MoVo-guided Traditional Chinese Kegel Exercises for Preventing Postpartum Urinary Incontinence.

NCT07742202 | Not Yet Recruiting DMC

• 1 other identifier: GDSHLXHYJYB202608
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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)

  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

Secondary Outcomes (3)

• Adherence to the antenatal exercise intervention, assessed by exercise diary completion rate

  at 3 months post-intervention

• Pelvic floor muscle strength assessed by the Modified Oxford Grading Scale.

  42 days postpartum

• Change in self-efficacy for pelvic floor exercises, assessed by the Pelvic Floor Exercise Self-Efficacy Scale

  Enrolment, 37 weeks of gestation, 42 days postpartum

Study Arms (3)

control group

PLACEBO COMPARATOR

Routine prenatal care with only verbal instructions on Kegel exercises (no app, no supervision).

Behavioral: Routine Verbal Instruction Group

App-Kegel group

EXPERIMENTAL

App-supervised daily conventional Kegel exercises (same platform, no Liuzijue/MoVo).

Behavioral: App-Supervised Kegel Exercise Group

TCM comprehensive group

EXPERIMENTAL

App-supervised daily Liuzijue combined with levator ani training, guided by MoVo theory.

Behavioral: Liuzijue & Levator Ani Training Group

Interventions

Routine Verbal Instruction Group BEHAVIORAL

Routine prenatal care with only verbal instructions on Kegel exercises (no app, no supervision)

control group

App-Supervised Kegel Exercise Group BEHAVIORAL

App-supervised daily conventional Kegel exercises (same platform, no Liuzijue/MoVo).

App-Kegel group

Liuzijue & Levator Ani Training Group BEHAVIORAL

App-supervised daily Liuzijue combined with levator ani training, guided by MoVo theory.

TCM comprehensive group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yu xin Qian: lead

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; 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 Officials

• ming M Yang

  Guangzhou University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuxin Y Qian

CONTACT

+8613247548104; 2710559471@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 3, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07