N/A
N=47
Dose-response of Physical Exercise on Pelvic Floor Muscle Function in Postmenopausal Women With Urinary Incontinence
Urinary Incontinence · Pelvic Floor Muscle Weakness
Bottom Line
View on ClinicalTrials.gov: NCT04351750 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Pelvic Floor Muscle Function Measured by Digital Palpation — 4.00; 3.25; 3.75 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- general exercise (Other); pelvic floor muscle training (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- National Cheng Kung University
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pelvic Floor Muscle Function Measured by Digital Palpation |
4.00; 3.25; 3.75 | — |
| PRIMARY Pelvic Floor Muscle Function Measured by Manometry |
16.64; 8.58; 13.23 | — |
| SECONDARY International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form |
6.75; 4.92; 7.15 | — |
| SECONDARY International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life |
32.17; 27.85; 32.69 | — |
| SECONDARY International Prostate Symptom Score |
7.25; 6.31; 8.23 | — |
| SECONDARY 3-day Bladder Diary |
7.76; 8.00; 8.18 | — |
| SECONDARY International Physical Activity Questionnaire |
2624.35; 2133.54; 1814.25 | — |
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. 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).
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women: amenorrhoea for longer than 12 months.
- Symptomatic UI: The questionnaire for urinary incontinence diagnosis (QUID) score >0
- Sedentary lifestyle: 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
Data sourced from ClinicalTrials.gov (NCT04351750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.