Pelvic floor dysfunction Urological and Genital Diseases
Conditions
Interventions
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 in
Sponsors
Bournemouth University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Primiparous women over the age of 18 years with a viable pregnancy and the ability to send and receive e-mail
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactRosie Harper
Outcome results
None listed