Efficacy of a Face-to-face Versus a Remote Physiotherapy Instruction Session About Pelvic Floor in the Pelvic Floor Muscle Capacity of Incontinent Women: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Incontinence
- Sponsor
- University of Sao Paulo
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change in self-perception of the PFM
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to assess and to compare the efficacy of a face to face versus a remote physiotherapy instruction session about pelvic floor muscle (PFM) function, including teaching women how to contract their PFM and how to perceive a correct PFM contraction. Study participants will be randomly assigned to participate in one of the three study groups: Group 1 will receive face to face instructions, Group 2 will receive real time remote instructions and Group 3 will not receive any instruction. The primary outcome measure is PFM function assessed using the modified Oxford Scale.
Investigators
Caroline Caetano Pena
Principal investigator
University of Sao Paulo
Eligibility Criteria
Inclusion Criteria
- •Women who are not able to contract their PFM (≤ 2 of Modified Oxford Scale);
- •Cognitive ability, hearing and visual acuity preserved (through 10-point cognitive screener and Snellen test, respectively);
- •Non-neurogenic UI;
- •No history of neurological disorders;
- •No symptoms of a vaginal or urinary tract infection;
- •Pelvic organ prolapse ≤2 (according to the Baden and Walker scale);
- •Who have not already been instructed on how to perform PFM contraction or who is not already performing PFM training;
- •No suspected or confirmed pregnancy.
Exclusion Criteria
- •Who have intolerance to physical examination, or latex allergy;
- •Who withdraws from participating in the study.
Outcomes
Primary Outcomes
Change in self-perception of the PFM
Time Frame: At baseline, immediately after intervention and 20 days after the intervention.
The Modified Oxford Scale will be used to assess change in the participants' self-perception of their contraction after vaginal palpation. The Modified Oxford Scale is a categorical variable with 6 possible answers ranging from 0 to 5. High scores of Modified Oxford Scale mean better PFM function and lower scores mean worse PFM function.
Change in contraction capacity
Time Frame: At baseline, immediately after intervention and 20 days after the intervention.
The Modified Oxford Scale will be used to assess change in the capacity to perform a PFM contraction through vaginal palpation. The Modified Oxford Scale is a categorical variable with 6 possible answers ranging from 0 to 5. High scores of Modified Oxford Scale mean better PFM function and lower scores mean worse PFM function.
Secondary Outcomes
- System usability assessment(Immediately after intervention)
- Satisfaction with the orientations(Immediately after intervention)
- Self-report of UI symptoms(At baseline and 20 days after the intervention.)
- Assessment of the usefulness of teaching resources(Immediately after intervention)