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Study's flaws may be misleading
EDITOR In a prospective randomised study comparing the efficacy of pelvic
floor exercises in combination with vaginal cones, vaginal cones alone,
and vaginal electrical stimulation alone, again the combination of two
techniques produced greater improvement in urinary
incontinence.3
We are also concerned about the differing numbers of visits to a
therapist for each group. The pelvic floor exercise group had weekly
visits whereas the other groups were seen monthly. This would introduce
bias; Wyman et al proposed that the specific conservative treatments
are not as important as having frequent contact with the patients, with
education and counselling.4 Thus the pelvic floor exercise
group should have a better response to treatment owing to the increased
time they had with a therapist.
Bø et al's study comparing the various methods used in
the conservative management of genuine stress incontinence has several
flaws, which may mislead readers.1 The study has been described as pragmatic, reflecting current practice. This view is
undermined by the instructions to the women in the vaginal cone and
electrical stimulation groups not to perform pelvic floor exercises
while using their treatments; this does not reflect current clinical
practice. In a prospective randomised study comparing the efficacy of
pelvic floor exercises in combination with vaginal cones and pelvic
floor exercises alone the combination of the two treatments was
significantly more efficacious than either alone.2
vkhullar{at}cwcom.net
Stefano Salvatore
John Bidmead
Kate Anders
Linda Cardozo
Department of Urogynaecology, King's College Hospital, London
SE5 9RS
| 1. |
Bø K, Talseth T, Holme I.
Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women.
BMJ
1999;
318:
487-493 |
| 2. | Haken J, Benness C, Cardozo L, Cutner A. A randomised trial of vaginal cones and pelvic floor exercises in the management of genuine stress incontinence. Neurourol Urodyn 1991; 10: 393-394. |
| 3. | Wise BG, Haken J, Cardozo L, Wise BG, Plevnik S. A comparative study of vaginal cone therapy, cones and Kegel exercises and maximal electrical stimulation in the treatment of female genuine stress incontinence. Neurourol Urodyn 1993; 12: 436-437. |
| 4. | Wyman JF, Fantl JA, McClish DK, Bump RC. Comparative efficacy of behavioral interventions in the management of female urinary incontinence. Am J Obstet Gynecol 1998; 179: 999-1006[Medline]. |
Authors' reply
EDITOR If the women are contracting simultaneously with the current, how can
we then conclude that it is the electrical stimulation and not the
voluntary contraction that gives the effect? The point of this study
was to evaluate the effect of electrical stimulation and cones. An
interesting hypothesis is whether contraction simultaneously with
electrical stimulation gives better results than contraction without.
This should be investigated in a future study. Other studies have shown
no significant additional effect of adding electrical stimulation to
exercise.1
Strong motivation and instruction are important factors in increasing
muscle strength and part of strength training regimens. One of the
benefits advocated by manufacturers of vaginal cones and electrical
stimulators is that these methods can be used at home without the
therapist, thus being cheaper. These methods have been used in this way
in the Scandinavian countries for years. In our study all groups had
the same monthly visits, for motivation, individual follow up, and
contact with the therapist. The exercise group had weekly contacts in
groups in addition. This may have enhanced their improvement. This is
the way we teach pelvic floor muscle exercise, and it is difficult to
understand how this group contact could give such huge differences in a
provocation test at the office of a blinded investigator.
Khullar et al give references to their own work presented as two
abstracts. As far as we can see their results are similar to our
findings. In the first study exercise and vaginal cones did not give
significantly different results. However, the drop out rate in the
vaginal cone group was 25%, and no intention to treat analysis was
performed. In the second study, adding pelvic floor muscle exercise to
treatment with vaginal cones was more effective than treatment with
vaginal cones alone.
We tried to give the best possible treatment for all
groups within a pragmatic setting. Thus the electrical stimulation and
vaginal cones groups had 30 and 20 minutes' training daily, respectively, whereas the exercise group had less than 8-10 minutes' training. This should favour the electrical stimulation and vaginal cones groups, and it is strange that Khullar et al do not mention this
as a flaw. Another flaw that works against the exercise group is that
both the vaginal cones and electrical stimulation groups had individual
treatment with direct proprioception to the pelvic floor, while the
exercise group was taught without proprioception.
karib{at}brage.idrettshs.no
Ingar Holme
Norwegian Centre for Physiotherapy Research and Norwegian
University of Sport and Physical Education, PO Box 4014, Ullevål
Stadion, 0806 Oslo, Norway
Trygve Talseth
National Hospital of Norway, Oslo
1.
Knight S, Laycock J, Naylor D.
Evaluation of neuromuscular electrical stimulation in the treatment of genuine stress incontinence.
Physiotherapy
1998;
84:
61-71.
© BMJ 1999
What can you learn from this BMJ paper? Read Leanne Tite's Paper+