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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

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). Read more about this study

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
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.

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 groupRoleWhat they receive
The intervention groupExperimentalThe 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 groupActive comparatorThe 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  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: 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.

  1. First posted20 Feb 2020
  2. Study startAug 2009
  3. Primary completionOct 2011
  4. Study completionJan 2012

Resources

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

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; AzTrials last refreshed its copy on 7 Nov 2026.

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