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 G 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^*, Andrew Elders, Susan Stratton, Nicole Sergenson, Carol Bugge, Sarah G 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

66 Citations (Scopus)

101 Downloads (Pure)

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
Number of pages	11
Journal	BMJ
Volume	371
DOIs	https://doi.org/10.1136/bmj.m3719
Publication status	Published - 14 Oct 2020

Keywords

incontinence
biofeedback
pelvic floor muscle training

ASJC Scopus subject areas

General Medicine

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10.1136/bmj.m3719

Hagen, S. et al (2020) Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial
Copyright © 2020 BMJ Publishing Group Ltd This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is noncommercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Final published version, 426 KBLicence: CC BY-NC

66 Citations
1 Article

Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT
Hagen, S., Bugge, C., Dean, S. G., Elders, A., Hay-Smith, J., Kilonzo, M., McClurg, D., Abdel-Fattah, M., Agur, W., Andreis, F., Booth, J., Dimitrova, M., Gillespie, N., Glazener, C., Grant, A., Guerrero, K. L., Henderson, L., Kovandzic, M., McDonald, A. & Norrie, J. & 4 others, Sergenson, N., Stratton, S., Taylor, A. & Williams, L. R., 8 Dec 2020, In: Health Technology Assessment. 24, 70, p. 1-172 172 p.
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29 Citations (Scopus)

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Hagen, S., Elders, A., Stratton, S., Sergenson, N., Bugge, C., Dean, S. G., 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, Article m3719. https://doi.org/10.1136/bmj.m3719

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

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{\textquoteright}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.",

keywords = "incontinence, biofeedback, pelvic floor muscle training",

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

note = "Acceptance from webpage. OA article - replaced AAM with VoR ",

year = "2020",

month = oct,

day = "14",

doi = "10.1136/bmj.m3719",

language = "English",

volume = "371",

journal = "BMJ",

issn = "0959-8138",

publisher = "BMJ Publishing Group",

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Hagen, S, Elders, A, Stratton, S, Sergenson, N, Bugge, C, Dean, SG, 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, m3719. https://doi.org/10.1136/bmj.m3719

TY - JOUR

T1 - Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial

AU - Hagen, Suzanne

AU - Elders, Andrew

AU - Stratton, Susan

AU - Sergenson, Nicole

AU - Bugge, Carol

AU - Dean, Sarah G

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

AU - Williams, Louise R.

AU - McClurg, Doreen

N1 - Acceptance from webpage. OA article - replaced AAM with VoR

PY - 2020/10/14

Y1 - 2020/10/14

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.

KW - incontinence

KW - biofeedback

KW - pelvic floor muscle training

U2 - 10.1136/bmj.m3719

DO - 10.1136/bmj.m3719

M3 - Article

SN - 0959-8138

VL - 371

JO - BMJ

JF - BMJ

M1 - m3719

ER -

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

Abstract

Keywords

ASJC Scopus subject areas

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Research output

Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT

Cite this