Urinary IncontinenceNCT05242809
Development and Feasibility Testing of a Group-based PFMT Programme for Antenatal Women in Nanjing City in China
A study testing Group-based PFMT group in people with Urinary Incontinence, run by King's College London at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Group-based PFMT group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2022to 7 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210000
About this study
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.
Read the 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.
- Conditions
- Urinary Incontinence
- Being tested
- Group-based PFMT group
- Keywords
- Urinary Incontinence, Pelvic floor muscle training
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based PFMT groupBehavioural
The intervention group receives PFMT supervision in groups of about 6-8 women
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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. |
| Group-based PFMT group | Experimental | 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). Receives: Behavioral: Group-based PFMT group |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported UI change
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.
Measured: 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)
the impact of UI on quality of life change
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.
Measured: 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)
adherence to PFMT programme change 1
assessed by attendance records from the group-based training sessions
Measured: completion of the intervention (week 13)
adherence to PFMT programme change 2
assessed by record of a training diary which includes the frequency the participants self-report doing the exercises.
Measured: completion of the intervention (week 13)
Secondary outcomes (7)
Recruitment rates
The percentage of participants take part in the intervention
Measured: completion of the intervention (week 13)
Retention of participants
The percentage of participants who complete the intervention
Measured: completion of the intervention (week 13)
The acceptability of randomization
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.
Measured: completion of the intervention (week 13)
The acceptability of the outcome measures
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.
Measured: completion of the intervention (week 13)
The completion rates of the outcome measures
The percentage of the participants complete the ICIQ-SF and the training diary.
Measured: completion of the intervention (week 13)
participants' advice on group-based PFMT programme
This is a qualitative measure which will be assessed through semi-structured interview.
Measured: completion of the intervention (week 13)
midwife's advice on group-based PFMT programme
This is a qualitative measure which will be assessed through semi-structured interview.
Measured: completion of the intervention (week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start21 Aug 2022
- Primary completion17 Nov 2022
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be randomly allocated to two arms: intervention group and control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Maternity and Child Health Care Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242809
- Sponsor's protocol ID
- 20220107
- Status last verified
- Aug 2022
- First submitted
- 24 Jan 2022
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang X, Zhang A, Sayer L, Bassett S, Woodward S. Co-design of a group-based programme to facilitate adherence to pelvic floor muscle training in pregnant women in China: Describing the process of developing an intervention underpinned by the behaviour change wheel. Midwifery. 2025 May;144:104316. doi: 10.1016/j.midw.2025.104316. Epub 2025 Feb 10.
PubMed 40037186Yang X, Sayer L, Bassett S, Woodward S. Group-based pelvic floor muscle training for pregnant women: A randomized controlled feasibility study. J Adv Nurs. 2025 Apr;81(4):2099-2112. doi: 10.1111/jan.16365. Epub 2024 Aug 14.
PubMed 39140698Yang X, Zhang A, Zhu R, Sayer L, Bassett S, Woodward S. Group-based PFMT programme for preventing and/or treating UI in pregnant women: protocol of a randomized controlled feasibility study. Pilot Feasibility Stud. 2023 Oct 31;9(1):180. doi: 10.1186/s40814-023-01410-2.
PubMed 37907990
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility Testing of a Group-based PFMT Programme for Antenatal Women in Nanjing City in China
- ClinicalTrials.gov ID
- NCT05242809
- Acronym / sponsor ID
- 20220107
- Conditions
- Urinary Incontinence
- Keywords
- Urinary Incontinence, Pelvic floor muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Nanjing Maternity and Child Health Care Hospital
- Study start
- 21 Aug 2022 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The participants will be randomly allocated to two arms: intervention group and control group.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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. |
| Group-based PFMT group | Experimental | Behavioral: Group-based PFMT groupThe 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-based PFMT groupThe intervention group receives PFMT supervision in groups of about 6-8 women | Behavioural | Group-based PFMT group |
Primary outcome
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)
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.
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)
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.
adherence to PFMT programme change 1
Time frame: completion of the intervention (week 13)
assessed by attendance records from the group-based training sessions
adherence to PFMT programme change 2
Time frame: completion of the intervention (week 13)
assessed by record of a training diary which includes the frequency the participants self-report doing the exercises.
7 secondary outcomes
Recruitment rates
Time frame: completion of the intervention (week 13)
Retention of participants
Time frame: completion of the intervention (week 13)
The acceptability of randomization
Time frame: completion of the intervention (week 13)
The acceptability of the outcome measures
Time frame: completion of the intervention (week 13)
The completion rates of the outcome measures
Time frame: completion of the intervention (week 13)
participants' advice on group-based PFMT programme
Time frame: completion of the intervention (week 13)
midwife's advice on group-based PFMT programme
Time frame: completion of the intervention (week 13)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Derived from this study: PubMed 40037186Yang X, Zhang A, Sayer L, Bassett S, Woodward S. Co-design of a group-based programme to facilitate adherence to pelvic floor muscle training in pregnant women in China: Describing the process of developing an intervention underpinned by the behaviour change wheel. Midwifery. 2025 May;144:104316. doi: 10.1016/j.midw.2025.104316. Epub 2025 Feb 10.
- Derived from this study: PubMed 39140698Yang X, Sayer L, Bassett S, Woodward S. Group-based pelvic floor muscle training for pregnant women: A randomized controlled feasibility study. J Adv Nurs. 2025 Apr;81(4):2099-2112. doi: 10.1111/jan.16365. Epub 2024 Aug 14.
- Derived from this study: PubMed 37907990Yang X, Zhang A, Zhu R, Sayer L, Bassett S, Woodward S. Group-based PFMT programme for preventing and/or treating UI in pregnant women: protocol of a randomized controlled feasibility study. Pilot Feasibility Stud. 2023 Oct 31;9(1):180. doi: 10.1186/s40814-023-01410-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based PFMT group in people with Urinary Incontinence, run by King's College London at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05242809, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.