Pelvic (floor) Reminders (to) Explore Perinatal (women's) Acceptability (of) Reminders (to) Exercise (PREPARE) study
| ISRCTN | ISRCTN32494719 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32494719 |
| IRAS number | 328225 |
| Secondary identifying numbers | IRAS 328225, CPMS 58654 |
- Submission date
- 26/08/2023
- Registration date
- 27/09/2023
- Last edited
- 09/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Pelvic floor muscle dysfunction (PFMD) is a condition that affects up to one in three women at some point in their lifetime and can be commonly traced back to the perinatal period due to the physiological changes associated with pregnancy and childbirth. The most prevalent symptom of PFMD is stress urinary incontinence (SUI), defined as the involuntary loss of urine on effort or physical exertion (e.g., sporting activities), or on sneezing or coughing. The social, emotional, economic, and environmental impact of SUI is well documented and includes social isolation, difficulty returning to work, impaired sexual function and prevention of vigorous exercise.
Supervised pelvic floor muscle training (PFMT) is the gold standard of treatment for symptoms of SUI. Pelvic floor muscle training is defined as exercise to improve pelvic floor muscle strength, endurance, power, relaxation or a combination of these parameters. Women are less likely to develop urinary incontinence during pregnancy or in the early post-natal period if they regularly complete PFMT. PFMT involves women completing supervised PFMT three times a day for a minimum of three months for it to be effective at reducing symptoms of PFMD; however, clinically, it is recognised women do not regularly adhere to this exercise prescription.
Health apps commonly use reminders for long-term conditions to promote self-management and have been proven effective in other long-term conditions. The use of digital technology, such as mobile apps, in maternity care can personalise the treatment individual women receive thus improving healthcare delivery and in particular the management of PFMD. Personalisation of PFMT may be enhanced by providing digital ‘nudges’ as reminders and encouragement to enhance adherence to exercises.
Who can participate?
Women between the ages of 18 and 45 years who have a viable pregnancy and have given birth once before
What does the study involve?
The feasibility trial will determine whether a future randomised controlled trial can be conducted. The feasibility trial will compare an intervention and a control group. The intervention group will receive a PFMT mobile app and digital nudges. The control group will receive a leaflet on the role of the pelvic floor and how to complete PFMT developed by a UK-based professional network of clinical specialist physiotherapists. Perinatal women will have three telephone follow-ups lasting no longer than 30 minutes. The timing of these follow-ups will be at 9, 21 and 31 weeks. These follow-ups correspond to the late antenatal stage of gestation (36 weeks), around 1 month postnatal and 4 months postnatal.
What are the possible benefits and risks of participating?
The immediate advantage to participants is support with pelvic floor muscle training during pregnancy. Whilst the researchers do not anticipate any risks to participants there is a very small risk of emotional distress talking about pelvic floor-related symptoms. For those in the intervention group, there is a small but possible chance that participants find digital reminders a burden. There is a small but possible risk participants may find the statements in the digital nudges hard to understand. Participants randomised into a group they are not happy with may experience negative feelings.
Where is the study run from?
Bournemouth University (UK)
When is the study starting and how long is it expected to run for?
January 2023 to April 2025
Who is funding the study?
1. Bournemouth University (UK)
2. University Hospitals Dorset (UK)
3. National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) Wessex (UK)
Who is the main contact?
Rosie Harper, rharper1@bournemouth.ac.uk
Contact information
Public
Faculty of Health and Sports Sciences
Bournemouth Gateway Building
12 St Paul's Ln
Bournemouth
BH8 8GP
United Kingdom
 ORCID ID |
0000-0003-3414-7580 |
|---|---|
| Phone | +44 (0)1202 969696 |
| rharper1@bournemouth.ac.uk |
Scientific
Faculty of Health and Sports Sciences
Bournemouth Gateway Building
12 St Paul's Ln
Bournemouth
BH8 8GP
United Kingdom
| Phone | +44 (0)1202 969696 |
|---|---|
| rharper1@bournemouth.ac.uk |
Principal Investigator
Faculty of Health and Sports Sciences
Bournemouth Gateway Building
12 St Paul's Ln
Bournemouth
BH8 8GP
United Kingdom
| ORCID ID |
0000-0002-9296-7141 |
|---|---|
| Phone | +44 (0)1202 969696 |
| cclark@bournemouth.ac.uk |
Study information
| Study design | Single-centre interventional mixed methods feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Feasibility trial |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Pelvic (floor) Reminders (to) Explore Perinatal (women's) Acceptability (of) Reminders (to) Exercise (PREPARE) |
| Study acronym | PREPARE |
| Study objectives | The principal research objective is to determine the feasibility of undertaking a randomized controlled trial that explores whether a physiotherapy-led digital intervention can increase pelvic floor muscle training adherence in women. |
| Ethics approval(s) | 1. Approved 19/12/2023, HRA REC South Central (South Central – Hampshire A, Southampton, SO17 1BJ, United Kingdom; +44 (0)207 104 8120, +44 (0)207 104 8210, +44 (0)207 104 8290; hampshirea.rec@hra.nhs.uk), ref: 23/SC/0407 2. Approved 12/01/2024, Bournemouth University (Faculty of Health and Sports Sciences, Bournemouth, BH8 8GP, United Kingdom; +44 (0)1202 524111; researchethics@bournemouth.ac.uk), ref: 52246 |
| Health condition(s) or problem(s) studied | Pelvic floor dysfunction |
