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

Genitourinary Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04277871
• Other study ID #: 97-2314-B-038-039
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: January 2012

Study information

• Verified date: February 2020
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 47 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Genitourinary Symptoms

Intervention

Behavioral:
• Pelvic floor muscles training (PFMT) combined with yoga
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Yang Ming University	National Science Council, Taiwan

References & Publications (10)

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Am J Obstet Gynecol. 2002 Jul;187(1):116-26. — View Citation

Cramer H, Peng W, Lauche R. Yoga for menopausal symptoms-A systematic review and meta-analysis. Maturitas. 2018 Mar;109:13-25. doi: 10.1016/j.maturitas.2017.12.005. Epub 2017 Dec 6. Review. — View Citation

Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018 Oct 4;10:CD005654. doi: 10.1002/14651858.CD005654.pub4. — View Citation

Fuh JL, Wang SJ, Lu SR, Juang KD, Lee SJ. Psychometric evaluation of a Chinese (Taiwanese) version of the SF-36 health survey amongst middle-aged women from a rural community. Qual Life Res. 2000;9(6):675-83. — View Citation

Greene JG. Constructing a standard climacteric scale. Maturitas. 2008 Sep-Oct;61(1-2):78-84. — View Citation

Kim GS, Kim EG, Shin KY, Choo HJ, Kim MJ. Combined pelvic muscle exercise and yoga program for urinary incontinence in middle-aged women. Jpn J Nurs Sci. 2015 Oct;12(4):330-9. doi: 10.1111/jjns.12072. Epub 2015 Feb 23. — View Citation

Liao YM, Dougherty MC, Boyington AR, Lynn MR, Palmer MH. Developing and validating a Chinese instrument to measure lower urinary tract symptoms among employed women in Taiwan. Nurs Outlook. 2006 Nov-Dec;54(6):353-61. — View Citation

Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2. — View Citation

Mercier J, Morin M, Zaki D, Reichetzer B, Lemieux MC, Khalifé S, Dumoulin C. Pelvic floor muscle training as a treatment for genitourinary syndrome of menopause: A single-arm feasibility study. Maturitas. 2019 Jul;125:57-62. doi: 10.1016/j.maturitas.2019.03.002. Epub 2019 Mar 29. — View Citation

Sha K, Palmer MH, Yeo S. Yoga's Biophysiological Effects on Lower Urinary Tract Symptoms: A Scoping Review. J Altern Complement Med. 2019 Mar;25(3):279-287. doi: 10.1089/acm.2018.0382. Epub 2019 Feb 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health-related Quality of Life	We used the Taiwan version of the Short Form-36 (SF-36) Health Survey to measure quality of life (Fuh et al., 2000).	Baseline
Other	Health-related Quality of Life	We used the Taiwan version of the Short Form-36 (SF-36) Health Survey to measure quality of life (Fuh et al., 2000).	3-month follow-up
Other	Health-related Quality of Life	We used the Taiwan version of the Short Form-36 (SF-36) Health Survey to measure quality of life (Fuh et al., 2000).	6-month follow-up
Other	Health-related Quality of Life	We used the Taiwan version of the Short Form-36 (SF-36) Health Survey to measure quality of life (Fuh et al., 2000).	9-month follow-up
Other	Health-related Quality of Life	We used the Taiwan version of the Short Form-36 (SF-36) Health Survey to measure quality of life (Fuh et al., 2000).	12-month follow-up
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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