Randomised controlled trial of conservative management of postnatal ur
http://www.100md.com
《英国医生杂志》
1 Health Services Research Unit, University of Aberdeen Medical School, Foresterhill, Aberdeen AB25 2ZD, 2 Department of Preventive and Social Medicine, Dunedin School of Medicine, University of Otago, PO Box 913, Dunedin, New Zealand, 3 Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, 4 Department of Public Health and Epidemiology, University of Birmingham, PO Box 363, Edgbaston, Birmingham B15 2TT
Correspondence to: C M A Glazener c.glazener@abdn.ac.uk
Abstract
About 20-30% of women have postpartum urinary incontinence,1 and 3-5% have faecal incontinence.2 Controversy exists about how to manage these problems. A Cochrane review suggested that pelvic floor muscle training is better than no treatment and that more intensive exercising is best.3 The trials included in the review were in general populations of older women with stress incontinence with only two randomised trials among postnatal women.4 5
Pelvic floor muscle training is routinely taught in maternity care, but its effectiveness in prevention of incontinence is questionable.6 A Cochrane review of prevention of incontinence was inconclusive,6 and trials targeting antenatal7 8 and postpartum9 10 women had conflicting findings. Maximum follow up was one year. These inconsistent findings, together with electrophysiological evidence of postpartum nerve recovery,11 suggested that targeting women with persistent incontinence might be more effective.4
Our multi-centre, randomised controlled trial of nurse-led enhanced conservative interventions in 747 women who reported urinary incontinence three months after delivery5 showed that at one year fewer women in the intervention group had urinary incontinence (60% v 69%, P = 0.037) and fewer had faecal incontinence (4% v 11%, P = 0.012). We examined the long term outcomes to determine whether these differences persisted.
Methods
Principal findings
Although at one year after delivery women who received active pelvic floor muscle training (with bladder training if appropriate) had lower rates of both urinary and faecal incontinence than women who received standard care, these differences did not persist to six years. There were no subgroups in which the intervention was more successful long term, even among those who had not had a further pregnancy.
Three quarters of those with urinary incontinence at baseline still had urinary incontinence six years later. Two fifths of women with faecal incontinence at baseline still reported it six years later, and another one in 20 developed it as a new symptom.
Strengths and weaknesses
There was about a 30% non-response rate at both one and six years. Those responding, however, were similar to nonresponders in terms of age, parity, delivery mode, and baseline urinary or faecal incontinence. The results were the same when we considered only those who responded at both times. The study was powered to detect a 10% difference. Although it was not possible to rule out a difference of this size (95% confidence interval of the difference -10.2% to 4.1%), results for other outcomes support the finding of no difference.
Women with faecal incontinence all had coexisting urinary incontinence. A further 329/4818 (7%) were continent to urine but incontinent to faeces at baseline but were not eligible for the trial because our inclusion criterion was urinary incontinence. Our findings regarding faecal incontinence cannot therefore be generalised to women who do not also have urinary incontinence.
Meaning of the findings
The moderate short term intervention effect (about 1 in 11 fewer women having urinary incontinence and 1 in 16 fewer having faecal incontinence) was not present in the long term. Similarly, the earlier difference in the performance of pelvic floor muscle exercises had also disappeared, which could account for the lack of difference in urinary and faecal outcomes. The effect might have persisted for longer if there had been continual reinforcement or if it had been carried out by physiotherapists rather than nurses, but these suggestions would need to be tested by controlled trial.
These findings are also disappointing because pelvic floor muscle training and bladder training have the merit of being simple to teach and perform (although expensive in terms of teaching time by health professionals) and have few if any adverse effects. The findings, however, are in line with Cochrane reviews of pelvic floor muscle training3 and bladder training12 for urinary incontinence and conservative treatment for faecal incontinence.13 Our results represent the longest follow up of any trial so far. There is a need to identify conservative strategies for both urinary and faecal incontinence that have longer term effects than those seen in this study and then to test them rigorously by randomised controlled trials with long term follow up.
What is already known on this topic
Childbirth is a major cause of urinary and faecal incontinence in women
A one year follow up study showed that women who were randomised to active pelvic floor muscle training (with bladder training if appropriate) were more often continent than women in a control group and were also more likely to be performing pelvic floor exercises
What this study adds
At six years after the index delivery, three quarters of the women still had urinary incontinence and over 10% had faecal incontinence
The benefits seen at one year were no longer apparent
Only half the women were still performing any pelvic floor exercises, irrespective of initial group assignment
We are grateful to Anne-Marie Rennie, Alison McDonald, Jane Harvey, and Jane Cook, who provided nursing and administrative support to the original trial. Anne-Marie Rennie conducted the six year follow up in Aberdeen and Birmingham, and Ros Herbison in Dunedin. Magnus McGee provided extra statistical help.
Contributors: All authors contributed to the design, analysis, and writing up of the study. CMAG is guarantor.
