Community Based Health Education for Prevention of Pelvic Floor Dysfunction in Fertile Women in Rural China

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pelvic Floor Dysfunction
• Intervention / Treatment: Behavioral: Health education intervention

• Study Type: Interventional
• Enrollment (Anticipated): 1139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100871
      • Peking University China Center for Health Economic Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Married women who are 18-65 years old

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Health education intervention; 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.	Behavioral: Health education intervention; 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.
No Intervention: Control without 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	12 weeks after the start of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	12 weeks after the intervention

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Principal Investigator: Guoen Liu, PhD, Peking University

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2022
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): August 5, 2023

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 23, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PekingUni_Liangshan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data can be provided according to the needs of the researcher, but does not include all personal data
• IPD Sharing Time Frame: The data will be available in 2025
• IPD Sharing Access Criteria: The data are for research purposes only
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No