Development and Feasibility Testing of a Group-based PFMT Programme for Antenatal Women in Nanjing City in China
- Conditions
- Urinary Incontinence
- Interventions
- Behavioral: Group-based PFMT group
- Registration Number
- NCT05242809
- Lead Sponsor
- King's College London
- Brief Summary
The main objective is to co-design and assess the practicality of group-based Pelvic floor muscle training (PFMT) programme in pregnant women. The co-design of the PFMT programme will involve the stakeholder meeting. The feasibility of the group-based Pelvic floor muscle training (PFMT) programme will be achieved by using ICIQ-SF questionnaire before intervention, the completion time of the intervention and 42-day after delivery. Pregnant women with or without UI at Nanjing maternity and child health care hospital will be offered to participate if they meet the criteria of the research. Participants will be randomized into two groups, interventions and control group that gets standard care at the hospital. The intervention group will meet the midwife to receive supervised group-based PFMT once a month for 4 months in groups. Doing correct PFMT during pregnancy can help women to prevent or decrease the risk of developing UI in pregnancy and postnatal period.
- Detailed Description
This study is to co-design and assess the practicality of group-based Pelvic floor muscle training (PFMT) programme in pregnant women.
PFMT has been recommended as the first-line treatment for stress urinary incontinence and the other types of urinary incontinence (UI), however, it was not well implemented in many countries due the lack of human resource and financial support. Compared to individual PFMT supervision, which is commonly conducted in hospital with additional fees, delivering PFMT in groups can help more women. Therefore, this study is to codesign and investigate the feasibility of group-based PFMT programme.
The first phase is to co-design the group-based PFMT programme: The stakeholders will be involved in this phase. The stakeholder development group will purposively sample both health professionals and pregnant women with or without UI. The stakeholder development group members will include the principal researcher, two pregnant women without UI, two pregnant women with a history of UI, two midwives (one of the midwives will help the principal researcher to deliver the training session), two physiotherapists. Data from group meetings will be digitally audio-recorded following consent and notes will be taken during the meeting. The data will be analyzed to identify the content and mode of delivery of the group-based PFMT programme along with potential barriers and facilitators.
The second phase is implementation and evaluation of the group-based PFMT programme (randomised controlled feasibility study): Participants will be randomized into two groups, intervention and control group. The control group gets standard care at the hospital. The interventional group gets supervised group-based PFMT. The intervention will be teaching the participants to do PFMT in groups. The intervention will help women to identify their pelvic floor muscles and then guide them how to contract the pelvic floor muscle correctly (the detail of the intervention will be discussed and determined in phase 1 of this project). The core outcome measures are likely to include self-reported UI, which is commonly used in studies and is able to evaluate the effectiveness of PFMT intervention in pregnant women, and UI severity which may be assessed by ICIQ-SF (a validated questionnaire which both assesses the severity of urinary loss and quality of life impact). The adherence to the programme may be assessed by attendance records from the group-based training sessions and completion of a training diary which includes the frequency and duration the participants self-report doing the exercises. The training diary will be submitted to the principal researcher after the training sessions.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 48
- Nulliparous women who are aged 18 years and older;
- Gestational ages of 19-24 weeks;
- With or without the symptom of UI;
- Singleton fetus
- Capable of giving valid informed consent
- Women with pregnancy complications or urine tract infection
- Women with previous UI symptoms before pregnancy
- High risk of preterm labour
- Women with previous urogenital surgery or diseases which may interfere with pelvic floor muscle strength, for example, pelvic organ prolapse, neurological disorders, diabetes.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group-based PFMT group Group-based PFMT group The participants in the intervention group will receive PFMT supervision in groups. The number of women per group and the detail of the intervention will be decided through stakeholder development group meetings.The intervention will be teaching the participants to do PFMT in groups. The intervention will help women to identify their pelvic floor muscles and then guide them how to contract the pelvic floor muscle correctly (the detail of the intervention will be discussed and determined in phase 1 of this project).
- Primary Outcome Measures
Name Time Method adherence to PFMT programme change 1 completion of the intervention (week 13) assessed by attendance records from the group-based training sessions
the impact of UI on quality of life change baseline(before the intervention starts, week 0); completion of the intervention (week 13); 42 days after delivery (an average of week 19 to week 20) assessed by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). The fifth question is the overall impact of UI which ranged from 0 to 10. In the scale, 0 means the impact on life is not at all while 10 means the impact on life is a great deal with larger number represents greater impact on life.
self-reported UI change baseline(before the intervention starts, week 0); completion of the intervention (week 13); 42 days after delivery (an average of week 19 to week 20) assessed by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). The third question in this questionnaire is the frequency of UI which can present the self-reported UI change.
adherence to PFMT programme change 2 completion of the intervention (week 13) assessed by record of a training diary which includes the frequency the participants self-report doing the exercises.
- Secondary Outcome Measures
Name Time Method The acceptability of randomization completion of the intervention (week 13) This is a qualitative measure which will be assessed through semi-structured interview. The participants will be asked whether randomization is acceptable and the reason if the answer is not.
The completion rates of the outcome measures completion of the intervention (week 13) The percentage of the participants complete the ICIQ-SF and the training diary.
Recruitment rates completion of the intervention (week 13) The percentage of participants take part in the intervention
midwife's advice on group-based PFMT programme completion of the intervention (week 13) This is a qualitative measure which will be assessed through semi-structured interview.
Retention of participants completion of the intervention (week 13) The percentage of participants who complete the intervention
participants' advice on group-based PFMT programme completion of the intervention (week 13) This is a qualitative measure which will be assessed through semi-structured interview.
The acceptability of the outcome measures completion of the intervention (week 13) This is a qualitative measure which will be assessed through semi-structured interview. The participants will be asked whether the outcome measures are acceptable and the reason if the answer is not.
Trial Locations
- Locations (1)
Nanjing Maternity and Child Health Care Hospital
🇨🇳Nanjing, Jiang Su, China