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Female urgency, trial of urodynamics as routine evaluation (FUTURE study): a superiority randomised clinical trial to evaluate the effectiveness and cost-effectiveness of invasive urodynamic investigations in management of women with refractory overactive bladder symptoms

Female urgency, trial of urodynamics as routine evaluation (FUTURE study): a superiority randomised clinical trial to evaluate the effectiveness and cost-effectiveness of invasive urodynamic investigations in management of women with refractory overactive bladder symptoms
Female urgency, trial of urodynamics as routine evaluation (FUTURE study): a superiority randomised clinical trial to evaluate the effectiveness and cost-effectiveness of invasive urodynamic investigations in management of women with refractory overactive bladder symptoms

Background: overactive bladder (OAB) syndrome is a symptom complex affecting 12-14% of the UK adult female population. Symptoms include urinary urgency, with or without urgency incontinence, increased daytime urinary frequency and nocturia. OAB has a negative impact on women's social, physical, and psychological wellbeing. Initial treatment includes lifestyle modifications, bladder retraining, pelvic floor exercises and pharmacological therapy. However, these measures are unsuccessful in 25-40% of women (refractory OAB). Before considering invasive treatments, such as Botulinum toxin injection or sacral neuromodulation, most guidelines recommend urodynamics to confirm diagnosis of detrusor overactivity (DO). However, urodynamics may fail to show evidence of DO in up to 45% of cases, hence the need to evaluate its effectiveness and cost-effectiveness. FUTURE (Female Urgency, Trial of Urodynamics as Routine Evaluation) aims to test the hypothesis that, in women with refractory OAB, urodynamics and comprehensive clinical assessment is associated with superior patient-reported outcomes following treatment and is more cost-effective, compared to comprehensive clinical assessment only.

Methods: FUTURE is a pragmatic, multi-centre, superiority randomised controlled trial. Women aged ≥ 18 years with refractory OAB or urgency predominant mixed urinary incontinence, and who have failed/not tolerated conservative and medical treatment, are considered for trial entry. We aim to recruit 1096 women from approximately 60 secondary/tertiary care hospitals across the UK. All consenting women will complete questionnaires at baseline, 3 months, 6 months and 15 months post-randomisation. The primary outcome is participant-reported success at 15 months post-randomisation measured using the Patient Global Impression of Improvement. The primary economic outcome is incremental cost per quality-adjusted life year gained at 15 months. The secondary outcomes include adverse events, impact on other urinary symptoms and health-related quality of life. Qualitative interviews with participants and clinicians and a health economic evaluation will also be conducted. The statistical analysis of the primary outcome will be by intention-to-treat. Results will be presented as estimates and 95% CIs.

Discussion: the FUTURE study will inform patients, clinicians and policy makers whether routine urodynamics improves treatment outcomes in women with refractory OAB and whether it is cost-effective.

Trial registration: ISRCTN63268739 . Registered on 14 September 2017.

Female, Filling cystometry, Overactive bladder, Randomised controlled trial, Urodynamics, Uroflowmetry
1745-6215
Abdel-Fattah, M
5531cad3-00fa-4ec9-9664-d1e64467d5fc
Chapple, C
01a9189c-86ff-44f8-af2e-28a78f0eecf4
Guerrero, K
c51bca11-bd68-40d6-81cc-1d3846cfd7f8
Dixon, S
78ecc9f3-c6c5-468d-9914-6ab73f35facd
Cotterill, N
c0ef5dfc-a9ae-4ebb-a3ed-5afb7805ff92
Ward, K
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Hashim, H
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Monga, A
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Brown, K
b83c1160-f4ef-4401-9f6d-3a3ec3fafc0a
Drake, M J
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Gammie, A
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Mostafa, A
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Bladder Health, U K
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Breeman, S
d424aa14-c91f-4023-a758-823a6dcab27c
Cooper, D
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MacLennan, G
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Norrie, J
d648d104-39a0-481f-af0f-9a7209d50fb5
Abdel-Fattah, M
5531cad3-00fa-4ec9-9664-d1e64467d5fc
Chapple, C
01a9189c-86ff-44f8-af2e-28a78f0eecf4
Guerrero, K
c51bca11-bd68-40d6-81cc-1d3846cfd7f8
Dixon, S
78ecc9f3-c6c5-468d-9914-6ab73f35facd
Cotterill, N
c0ef5dfc-a9ae-4ebb-a3ed-5afb7805ff92
Ward, K
f8b1011e-e7c5-4bbb-9fe0-85faaec5e9e0
Hashim, H
5e4bf080-e28b-4fa6-99a2-675ed622acce
Monga, A
e28686b0-b128-403d-b6d5-5e39e738c7d3
Brown, K
b83c1160-f4ef-4401-9f6d-3a3ec3fafc0a
Drake, M J
60d630c3-0d89-4513-94b6-72671bd28b94
Gammie, A
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Mostafa, A
c49607b1-e4a0-47b1-8b4e-8568b8516266
Bladder Health, U K
285f2970-81e6-4e5f-8146-52edd6fc422a
Breeman, S
d424aa14-c91f-4023-a758-823a6dcab27c
Cooper, D
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MacLennan, G
209593f8-0b7c-44fd-9abc-c1ea575b6c61
Norrie, J
d648d104-39a0-481f-af0f-9a7209d50fb5

