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.
| Original language | English |
|---|---|
| Article number | 745 |
| Number of pages | 18 |
| Journal | Trials |
| Volume | 22 |
| Issue number | 1 |
| Early online date | 26 Oct 2021 |
| DOIs | |
| Publication status | Published - 26 Oct 2021 |
Bibliographical note
AcknowledgementsThe authors would like the thank the following people who helped to deliver the FUTURE trial: Tracey Davidson, Victoria Bell and Gillian Ferry for trial management support; Becky Bruce for secretarial support and data management; previous assistant trial managers (Karlee Dyck and Elerita Flammini) for their trial management support; Megan Pardoe for implementation of the qualitative aspect of the protocol; Abualbishr Alshreef for implementation of the health economic aspect of the protocol; Alison McDonald (CHaRT Senior Trials Manager), Ruth Thomas (CHaRT Research Manager) and the CHaRT programming team led by Mark Forrest; the local recruiting teams and the participants.
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.
Data Availability Statement
Data may be available on request to the Chief Investigator (CI), Professor Mohamed Abdel-fattah ([email protected]).Keywords
- Female
- Filling cystometry
- Overactive bladder
- Randomised controlled trial
- Urodynamics
- Uroflowmetry
Access to Document
- Abdel-fattah_et_al_Female_urgency_Trials_vor
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