Funding: Birthright (now WellBeing), Royal College of Obstetricians and Gynaecologists, London; New Zealand Lottery Grant Board; Health Services Research Unit, University of Aberdeen. The health services research unit is funded by the Chief Scientist Office of the Scottish Executive Health Department.
Competing interests: None declared.
Ethical approval: Ethical approval was obtained in each centre for the original and follow up studies from each local ethics committee.
References
Wilson PD, Herbison RM, Herbison GP. Obstetric practice and the prevalence of urinary incontinence three months after delivery. Br J Obstet Gynaecol 1996;103: 154-61.
MacArthur C, Bick DE, Keighley MR. Faecal incontinence after childbirth. Br J Obstet Gynaecol 1997;104: 46-50.
Hay-Smith EJC, Bo K, Berghmans LCM, Hendriks HJM, de Bie RA, van Waalwijk van Doorn ESC. Pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev 2001;(1): CD001407.
Wilson PD, Herbison GP. A randomized controlled trial of pelvic floor muscle exercises to treat postnatal urinary incontinence. Int Urogynecol J 1998;9: 257-64.
Glazener CMA, Herbison GP, Wilson PD, MacArthur C, Lang GD, Gee H, et al. Conservative management of persistent postnatal urinary and faecal incontinence: a randomised controlled trial. BMJ 2001;323: 593-6.
Hay-Smith EJC, Herbison P, M?rkved S. Physical therapies for prevention of urinary and faecal incontinence in adults. Cochrane Database Syst Rev 2002;(2): CD003191.
Hughes P, Jackson S, Smith P, Abrams P. Can antenatal pelvic floor exercises prevent postnatal incontinence . Neurourol Urodyn 2001;20: 447-8.
Salvesen KA,.Morkved S. Randomised controlled trial of pelvic floor muscle training during pregnancy. BMJ 2004;329: 378-80.
Sleep J, Grant A. Pelvic floor exercises in postnatal care. Midwifery 1987;3: 158-64.
Chiarelli P, Cockburn J. Promoting urinary continence in women after delivery: randomised controlled trial. BMJ 2002;324: 1241.
Snooks SJ, Badenoch DF, Tiptaft RC, Swash M. Perineal nerve damage in genuine stress urinary incontinence. An electrophysiological study. Br J Urol 1985;57: 422-6.
Wallace SA, Roe B, Williams K, Palmer M. Bladder training for urinary incontinence in adults. Cochrane Database Syst Rev 2004;(4): CD001308.
Norton C, Hosker G, Brazzelli M. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults. Cochrane Database Syst Rev 2000;(2): CD002111.(Cathryn M A Glazener, senior clinical re)
Correspondence to: C M A Glazener c.glazener@abdn.ac.uk
Abstract
About 20-30% of women have postpartum urinary incontinence,1 and 3-5% have faecal incontinence.2 Controversy exists about how to manage these problems. A Cochrane review suggested that pelvic floor muscle training is better than no treatment and that more intensive exercising is best.3 The trials included in the review were in general populations of older women with stress incontinence with only two randomised trials among postnatal women.4 5
Pelvic floor muscle training is routinely taught in maternity care, but its effectiveness in prevention of incontinence is questionable.6 A Cochrane review of prevention of incontinence was inconclusive,6 and trials targeting antenatal7 8 and postpartum9 10 women had conflicting findings. Maximum follow up was one year. These inconsistent findings, together with electrophysiological evidence of postpartum nerve recovery,11 suggested that targeting women with persistent incontinence might be more effective.4
Our multi-centre, randomised controlled trial of nurse-led enhanced conservative interventions in 747 women who reported urinary incontinence three months after delivery5 showed that at one year fewer women in the intervention group had urinary incontinence (60% v 69%, P = 0.037) and fewer had faecal incontinence (4% v 11%, P = 0.012). We examined the long term outcomes to determine whether these differences persisted.
Methods
Principal findings
Although at one year after delivery women who received active pelvic floor muscle training (with bladder training if appropriate) had lower rates of both urinary and faecal incontinence than women who received standard care, these differences did not persist to six years. There were no subgroups in which the intervention was more successful long term, even among those who had not had a further pregnancy.
Three quarters of those with urinary incontinence at baseline still had urinary incontinence six years later. Two fifths of women with faecal incontinence at baseline still reported it six years later, and another one in 20 developed it as a new symptom.
Strengths and weaknesses
There was about a 30% non-response rate at both one and six years. Those responding, however, were similar to nonresponders in terms of age, parity, delivery mode, and baseline urinary or faecal incontinence. The results were the same when we considered only those who responded at both times. The study was powered to detect a 10% difference. Although it was not possible to rule out a difference of this size (95% confidence interval of the difference -10.2% to 4.1%), results for other outcomes support the finding of no difference.
