Clinical trial NCT05595967: Community Based Health Education for Prevention of Pelvic Floor Dysfunction in Fertile Women in Rural China
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Floor Dysfunction
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 1139
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The score of Pelvic Floor Distress Inventory-short form 20 (PFDI-20)
timeFrame: 12 weeks after the start of intervention
measure: The change in the incidence of pelvic floor dysfunction symptoms
timeFrame: 12 weeks after the start of intervention
Secondary outcomes:
measure: The score of Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
timeFrame: 12 weeks after the intervention
measure: The score of Prolapse and Incontinence Knowledge Quiz (PIKQ)
timeFrame: 12 weeks after the intervention
measure: Self-reported monthly working days by questionnaire (day)
timeFrame: 12 weeks after the intervention
measure: Self-reported monthly personal income by questionnaire (Yuan)
timeFrame: 12 weeks after the intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University China Center for Health Economic Research
state: Beijing
Study officials:
affiliation: Peking University
name: Guoen Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: