A Randomized, Double Blind, Placebo Controlled Trial of Pelvic Floor Exercises in the Treatment of Genuine Stress Incontinence.

This was one of the articles that was cited in the last Pelvic Physiotherapy Distance Journal club discussion on Optimizing pelvic floor muscle exercises.  This article randomized 44 patients to perform home exercises of 4 second PFM exercises or 4 second hip abductor exercises. 

·         Both groups had 64% of patients reporting improvement (no formal outcome measure, no specifics of how much change). 

·         No difference in 2 groups perineometry scores – both got better – no numbers given

·         Pad test better in abductor group, worse in PFM exercise group – WOW

·         The really interesting point is the adherence to exercises.  – on average participants did 52 exercises per week – 7 or 8 per day.  I think we can all agree (including the authors) this is not enough.

Overall I would say the study design was poor and though the results are intriguing, I would have to see a better study to believe that hip abductor exercises are as effective as PFM exercises in decreasing SUI.   Read for yourself.

Proceedings of the International Continence Society Meeting 1990

Neurourology and Urodynamics Volume 9, Issue 4, pages 398–399, 1990

Abstract # 59

I.N. Ramsay, M.Thou

Department of Obstetrics and Gynecology, Southwestern General Hospital, and Department of  Physiotherapy, Queens College, Glasgow, U.K.

A Randomized, Double Blind, Placebo Controlled Trial of Pelvic Floor Exercises in the Treatment of Genuine Stress Incontinence.

AIMS OF STUDY

Physiotherapy, by way of pelvic floor exercises (PFE), is the accepted first line non-surgical treatment of genuine stress incontinence (GSI), but when this form of treatment is evaluated, success rates vary markedly. We have performed a double blind, placebo controlled trial of PFE in the treatment of GSI to assess: a) the - effectiveness of physiotherapy; b) what proportion of success can be attributed directly to PFEs as opposed to general support and counseling obtained during physiotherapy; c) the compliance of patients undergoing home based, taught PFEs.

METHODS

44 women whose only urinary symptom was stress incontinence, were included in the trial. Initial assessment consisted of urine culture, subjective assessment of severity of problem and amount and frequency of urine loss, and objective assessment via perineometry scores and pad testing. Patients were then randomly allocated to receive instruction of active PPEs or placebo exercises. PFEs consisted of four maximum isometric contractions of the pelvic floor, held for a count of four seconds with a ten second rest between contractions. The regime for the placebo exercises was the same; the exercise consisting of  abductor hip muscle contraction (crossing the feet at the ankles). Patients were instructed to perform the exercises every waking hour, each day, for three months, and to keep a diary documenting this. At the end of the trial period the subjective and objective assessment was repeated, and the change documented. Exercise compliance was assessed from the diary.

RESULTS

There was no difference in the change in subjective assessment between the two groups, with cumulative subjective changes of improvement in 14 patients in each group, 6 subjects deteriorating in the PFE group and 2 in the placebo group, and 2 subjects in the PFE group, and 6 in the placebo group reporting no change. Perineometry scores were not statistically different between the two groups; the mean score in each group improving. On pad testing, the placebo group improved (mean improvement 2.1g), whereas the treatment group deteriorated (mean increase in urine loss 1.5g), and these results are significant. Analysis of the diary showed very poor levels of adherence overall , the highest number of exercises performed in one week being 130, about 30% of the maximum possible. The mean frequency of exercises per week was almost identical at 52 per week in the treatment group, and 54 per week in the placebo group. This represents about 15% of the requested level.

CONCLUSIONS

The apparently surprising results in subjective and objective change need to be viewed in light of the very poor exercise levels achieved by either group, as it may be that this level of exercising is insufficient to bring about physiological change. Poor compliance has been noted previously in "home" based PPE regimes (Wilson 1987), however we were unable to demonstrate the previously reported increased compliance in PFE regimes which include a daily diary (Sleep 1987).

From our findings thus far we would conclude: a) the effectiveness of physiotherapy is variable; b) the amount of benefit brought about as a direct result of pelvic floor contraction is unclear, but may not be as much as previously thought; c) PFE programs which have no support structure have inherent difficulties in terms of patient compliance. A further placebo controlled trial is underway using a hospital based, group orientated, PFE program and the results should help to further clarify the situation.

REFERENCES

Sleep J, and Grant A. 1987. Pelvic f loo r exercises in post natal care. Midwifery 3: 158-164.

Wilson P D, et al 1987. An objective assessment of physiotherapy for female genuine stress incontinence. Br J Obstet Gynecol 94: 575-582.