| Intervention | Participants will be randomised between 26-28 weeks of pregnancy by assigning random numbers to each subject using permuted block randomisation in REDCapTM software. Participants will be randomised into one of two arms of the study: the intervention group or the control group. The researchers are unable to blind the participants in the study. It was not possible to blind data collectors in the study. The control group will receive a leaflet on the role of the pelvic floor and how to complete PFMT developed by a UK-based professional network of clinical specialist physiotherapists. The intervention consists of 31 targeted digital PFMT ‘nudges’ and a pelvic floor muscle training mobile app. The digital nudges were co-designed as part of a larger research study to support perinatal women to complete regular pelvic floor muscle training. The total number of digital nudges is 31 to account for the number of weeks between 26 weeks of pregnancy and 4 months postnatal. The nudges target different stages of the perinatal period and have been divided into the following categories: 1. Late antenatal 2. Early postnatal 3. Late postnatal The nudges will be in the form of push notifications. A digital nudge will be sent once a week to each participant. Women will receive the first digital nudge between 26-28 weeks of pregnancy soon after they have been enrolled in the study. Each digital nudge is unique and the last digital nudge will be sent around 4 months post-natal. The control group will receive a leaflet on the role of the pelvic floor and how to complete PFMT developed by a UK-based professional network of clinical specialist physiotherapists. |
| Intervention type | Behavioural |
| Primary outcome measure | Several outcome measures will be trialled in the study to determine whether the study design and intervention can be taken forward for an RCT. Primary outcome measures include: 1. Quality of life measured using EQ5D5L at baseline, 9 weeks, 21 weeks and 31 weeks 2. Severity of urinary incontinence symptoms measured using International Consultation of Incontinence Questionnaire of Urinary Incontinence- Short Form (ICIQ-UI) at baseline, 9 weeks, 21 weeks and 31 weeks 3. Self-efficacy around pelvic floor muscle training measured using the Broome pelvic muscle self-efficacy scale at baseline and 31 weeks 4. Adherence to pelvic floor muscle training measured using in-app adherence data that will be collected weekly throughout the study 5. Adherence to pelvic floor muscle training measured using online and paper diaries at 9 weeks, 21 weeks and 31 weeks 6. Participant engagement with the intervention measured using in-app algorithms e.g. interaction response time and will be collected continuously throughout the study |
| Secondary outcome measures | Secondary outcome measures will be used to add greater depth to the quantitative data collected in the study to explore participants' acceptability of the intervention. The secondary outcome measures include: 1. Participant's views on the acceptability of the digital nudges and study processes will be measured using semi-structured interviews at just after 31 weeks 2. Participant's acceptability of the intervention will be captured using one open-ended questions ‘which nudges best supported you in your training and why’ at 9 weeks, 21 weeks and 31 weeks |
| Overall study start date | 01/01/2023 |
| Completion date | 30/04/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target number of participants | 74 |
| Total final enrolment | 44 |
| Key inclusion criteria | Primiparous women over the age of 18 years with a viable pregnancy and the ability to send and receive e-mail |
| Key exclusion criteria | 1. Under the age of 18 years 2. Haematuria 3. Difficulty passing urine or bladder emptying difficulties 4. Present malignancy of the pelvic area 5. A neurological disease that affects the urinary system 6. Pyelonephritis 7. Severe comorbidities in pregnancy (including placenta previa, threatened premature labour, pregnancy-induced hypertension) 8. Hyperactivity of the pelvic floor 9. Active urinary tract infection 10. History of stroke, diabetes or gestational diabetes 11. Use of another PFMT mobile app 12. Cannot read or understand written English |
| Date of first enrolment | 23/02/2024 |
| Date of final enrolment | 23/05/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Poole Hospital
Longfleet Road
Poole
BH15 2JB
United Kingdom
Sponsor information
University/education
Fern Barrow
Poole
BH12 5BB
England
United Kingdom
| Phone | +44 (0)1202 969696 |
|---|---|
| askbu@bournemouth.ac.uk | |
| Website | https://www1.bournemouth.ac.uk/ |
"ROR" |
https://ror.org/05wwcw481 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- BU
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 01/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Rosie Harper (rharper1@bournemouth.ac.uk). Consent from participants will be required and obtained and participants will be pseudo-anonymised using a unique study identity code. All other details will be added to the study record at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol (preprint) | 19/01/2024 | 13/05/2024 | No | No |
Editorial Notes
09/04/2025: The contact confirmed the record is up to date.
07/10/2024: The following changes were made:
1. The overall study end date was changed from 30/09/2024 to 30/04/2025.
2. The Intention to publish date was changed from 01/05/2025 to 01/09/2025.
3. The total final enrolment was added.
13/05/2024: The following changes were made to the study record:
1. The recruitment start date was changed from 22/02/2024 to 23/02/2024.
2. The recruitment end date was changed from 01/05/2024 to 23/05/2024.
3. Protocol preprint added.
07/03/2024: The ethics approval (2) was added.
28/02/2024: The ethics approval (1) was added.
23/02/2024: The recruitment start date was changed from 01/02/2024 to 22/02/2024.
13/10/2023: The funder "University Hospitals Dorset" was added.
09/10/2023: The funder "Dorset HealthCare University NHS Foundation Trust" was removed.
06/10/2023: Planned ethics submission dates were added.
04/10/2023: Internal review.
15/09/2023: Study's existence confirmed by Bournemouth University.
