MoVo-guided Traditional Chinese Kegel Exercises for Preventing Postpartum Urinary Incontinence.
A Prospective Randomized Controlled Trial of MoVo-guided Liuzijue Combined With Traditional Levator Ani Exercise During Pregnancy for Preventing Postpartum Urinary Incontinence.
The goal of this clinical trial is to determine whether a prenatal exercise program integrating Liuzijue qigong with traditional levator ani training, guided by the MoVo (Motivation-Volition) theory and delivered via a supervised mobile application, can effectively prevent postpartum urinary incontinence and pelvic organ prolapse in pregnant women, compared with app-supervised conventional Kegel exercises and routine prenatal care.
The main questions it aims to answer are:
Does the integrated Liuzijue-and-levator-ani program reduce the incidence of postpartum urinary incontinence and prolapse more effectively than app-supervised Kegel exercises or routine care?
Can the MoVo-based behavioural framework (motivation enhancement, action planning, and self-monitoring) improve long-term adherence to pelvic floor training during pregnancy and the postpartum period?
What are the effects of the three interventions on pelvic floor muscle function, exercise self-efficacy, anxiety levels, and delivery outcomes?
Researchers will compare three parallel groups: (1) the integrated Liuzijue-and-levator-ani exercise group, (2) the app-supervised conventional Kegel exercise group, and (3) the routine care control group receiving only verbal instruction on pelvic floor exercises during standard prenatal visits. All three groups will be followed from enrolment through 6 weeks postpartum to determine whether the culturally adapted mind-body intervention offers superior pelvic floor protection beyond app-delivered Kegel training and routine care.
Participants will:
Be enrolled in the third trimester and randomly assigned to one of the three groups.
In the integrated exercise group, perform daily combined Liuzijue-and-levator-ani exercises via a supervised mobile app and attend periodic check-ins until 6 weeks postpartum.
In the app-supervised Kegel group, perform daily conventional Kegel exercises via the same mobile app platform with the same supervision schedule.
In the routine care group, receive only standard verbal instructions on Kegel exercises during regular antenatal check-ups, without app supervision.
Undergo outcome evaluations at enrolment, before delivery, and at the postpartum follow-up visit, including assessments of urinary incontinence, pelvic organ prolapse, exercise adherence, self-efficacy, anxiety, and any adverse events.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yuxin Y Qian
- Número de teléfono: +8613247548104
- Correo electrónico: 2710559471@qq.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age ≥ 19 years
- Singleton pregnancy with cephalic presentation；
- No absolute contraindications to vaginal delivery；
- No history of urinary incontinence, pelvic organ prolapse, or pelvic floor surgery before pregnancy；
- Ability and willingness to comply with the full prenatal and postpartum follow-up schedule；
- Signed written informed consent.
Exclusion Criteria:
- History of second- or third-trimester miscarriage, recurrent miscarriage, or spontaneous preterm birth；
- Presence of pregnancy complications, such as severe preeclampsia, fetal distress, placenta previa, placental abruption, or symptoms of threatened preterm labour；
- Contraindications to exercise, including cervical shortening, cervical insufficiency, or unexplained vaginal bleeding or fluid leakage；
- Comorbid conditions, such as asthma, cardiovascular disease, hypertension, uncontrolled diabetes mellitus, or thyroid disease；
- Metabolic bone disease or limited joint mobility；
- Cognitive or psychiatric disorders that prevent the participant from completing diary records；
- Concurrent participation in another pelvic floor intervention study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: control group
Routine prenatal care with only verbal instructions on Kegel exercises (no app, no supervision).
|
Routine prenatal care with only verbal instructions on Kegel exercises (no app, no supervision)
|
|
Experimental: App-Kegel group
App-supervised daily conventional Kegel exercises (same platform, no Liuzijue/MoVo).
|
App-supervised daily conventional Kegel exercises (same platform, no Liuzijue/MoVo).
|
|
Experimental: TCM comprehensive group
App-supervised daily Liuzijue combined with levator ani training, guided by MoVo theory.
|
App-supervised daily Liuzijue combined with levator ani training, guided by MoVo theory.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of participants with urinary incontinence at 42 days postpartum, assessed by the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
Periodo de tiempo: 42 days postpartum
|
The ICIQ-UI SF is a validated, self-administered questionnaire that evaluates the frequency, volume, and impact of urinary incontinence (UI) over the previous 4 weeks.
Total scores range from 0 to 21, with higher scores indicating more severe symptoms.
This outcome is defined as the proportion of participants reporting any urine leakage (score ≥1) on the ICIQ-UI SF at the 42-day postpartum follow-up.
The chi-square test will be used to compare the incidence of urinary incontinence between the intervention and control groups.
|
42 days postpartum
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Adherence to the antenatal exercise intervention, assessed by exercise diary completion rate
Periodo de tiempo: at 3 months post-intervention
|
Adherence is evaluated by two combined measures: (1) exercise diary completion rate = (actual number of training sets completed / planned number of training sets) × 100%; and (2) the proportion of participants who perform active training on at least 4 days per week, with each training day defined as completing at least 50% of the planned sets.
The mean adherence rate and the proportion of adherent participants will be reported for the intervention group.
|
at 3 months post-intervention
|
|
Pelvic floor muscle strength assessed by the Modified Oxford Grading Scale.
Periodo de tiempo: 42 days postpartum
|
The Modified Oxford Grading Scale evaluates pelvic floor muscle contraction strength via vaginal palpation, with grades ranging from 0 (no contraction) to 5 (strong contraction).
Median and interquartile range will be reported for each group, and the Mann-Whitney U test will be used for comparison.
|
42 days postpartum
|
|
Change in self-efficacy for pelvic floor exercises, assessed by the Pelvic Floor Exercise Self-Efficacy Scale
Periodo de tiempo: Enrolment, 37 weeks of gestation, 42 days postpartum
|
The Pelvic Floor Exercise Self-Efficacy Scale is a validated self-report instrument that measures the participant's confidence in adhering to pelvic floor exercise.
Total scores range from 0 to 100, with higher scores indicating greater self-efficacy.
Assessments will be performed at three time points: enrolment, 37 weeks of gestation, and 42 days postpartum.
Mean ± standard deviation of scores and change from baseline will be reported for each group.
Repeated-measures analysis of variance (ANOVA) will be used to compare differences between groups.
|
Enrolment, 37 weeks of gestation, 42 days postpartum
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: ming M Yang, Guangzhou University of Chinese Medicine
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades urogenitales masculinas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Trastornos de la micción
- Síntomas del tracto urinario inferior
- Manifestaciones Urológicas
- Incontinencia urinaria
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Incontinencia Urinaria, Estrés
Otros números de identificación del estudio
- GDSHLXHYJYB202608
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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