Dose-response of Physical Exercise on Pelvic Floor Muscle Function in Postmenopausal Women With Urinary Incontinence: a Randomized Controlled Trial
Phase: NA
Conditions: Urinary Incontinence, Pelvic Floor Muscle Weakness
Sponsor: National Cheng Kung University

Official title: Dose-response of physical exercise on pelvic floor muscle function in 
postmenopausal women with urinary incontinence 
Number: NCT04351750 
Document date: 12/22/2021 
 
 

Study protocol 
Urinary incontinence (UI) symptoms are highly prevalent among women, and 
menopause may be a risk of developing urinary incontinence1. During the menopausal 
transition, not only the hormonal secretion is changed but also the physical activity is 
affected. The time women spend in physical activity is reduced and the time spend in 
sedentary behavior is increased in postmenopausal women2. Studies have shown that 
physical activity acts in a bidirectional manner, exerting either a preventive or an 
aggravating effect on urinary incontinence3. 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 was 
needed as the use of self-reported measures may cause response bias4. The aim of the 
study was to investigate the effect of different intensity of exercise on pelvic floor 
muscle function and health-related quality of life (HRQoL) in postmenopausal women 
with UI. We hypothesized that (a) both high- and low-intensity physical activities 
could improve pelvic floor muscle strength and HRQoL in postmenopausal women 
with UI, and (b) the improvement in high-intensity group would be higher than that in 
low-intensity group. A randomized trial was conducted to compare the effect of 
different exercise intensity on pelvic floor muscle function in postmenopausal women 
with UI (n=38). The participants were randomly allocated to high-intensity group, 
low-intensity group or control group. Each group received an 8-week intervention. 
Both high-intensity group and low-intensity group received a multimodal exercise 
program including aerobic exercise, resistance exercise, and pelvic floor muscle 
training. The control group underwent only pelvic floor muscle training. The outcome 
measures including pelvic floor muscle function, UI symptom severity, HRQoL, 

voiding function, and physical activity levels were assessed at baseline and after 8-
week intervention. 
Statistical analysis plan 
Data analysis was performed by Statistical Product and Service Solutions (SPSS) 
version 22.0 (SPSS, Chicago, IL, USA). The descriptive data were presented as mean, 
standard deviation (SD), number and percentage. The one-way ANOVA tests were 
used to compare the continuous data between two groups and chi-square tests were 
used for categorical data. Shapiro-wilk tests were used to assess the normality of data. 
Paired-t tests and McNemar’s test were used for within-group comparisons. The 
repeated-measure ANOVA tests and chi-square tests were used to compare changes in 
outcomes between groups after intervention; ANCOVA tests were used if adjustment 
for significant differences between groups on outcomes at baseline was needed. A 
significant level was set at p-value<0.05. 
Reference 
1. 
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;27(6):887-893. 
2. 
Duval K, Prud'homme D, Rabasa-Lhoret R, et al. Effects of the menopausal 
transition on energy expenditure: a MONET Group Study. Eur J Clin Nutr. 
2013;67(4):407-411. 
3. 
Bo K, Nygaard IE. Is Physical Activity Good or Bad for the Female Pelvic 
Floor? A Narrative Review. Sports Med. 2020;50(3):471-484. 
4. 
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;27(4):906-913.