Muscle Clinical Trial
Official title:
Intravaginal Electrical Nerve Stimulation to Achieve a Voluntary Contraction in Women With Non-contracting Pelvic Floor: a Randomized Controlled Trial
It is estimated that about 30% of women cannot voluntarily contract the pelvic floor muscles (PFM). PFM training (PFMT) represents the first therapeutic option for the treatment of female urinary incontinence (UI), however the inability to contract this muscle makes PFMT unfeasible. The primary objective of this project is to evaluate clinically the efficacy of intravaginal electrical stimulation associated with verbal instructions to provide the ability of women to contract voluntary their PFM. The secondary objective is to evaluate the UI prevalence and impact on quality of life.
This is a randomized controlled trial. A simple randomization procedure will be conducted
using computer generated list. This list will be kept with a secretary not involved with the
research. A concealed allocation will be performed. All participants will be recruited at
Rehabilitation Center of the Clinical Hospital of Ribeirão Preto Medical School, University
of São Paulo. The primary outcome of the study will be vaginal palpation, to differentiate
women capable or not capable to perform a PFM contraction. The secondary outcome will be
measured using the ICIQ- UI SF questionnaire.
To analyze the proportions of improvement after the intervention in relation to primary
outcome we will consider the proportion of women with values equal or above 2 and 3 as
specified in the outcome measure section, using the modified oxford grading scale. The sample
size calculation will be done based in a pilot study after the study initiate (after
registration) considering we found no data from a RCT investigating exactly the same
intervention. The study of Vasconcelos et al. (2017) that investigated a similar intervention
in the same population performed a sample size calculation using a test of differences
between proportions and Fisher's exact test based in the proportion of change in the group
receiving electrical stimulation ( 0.35 point) and in the control group (CG) (0.13 point).
Considering a significance level of 5% and 80% test power, in the comparison between the
intervention group (IG) and control group (CG), the minimum number indicated was 61
participants per group; however as the intervention was not exactly the same and the control
group received instructions to perform home training we intend to do this calculation again
based in a pilot sample after the study initiate (after registration).
As stated before in the initial registration, the sample size calculation was conducted based
on a pilot test carried out by the researcher. The sample calculation was used for
qualitative data (primary outcome measure) and non-paired sample based on the proportion of
improvement after the intervention. The sample calculation compared n=14 in the control group
and n= 9 in the intervention group. Considering the proportion of improvement, after
intervention, in women with values equal or above 2 is suggested that a sample size of 14
participants per group would be adequate to see between group differences at power=0.90 and
α=0.05. In a second situation, the proportion of improvement will be considered as a value
equal or above 3, in this case a sample size of 28 participants per group would be adequate
to see between group differences at power=0.80 and α=0.05, and 37 participants per group
would be adequate to see between group differences at power=0.90 and α=0.05.
Data analysis The data will be analyzed initially through descriptive statistics, which will
enable the characterization of the sample regarding the variables collected. This methodology
has as basic objective to synthesize a series of values of the same nature, allowing a global
view of the variation of these values, organizing and describing the data through tables of
frequencies and descriptive measures.
To verify the association between the categorical variables, the data will be submitted to
Fisher's exact test. The association quantification will be measured through logistic
regression models, where the crude odds ratio with its respective 95% confidence intervals
will be calculated.
The analysis of variance (ANOVA) will be used to verify the homogeneity between the groups of
quantitative variables. The Student's t-test will be used to compare two means from unpaired
samples. To test whether the variances of the two groups are statistically equal, and if the
data follows the normal distribution, the PROC TEST procedure of the SAS software will be
used. The mixed effects linear models (random and fixed effects) will be used for the
analysis of the ICIQ-S questionnaire. This method is used in the analysis of data where the
responses of the same individual are grouped and the assumption of independence between
observations in the same group is not adequate (Schall, 1991). In the mixed-effects model
used, individuals will be considered as random effects and, as fixed effects, the groups, the
times and the interaction between them. The adjustment of the model will be done through the
PROC MIXED procedure of the statistical software SAS.
The results will be reported as estimates of effect size. In relation to the primary outcome
we will present the proportion of improvement, crude odds ratio with respective confidence
intervals of 95%. For the secondary outcome measure we will present mean difference and 95%
CI).
Data will be analyzed Independent of compliance to intervention (intention to treat
analysis). A secondary per-protocol analysis will be done to verify the effect of trial
adherence on the primary outcome. This analysis will include only women who received at least
80% of the physiotherapy sessions.
A sensitivity analysis will be performed if necessary to adjust for possible baseline
imbalances.
All statistical analyzes will be performed using the SAS® 9 statistical software. The level
of significance adopted for all tests will be 5%.
Quality assurance plan that addresses data validation and registry procedures, including any
plans for site monitoring and auditing.
Data checks to compare data entered into the registry against predefined rules for range or
consistency with other data fields in the registry.
Source data verification to assess the accuracy, completeness, or representativeness of
registry data by comparing the data to external data sources (for example, medical records,
paper or electronic case report forms, or interactive voice response systems).
Data dictionary that contains detailed descriptions of each variable used by the registry,
including the source of the variable, coding information if used (for example, World Health
Organization Drug Dictionary, MedDRA), and normal ranges if relevant.
Standard Operating Procedures to address registry operations and analysis activities, such as
patient recruitment, data collection, data management, data analysis, reporting for adverse
events, and change management.
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