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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Change in self-perception of the PFM
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Face to face intervention group
This group will be composed of participants who will receive face to face physiotherapy instruction session.
Intervention: Face to face intervention group (Other)
Remote intervention group
This group will be composed of participants who will receive real time remote physiotherapy instruction session.
Intervention: Remote intervention group (Other)
Control group
This group will be composed of participants who will not receive any type of physiotherapy instruction session during the period of the study.
Intervention: Control group (Other)
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)
Investigators
Caroline Caetano Pena
Principal investigator
University of Sao Paulo