Development and Feasibility Testing of a Group-based PFMT Programme for Antenatal Women in Nanjing City in China

NCT05242809 | Completed

• 1 other identifier: 20220107
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

Urinary Incontinence; Pelvic floor muscle training

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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

  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.

  completion of the intervention (week 13)

Secondary Outcomes (7)

• Recruitment rates

  completion of the intervention (week 13)

• Retention of participants

  completion of the intervention (week 13)

• The acceptability of randomization

  completion of the intervention (week 13)

• The acceptability of the outcome measures

  completion of the intervention (week 13)

• The completion rates of the outcome measures

  completion of the intervention (week 13)

Study Arms (2)

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).

Behavioral: Group-based PFMT group

Interventions

Group-based PFMT group BEHAVIORAL

The intervention group receives PFMT supervision in groups of about 6-8 women

Group-based PFMT group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• Nanjing Maternity and Child Health Care Hospital: collaborator

Study Sites (1)

Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210000, China

Location

Related Publications (3)

• 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.

  PMID: 40037186 DERIVED

• Yang 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.

  PMID: 39140698 DERIVED

• Yang 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.

  PMID: 37907990 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The principal researcher as the outcome assessor will be blinded when analyzing quantitative data, for example, the demographic data and scores of ICIQ-SF, but will not be blinded to the qualitative interview data, as these interviews will be conducted by the principal researcher.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants will be randomly allocated to two arms: intervention group and control group.

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 16, 2022
• Study Start: August 21, 2022
• Primary Completion: November 17, 2022
• Study Completion: February 7, 2023
• Last Updated: June 27, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)