Abdel-Fattah, M, Chapple, C, Guerrero, K, Dixon, S, Cotterill, N, Ward, K, Hashim, H, Monga, A, Brown, K, Drake, M J, Gammie, A, Mostafa, A, Bladder Health, U K, Breeman, S, Cooper, D, MacLennan, G and Norrie, J (2021) Female urgency, trial of urodynamics as routine evaluation (FUTURE study): a superiority randomised clinical trial to evaluate the effectiveness and cost-effectiveness of invasive urodynamic investigations in management of women with refractory overactive bladder symptoms. Trials, 22 (1), [745]. (doi:10.1186/s13063-021-05661-3).

Record type: Article

Abstract

Background: overactive bladder (OAB) syndrome is a symptom complex affecting 12-14% of the UK adult female population. Symptoms include urinary urgency, with or without urgency incontinence, increased daytime urinary frequency and nocturia. OAB has a negative impact on women's social, physical, and psychological wellbeing. Initial treatment includes lifestyle modifications, bladder retraining, pelvic floor exercises and pharmacological therapy. However, these measures are unsuccessful in 25-40% of women (refractory OAB). Before considering invasive treatments, such as Botulinum toxin injection or sacral neuromodulation, most guidelines recommend urodynamics to confirm diagnosis of detrusor overactivity (DO). However, urodynamics may fail to show evidence of DO in up to 45% of cases, hence the need to evaluate its effectiveness and cost-effectiveness. FUTURE (Female Urgency, Trial of Urodynamics as Routine Evaluation) aims to test the hypothesis that, in women with refractory OAB, urodynamics and comprehensive clinical assessment is associated with superior patient-reported outcomes following treatment and is more cost-effective, compared to comprehensive clinical assessment only.

Methods: FUTURE is a pragmatic, multi-centre, superiority randomised controlled trial. Women aged ≥ 18 years with refractory OAB or urgency predominant mixed urinary incontinence, and who have failed/not tolerated conservative and medical treatment, are considered for trial entry. We aim to recruit 1096 women from approximately 60 secondary/tertiary care hospitals across the UK. All consenting women will complete questionnaires at baseline, 3 months, 6 months and 15 months post-randomisation. The primary outcome is participant-reported success at 15 months post-randomisation measured using the Patient Global Impression of Improvement. The primary economic outcome is incremental cost per quality-adjusted life year gained at 15 months. The secondary outcomes include adverse events, impact on other urinary symptoms and health-related quality of life. Qualitative interviews with participants and clinicians and a health economic evaluation will also be conducted. The statistical analysis of the primary outcome will be by intention-to-treat. Results will be presented as estimates and 95% CIs.

Discussion: the FUTURE study will inform patients, clinicians and policy makers whether routine urodynamics improves treatment outcomes in women with refractory OAB and whether it is cost-effective.

Trial registration: ISRCTN63268739 . Registered on 14 September 2017.

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s13063-021-05661-3 - Version of Record
Available under License Creative Commons Attribution.
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More information

Accepted/In Press date: 24 September 2021
Published date: December 2021
Additional Information: This study is funded by the National Institute for Health Research (NIHR) HTA programme (Project 15/150/05). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
Keywords: Female, Filling cystometry, Overactive bladder, Randomised controlled trial, Urodynamics, Uroflowmetry

Identifiers

Local EPrints ID: 452778
URI: http://eprints.soton.ac.uk/id/eprint/452778
ISSN: 1745-6215
PURE UUID: 23a50dbc-46d2-4437-8611-a08119307b6f

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Date deposited: 20 Dec 2021 17:35
Last modified: 16 Mar 2024 15:15

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Contributors

Author: M Abdel-Fattah
Author: C Chapple
Author: K Guerrero
Author: S Dixon
Author: N Cotterill
Author: K Ward
Author: H Hashim
Author: A Monga
Author: K Brown
Author: M J Drake
Author: A Gammie
Author: A Mostafa
Author: U K Bladder Health
Author: S Breeman
Author: D Cooper
Author: G MacLennan
Author: J Norrie

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