Condition category
Urological and Genital Diseases
Date applied
25/10/2019
Date assigned
09/03/2020
Last edited
09/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

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

Publication citations

Additional files

Editorial Notes

09/04/2020: Due to current public health guidance, recruitment for this study has been paused. 10/03/2020: Internal review. 11/11/2019: Trial’s existence confirmed by National Institute for Health Research (NIHR)