Effects of an Intervention on Improving Midlife Women's Menopause-related Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of an Intervention on Improving Midlife Women's Menopause-related Symptoms

Conditions
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Genitourinary Symptoms

Intervention / Treatment
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* Behavioral: Pelvic floor muscles training (PFMT) combined with yoga


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 47 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The intervention group<br>The intervention group received an educational section and related educational materials. The educational section involved two sub-sections: a discussion section and an abbreviated practice section. The intervention group attended on-site group practice sections and performed individual home-based practice. | Behavioral: Pelvic floor muscles training (PFMT) combined with yoga<br>* All study participants were instructed to perform PFMT combined with yoga with an expectation of performing a 70-minute practice section 3 days in a week. All study participants received a booklet with menopause-related information, a booklet plus an instructional Digital Video Disc for PFMT and yoga practice.<br>|
| Active Comparator: The comparison group<br>The comparison group received an educational section and related educational materials. The educational section involved two sub-sections: a discussion section and an abbreviated practice section. The comparison group performed individual home-based practice only. | Behavioral: Pelvic floor muscles training (PFMT) combined with yoga<br>* All study participants were instructed to perform PFMT combined with yoga with an expectation of performing a 70-minute practice section 3 days in a week. All study participants received a booklet with menopause-related information, a booklet plus an instructional Digital Video Disc for PFMT and yoga practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genitourinary Symptoms | Self-reporting 11 genitourinary symptoms: We generated three items to measure genital symptoms based on available information (The North American Menopause Society, 2013), and used the Lower Urinary Tract Symptoms (LUTS) subscale in the Taiwan Teacher Bladder Survey for measuring LUTS (Liao et al., 2006). | Baseline | 
| Genitourinary Symptoms | Self-reporting 11 genitourinary symptoms: We generated three items to measure genital symptoms based on available information (The North American Menopause Society, 2013), and used the Lower Urinary Tract Symptoms (LUTS) subscale in the Taiwan Teacher Bladder Survey for measuring LUTS (Liao et al., 2006). | 3-month follow-up | 
| Genitourinary Symptoms | Self-reporting 11 genitourinary symptoms: We generated three items to measure genital symptoms based on available information (The North American Menopause Society, 2013), and used the Lower Urinary Tract Symptoms (LUTS) subscale in the Taiwan Teacher Bladder Survey for measuring LUTS (Liao et al., 2006). | 6-month follow-up | 
| Genitourinary Symptoms | Self-reporting 11 genitourinary symptoms: We generated three items to measure genital symptoms based on available information (The North American Menopause Society, 2013), and used the Lower Urinary Tract Symptoms (LUTS) subscale in the Taiwan Teacher Bladder Survey for measuring LUTS (Liao et al., 2006). | 9-month follow-up | 
| Genitourinary Symptoms | Self-reporting 11 genitourinary symptoms: We generated three items to measure genital symptoms based on available information (The North American Menopause Society, 2013), and used the Lower Urinary Tract Symptoms (LUTS) subscale in the Taiwan Teacher Bladder Survey for measuring LUTS (Liao et al., 2006). | 12-month follow-up | 
| Climacteric Symptoms | Self-reporting 21 physical and psychological symptoms: We used the Taiwan-version of the Greene Climacteric Scale for measuring climacteric symptoms (Greene, 2008). | Baseline | 
| Climacteric Symptoms | Self-reporting 21 physical and psychological symptoms: We used the Taiwan-version of the Greene Climacteric Scale for measuring climacteric symptoms (Greene, 2008). | 3-month follow-up | 
| Climacteric Symptoms | Self-reporting 21 physical and psychological symptoms: We used the Taiwan-version of the Greene Climacteric Scale for measuring climacteric symptoms (Greene, 2008). | 6-month follow-up | 
| Climacteric Symptoms | Self-reporting 21 physical and psychological symptoms: We used the Taiwan-version of the Greene Climacteric Scale for measuring climacteric symptoms (Greene, 2008). | 9-month follow-up | 
| Climacteric Symptoms | Self-reporting 21 physical and psychological symptoms: We used the Taiwan-version of the Greene Climacteric Scale for measuring climacteric symptoms (Greene, 2008). | 12-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Pelvic Floor Muscles Strength | For the intervention group, we obtained the Pelvic Floor Muscles' perianal surface electromyography by using the FemiScan pelvic floor therapy system. Two parameters (activity and peak; µV) resulted from the electromyography were used to represent the Pelvic Floor Muscles strength (Mega Electronics Ltd, 2002-2006). | Baseline | 
| The Pelvic Floor Muscles Strength | For the intervention group, we obtained the Pelvic Floor Muscles' perianal surface electromyography by using the FemiScan pelvic floor therapy system. Two parameters (activity and peak; µV) resulted from the electromyography were used to represent the Pelvic Floor Muscles strength (Mega Electronics Ltd, 2002-2006) . | 3-month follow-up | 
| The Pelvic Floor Muscles Strength | For the intervention group, we obtained the Pelvic Floor Muscles' perianal surface electromyography by using the FemiScan pelvic floor therapy system. Two parameters (activity and peak; µV) resulted from the electromyography were used to represent the Pelvic Floor Muscles strength (Mega Electronics Ltd, 2002-2006). | 6-month follow-up | 
| The Pelvic Floor Muscles Strength | For the intervention group, we obtained the Pelvic Floor Muscles' perianal surface electromyography by using the FemiScan pelvic floor therapy system. Two parameters (activity and peak; µV) resulted from the electromyography were used to represent the Pelvic Floor Muscles strength (Mega Electronics Ltd, 2002-2006). | 9-month follow-up | 
| The Pelvic Floor Muscles Strength | For the intervention group, we obtained the Pelvic Floor Muscles' perianal surface electromyography by using the FemiScan pelvic floor therapy system. Two parameters (activity and peak; µV) resulted from the electromyography were used to represent the Pelvic Floor Muscles strength (Mega Electronics Ltd, 2002-2006). | 12-month follow-up |