CompletedNCT04277871Updated Feb 20, 2020

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

An interventional study of Pelvic floor muscles training (PFMT) combined with yoga in Genitourinary Symptoms, sponsored by National Yang Ming Chiao Tung University. Completed. Open to female participants aged 47 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-02-20.

Sponsored by National Yang Ming Chiao Tung University · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 10 years 6 months after the study started (first participant enrolled Aug 2009, registered Feb 2020).

Phase: Not applicable
Study type: Interventional
Enrollment: 91
Allocation: Randomized
Ages: 47 Years to 65 Years
Sex: Female

Study 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.

Read the 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.

Conditions studied

Genitourinary Symptoms

In context

Lead sponsor

National Yang Ming Chiao Tung University is the lead sponsor of 201 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 47 Years to 65 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

Women who experienced ≥1 genitourinary symptoms.

Exclusion criteria

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 91 participants (actual)

Study arms

Experimental
The intervention group
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
Active comparator
The comparison group
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

Interventions

BehavioralPelvic 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.

What researchers measure

Primary outcomes

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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 12-month follow-up

Secondary outcomes

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).
Time frame: 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) .
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 12-month follow-up

Other outcomes

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).
Time frame: Baseline
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).
Time frame: 3-month follow-up
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).
Time frame: 6-month follow-up
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).
Time frame: 9-month follow-up
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).
Time frame: 12-month follow-up

Study locations

No study locations are listed for this record.

References and documents

Publications

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(10):CD005654. doi: 10.1002/14651858.CD005654.pub4. PubMed 30288727 ↗
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. PubMed 29452777 ↗
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. PubMed 30735055 ↗
Mercier J, Morin M, Zaki D, Reichetzer B, Lemieux MC, Khalife 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. PubMed 31133219 ↗
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. PubMed 25705816 ↗
Greene JG. Constructing a standard climacteric scale. Maturitas. 2008 Sep-Oct;61(1-2):78-84. doi: 10.1016/j.maturitas.2008.09.011. PubMed 19434881 ↗
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. doi: 10.1016/j.outlook.2006.09.003. PubMed 17142154 ↗
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. doi: 10.1023/a:1008993821633. PubMed 11236857 ↗
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. PubMed 23985562 ↗
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. doi: 10.1067/mob.2002.125704. No abstract available. PubMed 12114899 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04277871
Lead sponsor: National Yang Ming Chiao Tung University
Collaborators: National Science Council, Taiwan
Responsible party: Sponsor
First posted: Feb 20, 2020
Start date: Aug 2009
Primary completion: Oct 2011
Completion: Jan 2012
Last update: Feb 20, 2020

Study contacts

Yuan-Mei Liao, PhD

principal investigator · National Yang-Ming University, Taiwan, R.O.C

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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