- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05242809
Development and Feasibility Testing of a Group-based PFMT Programme for Antenatal Women in Nanjing City in China
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xiaowei Yang, Master
- Phone Number: 008618061775801
- Email: xiaowei.yang@kcl.ac.uk
Study Contact Backup
- Name: Sue Woodward, Doctor
- Phone Number: +44 (0)20 7836 5454
- Email: sue.woodward@kcl.ac.uk
Study Locations
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Jiang Su
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Nanjing, Jiang Su, China, 210000
- Nanjing Maternity and Child Health Care Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
The control group receives standard care, which means the participants will receive verbal instruction on PFMT from midwives without any further supervision.
For reasons of equipoise, women in the comparator group will be offered the group-based PFMT intervention at the end of the study if they wish.
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Experimental: 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).
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The intervention group receives PFMT supervision in groups of about 6-8 women
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
self-reported UI change
Time Frame: 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)
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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.
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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)
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the impact of UI on quality of life change
Time Frame: 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)
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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.
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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)
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adherence to PFMT programme change 1
Time Frame: completion of the intervention (week 13)
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assessed by attendance records from the group-based training sessions
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completion of the intervention (week 13)
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adherence to PFMT programme change 2
Time Frame: completion of the intervention (week 13)
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assessed by record of a training diary which includes the frequency the participants self-report doing the exercises.
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completion of the intervention (week 13)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment rates
Time Frame: completion of the intervention (week 13)
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The percentage of participants take part in the intervention
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completion of the intervention (week 13)
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Retention of participants
Time Frame: completion of the intervention (week 13)
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The percentage of participants who complete the intervention
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completion of the intervention (week 13)
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The acceptability of randomization
Time Frame: completion of the intervention (week 13)
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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.
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completion of the intervention (week 13)
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The acceptability of the outcome measures
Time Frame: completion of the intervention (week 13)
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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.
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completion of the intervention (week 13)
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The completion rates of the outcome measures
Time Frame: completion of the intervention (week 13)
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The percentage of the participants complete the ICIQ-SF and the training diary.
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completion of the intervention (week 13)
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participants' advice on group-based PFMT programme
Time Frame: completion of the intervention (week 13)
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This is a qualitative measure which will be assessed through semi-structured interview.
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completion of the intervention (week 13)
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midwife's advice on group-based PFMT programme
Time Frame: completion of the intervention (week 13)
|
This is a qualitative measure which will be assessed through semi-structured interview.
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completion of the intervention (week 13)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urination Disorders
- Elimination Disorders
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Urinary Incontinence
- Enuresis
Other Study ID Numbers
- 20220107
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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