- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04351750
Dose-response of Physical Exercise on Pelvic Floor Muscle Function in Postmenopausal Women With Urinary Incontinence
Dose-response of Physical Exercise on Pelvic Floor Muscle Function in Postmenopausal Women With Urinary Incontinence: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tainan, Taiwan, 704
- National Cheng Kung University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: high-intensity group
The 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.
|
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.
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.
|
Experimental: low-intensity group
The 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.
|
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.
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.
|
Active Comparator: control group
The participants will only receive pelvic floor muscle training in control group.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pelvic Floor Muscle Function Measured by Digital Palpation
Time Frame: absolute values at 8 weeks
|
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).
|
absolute values at 8 weeks
|
Pelvic Floor Muscle Function Measured by Manometry
Time Frame: absolute values at 8 weeks
|
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.
|
absolute values at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Time Frame: absolute values at 8 weeks
|
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.
|
absolute values at 8 weeks
|
International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life
Time Frame: absolute values at 8 weeks
|
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.
|
absolute values at 8 weeks
|
International Prostate Symptom Score
Time Frame: absolute values at 8 weeks
|
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.
|
absolute values at 8 weeks
|
3-day Bladder Diary
Time Frame: absolute values at 8 weeks
|
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.
|
absolute values at 8 weeks
|
International Physical Activity Questionnaire
Time Frame: absolute values at 8 weeks
|
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.
|
absolute values at 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kuan-Yin Lin, PhD, National Cheng Kung University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Eur J Clin Nutr. 2014 Jan;68(1):142.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Urination Disorders
- Neuromuscular Manifestations
- Elimination Disorders
- Urinary Incontinence
- Muscle Weakness
- Enuresis
Other Study ID Numbers
- A-BR-108-091
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urinary Incontinence
-
University of New MexicoRecruitingUrinary Incontinence | Urge Incontinence | Stress Incontinence, FemaleUnited States
-
Juna d.o.o.CompletedFemale Stress Urinary Incontinence | Mixed Incontinence, Urge and Stress
-
University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Stanford...CompletedUrinary Incontinence, Stress | Urge Incontinence | Urinary Stress Incontinence | Stress Incontinence, Urinary | Stress Incontinence | Stress Incontinence, Female | Urgency UrinaryUnited States
-
Ludwig-Maximilians - University of MunichUnknownIncontinence, Overactive Bladder, Stress Urinary IncontinenceGermany
-
San Diego Sexual MedicineRecruitingStress Urinary Incontinence | Urge IncontinenceUnited States
-
Copenhagen University Hospital at HerlevZealand University HospitalTerminatedStress Urinary Incontinence | Urge Urinary IncontinenceDenmark
-
ScitonCompletedUrinary Incontinence | Stress Urinary Incontinence | Urge IncontinenceUnited States
-
Far Eastern Memorial HospitalRecruitingWomen With Stress Urinary IncontinenceTaiwan
-
Université de SherbrookeRecruitingUrinary Incontinence | Urinary Stress Incontinence | Post-Prostatectomy Incontinence | Stress Incontinence, MaleCanada
-
University of ZurichCompletedStress Urinary Incontinence | Urge Urinary Incontinence
Clinical Trials on general exercise
-
Helsinki University Central HospitalCompletedGestational Diabetes | Cardiovascular Risk FactorsFinland
-
Sahmyook UniversityRecruitingChronic Nonspecific Neck PainKorea, Republic of
-
Universidad San JorgeMutua MAZ; BSH electrodomésticos España S.A.Completed
-
University of ValenciaCompletedPostpartum WomenSpain
-
Khon Kaen UniversityCompletedChronic Low Back PainThailand
-
Concordia University, MontrealCompletedLow Back Pain | Muscle Atrophy | Diagnostic Imaging | Exercise TherapyCanada
-
University of AlbertaRecruitingBreast Cancer | Upper Extremity DysfunctionCanada
-
Khon Kaen UniversityCompleted
-
Centro Universitari FieoUniversity of Sao PauloCompleted
-
University of VermontEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed