Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial

Suzanne Hagen; Andrew Elders; Susan Stratton; Nicole Sergenson; Carol Bugge; Sarah Dean; Jean Hay-Smith; Mary Kilonzo; Maria Dimitrova; Mohamed Abdel-Fattah; Wael Agur; Jo Booth; Cathryn Glazener; Karen Guerrero; Alison McDonald; John Norrie; Louise R Williams; Doreen McClurg

doi:10.1136/bmj.m3719

Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial

Suzanne Hagen^* (Corresponding Author), Andrew Elders, Susan Stratton, Nicole Sergenson, Carol Bugge, Sarah Dean, Jean Hay-Smith, Mary Kilonzo, Maria Dimitrova, Mohamed Abdel-Fattah, Wael Agur, Jo Booth, Cathryn Glazener, Karen Guerrero, Alison McDonald, John Norrie, Louise R Williams, Doreen McClurg

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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Abstract

OBJECTIVE: To assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women. DESIGN: Parallel group randomised controlled trial. SETTING: 23 community and secondary care centres providing continence care in Scotland and England. PARTICIPANTS: 600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 were randomised to PFMT plus electromyographic biofeedback and 300 to PFMT alone. INTERVENTIONS: Participants in both groups were offered six appointments with a continence therapist over 16 weeks. Participants in the biofeedback PFMT group received supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback during clinic appointments and at home. The PFMT group received supervised PFMT and a home PFMT programme. PFMT programmes were progressed over the appointments. MAIN OUTCOME MEASURES: The primary outcome was self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity) at 24 months. Secondary outcomes were cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years. RESULTS: Mean ICIQ-UI SF scores at 24 months were 8.2 (SD 5.1, n=225) in the biofeedback PFMT group and 8.5 (SD 4.9, n=235) in the PFMT group (mean difference -0.09, 95% confidence interval -0.92 to 0.75, P=0.84). Biofeedback PFMT had similar costs (mean difference £121 ($154; €133), -£409 to £651, P=0.64) and quality adjusted life years (-0.04, -0.12 to 0.04, P=0.28) to PFMT. 48 participants reported an adverse event: for 23 this was related or possibly related to the interventions. CONCLUSIONS: At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups. Routine use of electromyographic biofeedback with PFMT should not be recommended. Other ways of maximising the effects of PFMT should be investigated. TRIAL REGISTRATION: ISRCTN57756448.

Original language	English
Article number	m3719
Pages (from-to)	m3719
Number of pages	11
Journal	BMJ
Volume	371
Issue number	8264
Early online date	14 Oct 2020
DOIs	https://doi.org/10.1136/bmj.m3719
Publication status	Published - 17 Oct 2020

Bibliographical note

Funding: This trial was funded by the National Institute for Health Research (NIHR), Health Technology Assessment programme (project No 11/71/03). The Chief Scientist Office, Scottish Government Health and Social Care Directorates funded SH’s post, and the NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula at the Royal Devon and Exeter NHS Foundation Trust supported SD. The study funders had no role in the study design, data collection, data analysis, data interpretation, writing of the manuscript, or decision to submit for publication. The research team was independent from the funders. All authors had access to all study data and take responsibility for its integrity and the accuracy of the data analysis. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health and Social Care. The trial sponsor was Glasgow Caledonian University.

Data sharing: Individual participant data collected for this trial, and a data dictionary defining each field in the dataset, will be made available to others; all available data will be de-identified participant data. The protocol, statistical analysis plan, informed consent form, and ethics committee approval are available (https://www.journalslibrary.nihr.ac.uk/programmes/hta/117103/#/). To access data, a request should be submitted to the corresponding author (s.hagen@gcu.ac.uk) with a scientific proposal including objectives. Written proposals will be assessed by members of the trial steering committee and a decision made about the appropriateness of the request. The data will only be shared after the data sharing agreement is fully executed.

Keywords

QUALITY-OF-LIFE
URODYNAMIC STRESS
QUESTIONNAIRE
TERMINOLOGY
ICIQ
STANDARDIZATION
EXERCISES
SYMPTOMS
FORM

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Hagen, S., Elders, A., Stratton, S., Sergenson, N., Bugge, C., Dean, S., Hay-Smith, J., Kilonzo, M., Dimitrova, M., Abdel-Fattah, M., Agur, W., Booth, J., Glazener, C., Guerrero, K., McDonald, A., Norrie, J., Williams, L. R., & McClurg, D. (2020). Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial. BMJ, 371(8264), m3719. Article m3719. https://doi.org/10.1136/bmj.m3719

Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial. / Hagen, Suzanne (Corresponding Author); Elders, Andrew; Stratton, Susan et al.
In: BMJ, Vol. 371, No. 8264, m3719, 17.10.2020, p. m3719.

Research output: Contribution to journal › Article › peer-review

Hagen, S, Elders, A, Stratton, S, Sergenson, N, Bugge, C, Dean, S, Hay-Smith, J, Kilonzo, M, Dimitrova, M, Abdel-Fattah, M, Agur, W, Booth, J, Glazener, C, Guerrero, K, McDonald, A, Norrie, J, Williams, LR & McClurg, D 2020, 'Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial', BMJ, vol. 371, no. 8264, m3719, pp. m3719. https://doi.org/10.1136/bmj.m3719

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abstract = "OBJECTIVE: To assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women. DESIGN: Parallel group randomised controlled trial. SETTING: 23 community and secondary care centres providing continence care in Scotland and England. PARTICIPANTS: 600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 were randomised to PFMT plus electromyographic biofeedback and 300 to PFMT alone. INTERVENTIONS: Participants in both groups were offered six appointments with a continence therapist over 16 weeks. Participants in the biofeedback PFMT group received supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback during clinic appointments and at home. The PFMT group received supervised PFMT and a home PFMT programme. PFMT programmes were progressed over the appointments. MAIN OUTCOME MEASURES: The primary outcome was self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity) at 24 months. Secondary outcomes were cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years. RESULTS: Mean ICIQ-UI SF scores at 24 months were 8.2 (SD 5.1, n=225) in the biofeedback PFMT group and 8.5 (SD 4.9, n=235) in the PFMT group (mean difference -0.09, 95% confidence interval -0.92 to 0.75, P=0.84). Biofeedback PFMT had similar costs (mean difference £121 ($154; €133), -£409 to £651, P=0.64) and quality adjusted life years (-0.04, -0.12 to 0.04, P=0.28) to PFMT. 48 participants reported an adverse event: for 23 this was related or possibly related to the interventions. CONCLUSIONS: At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups. Routine use of electromyographic biofeedback with PFMT should not be recommended. Other ways of maximising the effects of PFMT should be investigated. TRIAL REGISTRATION: ISRCTN57756448.",

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note = "Funding: This trial was funded by the National Institute for Health Research (NIHR), Health Technology Assessment programme (project No 11/71/03). The Chief Scientist Office, Scottish Government Health and Social Care Directorates funded SH{\textquoteright}s post, and the NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula at the Royal Devon and Exeter NHS Foundation Trust supported SD. The study funders had no role in the study design, data collection, data analysis, data interpretation, writing of the manuscript, or decision to submit for publication. The research team was independent from the funders. All authors had access to all study data and take responsibility for its integrity and the accuracy of the data analysis. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health and Social Care. The trial sponsor was Glasgow Caledonian University. Data sharing: Individual participant data collected for this trial, and a data dictionary defining each field in the dataset, will be made available to others; all available data will be de-identified participant data. The protocol, statistical analysis plan, informed consent form, and ethics committee approval are available (https://www.journalslibrary.nihr.ac.uk/programmes/hta/117103/#/). To access data, a request should be submitted to the corresponding author (s.hagen@gcu.ac.uk) with a scientific proposal including objectives. Written proposals will be assessed by members of the trial steering committee and a decision made about the appropriateness of the request. The data will only be shared after the data sharing agreement is fully executed. ",

