| Title: |
Invasive urodynamic investigations in the management of women with refractory overactive bladder symptoms: FUTURE, a superiority RCT and economic evaluation |
| Authors: |
Abdel-Fattah, Mohamed; Chapple, Christopher; Breeman, Suzanne; Cooper, David; Bell-Gorrod, Helen; Kuppanda, Preksha; Guerrero, Karen; Dixon, Simon; Cotterill, Nikki; Ward, Karen; Hashim, Hashim; Monga, Ash; Brown, Karen; Drake, Marcus; Gammie, Andrew; Mostafa, Alyaa; Bruce, Rebecca; Bell, Victoria; Kennedy, Christine; Evans, Suzanne; MacLennan, Graeme; Norrie, John |
| Publisher Information: |
NIHR Journals Library |
| Publication Year: |
2025 |
| Collection: |
University of the West of England, Bristol: UWE Research Repository |
| Description: |
Background Overactive bladder is a common problem affecting the United Kingdom adult female population. Symptoms include urinary urgency, with or without urgency incontinence, increased daytime urinary frequency and nocturia. Initial conservative treatments for overactive bladder are unsuccessful in 25–40% of women (refractory overactive bladder). Before considering invasive treatments, such as botulinum toxin injection-A or sacral neuromodulation, guidelines recommend urodynamics to confirm diagnosis of detrusor overactivity. However, the clinical and cost effectiveness of urodynamics has never been robustly assessed. Objectives To compare the clinical and cost effectiveness of urodynamics plus comprehensive clinical assessment versus comprehensive clinical assessment only in the management of refractory overactive bladder in women. Design Parallel-group, multicentre, superiority, open-label, randomised controlled trial. Allocation by remote web-based randomisation (1 : 1 ratio). The cost-effectiveness analysis took the National Health Service perspective with a model-based lifetime time horizon, as informed by a within-trial analysis. Setting Sixty-three United Kingdom secondary and tertiary hospitals. Participants Women aged ≥ 18 years with refractory overactive bladder or urgency-predominant mixed urinary incontinence who had failed conservative management and pharmacological treatment and were being considered for invasive treatment. Women were excluded if any of the following criteria were met: predominant stress urinary incontinence; previous urodynamics in last 12 months; current pelvic malignancy or clinically significant pelvic mass; bladder pain syndrome; neurogenic bladder; urogenital fistulae; previous treatment with botulinum toxin injection-A or sacral neuromodulation for urinary incontinence; previous pelvic radiotherapy; prolapse beyond introitus; pregnant or planning pregnancy; recurrent urinary tract infection where a significant pathology has not been excluded; and inability to give an ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| ISSN: |
1366-5278 |
| Relation: |
https://uwe-repository.worktribe.com/file/14705781/1/Invasive%20urodynamic%20investigations%20in%20the%20management%20of%20women%20with%20refractory%20overactive%20bladder%20symptoms%3A%20FUTURE,%20a%20superiority%20RCT%20and%20economic%20evaluation; https://uwe-repository.worktribe.com/output/14705781 |
| DOI: |
10.3310/ukyw4923 |
| Availability: |
https://uwe-repository.worktribe.com/output/14705781; https://doi.org/10.3310/ukyw4923 |
| Rights: |
openAccess ; http://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.FD0616F9 |
| Database: |
BASE |