Clinical trial NCT04277871: Effects of an Intervention on Improving Midlife Women's Menopause-related Symptoms
Official title: Effects of an Intervention on Improving Midlife Women's Menopause-related Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genitourinary Symptoms
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2020-02-20
Enrollment: 91
Sex: FEMALE
Minimum age (years): 47
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was an experimental study with repeated measures. Study aims were to examine the effects of pelvic floor muscles training (PFMT) combined with yoga on improving genitourinary/climacteric symptoms, the pelvic floor muscles strength, and health-related quality of life (HRQL). Study participants were assigned to the intervention group or comparison group. Data analyses were based on the information obtained from 91 midlife women with a mean age of 56.6 years. Information related o the pelvic floor muscles strength was only obtained from 45 women. Descriptive statistics were used to represent study participants' individual characteristics, genitourinary/climacteric symptoms, the pelvic floor muscles strength, and HRQL. Paired t tests, independent t tests, and Generalized Estimating Equation (GEE) procedures were used to examine the intervention effects.

Detailed description: This study was an experimental study with repeated measures. Study aims were to examine the effects of PFMT combined with yoga on improving genitourinary/climacteric symptoms, the pelvic floor muscles strength, and HRQL. Study participants were randomly assigned to the intervention group or comparison group. All study participants received an educational section (a discussion section and an abbreviated practice section) and related educational materials. The intervention group attended on-site group practice sessions and performed individual home-based practice. The comparison group performed individual home-based practice only. Data analyses were based on the information obtained from a sample of midlife women with a mean age of 56.6 years. Relevant information was mainly collected by a structured questionnaire. Information related to the pelvic floor muscles strength was only obtained from 45 women in the intervention group by using the FemiScan pelvic floor therapy system. Descriptive statistics were used to represent study participants' individual characteristics, genitourinary/climacteric symptoms, the pelvic floor muscles strength, and HRQL. Paired t tests, independent t tests, and GEE procedures were used to examine the intervention effects.

Eligibility criteria: Inclusion Criteria:

* Women who experienced ≥1 genitourinary symptoms.

Exclusion Criteria:

* Being pregnancy or breastfeeding, experiencing iatrogenic menopause (e.g., surgery, chemotherapy or radiation related), maintaining regular PFMT and/or yoga practices, using oral contraceptive or psychiatric medications, and having physical weakness/limitation or major cognitive impairment.

Primary outcomes:
measure: Genitourinary Symptoms
timeFrame: Baseline
measure: Genitourinary Symptoms
timeFrame: 3-month follow-up
measure: Genitourinary Symptoms
timeFrame: 6-month follow-up
measure: Genitourinary Symptoms
timeFrame: 9-month follow-up
measure: Genitourinary Symptoms
timeFrame: 12-month follow-up
measure: Climacteric Symptoms
timeFrame: Baseline
measure: Climacteric Symptoms
timeFrame: 3-month follow-up
measure: Climacteric Symptoms
timeFrame: 6-month follow-up
measure: Climacteric Symptoms
timeFrame: 9-month follow-up
measure: Climacteric Symptoms
timeFrame: 12-month follow-up
Secondary outcomes:
measure: The Pelvic Floor Muscles Strength
timeFrame: Baseline
measure: The Pelvic Floor Muscles Strength
timeFrame: 3-month follow-up
measure: The Pelvic Floor Muscles Strength
timeFrame: 6-month follow-up
measure: The Pelvic Floor Muscles Strength
timeFrame: 9-month follow-up
measure: The Pelvic Floor Muscles Strength
timeFrame: 12-month follow-up
Other outcomes:
measure: Health-related Quality of Life
timeFrame: Baseline
measure: Health-related Quality of Life
timeFrame: 3-month follow-up
measure: Health-related Quality of Life
timeFrame: 6-month follow-up
measure: Health-related Quality of Life
timeFrame: 9-month follow-up
measure: Health-related Quality of Life
timeFrame: 12-month follow-up
Locations:
Study officials:
affiliation: National Yang-Ming University, Taiwan, R.O.C
name: Yuan-Mei Liao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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