Development and Feasibility Testing of a Group-based PFMT Programme for Antenatal Women in Nanjing City in China
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

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.
    

Intervention name(s): Group-based PFMT group
Intervention type(s): Behavioral
Intervention description(s): The intervention group receives PFMT supervision in groups of about 6-8 women
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants will be randomly allocated to two arms: intervention group and control group.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Urinary Incontinence; Pelvic floor muscle training