Plain English Summary
Background and study aims
Pregnancy and birth are the main risk factors for women to develop urinary incontinence. Despite experiencing symptoms of UI, many women ‘suffer’ in silence as they are embarrassed about their condition, or accept symptoms as ‘normal’ after having a baby, despite evidence that pelvic floor muscle exercises (PFME), if performed correctly in pregnancy, can reduce women’s risk of developing urinary incontinence after giving birth. Guidelines recommend that midwives provide specific advice about PFME at the woman’s antenatal booking appointment, but this very often doesn’t happen, or if it does advice is often scant and insufficient for the woman to undertake effective exercises.
The APPEAL pilot trial will train teams of midwives to better explain and encourage pregnant women to undertake their pelvic floor muscle exercises. It will consider whether it would be feasible to undertake a future definitive trial to see if this training reduces the incidence of urinary incontinence in women under their care.
Who can participate?
All women who have antenatal care under the care of each of the community midwifery teams (clusters) in the two NHS trusts.
What does the study involve?
Teams of community midwifes will be randomised to either continuing with their usual practice of providing advice and encouragement to the women under their care, or receiving a specially devised training package to better encourage women under their care to undertake pelvic floor muscle exercises (PFME).
At around 3 months after they have given birth, the women under the care of these midwifery teams during the period of this study will be asked to complete a questionnaire to determine whether they had advice from their midwife about PFME, whether they undertook PFME themselves and whether they experienced of any incontinence they may suffer after giving birth.
What are the possible benefits and risks of participating?
As the intervention is to encourage midwives to deliver best practice, we can foresee no risks, potential adverse effects, pain, discomfort, distress, intrusion, inconvenience or changes to lifestyle to the women receiving antenatal care from the midwifery teams in the intervention arm. Nor can we see any potential risk or burden to the midwives in each cluster who participate in the study
Where is the study run from?
Birmingham Women's and Children's Hospital NHS Foundation Trust, UK
When is the study starting and how long is it expected to run for?
March 2020 to June 2021
Who is funding the study?
National Institute for Health Research (NIHR)
Who is the main contact?
Dr William McKinnon
w.mckinnon@bham.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Dr William McKinnon
ORCID ID
Contact details
Birmingham Clinical Trials Unit
University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 8335
w.mckinnon@bham.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
0.9, CPMS 43784, IRAS 272603
Study information
Scientific title
Antenatal preventative pelvic floor muscle exercise intervention led by midwives to reduce postnatal urinary incontinence (APPEAL): A feasibility and pilot cluster randomised controlled trial
Acronym
APPEAL
Study hypothesis
The aim of this feasibility and pilot cluster trial is to assess the potential to undertake a future definitive cluster trial to compare clinical and cost-effectiveness of a midwifery-led antenatal pelvic floor muscle exercise (PFME) intervention to reduce urinary incontinence in postnatal women. Specific objectives include assessment of the acceptability of the trial intervention and procedures to midwives, questionnaire return rates and prevalence of UI and other outcomes at 10 – 12 weeks postnatal
Ethics approval
Not provided at time of registration
Study design
Two centre feasibility and pilot cluster randomized controlled trial with nested process evaluation
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Postpartum urinary incontinence
Intervention
The intervention in this pilot and feasibility cluster randomized controlled trial comprises an antenatal midwife training package aimed at enhancing midwife ability and motivation to inform and support women in their practice of PFME.
Midwives in the community midwifery teams randomly allocated to the intervention will be trained how to teach PFME Following training, midwives in intervention clusters will be asked to provide verbal information and a resource pack to all women in their care to assist them in performing PFME. The midwifery-led intervention will be introduced to the women at their antenatal booking, with support and advice to undertake PFME included as part of each subsequent follow-up appointment throughout the rest of the pregnancy. Midwives will also be given resource packs to give to each woman to assist them in performing PFME, which will include recommended ‘apps’, a specially prepared leaflet and other reminders.
Women whose community midwifery teams are allocated to the control will receive standard antenatal care only. The current NICE antenatal care guideline (NICE 2010) recommends that midwives give women advice about exercise, including PFME, at the antenatal booking visit but research suggests that this either does not happen at all, or not in a manner likely to result in sufficient PFME practice.
Fourteen community midwifery teams in two participating NHS trusts will comprise the trial clusters. Midwifery teams will be randomised in a 1:1 ratio to either standard care only or intervention using a dedicated computer programme supplied by BCTU. As randomisation will be by cluster, and the number of clusters allocated to trial arm will be small, it is important to balance the allocation to trial arms according to any factors known or believed to be associated with the study outcomes. A minimisation algorithm will be used within the randomisation system to ensure approximate balance in the treatment allocation over the following variables:
- Midwifery team size as defined by number of births (‘small’ versus ‘large’)
- Trust (BWCH or UHB)
At the first postnatal home visit women will be informed by their community midwife that they will receive a questionnaire at 10-12 weeks after their birth asking that they will receive a postal questionnaire at 10-12 weeks postpartum asking about advice on, and performance of, PFME and about any urinary and faecal incontinence they may have had
Midwives in the participating teams will provide antenatal care to around 1400-1500 women during the study period, of whom a proportion will return questionnaires.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Dichotomous feasibility measures, such as recruitment and questionnaire return rates, as well as data completeness, will be reported as numbers and percentages
2. The feasibility and pilot cluster trial questionnaire will provide data to facilitate estimation of the sample size required for a future RCT
3. Outcome data on urinary incontinence and PFME will be collected from women at 10-12 weeks postnatally
Secondary outcome measures
none
Overall trial start date
01/07/2019
Overall trial end date
30/06/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All women who receive antenatal care from a participating community midwifery team (cluster) during the trial period
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
14 midwife teams (clusters) with an average sample size of 100 women per cluster
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
09/03/2020
Recruitment end date
31/08/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Birmingham Women's and Children's Hospital NHS Foundation Trust
Mindelsohn Way
Edgbaston
Birmingham
B15 2TG
United Kingdom
Sponsor information
Organisation
Birmingham Women's and Children's NHS Foundation Trust
Sponsor details
Mindlesohn Way
Edgbaston
Birmingham
B15 2GT
United Kingdom
+44 (0)1213338749
e.adey@nhs.net
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
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Once the results of the study become available it is planned that they will be made public through a variety of sources including manuscripts, presentations at conferences, and public facing media.
Women who participated in the study will be given the option of receiving results which will be presented in a lay friendly manner.
Conferences: The findings will be presented by the members of the TMG via national and international specialist conferences and other events.
Peer reviewed publications: We will endeavor to publish the findings in appropriate peer reviewed journals with a high impact factor.
NIHR Journals Library: The study and its results will be lodged with the NIHR Journals Library.
Media: In consultation with the investigators and appropriate journal representatives, a press release will be issued to the media upon publication of the results.
We will submit a formal notification to the REC, and the Department of Health. We anticipate additional outreach to other stakeholders (trial networks, healthcare advocates).
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.
Intention to publish date
01/05/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list