Pelvic Floor DysfunctionNCT05595967
Community Based Health Education for Prevention of Pelvic Floor Dysfunction in Fertile Women in Rural China
A study testing Health education intervention in people with Pelvic Floor Dysfunction, run by Peking University at 1 site in China.
Trial summary
According to the experts in charge of the healthcare department in the Liangshan area, Liangshan is one of the largest Yi inhabited areas in China. Influenced by local culture and production history, most women there are multiparas, with more than one child, and their awareness of postpartum recovery is relatively… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Dysfunction
- What is being tested?
- Health education intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,139 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2022to 5 Aug 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Married women who are 18-65 years old
Who cannot join
- Women who are unable to attend the person-to-person health education classes at the first and forth month of the intervention;
- Women who have received pelvic floor muscle training, pelvic floor muscle health education, pelvic floor muscle surgery within one year of the baseline survey;
- Women who are planning pregnancy, pregnant, or have delivered a baby in the past 6 months since the baseline survey;
- Women who are unable to understand the instructions or questions from others.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University China Center for Health Economic Research
Beijing, Beijing Municipality, 100871
About this study
Official title: Community Based Health Education for Prevention of Pelvic Floor Dysfunction in Fertile Women in Rural China: Study Protocol for a Non-randomised Cluster Controlled Trial
According to the experts in charge of the healthcare department in the Liangshan area, Liangshan is one of the largest Yi inhabited areas in China. Influenced by local culture and production history, most women there are multiparas, with more than one child, and their awareness of postpartum recovery is relatively weak. Therefore, the prevalence and incidence rate of pelvic floor dysfunction diseases is high in the Liangshan area.
In addition, women in the Liangshan area shoulder the responsibility of taking care of family members, farmland, and livestock. They play an important role in family production, which guarantees the opportunity for other family members to go out to work. However, pelvic floor dysfunction can be manifested by persistent pelvic distension, frequent urination, the urgency of urination, difficulty in urination or defecation, and pain or difficulty in sexual intercourse, which decreases the quality of normal life, and the efficiency of production, posing many psychological problems and family contradictions.
There is no research to prove the exact intervention measures that can effectively improve the pelvic floor function of women in Liangshan ethnic minority areas. This study aims to promote the formation of women's healthy living habits and behaviors, improve women's pelvic floor function, and then develop the quality of life and labor output of local women through intervention including health knowledge education and pelvic floor muscle exercise.
- Conditions
- Pelvic Floor Dysfunction
- Being tested
- Health education intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education interventionBehavioural
Both the two session contains modules focusing on heath related knowledge and pelvic floor muscle exercise. Both two session will be delivered by primary healthcare women workers in small groups (about 20 women per group). The local healthcare workers are responsible for making appointment with each participant through group activities. Each participant will receive a healthy calendar practice to record the number of exercises per day which will be supervised by primary healthcare workers. All healthcare workers are required to attend a full-day workshop organized base on the scheme and teaching materials developed by our research team. The contents of the workshop include: (1) introduction of pelvic floor dysfunction; (2) risk factors and prevention of pelvic floor dysfunction; (3) kegel movement; (4) methods of dealing with severe illness; (5) a standard procedure of group activities or one-on-one activities; (6) skills needed for the delivery of health education intervention.
| Study group | Role | What they receive |
|---|---|---|
| Health education intervention | Active comparator | According the data collected in baseline survey, all participants will be divided into two groups: asymptomatic or mildly symptomatic and severe according the risk level of pelvic floor dysfunction. Intervention for high risk of pelvic floor women focus on emphasizing the need for medical care and access to medical resourced. The first intervention will be performed immediately after baseline survey. The second intervention will be repeated with the first one and performed three months after the first intervention. Both the two session contains modules focusing on heath related knowledge and pelvic floor muscle exercise. Receives: Behavioral: Health education intervention |
| Control without intervention | No intervention | No health education is provided to the participants in the control group so as to investigate the effects of health education. However, materials provided to interventional group will also be sent to the control group after the completion of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score of Pelvic Floor Distress Inventory-short form 20 (PFDI-20)
This participant completed questionnaire comprises three subscales with scores ranging from 0 to 100: the Pelvic Organ Prolapse Distress Inventory-6 assessing prolapse symptoms, the ColoRectal-Anal Distress Inventory-8 assessing colorectal/anal symptoms, and the Urinary Distress Inventory-6 assessing urinary symptoms. A higher PFDI-20 score (sum of three subscale scores, range 0-300) indicates a higher symptom burden.
Measured: 12 weeks after the start of intervention
The change in the incidence of pelvic floor dysfunction symptoms
It is defined by the proportion of people who get a PFDI-20 score not equal to 0.
Measured: 12 weeks after the start of intervention
Secondary outcomes (4)
The score of Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
The Pelvic Floor Impact Questionnaire-7 (PFIQ-7) measuring the changes in condition specific quality of life, which ranges 0-300, with higher scores indicating greater effect.
Measured: 12 weeks after the intervention
The score of Prolapse and Incontinence Knowledge Quiz (PIKQ)
The PIKQ consists of 24 accurate and inaccurate statements related to the epidemiology, pathogenesis, diagnosis and treatment options for urinary incontinence and POP, with which participants were asked if they agreed or disagreed. Each correct response received a score of one, whereas incorrect and "don't know" responses were scored zero. The PIKQ scores (ranging from 0 to 24) were summed and converted to percentages, with higher totals indicating greater pelvic floor knowledge).
Measured: 12 weeks after the intervention
Self-reported monthly working days by questionnaire (day)
This outcome measures the working days of the participants by questionnaire, which indicates whether they are qualified for work.
