Study design, materials and methods
Randomized controlled trial (RCT) with two arms, one that received an online intervention (IG) and a control group (CG) that did not receive any treatment during the period of the study. The study included women who were literate, over 18 years old, with a Body Mass Index (BMI) > 30 kg/m2, who were not pregnant or in the postpartum period, reporting UI in the last four weeks (ICIQ-SF).
This study was approved by the Human Research Ethics Committee and was prospectively registered in the Clinical Trials Register. The sample size calculation was based in a pilot study, considered a significance level of 5% and statistical power of 80%, indicating a minimum of 34 participants per group.
Randomization was carried out using a computerized list of random numbers and the allocation of participants was conceallead.
The IG protocol consisted of four sets of 10 maximum voluntary contractions held for six seconds practiced in 4 different body positions. At the end of each series of 10 contractions, five rapid contractions were performed, with a six-second interval between contractions. The supervised protocol was offered once a week for 12 weeks and a written digital pamphlet that was sent to the participants by e-mail. Data was collected at baseline and after 12 weeks.
The primary outcome was self-reported UI assessed using the ICIQ-SF. The secondary outcomes were assessed by the registration of the participants adherence to the telephysiotherapy sessions and home PFMT sessions using a diary. Satisfaction with treatment was measured using a visual analog scale.
A mixed-effects model was used to analyse and compare the results between groups, 95% confidence intervals were calculated for the mean differences observed, between groups.
The significance level adopted was α = 0.05, and all analyzes were performed using the R software (Version 2024.04.1+748).
Interpretation of results
This study found a clinically relevant improvement in UI reports and severity in the group that underwent PFMT compared to the CG. PFMT was effective through telephysiotherapy in obese women and showed high adherence and satisfaction with the treatment.