Condition category
Urological and Genital Diseases
Date applied
20/08/2018
Date assigned
10/09/2018
Last edited
06/12/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Pregnancy and childbirth are important risk factors for Urinary Incontinence (UI) in women. Between two-thirds to three-quarters of women may still experience UI symptoms 12 years after childbirth. Incontinence places a large burden on women’s health and impacts on physical, mental and social quality of life with associated pressure on NHS resources. This study is being undertaken as part of a programme that aims to prevent child-birth related UI by increasing the number of women doing pelvic floor muscle exercises (PFMEs) during pregnancy. The aim of this study is to try out two postal questionnaire data collection methods in order to provide estimates for UI rates and find the postal method with the best response rate to be used in the main trial.

Who can participate?
Women aged over 16 who have delivered under the care of a participating community midwife team during a defined period

What does the study involve?
Participants are randomly allocated to receive either a long form or short form postal questionnaire.
The questionnaires assess stress urinary incontinence, bowel incontinence, effectiveness of PFMEs and general health, as well as some questions about advice and information that the women received on PFMEs in their pregnancy and their own practice of PFME. Should the completed questionnaire (of either type) not be received at two weeks from the date of initial posting, then the initial questionnaire is sent again. Should no response be forthcoming then no further questionnaires are sent.

What are the possible benefits and risks of participating?
The benefits to the women are assisting with improving continence in future generations of women. The first questionnaire is accompanied by a £10 voucher which is redeemable in many High Street shops and online as a gratuity for the woman’s time in completing and returning the questionnaires. There are no risks of participating in this study.

Where is the study run from?
1. Birmingham Women's & Children's NHS Foundation Trust (UK)
2. Heart of England NHS Trust (UK)
3. Sandwell & West Birmingham Hospitals NHS Trust (UK)

When is the study starting and how long is it expected to run for?
March 2018 to November 2018

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

Who is the main contact?
Mrs Sara Webb
s.s.webb@bham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Sara Webb

ORCID ID

http://orcid.org/0000-0002-4924-3017

Contact details

Institute of Applied Health Research
College of Medical and Dental Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44 (0)121 4158846
s.s.webb@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

39050

Study information

Scientific title

Postal questionnaire data collection pilot study: Antenatal Preventative Pelvic Floor Exercises and Localisation (APPEAL) programme

Acronym

APPEAL

Study hypothesis

Pregnancy and childbirth are important risk factors for Urinary Incontinence (UI) in women. Between two-thirds to three-quarters of women may still experience UI symptoms 12 years after childbirth. Incontinence places a large burden on women’s health and impacts on physical, mental and social quality of life with associated pressure on NHS resources.

This postal questionnaire data collection pilot study is being undertaken as part of a five year NIHE funded Antenatal Preventative Pelvic Floor Exercises and Localisation (APPEAL) programme that aims to prevent child-birth related UI (Urinary Incontinence) by increasing the number of women doing pelvic floor muscle exercises during pregnancy. This pilot study is necessary to try out two postal questionnaire data collection methods in order to provide estimates for UI rates and find the postal method that optimises response rates that can be used in the subsequent trial.

Ethics approval

London - Brighton & Sussex Research Ethics Committee, 18/05/2018, ref: 18/LO/0934

Study design

Multicentre randomised controlled open-label parallel-group two-arm pilot trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Reproductive Health and Childbirth, Primary sub-specialty: General Gynaecology; Health Category: Renal and Urogenital; Disease/Condition: Other diseases of urinary system

Intervention

In this pilot study the intervention is type of postal questionnaire design (long form or short form) which is provided to the women.

The question set for the pilot study consists of a number of validated questionnaires to assess stress urinary incontinence (ICIQ-UI SF), bowel incontinence (RFIS), efficacy of PFME (PFMSES) and general health (SF-12) as well as some questions about advice and information that the women received on PFME in their pregnancy and their own practice of PFME. In order to investigate the most efficacious way of receiving these data back from the women this pilot study will send out the questionnaires in two configurations:

Long form questionnaire
This includes all of the questions necessary to satisfy both the primary and secondary outcome measures for the subsequent cluster randomised controlled trial (APPEAL) and to provide estimates for urinary stress incontinence rates for use in sample size calculation and intra-cluster correlation co-efficient (ICC)
This questionnaire will include a tick box to allow the women to give consent to access her maternity hospital records for the relevant maternity data, alongside tick boxes to request the study results and whether she agrees to be contacted in the future for further research.

Short form questionnaire
In the short form (two part) version of the questionnaire the first part (Part A), contains the questions necessary to address the primary outcome of the subsequent cluster randomised controlled trial alongside secondary outcomes of bowel incontinence as well as questions about advice and information that the woman received on PFME in their pregnancy and their own practice of PFME.
Part A of the short form questionnaire will include a tick box option to allow the woman to give consent to access her hospital records for relevant maternity data, alongside tick boxes to request the study results and whether she agrees to be contacted in the future for further research.
The second part of the short form questionnaire (Part B) includes the PFMSES and SF-12 questionnaires. This will only be sent out to the participants in the short form questionnaire arm following receipt of the completed Part A questionnaire.

Should the completed questionnaire (of either type) not be received at two weeks from the date of initial posting, then the initial questionnaire will be sent again. Should no response be forthcoming then no further questionnaires will be sent. The questionnaires will be sent to the eligible woman in both arms by members of the local team employed by the trust who were responsible for the woman’s care during her pregnancy and birth. The first questionnaire will be accompanied by a £10 voucher which is redeemable in many High Street shops and online as a gratuity for the woman’s time in completing and returning the questionnaires.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The response rate for completion of urinary stress incontinence to the full and split questionnaire processes. The process that optimises the response rate for collection of urinary stress incontinence rates will then be used in the subsequent cluster randomised controlled trial (APPEAL).

Secondary outcome measures

1. Stress urinary and bowel incontinence rates at questionnaire completion (10-12 weeks postnatal), the former for use in sample size calculation for the subsequent cluster randomised controlled trial
2. Intra-cluster correlation co-efficient (ICC) for primary outcome for use in the subsequent cluster randomised controlled trial

Overall trial start date

01/03/2018

Overall trial end date

30/11/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Women who have delivered under the care of a participating community midwife team during a defined period

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 800; UK Sample Size: 800

Participant exclusion criteria

Women who:
1. Are under 16 years of age at the point their notes are reviewed
2. Have a non-live baby on discharge home after birth
3. Have informed the study team that they do not wish to receive the questionnaire

Recruitment start date

08/10/2018

Recruitment end date

05/11/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Birmingham Women's & Children's NHS Foundation Trust
Mindlesohn Way Edgbaston
Birmingham
B15 2TG
United Kingdom

Trial participating centre

Heart of England NHS Trust
Birmingham Heartlands Hospital Bordesley Green East
Birmingham
B9 5SS
United Kingdom

Trial participating centre

Sandwell & West Birmingham Hospitals NHS Trust
Department of Research & Development D46, 2nd Floor Sheldon Block, City Hospital, Dudley Road
Birmingham
B18 7QH
United Kingdom

Sponsor information

Organisation

Birmingham Women’s & Children’s NHS Foundation Trust

Sponsor details

c/o Mrs Kelly Hard
Head of R&D
Mindlesohn Way
Edgbaston
Birmingham
B15 2GT
United Kingdom
+44 (0)7718563325
Kelly.hard@bwnft.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-0514-20002

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal with intent for publication around one year after overall trial end date.

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

30/11/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/12/2018: The recruitment end date has been changed from 04/11/2018 to 05/11/2018.