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

Not Applicable

Completed

• Conditions: Genitourinary Symptoms
• Interventions: Behavioral: Pelvic floor muscles training (PFMT) combined with yoga

• Registration Number: NCT04277871
• Lead Sponsor: National Yang Ming Chiao Tung University

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.

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2011-10
• Study Completion: 2012-01
• Status Verified: 2020-02
• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-19
• Last Update Submitted: 2020-02-19
• Study First Posted: 2020-02-20
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 91

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The comparison group	Pelvic floor muscles training (PFMT) combined with yoga	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.
The intervention group	Pelvic floor muscles training (PFMT) combined with yoga	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.

Primary Outcome Measures

Name	Time	Method
Climacteric Symptoms	12-month follow-up	Self-reporting 21 physical and psychological symptoms: We used the Taiwan-version of the Greene Climacteric Scale for measuring climacteric symptoms (Greene, 2008).
Genitourinary Symptoms	12-month follow-up	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).

Secondary Outcome Measures

Name	Time	Method
The Pelvic Floor Muscles Strength	12-month follow-up	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).