studies (10–12). On the other hand,
ent, may have contributed to non significant results some research groups have not found such associ-
when correcting for pre-test values. The effect may ations. Berglund & Fugl-Meyer found that neither
therefore be underestimated, and the results should the magnitude of the leakage nor the duration of
be interpreted with some caution. Although this the GSI influenced the women’s sexual experiences
sample of women had substantial GSI measured significantly (13). Klemm & Creason found that
by stress pad test (2), it did not make many women none of the women they included in their study
avoid places and situations in general. Other felt differently about themselves sexually, or as a
studies have documented that, even though pa- woman, because of their UI (14). Samuelsson et
tients express some negative feelings about their al. did not find a statistically significant difference
UI, they use a variety of strategies to live their lives between continent and incontinent women on a
in a manner that enables them to feel normal (14, generic QoL instrument (15).
24, 25). It has been claimed that PFM training is im-
It has been documented that co-morbidity is not portant for female sexuality, and PFM exercise are
a determinant of UI (15), which leads to the con- often recommended if women have sexual prob-
clusion that ‘middle aged’ women with UI often lems (16, 17). These recommendations seem to be
C Acta Obstet Gynecol Scand 79 (2000)
602 K. Bø et al.
based more on anecdotal stories than scientific evi- kin D et al. Conservative treatment for women. In: Abrams
dence, and the theoretical background for how and P, Khory S, Wein A. Incontinence. WHO 1st consultation
on incontinence. Plymbridge Distributors Ltd, 1999.
why the training should improve women’s sexual 4. Lagro-Janssen A, Debruyne F, Smiths A, Van Weel C. The
function is rather vague. It is not easy to under- effects of treatment of urinary incontinence in general prac-
stand whether the authors are referring to women’s tice. Fam Pract 1992; 9(3): 284–9.
ability to achieve orgasm, length and strength of 5. International Classification of Impairment, Disability, and
Handicap (ICIDH). Zeist, The Netherlands. WHO. 1997;
orgasm, number of orgasms, perception in the va- ICIDH-2-Beta-1 Draft.
gina during intercourse, a more general feeling of 6. Norton P, MacDonald LD, Sedgwick PM, Stanton SL. Dis-
well-being and self-esteem, or even whether it is tress and delay associated with urinary incontinence, fre-
referred to male or female perception. Some quency, and urgency in women. BMJ 1988; 297: 1187–9.
authors have shown that there is no link with PFM 7. Hunskaar S, Vinsnes A. The quality of life in women with
urinary incontinence as measured by the sickness impact
strength and female orgasm (31, 32). profile. JAGS 1991; 39: 378–82.
In the present study fewer women in the PFM 8. Fantl J, Newman D, Colling J et al. Urinary incontinence in
exercise group reported their sex-life to be spoilt adults: acute and chronic management 2, update. Rockville,
by urinary leakage than in the control group after MD: U.S. Department of Health and Human Services,
Public Health Service, Agency for Health Care Policy and
treatment. However, this significance disappeared
Research. 1996; 96–0682. Clinical Practice Guideline.
when corrected for pre-values. Larger sample sizes 9. Blaivas J, Appell R, Fantl J, Leach G, McGuire E, Resnick
may change this in favor of training. The number N et al. Standards of efficacy for evaluation of treatment
of women reporting this to be a problem for them outcomes in urinary incontinence: recommendations of the
was, however, significantly fewer in the exercise urodynamic society. Neurourol Urodyn 1997; 16(145):
147.
group. This is different from the findings of Wilson 10. Clark A, Romm J. Effect of urinary incontinence on sexual
and Herbison (33). However, they used another activity in women. J Reprod Med 1993; 38(9): 679–83.
questionnaire and were investigating a population 11. Kelleher C, Cardozo L, Wise B et al. The impact of urinary
of postnatal women. A direct comparison of re- incontinence on sexual function. [Abstract] Neurourol Uro-
sults cannot, therefore, be done. dyn 1992; 11(4): 359–60.
12. Hilton P. Urinary incontinence during sexual intercourse:
Our results point to the value of PFM exercise a common, but rarely volunteered, symptom. Br J Obstet
on some sex-life issues. However, the results of the Gynaecol 1988; 95: 337–81.
present study should be interpreted with caution. 13. Berglund A, Fugl-Meyer K. Some sexological character-
The small number of women having a sex-life bias istics of stress incontinent women. Scand J Urol Nephrol
the interpretation of the results. A more in-depth 1996; 30: 207–12.
14. Klemm L, Creason N. Self-care practices of women with
information about dysfunction related to the sex- urinary incontinence – a preliminary study. Health Care
ual response cycle is necessary in order to under- Women Int 1991; 12(2): 199–209.
stand the complexity of women’s sexuality. We 15. Samuelsson E, Victor A, Tibblin G. A population study of
need further information about the occurrence of urinary incontinence and nocturia among women aged 20–
UI during intercourse, e.g. whether the leakage oc- 59 years. Prevalence, well-being and wish for treatment.
Acta Obstet Gynecol Scand 1997; 76(1): 74–80.
curs during the penetration movements or whether 16. Kegel A. Sexual functions of the pubococcygeus muscle. W
the occurrence of UI during intercourse is related J Surg, Obstet Gynecol 1952; 60: 521–4.
to one of the phases: desire, excitement, orgasm or 17. Graber B, Kline-Graber G. Female orgasm : role of pubo-
resolution phases. coccygeus muscle. J Clin Psychiatry 1979; 40: 348–51.
18. Wyman J. The psychiatric and emotional impact of female
pelvic floor dysfunction. Curr Opin Obstet Gynecol 1994;
6(4): 336–69.
Acknowledgments 19. Bø K, Hagen RH, Kvarstein B, Jørgensen J, Larsen S. Pel-
We thank Ingar Holme, Professor in Biostatistics, for valuable vic floor muscle exercise for the treatment of female stress
help with the statistical analyses. urinary incontinence: III. Effects of two different degrees
This research was funded by The Norwegian Fund for Post- of pelvic floor muscle exercise. Neurourol Urodyn 1990; 9:
graduate Studies in Physiotherapy and The Norwegian Re- 489–502.
search Council. In addition, Coloplast AS gave financial sup- 20. Wahl A, Burckhardt C, Wiklund I, Hanestad V. The Nor-
port to the study. wegian version of the quality of life scale (QoLS-N). Scand
J Caring Sci 1998; 12: 215–22.
21. Burckhardt C, Woods S, Schultz A, Ziebarth D. Quality of
References life in adults with chronic illness: a psychometric study. Res
Nurs Health 1989; 12: 347–54.
1. Henalla S, Hutchins C, Robinson P, MacVicar J. Non-oper- 22. Jackson S, Shepherd A, Brookes S, Abrams P. The effect
ative methods in the treatment of female genuine stress in- of oestrogen supplementation on post-menopausal urinary
continence of urine. J Obstet Gynaecol 1989; 9: 222–5. stress incontinence: a double-blind placebo-controlled trial.
2. Bø K, Talseth T, Holme I. Single blind, randomised con- Br J Obstet Gynaecol 1999; 106: 711–18.
trolled trial of pelvic floor exercises, electrical stimulation, 23. Jackson S, Donovan J, Brookes S, Eckford S, Swithinbank
vaginal cones, and no treatment in management of genuine L, Abrams P. The Bristol female lower urinary tract symp-
stress incontinence in women. BMJ 1999; 318: 487–93. toms questionnaire: development and psychometric testing.
3. Wilson D, Hay-Smith E, Bø K, Wyman J, Nygaard I, Stas- Br J Urol 1996; 77: 805–12.

C Acta Obstet Gynecol Scand 79 (2000)


Pelvic floor muscle exercise, lifestyle and sex-life 603
24. Skoner M, Haylor M. Managing incontinence: women’s sensus statement. Champaign: Human Kinetics Publishers;
normalizing strategies. Health Care Women Int 1993; 14(6): 1994.
549–60. 31. Chambless D, Stern T, Sultan F, Williams A, Goldstein A,
25. Thomas A, Morse J. Managing urinary incontinence with Lineberger M et al. The pubococcygens and female orgasm:
self-care practices. J Gerontol Nurs 1991; 17(6): 9–14. a correlation study with normal subjects. Arch Sex Behav
26. Wyman J, Fantl J, McClish D, Harkins S, Uebersax J, Ory 1982; 11(6): 479–90.
M. Quality of life following bladder training in older 32. Roughan P, Kunst L. Do pelvic floor exercises really im-
women with urinary incontinence. Int Urogynecol J 1997; prove orgasmic potential? J Sex Marital Ther 1981; 7: 223–
8: 223–9. 9.
27. Sander P, Mouritsen L, Andresen J, Fischer-Rasmussen W. 33. Wilson P, Herbison P. A randomized controlled trial of pel-
Non-operative treatment of urinary incontinence in an vic floor muscle exercises to treat postnatal urinary inconti-
open access clinic – the impact of quality of life (by the SF- nence. Int Urogynecol J 1998; 9: 257–64.
36). Neurourol Urodyn 1996; 15(4): 413–14.
28. Bø K, Hagen R, Kvarstein B, Larsen S. Female stress uri-
nary incontinence and participation in different sport and Address for correspondence:
social activities. Scand J Sports Sci 1989; 11(3): 117–21. Professor Kari Bø, PT., Ex.Sci., Ph.D.
29. Nygaard I, DeLancey JOL, Arnsdorf L, Murphy E. Exer- Norwegian University of Sport and Physical Education
cise and incontinence. Obstet Gynecol 1990; 75: 848–51. PB. 4014, Ullevål Stadion
30. Bouchard C, Shephard R, Stephens T, editors.Physical ac- 0806 Oslo
tivity, fitness, and health. International procedings and con- Norway

C Acta Obstet Gynecol Scand 79 (2000)

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