Measured: 12 weeks after the intervention
Self-reported monthly personal income by questionnaire (Yuan)
This outcome measures the monthly income of the participants by questionnaire, which demonstrates the economic return of their work.
Measured: 12 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start18 Aug 2022
- Primary completion30 Jul 2023 (estimated)
- Study completion5 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DysfunctionStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Sun, Peking University
- Investigators
- Guoen Liu, PhD, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595967
- Sponsor's protocol ID
- PekingUni_Liangshan
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data can be provided according to the needs of the researcher, but does not include all personal data
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Based Health Education for Prevention of Pelvic Floor Dysfunction in Fertile Women in Rural China: Study Protocol for a Non-randomised Cluster Controlled Trial
- ClinicalTrials.gov ID
- NCT05595967
- Acronym / sponsor ID
- PekingUni_Liangshan
- Conditions
- Pelvic Floor Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,139 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 5 Aug 2023 (estimated)
- First posted
- 27 Oct 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.
According to the experts in charge of the healthcare department in the Liangshan area, Liangshan is one of the largest Yi inhabited areas in China. Influenced by local culture and production history, most women there are multiparas, with more than one child, and their awareness of postpartum recovery is relatively weak. Therefore, the prevalence and incidence rate of pelvic floor dysfunction diseases is high in the Liangshan area.
In addition, women in the Liangshan area shoulder the responsibility of taking care of family members, farmland, and livestock. They play an important role in family production, which guarantees the opportunity for other family members to go out to work. However, pelvic floor dysfunction can be manifested by persistent pelvic distension, frequent urination, the urgency of urination, difficulty in urination or defecation, and pain or difficulty in sexual intercourse, which decreases the quality of normal life, and the efficiency of production, posing many psychological problems and family contradictions.
There is no research to prove the exact intervention measures that can effectively improve the pelvic floor function of women in Liangshan ethnic minority areas. This study aims to promote the formation of women's healthy living habits and behaviors, improve women's pelvic floor function, and then develop the quality of life and labor output of local women through intervention including health knowledge education and pelvic floor muscle exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health education intervention | Active comparator | Behavioral: Health education interventionAccording the data collected in baseline survey, all participants will be divided into two groups: asymptomatic or mildly symptomatic and severe according the risk level of pelvic floor dysfunction. Intervention for high risk of pelvic floor women focus on emphasizing the need for medical care and access to medical resourced. The first intervention will be performed immediately after baseline survey. The second intervention will be repeated with the first one and performed three months after the first intervention. Both the two session contains modules focusing on heath related knowledge and pelvic floor muscle exercise. |
| Control without intervention | No intervention | –No health education is provided to the participants in the control group so as to investigate the effects of health education. However, materials provided to interventional group will also be sent to the control group after the completion of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Married women who are 18-65 years old
Key exclusion criteria (4 listed)
- Women who are unable to attend the person-to-person health education classes at the first and forth month of the intervention;
- Women who have received pelvic floor muscle training, pelvic floor muscle health education, pelvic floor muscle surgery within one year of the baseline survey;
- Women who are planning pregnancy, pregnant, or have delivered a baby in the past 6 months since the baseline survey;
- Women who are unable to understand the instructions or questions from others.
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 |
|---|---|---|
| Health education interventionBoth the two session contains modules focusing on heath related knowledge and pelvic floor muscle exercise. Both two session will be delivered by primary healthcare women workers in small groups (about 20 women per group). The local healthcare workers are responsible for making appointment with each participant through group activities. Each participant will receive a healthy calendar practice to record the number of exercises per day which will be supervised by primary healthcare workers. All healthcare workers are required to attend a full-day workshop organized base on the scheme and teaching materials developed by our research team. The contents of the workshop include: (1) introduction of pelvic floor dysfunction; (2) risk factors and prevention of pelvic floor dysfunction; (3) kegel movement; (4) methods of dealing with severe illness; (5) a standard procedure of group activities or one-on-one activities; (6) skills needed for the delivery of health education intervention. | Behavioural | Health education intervention |
Primary outcome
The score of Pelvic Floor Distress Inventory-short form 20 (PFDI-20)
Time frame: 12 weeks after the start of intervention
This participant completed questionnaire comprises three subscales with scores ranging from 0 to 100: the Pelvic Organ Prolapse Distress Inventory-6 assessing prolapse symptoms, the ColoRectal-Anal Distress Inventory-8 assessing colorectal/anal symptoms, and the Urinary Distress Inventory-6 assessing urinary symptoms. A higher PFDI-20 score (sum of three subscale scores, range 0-300) indicates a higher symptom burden.
The change in the incidence of pelvic floor dysfunction symptoms
Time frame: 12 weeks after the start of intervention
It is defined by the proportion of people who get a PFDI-20 score not equal to 0.
4 secondary outcomes
The score of Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
Time frame: 12 weeks after the intervention
The score of Prolapse and Incontinence Knowledge Quiz (PIKQ)
Time frame: 12 weeks after the intervention
Self-reported monthly working days by questionnaire (day)
Time frame: 12 weeks after the intervention
Self-reported monthly personal income by questionnaire (Yuan)
Time frame: 12 weeks after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: Yes. The data can be provided according to the needs of the researcher, but does not include all personal data
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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.
Guoen Liu, PhD principal investigator
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education intervention in people with Pelvic Floor Dysfunction, run by Peking University 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 1 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: status not confirmed, as of the sponsor's last update on 1 Nov 2022. 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?
Results are not available in the source record.
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?
The score of Pelvic Floor Distress Inventory-short form 20 (PFDI-20) (time frame: 12 weeks after the start of intervention). The study lists 2 primary outcomes in all. 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 1 Nov 2022.