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Urinary IncontinenceNCT04351750

Dose-response of Physical Exercise on Pelvic Floor Muscle Function in Postmenopausal Women With Urinary Incontinence

A study testing general exercise and pelvic floor muscle training in people with Urinary Incontinence and Pelvic Floor Muscle Weakness, run by National Cheng Kung University at 1 site in Taiwan.

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

Urinary incontinence (UI) symptoms are highly prevalent among women, and menopause is one of the risk factors for UI. During the menopausal transition, not only the hormonal secretion is changed but also the level of physical activity is affected. The time spent on physical activity is reduced in postmenopausal women. Read more about this study

Who is it for?
Ages Up to 80 years, women only
What is being tested?
general exercise and pelvic floor muscle training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteTaiwan
Study dates
1 Mar 2020to 24 May 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Up to 80 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Postmenopausal women: amenorrhoea for longer than 12 months.
  • Symptomatic UI: The questionnaire for urinary incontinence diagnosis (QUID) score >0
  • Sedentary lifestyle: < 150 minutes of moderate-intensity aerobic physical activity throughout the week, or < 75 minutes of vigorous-intensity aerobic physical activity throughout the week, or an equivalent combination of moderate and vigorous-intensity activity
  • Able to answer the questionnaire correctly (no language barrier or cognitive problems)
  • No other physical or psychological problem that would interfere participation in the study
  • No concurrent outpatient rehab attendance / supervised exercise

Who cannot join

  • Use hormone therapy
  • Age >80 y/o
  • Neurological condition: Spinal cord injury, multiple sclerosis, transverse myelitis, cerebrovascular accident
  • Radical surgery for pelvis, sling, and prolapse surgery
  • Malignancy for bladder, urethra, uterus, ovary, cervix, and rectum
  • Overflow incontinence or voiding dysfunction

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Cheng Kung University

    Tainan, 704

Other trials in Taiwan

About this study

Official title: Dose-response of Physical Exercise on Pelvic Floor Muscle Function in Postmenopausal Women With Urinary Incontinence: a Randomized Controlled Trial

Urinary incontinence (UI) symptoms are highly prevalent among women, and menopause is one of the risk factors for UI. During the menopausal transition, not only the hormonal secretion is changed but also the level of physical activity is affected. The time spent on physical activity is reduced in postmenopausal women. Studies have shown that physical activity acts in a bidirectional manner, exerting either a preventive or an aggravating effect on urinary incontinence. Individuals with sedentary lifestyle and insufficient physical activity (< 150 min/week) are at risk of developing UI, and regular physical activity exerts a protective effect in preventing UI, but the optimal type, duration, and intensity of exercise for the female older adult population remain unknown. In addition, objective measurements of pelvic floor muscle function is needed as the use of self-reported measures may cause response bias. The aim of the study is to investigate the effect of different intensity of exercise on pelvic floor muscle function and HRQoL in postmenopausal women with UI. The investigators hypothesize that (a) both high- and low-intensity physical activities can improve pelvic floor muscle strength and HRQoL in postmenopausal women with UI, and (b) the improvement in high-intensity group is higher than that in low-intensity group. A randomized trial will be conducted to compare the effect of different exercise intensity on pelvic floor muscle function in postmenopausal women with urinary incontinence (n=90).

Read the detailed description

In Taiwan, the prevalence of urinary incontinence (UI) in postmenopausal women was 29.8%. Previous studies have indicated that menopause may be associated with developing UI. As there are many estrogen receptors in pelvic floor, the estrogen decline after menopausal transition may lead to pelvic floor muscle dysfunction, and the subsequent development of UI. Pelvic floor muscle training (PFMT) has been recommended by the International Continence Society as the first-line conservative treatment for women with UI. In addition to the prevalent incontinence associated with postmenopausal status, many women tend to have a more sedentary lifestyle after menopausal transition. Previous studies have shown that a sedentary lifestyle is related to UI in older women and indicated the importance of physical activity on preventing incontinence. Regular physical exercise including aerobic exercise and resistance training has been proved to improve bone mineral density, stress management and autonomic functions in postmenopausal women. However, the effect of different intensity of physical exercise adding to PFMT on pelvic floor muscle function in postmenopausal women with UI remains unknown. Therefore, the aim of this study is to investigate the effect of different intensity of exercise on pelvic floor muscle function and health-related quality of life in postmenopausal women with UI.

