Genitourinary SymptomsNCT04277871

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

A study testing Pelvic floor muscles training (PFMT) combined with yoga in people with Genitourinary Symptoms, run by National Yang Ming Chiao Tung University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 47 to 65 years, women only
Conditions the study is for: Genitourinary Symptoms
What is being tested?: Pelvic floor muscles training (PFMT) combined with yoga
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: No sites listed yet
Study dates: Aug 2009to Jan 2012
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 47 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women who experienced ≥1 genitourinary symptoms.

Who cannot join

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.

About this study

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: Genitourinary Symptoms
Being tested: Pelvic floor muscles training (PFMT) combined with yoga

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pelvic floor muscles training (PFMT) combined with yogaBehavioural
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.

Study groups in NCT04277871
Study group	Role	What they receive
The intervention group	Experimental	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. Receives: Behavioral: Pelvic floor muscles training (PFMT) combined with yoga
The comparison group	Active comparator	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. Receives: Behavioral: Pelvic floor muscles training (PFMT) combined with yoga

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12-month follow-up

Secondary outcomes (5)

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).
Measured: 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) .
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Jan 2012

First posted20 Feb 2020
Study startAug 2009
Primary completionOct 2011
Study completionJan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Genitourinary SymptomsStudies of the same condition, open and under way.
More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04277871
Sponsor's protocol ID: 97-2314-B-038-039
Status last verified: Feb 2020
First submitted: 17 Feb 2020
Last updated: 20 Feb 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Genitourinary Symptoms trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of an Intervention on Improving Midlife Women's Menopause-related Symptoms
ClinicalTrials.gov ID: NCT04277871
Acronym / sponsor ID: 97-2314-B-038-039
Conditions: Genitourinary Symptoms
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: National Yang Ming Chiao Tung UniversityUniversity, hospital or other
Collaborators: National Science and Technology Council, Taiwan
Study start: Aug 2009 (actual)
Primary completion: Oct 2011 (actual)
Study completion: Jan 2012 (actual)
First posted: 20 Feb 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
The intervention group	Experimental	Behavioral: Pelvic floor muscles training (PFMT) combined with yogaThe 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.
The comparison group	Active comparator	Behavioral: Pelvic floor muscles training (PFMT) combined with yogaThe 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.

Who may qualify

Ages: 47 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Women who experienced ≥1 genitourinary symptoms.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pelvic floor muscles training (PFMT) combined with yogaAll 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.	Behavioural	The comparison group, The intervention group

Primary outcome

Genitourinary Symptoms
Time frame: Baseline
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).
Genitourinary Symptoms
Time frame: 3-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).
Genitourinary Symptoms
Time frame: 6-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).
Genitourinary Symptoms
Time frame: 9-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).
Genitourinary Symptoms
Time frame: 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).
Climacteric Symptoms
Time frame: Baseline
Self-reporting 21 physical and psychological symptoms: We used the Taiwan-version of the Greene Climacteric Scale for measuring climacteric symptoms (Greene, 2008).
Climacteric Symptoms
Time frame: 3-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).
Climacteric Symptoms
Time frame: 6-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).
Climacteric Symptoms
Time frame: 9-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).
Climacteric Symptoms
Time frame: 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).

5 secondary outcomes

The Pelvic Floor Muscles Strength
Time frame: Baseline
The Pelvic Floor Muscles Strength
Time frame: 3-month follow-up
The Pelvic Floor Muscles Strength
Time frame: 6-month follow-up
The Pelvic Floor Muscles Strength
Time frame: 9-month follow-up
The Pelvic Floor Muscles Strength
Time frame: 12-month follow-up

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
Background: PubMed 30288727Dumoulin 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.
Background: PubMed 29452777Cramer 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.
Background: PubMed 30735055Sha 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.
Background: PubMed 31133219Mercier 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.
Background: PubMed 25705816Kim 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.
Background: PubMed 19434881Greene JG. Constructing a standard climacteric scale. Maturitas. 2008 Sep-Oct;61(1-2):78-84. doi: 10.1016/j.maturitas.2008.09.011.
Background: PubMed 17142154Liao 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.
Background: PubMed 11236857Fuh 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.
Background: PubMed 23985562Management 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.
Background: PubMed 12114899Abrams 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yuan-Mei Liao, PhD principal investigator

National Yang-Ming University, Taiwan, R.O.C

Questions about this trial

What is this clinical trial studying?

A study testing Pelvic floor muscles training (PFMT) combined with yoga in people with Genitourinary Symptoms, run by National Yang Ming Chiao Tung University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Genitourinary Symptoms (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04277871, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.