Effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence

protocol for the OPAL randomised trial

Suzanne Hagen (Corresponding Author), Doreen McClurg, Carol Bugge, Jean Hay-Smith, Sarah Gerard Dean, Andrew Elders, Cathryn Glazener, Mohamed Abdel-Fattah, Wael Ibrahim Agur, Jo Booth, Karen Guerrero, John Norrie, Mary Kilonzo, Gladys McPherson, Alison McDonald, Susan Stratton, Nicole Sergenson, Aileen Grant, Lyndsay Wilson

Research output: Contribution to journalArticle

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Abstract

INTRODUCTION: Accidental urine leakage is a distressing problem that affects around one in three women. The main types of urinary incontinence (UI) are stress, urgency and mixed, with stress being most common. Current UK guidelines recommend that women with UI are offered at least 3 months of pelvic floor muscle training (PFMT). There is evidence that PFMT is effective in treating UI, however it is not clear how intensively women have to exercise to give the maximum sustained improvement in symptoms, and how we enable women to achieve this. Biofeedback is an adjunct to PFMT that may help women exercise more intensively for longer, and thus may improve continence outcomes when compared with PFMT alone. A Cochrane review was inconclusive about the benefit of biofeedback, indicating the need for further evidence.

METHODS AND ANALYSIS: This multicentre randomised controlled trial will compare the effectiveness and cost-effectiveness of PFMT versus biofeedback-mediated PFMT for women with stress UI or mixed UI. The primary outcome is UI severity at 24 months after randomisation. The primary economic outcome measure is incremental cost per quality-adjusted life-year at 24 months. Six hundred women from UK community, outpatient and primary care settings will be randomised and followed up via questionnaires, diaries and pelvic floor assessment. All participants are offered six PFMT appointments over 16 weeks. The use of clinic and home biofeedback is added to PFMT for participants in the biofeedback group. Group allocation could not be masked from participants and healthcare staff. An intention-to-treat analysis of the primary outcome will estimate the mean difference between the trial groups at 24 months using a general linear mixed model adjusting for minimisation covariates and other important prognostic covariates, including the baseline score.

ETHICS AND DISSEMINATION: Approval granted by the West of Scotland Research Ethics Committee 4 (16/LO/0990). Written informed consent will be obtained from participants by the local research team. Serious adverse events will be reported to the data monitoring and ethics committee, the ethics committee and trial centres as required. A Standard Protocol Items: Recommendations for Interventional Trials checklist and figure are available for this protocol. The results will be published in international journals and included in the relevant Cochrane review.

TRIAL REGISTRATION NUMBER: ISRCTN57746448; Pre-results.

Original languageEnglish
Article numbere024153
JournalBMJ Open
Volume9
Issue number2
Early online date8 Feb 2019
DOIs
Publication statusPublished - Apr 2019

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Pelvic Floor
Urinary Incontinence
Cost-Benefit Analysis
Muscles
Ethics Committees
Stress Urinary Incontinence
Clinical Trials Data Monitoring Committees
Exercise
OPAL protocol
Intention to Treat Analysis
Quality-Adjusted Life Years
Research Ethics Committees
Scotland
Ambulatory Care
Random Allocation
Informed Consent
Checklist
Linear Models
Primary Health Care
Appointments and Schedules

Keywords

  • adherence
  • biofeedback
  • electromyography
  • long-term
  • pelvic floor muscle training
  • urinary incontinence

Cite this

Effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence : protocol for the OPAL randomised trial. / Hagen, Suzanne (Corresponding Author); McClurg, Doreen; Bugge, Carol; Hay-Smith, Jean; Dean, Sarah Gerard; Elders, Andrew; Glazener, Cathryn; Abdel-Fattah, Mohamed; Agur, Wael Ibrahim; Booth, Jo; Guerrero, Karen; Norrie, John; Kilonzo, Mary; McPherson, Gladys; McDonald, Alison; Stratton, Susan; Sergenson, Nicole; Grant, Aileen; Wilson, Lyndsay.

In: BMJ Open, Vol. 9, No. 2, e024153, 04.2019.

Research output: Contribution to journalArticle

Hagen, S, McClurg, D, Bugge, C, Hay-Smith, J, Dean, SG, Elders, A, Glazener, C, Abdel-Fattah, M, Agur, WI, Booth, J, Guerrero, K, Norrie, J, Kilonzo, M, McPherson, G, McDonald, A, Stratton, S, Sergenson, N, Grant, A & Wilson, L 2019, 'Effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: protocol for the OPAL randomised trial', BMJ Open, vol. 9, no. 2, e024153. https://doi.org/10.1136/bmjopen-2018-024153
Hagen, Suzanne ; McClurg, Doreen ; Bugge, Carol ; Hay-Smith, Jean ; Dean, Sarah Gerard ; Elders, Andrew ; Glazener, Cathryn ; Abdel-Fattah, Mohamed ; Agur, Wael Ibrahim ; Booth, Jo ; Guerrero, Karen ; Norrie, John ; Kilonzo, Mary ; McPherson, Gladys ; McDonald, Alison ; Stratton, Susan ; Sergenson, Nicole ; Grant, Aileen ; Wilson, Lyndsay. / Effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence : protocol for the OPAL randomised trial. In: BMJ Open. 2019 ; Vol. 9, No. 2.
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T1 - Effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence

T2 - protocol for the OPAL randomised trial

AU - Hagen, Suzanne

AU - McClurg, Doreen

AU - Bugge, Carol

AU - Hay-Smith, Jean

AU - Dean, Sarah Gerard

AU - Elders, Andrew

AU - Glazener, Cathryn

AU - Abdel-Fattah, Mohamed

AU - Agur, Wael Ibrahim

AU - Booth, Jo

AU - Guerrero, Karen

AU - Norrie, John

AU - Kilonzo, Mary

AU - McPherson, Gladys

AU - McDonald, Alison

AU - Stratton, Susan

AU - Sergenson, Nicole

AU - Grant, Aileen

AU - Wilson, Lyndsay

N1 - Funding This work is supported by the NIHR Health Technology Assessment Programme (project reference: 11/71/03). Acknowledgments: The authors also acknowledge the support of the National Institute for Health Research, through the Comprehensive Clinical Research Network. SD’s position is partly supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care South West Peninsula at the Royal Devon and Exeter NHS Foundation Trust.

PY - 2019/4

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N2 - INTRODUCTION: Accidental urine leakage is a distressing problem that affects around one in three women. The main types of urinary incontinence (UI) are stress, urgency and mixed, with stress being most common. Current UK guidelines recommend that women with UI are offered at least 3 months of pelvic floor muscle training (PFMT). There is evidence that PFMT is effective in treating UI, however it is not clear how intensively women have to exercise to give the maximum sustained improvement in symptoms, and how we enable women to achieve this. Biofeedback is an adjunct to PFMT that may help women exercise more intensively for longer, and thus may improve continence outcomes when compared with PFMT alone. A Cochrane review was inconclusive about the benefit of biofeedback, indicating the need for further evidence.METHODS AND ANALYSIS: This multicentre randomised controlled trial will compare the effectiveness and cost-effectiveness of PFMT versus biofeedback-mediated PFMT for women with stress UI or mixed UI. The primary outcome is UI severity at 24 months after randomisation. The primary economic outcome measure is incremental cost per quality-adjusted life-year at 24 months. Six hundred women from UK community, outpatient and primary care settings will be randomised and followed up via questionnaires, diaries and pelvic floor assessment. All participants are offered six PFMT appointments over 16 weeks. The use of clinic and home biofeedback is added to PFMT for participants in the biofeedback group. Group allocation could not be masked from participants and healthcare staff. An intention-to-treat analysis of the primary outcome will estimate the mean difference between the trial groups at 24 months using a general linear mixed model adjusting for minimisation covariates and other important prognostic covariates, including the baseline score.ETHICS AND DISSEMINATION: Approval granted by the West of Scotland Research Ethics Committee 4 (16/LO/0990). Written informed consent will be obtained from participants by the local research team. Serious adverse events will be reported to the data monitoring and ethics committee, the ethics committee and trial centres as required. A Standard Protocol Items: Recommendations for Interventional Trials checklist and figure are available for this protocol. The results will be published in international journals and included in the relevant Cochrane review.TRIAL REGISTRATION NUMBER: ISRCTN57746448; Pre-results.

AB - INTRODUCTION: Accidental urine leakage is a distressing problem that affects around one in three women. The main types of urinary incontinence (UI) are stress, urgency and mixed, with stress being most common. Current UK guidelines recommend that women with UI are offered at least 3 months of pelvic floor muscle training (PFMT). There is evidence that PFMT is effective in treating UI, however it is not clear how intensively women have to exercise to give the maximum sustained improvement in symptoms, and how we enable women to achieve this. Biofeedback is an adjunct to PFMT that may help women exercise more intensively for longer, and thus may improve continence outcomes when compared with PFMT alone. A Cochrane review was inconclusive about the benefit of biofeedback, indicating the need for further evidence.METHODS AND ANALYSIS: This multicentre randomised controlled trial will compare the effectiveness and cost-effectiveness of PFMT versus biofeedback-mediated PFMT for women with stress UI or mixed UI. The primary outcome is UI severity at 24 months after randomisation. The primary economic outcome measure is incremental cost per quality-adjusted life-year at 24 months. Six hundred women from UK community, outpatient and primary care settings will be randomised and followed up via questionnaires, diaries and pelvic floor assessment. All participants are offered six PFMT appointments over 16 weeks. The use of clinic and home biofeedback is added to PFMT for participants in the biofeedback group. Group allocation could not be masked from participants and healthcare staff. An intention-to-treat analysis of the primary outcome will estimate the mean difference between the trial groups at 24 months using a general linear mixed model adjusting for minimisation covariates and other important prognostic covariates, including the baseline score.ETHICS AND DISSEMINATION: Approval granted by the West of Scotland Research Ethics Committee 4 (16/LO/0990). Written informed consent will be obtained from participants by the local research team. Serious adverse events will be reported to the data monitoring and ethics committee, the ethics committee and trial centres as required. A Standard Protocol Items: Recommendations for Interventional Trials checklist and figure are available for this protocol. The results will be published in international journals and included in the relevant Cochrane review.TRIAL REGISTRATION NUMBER: ISRCTN57746448; Pre-results.

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KW - electromyography

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