This is a randomized controlled trial (RCT). Postmenopausal women with UI and a sedentary lifestyle will be recruited. Eligible participants will be randomly allocated to the high-intensity group to receive high intensity general exercise plus PFMT program, the low-intensity group to receive low intensity general exercise plus PFMT, or the control group to receive only PFMT. The intervention will be provided twice weekly for eight weeks. The assessments will be conducted at baseline and after 8-week intervention. The primary outcome is pelvic floor muscle function measured by manometry and through digital palpation. The secondary outcomes are symptom severity measured using the International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-UI SF), health-related quality of life measured using the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol), and physical activity levels measured by the International Physical Activity Questionnaire (IPAQ). In addition, the participants will be asked to complete a 3-day bladder diary. Data analysis will be performed using Statistical Product and Service Solutions (SPSS) version 22.0. For continuous data, analysis of covariance tests will be used for within-group and between-group comparisons, respectively. For categorical data, McNemar's tests and chi-square tests will be used for within-group and between-group comparisons. The significant level is set at p-value < 0.05.

Being tested
general exercise, pelvic floor muscle training
Medical subject headings
Urinary Incontinence

What participants receive

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

  • general exerciseOther

    The participants will receive training sessions twice a week for 8 weeks. General exercise includes aerobic exercise (stationary bike) and resistance training (thera-band, sandbags, dumbbell and swiss ball), and the intensity and progression of both aerobic and resistance exercises will be provided as recommended by the ACSM, and the exercise will individualized based on participant's HRR, 1 RM weight and Borg Scale of Perceived Exertion Scale (Borg RPE scale). An oximeter will be utilized to monitor the heart rate and SPO2 of the participants to ensure safety during the training session.

  • pelvic floor muscle trainingOther

    Participants will do pelvic floor muscle training in different positions. Each session includes three sets of eight to twelve maximum voluntary contractions of pelvic floor muscle, with holding the contraction for 6 to 8 seconds, and if possible, to do three fast contractions at the end of each set.

Study groups in NCT04351750
Study groupRoleWhat they receive
high-intensity groupExperimentalThe participants will receive high-intensity general exercise and pelvic floor muscle training in high-intensity group. The intensity of aerobic exercise is 60 ~ 89% of heart rate reserve (HRR) or oxygen uptake reserve (VO2R), which is equivalent to the vigorous intensity exercise proposed in the American College of Sports Medicine (ACSM). The intensity of resistance exercise is 60~80% of 1 repetition maximum (RM), which is equivalent to the moderate-to-vigorous intensity exercise proposed in ACSM. After finishing the general exercise, participants will receive pelvic floor muscle training.
Receives: Other: general exercise; Other: pelvic floor muscle training
low-intensity groupExperimentalThe participants will receive low-intensity general exercise and pelvic floor muscle training in low-intensity group. The intensity of aerobic exercise is 40~59% of HRR or VO2R, which is equivalent to the moderate intensity exercise proposed in ACSM. The intensity of resistance exercise is 40~50% of 1RM, which is equivalent to the very light-to-light intensity exercise proposed in ACSM. After finishing the general exercise, participants will receive pelvic floor muscle training.
Receives: Other: general exercise; Other: pelvic floor muscle training
control groupActive comparatorThe participants will only receive pelvic floor muscle training in control group.
Receives: Other: pelvic floor muscle training

What is being measured

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

  1. Pelvic Floor Muscle Function Measured by Digital Palpation

    Pelvic floor muscle function (muscle strength) was measured through digital palpation. Three times of maximum contraction holding for five seconds with an interval resting of five seconds were performed, and the maximum value among three was recorded as the muscle strength of maximal voluntary contraction (MVC). The result was recorded using the modified Oxford grading scale, a six-point system with higher score indicated stronger muscle strength (0 = no contraction, 1 = flicker, 2 = weak, 3 = moderate with lift, 4 = good with lift, 5 = strong with lift).

    Measured: absolute values at 8 weeks

  2. Pelvic Floor Muscle Function Measured by Manometry

    The manometry supplied by Laborie® Biofeedback and Stimulation System was used to assess vaginal squeeze pressure, and the unit of pressure was registered in millimeter of mercury (mmHg). The participants were asked to perform 3 times of MVC, holding for 5 seconds with 5 seconds interval resting time, and the maximum value among the three MVC was recorded. The muscle strength was calculated as the value of MVC minus resting tone.

    Measured: absolute values at 8 weeks

Secondary outcomes (5)

  1. International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form

    The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form will be used to assess the severity of UI symptoms. The total score ranges from 0 to 21; a higher score indicates greater severity.

    Measured: absolute values at 8 weeks

  2. International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life

    The International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life will be used to evaluate quality of life in UI patients. The total score ranges from 19 to 76. A higher score indicates greater impact on quality of life.