Women with faecal incontinence all had coexisting urinary incontinence. A further 329/4818 (7%) were continent to urine but incontinent to faeces at baseline but were not eligible for the trial because our inclusion criterion was urinary incontinence. Our findings regarding faecal incontinence cannot therefore be generalised to women who do not also have urinary incontinence.
Meaning of the findings
The moderate short term intervention effect (about 1 in 11 fewer women having urinary incontinence and 1 in 16 fewer having faecal incontinence) was not present in the long term. Similarly, the earlier difference in the performance of pelvic floor muscle exercises had also disappeared, which could account for the lack of difference in urinary and faecal outcomes. The effect might have persisted for longer if there had been continual reinforcement or if it had been carried out by physiotherapists rather than nurses, but these suggestions would need to be tested by controlled trial.
These findings are also disappointing because pelvic floor muscle training and bladder training have the merit of being simple to teach and perform (although expensive in terms of teaching time by health professionals) and have few if any adverse effects. The findings, however, are in line with Cochrane reviews of pelvic floor muscle training3 and bladder training12 for urinary incontinence and conservative treatment for faecal incontinence.13 Our results represent the longest follow up of any trial so far. There is a need to identify conservative strategies for both urinary and faecal incontinence that have longer term effects than those seen in this study and then to test them rigorously by randomised controlled trials with long term follow up.
What is already known on this topic
Childbirth is a major cause of urinary and faecal incontinence in women
A one year follow up study showed that women who were randomised to active pelvic floor muscle training (with bladder training if appropriate) were more often continent than women in a control group and were also more likely to be performing pelvic floor exercises
What this study adds
At six years after the index delivery, three quarters of the women still had urinary incontinence and over 10% had faecal incontinence
The benefits seen at one year were no longer apparent
Only half the women were still performing any pelvic floor exercises, irrespective of initial group assignment
We are grateful to Anne-Marie Rennie, Alison McDonald, Jane Harvey, and Jane Cook, who provided nursing and administrative support to the original trial. Anne-Marie Rennie conducted the six year follow up in Aberdeen and Birmingham, and Ros Herbison in Dunedin. Magnus McGee provided extra statistical help.
Contributors: All authors contributed to the design, analysis, and writing up of the study. CMAG is guarantor.
Funding: Birthright (now WellBeing), Royal College of Obstetricians and Gynaecologists, London; New Zealand Lottery Grant Board; Health Services Research Unit, University of Aberdeen. The health services research unit is funded by the Chief Scientist Office of the Scottish Executive Health Department.
Competing interests: None declared.
Ethical approval: Ethical approval was obtained in each centre for the original and follow up studies from each local ethics committee.
References
Wilson PD, Herbison RM, Herbison GP. Obstetric practice and the prevalence of urinary incontinence three months after delivery. Br J Obstet Gynaecol 1996;103: 154-61.
MacArthur C, Bick DE, Keighley MR. Faecal incontinence after childbirth. Br J Obstet Gynaecol 1997;104: 46-50.
Hay-Smith EJC, Bo K, Berghmans LCM, Hendriks HJM, de Bie RA, van Waalwijk van Doorn ESC. Pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev 2001;(1): CD001407.
Wilson PD, Herbison GP. A randomized controlled trial of pelvic floor muscle exercises to treat postnatal urinary incontinence. Int Urogynecol J 1998;9: 257-64.
Glazener CMA, Herbison GP, Wilson PD, MacArthur C, Lang GD, Gee H, et al. Conservative management of persistent postnatal urinary and faecal incontinence: a randomised controlled trial. BMJ 2001;323: 593-6.
Hay-Smith EJC, Herbison P, M?rkved S. Physical therapies for prevention of urinary and faecal incontinence in adults. Cochrane Database Syst Rev 2002;(2): CD003191.
Hughes P, Jackson S, Smith P, Abrams P. Can antenatal pelvic floor exercises prevent postnatal incontinence . Neurourol Urodyn 2001;20: 447-8.
Salvesen KA,.Morkved S. Randomised controlled trial of pelvic floor muscle training during pregnancy. BMJ 2004;329: 378-80.
Sleep J, Grant A. Pelvic floor exercises in postnatal care. Midwifery 1987;3: 158-64.
Chiarelli P, Cockburn J. Promoting urinary continence in women after delivery: randomised controlled trial. BMJ 2002;324: 1241.
Snooks SJ, Badenoch DF, Tiptaft RC, Swash M. Perineal nerve damage in genuine stress urinary incontinence. An electrophysiological study. Br J Urol 1985;57: 422-6.
Wallace SA, Roe B, Williams K, Palmer M. Bladder training for urinary incontinence in adults. Cochrane Database Syst Rev 2004;(4): CD001308.
Norton C, Hosker G, Brazzelli M. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults. Cochrane Database Syst Rev 2000;(2): CD002111.(Cathryn M A Glazener, senior clinical re)