Stress Urinary IncontinenceNCT07742202
MoVo-guided Traditional Chinese Kegel Exercises for Preventing Postpartum Urinary Incontinence.
A study testing Routine Verbal Instruction Group, App-Supervised Kegel Exercise Group and Liuzijue & Levator Ani Training Group in people with Stress Urinary Incontinence, run by Yu xin Qian.
Trial 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… 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
- Stress Urinary Incontinence
- What is being tested?
- Routine Verbal Instruction Group, App-Supervised Kegel Exercise Group and Liuzijue & Levator Ani Training Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2026to 10 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
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
- Being tested
- Routine Verbal Instruction Group, App-Supervised Kegel Exercise Group, Liuzijue & Levator Ani Training Group
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Verbal Instruction GroupBehavioural
Routine prenatal care with only verbal instructions on Kegel exercises (no app, no supervision)
App-Supervised Kegel Exercise GroupBehavioural
App-supervised daily conventional Kegel exercises (same platform, no Liuzijue/MoVo).
Liuzijue & Levator Ani Training GroupBehavioural
App-supervised daily Liuzijue combined with levator ani training, guided by MoVo theory.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Routine prenatal care with only verbal instructions on Kegel exercises (no app, no supervision). Receives: Behavioral: Routine Verbal Instruction Group |
| App-Kegel group | Experimental | App-supervised daily conventional Kegel exercises (same platform, no Liuzijue/MoVo). Receives: Behavioral: App-Supervised Kegel Exercise Group |
| TCM comprehensive group | Experimental | App-supervised daily Liuzijue combined with levator ani training, guided by MoVo theory. Receives: Behavioral: Liuzijue & Levator Ani Training Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 42 days postpartum
Secondary outcomes (3)
Adherence to the antenatal exercise intervention, assessed by exercise diary completion rate
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.
Measured: at 3 months post-intervention
Pelvic floor muscle strength assessed by the Modified Oxford Grading Scale.
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.
Measured: 42 days postpartum
Change in self-efficacy for pelvic floor exercises, assessed by the Pelvic Floor Exercise Self-Efficacy Scale
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.
Measured: Enrolment, 37 weeks of gestation, 42 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start31 Jul 2026 (estimated)
- Primary completion10 Nov 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yu xin Qian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu xin Qian, Guangzhou University of Chinese Medicine
- Investigators
- ming M Yang, Principal investigator, Guangzhou University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742202
- Sponsor's protocol ID
- GDSHLXHYJYB202608
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of MoVo-guided Liuzijue Combined With Traditional Levator Ani Exercise During Pregnancy for Preventing Postpartum Urinary Incontinence.
- ClinicalTrials.gov ID
- NCT07742202
- Acronym / sponsor ID
- GDSHLXHYJYB202608
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Yu xin QianUniversity, hospital or other
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 3 Aug 2026 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Behavioral: Routine Verbal Instruction GroupRoutine prenatal care with only verbal instructions on Kegel exercises (no app, no supervision). |
| App-Kegel group | Experimental | Behavioral: App-Supervised Kegel Exercise GroupApp-supervised daily conventional Kegel exercises (same platform, no Liuzijue/MoVo). |
| TCM comprehensive group | Experimental | Behavioral: Liuzijue & Levator Ani Training GroupApp-supervised daily Liuzijue combined with levator ani training, guided by MoVo theory. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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；
Key exclusion criteria (7 listed)
- 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；
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 |
|---|---|---|
| Routine Verbal Instruction GroupRoutine prenatal care with only verbal instructions on Kegel exercises (no app, no supervision) | Behavioural | control group |
| App-Supervised Kegel Exercise GroupApp-supervised daily conventional Kegel exercises (same platform, no Liuzijue/MoVo). | Behavioural | App-Kegel group |
| Liuzijue & Levator Ani Training GroupApp-supervised daily Liuzijue combined with levator ani training, guided by MoVo theory. | Behavioural | TCM comprehensive group |
Primary outcome
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)
Time frame: 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.
3 secondary outcomes
Adherence to the antenatal exercise intervention, assessed by exercise diary completion rate
Time frame: at 3 months post-intervention
Pelvic floor muscle strength assessed by the Modified Oxford Grading Scale.
Time frame: 42 days postpartum
Change in self-efficacy for pelvic floor exercises, assessed by the Pelvic Floor Exercise Self-Efficacy Scale
Time frame: Enrolment, 37 weeks of gestation, 42 days postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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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.
ming M Yang principal investigator
Guangzhou University of Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Routine Verbal Instruction Group, App-Supervised Kegel Exercise Group and Liuzijue & Levator Ani Training Group in people with Stress Urinary Incontinence, run by Yu xin Qian.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuxin Y Qian (+8613247548104, 2710559471@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 42 days postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.