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AU - Stratton, Susan

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AU - Bugge, Carol

AU - Dean, Sarah

AU - Hay-Smith, Jean

AU - Kilonzo, Mary

AU - Dimitrova, Maria

AU - Abdel-Fattah, Mohamed

AU - Agur, Wael

AU - Booth, Jo

AU - Glazener, Cathryn

AU - Guerrero, Karen

AU - McDonald, Alison

AU - Norrie, John

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N1 - Funding: This trial was funded by the National Institute for Health Research (NIHR), Health Technology Assessment programme (project No 11/71/03). The Chief Scientist Office, Scottish Government Health and Social Care Directorates funded SH’s post, and the NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula at the Royal Devon and Exeter NHS Foundation Trust supported SD. The study funders had no role in the study design, data collection, data analysis, data interpretation, writing of the manuscript, or decision to submit for publication. The research team was independent from the funders. All authors had access to all study data and take responsibility for its integrity and the accuracy of the data analysis. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health and Social Care. The trial sponsor was Glasgow Caledonian University. Data sharing: Individual participant data collected for this trial, and a data dictionary defining each field in the dataset, will be made available to others; all available data will be de-identified participant data. The protocol, statistical analysis plan, informed consent form, and ethics committee approval are available (https://www.journalslibrary.nihr.ac.uk/programmes/hta/117103/#/). To access data, a request should be submitted to the corresponding author (s.hagen@gcu.ac.uk) with a scientific proposal including objectives. Written proposals will be assessed by members of the trial steering committee and a decision made about the appropriateness of the request. The data will only be shared after the data sharing agreement is fully executed.

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N2 - OBJECTIVE: To assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women. DESIGN: Parallel group randomised controlled trial. SETTING: 23 community and secondary care centres providing continence care in Scotland and England. PARTICIPANTS: 600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 were randomised to PFMT plus electromyographic biofeedback and 300 to PFMT alone. INTERVENTIONS: Participants in both groups were offered six appointments with a continence therapist over 16 weeks. Participants in the biofeedback PFMT group received supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback during clinic appointments and at home. The PFMT group received supervised PFMT and a home PFMT programme. PFMT programmes were progressed over the appointments. MAIN OUTCOME MEASURES: The primary outcome was self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity) at 24 months. Secondary outcomes were cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years. RESULTS: Mean ICIQ-UI SF scores at 24 months were 8.2 (SD 5.1, n=225) in the biofeedback PFMT group and 8.5 (SD 4.9, n=235) in the PFMT group (mean difference -0.09, 95% confidence interval -0.92 to 0.75, P=0.84). Biofeedback PFMT had similar costs (mean difference £121 ($154; €133), -£409 to £651, P=0.64) and quality adjusted life years (-0.04, -0.12 to 0.04, P=0.28) to PFMT. 48 participants reported an adverse event: for 23 this was related or possibly related to the interventions. CONCLUSIONS: At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups. Routine use of electromyographic biofeedback with PFMT should not be recommended. Other ways of maximising the effects of PFMT should be investigated. TRIAL REGISTRATION: ISRCTN57756448.

AB - OBJECTIVE: To assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women. DESIGN: Parallel group randomised controlled trial. SETTING: 23 community and secondary care centres providing continence care in Scotland and England. PARTICIPANTS: 600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 were randomised to PFMT plus electromyographic biofeedback and 300 to PFMT alone. INTERVENTIONS: Participants in both groups were offered six appointments with a continence therapist over 16 weeks. Participants in the biofeedback PFMT group received supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback during clinic appointments and at home. The PFMT group received supervised PFMT and a home PFMT programme. PFMT programmes were progressed over the appointments. MAIN OUTCOME MEASURES: The primary outcome was self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity) at 24 months. Secondary outcomes were cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years. RESULTS: Mean ICIQ-UI SF scores at 24 months were 8.2 (SD 5.1, n=225) in the biofeedback PFMT group and 8.5 (SD 4.9, n=235) in the PFMT group (mean difference -0.09, 95% confidence interval -0.92 to 0.75, P=0.84). Biofeedback PFMT had similar costs (mean difference £121 ($154; €133), -£409 to £651, P=0.64) and quality adjusted life years (-0.04, -0.12 to 0.04, P=0.28) to PFMT. 48 participants reported an adverse event: for 23 this was related or possibly related to the interventions. CONCLUSIONS: At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups. Routine use of electromyographic biofeedback with PFMT should not be recommended. Other ways of maximising the effects of PFMT should be investigated. TRIAL REGISTRATION: ISRCTN57756448.

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KW - FORM

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Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial

Abstract

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Mary Kilonzo

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Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial

Abstract

Bibliographical note

Keywords

Access to Document

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Profiles

Mary Kilonzo

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