    Measured: absolute values at 8 weeks

  3. International Prostate Symptom Score

    The International Prostate Symptom Score will be used to evaluate the severity of lower urinary tract symptoms. The total score ranges from 0 to 35. A higher score indicates greater severity.

    Measured: absolute values at 8 weeks

  4. 3-day Bladder Diary

    The participants had to record the frequency of daytime urination for three days but not necessarily consecutive. Daytime frequency was defined as the number of voids since first void after waking to last void before sleep.

    Measured: absolute values at 8 weeks

  5. International Physical Activity Questionnaire

    The International Physical Activity Questionnaire will be used to measure participants' physical activity levels. The questionnaire assessed the time people spending in physical activity in the last seven days, and the intensity of physical activity level was divided into vigorous, moderate, and walking. The total physical activity levels were calculated by a formula: total MET-minutes/week (Metabolic equivalent of task- minutes per week) = Vigorous intensity (8.0 METs*min*day) + Moderate intensity (4.0 METs*min*days) + Walking (3.3 METs*min*days). A higher score indicates a greater physical activity levels.

    Measured: absolute values at 8 weeks

Timeline

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

  1. First posted17 Apr 2020
  2. Study start1 Mar 2020
  3. Primary completion24 May 2021
  4. Study completion24 May 2021

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
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04351750
Sponsor's protocol ID
A-BR-108-091
Status last verified
Jun 2022
First submitted
14 Apr 2020
Last updated
31 Mar 2023
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nygaard I, Shaw J, Egger MJ. Exploring the association between lifetime physical activity and pelvic floor disorders: study and design challenges. Contemp Clin Trials. 2012 Jul;33(4):819-27. doi: 10.1016/j.cct.2012.04.001. Epub 2012 Apr 12.

    PubMed 22521947

  • Bo K, Nygaard IE. Is Physical Activity Good or Bad for the Female Pelvic Floor? A Narrative Review. Sports Med. 2020 Mar;50(3):471-484. doi: 10.1007/s40279-019-01243-1.

    PubMed 31820378

  • Faleiro DJA, Menezes EC, Capeletto E, Fank F, Porto RM, Mazo GZ. Association of Physical Activity With Urinary Incontinence in Older Women: A Systematic Review. J Aging Phys Act. 2019 Dec 1;27(4):906-913. doi: 10.1123/japa.2018-0313.

    PubMed 30859902

  • Akkus Y, Pinar G. Evaluation of the prevalence, type, severity, and risk factors of urinary incontinence and its impact on quality of life among women in Turkey. Int Urogynecol J. 2016 Jun;27(6):887-93. doi: 10.1007/s00192-015-2904-5. Epub 2015 Dec 5.

    PubMed 26638154

  • Duval K, Prud'homme D, Rabasa-Lhoret R, Strychar I, Brochu M, Lavoie JM, Doucet E. Effects of the menopausal transition on energy expenditure: a MONET Group Study. Eur J Clin Nutr. 2013 Apr;67(4):407-11. doi: 10.1038/ejcn.2013.33. Epub 2013 Feb 20.

    PubMed 23422924

  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PubMed 12900694

  • Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.

    PubMed 15227649

  • Barry MJ, Fowler FJ Jr, O'leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT; Measurement Committee of the American Urological Association. The American Urological Association Symptom Index for Benign Prostatic Hyperplasia. J Urol. 2017 Feb;197(2S):S189-S197. doi: 10.1016/j.juro.2016.10.071. Epub 2016 Dec 22.

    PubMed 28012747

  • Kelleher CJ, Cardozo LD, Khullar V, Salvatore S. A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol. 1997 Dec;104(12):1374-9. doi: 10.1111/j.1471-0528.1997.tb11006.x.

    PubMed 9422015

  • Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

    PubMed 39704322

  • Li YT, Tsai YJ, Wang LY, Ou YC, Kao YL, Lin KY. The feasibility of a multimodal exercise program for sedentary postmenopausal women with urinary incontinence: A pilot randomized controlled trial. Maturitas. 2023 Jan;167:90-98. doi: 10.1016/j.maturitas.2022.10.004. Epub 2022 Oct 27.

    PubMed 36327627

Questions about this trial

What is this clinical trial studying?

A study testing general exercise and pelvic floor muscle training in people with Urinary Incontinence and Pelvic Floor Muscle Weakness, run by National Cheng Kung University at 1 site in Taiwan.

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 6 inclusion and 6 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 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 31 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pelvic Floor Muscle Function Measured by Digital Palpation (time frame: absolute values at 8 weeks). The study lists 2 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 NCT04351750, which also lists 11 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 31 Mar 2023.

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