Condition category
Pregnancy and Childbirth
Date applied
11/09/2017
Date assigned
14/09/2017
Last edited
14/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Overactive bladder (OAB) affects 12-14% of the adult female population in the UK. Symptoms include increased frequency (going to pass urine more frequently), urgency (being unable to hold-on), urgency incontinence (UUI), and waking up at night to pass urine. Although rarely life-threatening, OAB can have a considerable negative impact on patients’ quality of life, restricting their social life and ability to work, and up-to social isolation in severe cases. OAB is first treated with lifestyle changes (such as reducing caffeine intake), pelvic floor exercises, bladder training and certain medications. Unfortunately these treatments do not work in 25-40% of patients (i.e. refractory OAB). These patients may be offered second line treatments such as injections of BOTOX into the bladder wall or SNM (an implant in the buttock which aim to regulate the bladder nerves in the lower spine). Before recommending second line treatments, doctors are advised to perform a diagnostic invasive test called “Urodynamics” to confirm the diagnosis. The test involves passing a thin tube into the bladder and another one into the back passage to measure the bladder activity and episodes of urinary incontinence (UI). Patients often find Urodynamics embarrassing and uncomfortable and some get cystitis (bladder infection) after the test. When asked, patients felt the test could be justified if it improves the treatment outcomes. However, in almost 40% of patients, Urodynamics does not show the underlying cause of the bladder problem and therefore is unable to guide doctors and patients in their decision making. The aim of this study is to assess whether routinely performing Urodynamics, in addition to the standard comprehensive clinical assessment, improves the outcome of treatments in women with refractory OAB compared to comprehensive clinical assessment only.

Who can participate?
Women aged 18 and older who have an overactive bladder (OAB).

What does the study involve?
Participants are randomly allocated. Those in the first group receive the standard clinical assessments as per their local NHS practice. Participants in the second group receive the Urodynamics test in addition to the comprehensive clinical assessment. Participants are posted questionnaires at three, six and 15 months after being allocated to groups to ask about their bladder symptoms, their quality of life and their views and experience with the treatment pathways.

What are the possible benefits and risks of participating?
There are no direct benefits with participating. There are no anticipated disadvantages or risks to participants in taking part in this study. Whichever group they are allocated to, the tests and assessments are performed by competent and trained clinicians. However it is important to note that there are risks associated with every test or treatment, and as part of routine clinical care, participants will be well informed of these potential risks. Steps are always taken to ensure that these risks are minimised.

Where is the study run from?
This study is being run by the University of Aberdeen (UK) and takes place in hospitals and treatment centres in the UK.

When is the study starting and how long is it expected to run for?
May 2017 to April 2021

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Suzanne Breeman

Trial website

Contact information

Type

Public

Primary contact

Dr Suzanne Breeman

ORCID ID

Contact details

Centre for Healthcare Randomised Trials (CHaRT)
Health Services Research Unit (HSRU)
3rd Floor Health Sciences Building
University of Aberdeen
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 1224 438169
s.breeman@abdn.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

36043

Study information

Scientific title

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

Acronym

FUTURE

Study hypothesis

Hypotheses:
1. Whether routine Urodynamics investigation and comprehensive clinical assessment significantly improves patient-reported success rates following treatment, compared to comprehensive clinical assessment only
2. Assess the cost-effectiveness of routine Urodynamics investigation and comprehensive clinical assessment, compared to comprehensive clinical assessment only

Ethics approval

North of Scotland Research Ethics Service, 27/03/2017, ref: 17/NS/0018

Study design

Randomised; Both; Design type: Treatment, Diagnosis, Active Monitoring, Validation of investigation/therapeutic procedures

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Available at: https://w3.abdn.ac.uk/hsru/FUTURE/Public/Public/index.cshtml

Condition

Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and Sexual Medicine; UKCRC code/ Disease: Reproductive Health and Childbirth/ Complications of labour and delivery, Renal and Urogenital/ Other disorders of kidney and ureter

Intervention

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 application based at the Centre for Healthcare Randomised Trials (CHaRT).

Comprehensive clinical assessment arm:
Participants undergo a detailed history including:
1. Assessment of Urinary symptoms: storage, filling and incontinence symptoms and the most bothersome urinary symptoms
2. Previous investigations and/ or treatments (conservative, pharmacological and or surgical) for UI and OAB
3. Past medical or surgical history of relevance
Participants also undergo a clinical examination including assessment for:
1. Stress urinary incontinence
2. Pelvic organ prolapse
3. Pelvic masses and other pelvic pathology
And finally participants have non invasive clinical assessments completed including:
1. Evaluation of Bladder Diary for 3 days to assess daytime frequency; 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 clinical assessments as the other arm however they also have a urodynamic clinical assessment. Urodynamics refers to comprehensive invasive and non invasive assessment of women with urinary symptoms and includes:
1. Detailed history, examination and bladder diary as above
2. Subtracted cystometry
3. Free uroflowmetry ± pressure flow studies ± Bladderscan

Participants are followed-up at three, six and 15 months post-randomisation by postal questionnaire. The questionnaires ask about their bladder symptoms, their quality of life and their views and experience with the treatment pathways.

Intervention type

Other

Phase

Drug names

Primary outcome measures

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

Secondary outcome measures

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 over the lifetime of patients

Overall trial start date

01/05/2017

Overall trial end date

30/04/2021

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 1096; UK Sample Size: 1096

Participant 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

Recruitment start date

01/10/2017

Recruitment end date

31/05/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom

Trial participating centre

Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom

Trial participating centre

Queen Elizabeth University Hospital
1345 Govan Road
Glasgow
G51 4TF
United Kingdom

Trial participating centre

Southmead Hospital Bristol
Southmead Road Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Trial participating centre

St Mary’s Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

Princess Anne Hospital
Coxford Road
Southampton
SO16 5YA
United Kingdom

Trial participating centre

Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Organisation

University of Aberdeen

Sponsor details

King's College
Aberdeen
AB24 3FX
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Organisation

Grampian Health Board

Sponsor details

Summerfield House
2 Eday Road
Aberdeen
AB15 6RE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer review journal. The Protocol can also be found at the following link:
https://w3.abdn.ac.uk/hsru/FUTURE/Public/Public/index.cshtml

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/04/2022

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes