Female urgency, trial of Urodynamics as routine evaluation

Conditions

Reproductive Health and Childbirth Pregnancy and Childbirth Reproductive Health and Childbirth

Mohamed Abdel‐Fattah, Christopher R. Chapple, Suzanne Breeman, David Cooper, Helen Bell‐Gorrod et al. (22 authors)

Health Technology Assessment2025-07-011 citations

Invasive urodynamic investigations in the management of women with refractory overactive bladder symptoms (FUTURE) in the UK: a multicentre, superiority, parallel, open-label, randomised controlled trial.

Abdel-Fattah M, Chapple C, Cooper D, Breeman S, Bell-Gorrod H, Kuppanda P, Guerrero K, Dixon S, Cotterill N, Ward K, Hashim H, Monga A, Brown K, Drake M, Gammie A, Mostafa A, Bruce R, Bell V, Kennedy C, Evans S, MacLennan G, Norrie J, FUTURE Study Group.

2025-03-228 citations

10.1016/s0140-6736(24)01886-5

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.

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

2021-10-2611 citations

10.1186/s13063-021-05661-3

Interventions

Participants are randomly allocated to one of two arms for their urodynamics investigation. urodynamics investigation in addition to clinical assessment. Participants are randomised using a web-based

nocturia

urgency and UUI episodes 2. Post voiding residual urine volume using a bladderscan Urodynamics and Comprehensive clinical assessment arm: Participants in this group receive the some comprehensive cl

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women aged =18 years with refractory OAB or urgency predominant MUI in whom OAB are their most bothersome symptom 2. Have failed conservative treatment (as per NICE guideline e.g. pelvic floor muscle training/ bladder retraining) 3. Have failed or have not tolerated pharmacological treatment (at least 2 different drugs) unless contra indicated 4. Being considered for further treatment

Exclusion criteria

Exclusion criteria: 1. Predominant SUI symptoms 2. Previous urodynamics in the last 12 month 3. Pelvic malignancy or clinically significant pelvic mass 4. Bladder Pain Syndrome 5. Neurological disease (e.g. Parkinson’s disease, Spinal injuries, etc) 6. Urogenital fistulae 7. Previous treatment with BoNT-A/ SNM 8. Previous pelvic radiotherapy 9. Prolapse beyond introitus 10. Pregnant or planning pregnancy 11. Recurrent UTI where a significant pathology has not been excluded 12. Unable to give an informed consent

Design outcomes

Primary

Measure	Time frame
1. Participant reported success is measured using the Patient Global Impression of Improvement – Index (PGI-I) at 15 months post randomisation (approximately 12 months post treatment). 2. Economic outcome is the incremental cost per quality adjusted life year (QALY) gained of Urodynamics and comprehensive clinical assessment compared to comprehensive clinical assessment only, modelled over the lifetime of the patients	—

Measure

Time frame

1. Participant reported success is measured using the Patient Global Impression of Improvement – Index (PGI-I) at 15 months post randomisation (approximately 12 months post treatment). 2. Economic outcome is the incremental cost per quality adjusted life year (QALY) gained of Urodynamics and comprehensive clinical assessment compared to comprehensive clinical assessment only, modelled over the lifetime of the patients

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Secondary

Measure	Time frame
1. Proportion of women receiving invasive treatment is measured by review of the clinical health records at 6 and 15 months post randomisation 2. Participant reported outcomes at 3, 6 and 15 months post randomisation which includes: 2.1. OAB symptoms measured by the ICIQ-OAB and UPS 2.2. Urgency and UUI episodes measured using the bladder diary 2.3. Other urinary symptoms measured using the 3 domains of the ICIQ-FLUTS (filling, voiding and incontinence) and the bladder Diary 2.4. Generic health related QoL status measured using general (EQ-5D-5L) and condition specific (ICIQ-LUTSqol) QoL assessment tools 3. Adverse Events is measured by review of the clinical health records at 6 and 15 months post randomisation 4. Qualitative study outcomes which includes: 4.1. Participants’ attitudes to invasive testing and expected outcomes (prior to randomisation or knowing their allocated study group) at baseline 4.2. Participants’ attitudes to potential treatment options (prior to randomisation or knowing their allocated study group) at baseline 4.3. Participants’ experience of Urodynamics and opinions regarding treatment outcome to include evaluation of treatment satisfaction or desire for further treatment (3 to 6 months post treatment) 4.4. Surgeon attitudes to the influence of Urodynamics on decision making at start of the study and 6 to 12 months after starting recruitment at their sites 5. Secondary economic outcomes which includes: 5.1. Incremental cost per QALY gained of Urodynamics and comprehensive clinical assessment compared to comprehensive clinical assessment only up to 15 months 5.2. Incremental cost per QALY gained of BoNT-A vs SNM as the initial treatment for refractory OAB over the lifetime of patients 5.3. Incremental cost per QALY gained of SNM test and BoNT-A treatment according to clinical assessment only compared to treatment guided by Urodynamics over the lifetime of patients 5.4. Expected value of perfect information and associated partial values ov	—

Measure

Time frame

1. Proportion of women receiving invasive treatment is measured by review of the clinical health records at 6 and 15 months post randomisation 2. Participant reported outcomes at 3, 6 and 15 months post randomisation which includes: 2.1. OAB symptoms measured by the ICIQ-OAB and UPS 2.2. Urgency and UUI episodes measured using the bladder diary 2.3. Other urinary symptoms measured using the 3 domains of the ICIQ-FLUTS (filling, voiding and incontinence) and the bladder Diary 2.4. Generic health related QoL status measured using general (EQ-5D-5L) and condition specific (ICIQ-LUTSqol) QoL assessment tools 3. Adverse Events is measured by review of the clinical health records at 6 and 15 months post randomisation 4. Qualitative study outcomes which includes: 4.1. Participants’ attitudes to invasive testing and expected outcomes (prior to randomisation or knowing their allocated study group) at baseline 4.2. Participants’ attitudes to potential treatment options (prior to randomisation or knowing their allocated study group) at baseline 4.3. Participants’ experience of Urodynamics and opinions regarding treatment outcome to include evaluation of treatment satisfaction or desire for further treatment (3 to 6 months post treatment) 4.4. Surgeon attitudes to the influence of Urodynamics on decision making at start of the study and 6 to 12 months after starting recruitment at their sites 5. Secondary economic outcomes which includes: 5.1. Incremental cost per QALY gained of Urodynamics and comprehensive clinical assessment compared to comprehensive clinical assessment only up to 15 months 5.2. Incremental cost per QALY gained of BoNT-A vs SNM as the initial treatment for refractory OAB over the lifetime of patients 5.3. Incremental cost per QALY gained of SNM test and BoNT-A treatment according to clinical assessment only compared to treatment guided by Urodynamics over the lifetime of patients 5.4. Expected value of perfect information and associated partial values ov

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Countries

England, Scotland, United Kingdom

Contacts

Public ContactSuzanne Breeman

s.breeman@abdn.ac.uk+44 1224 438169

Outcome results

None listed