Efficacy of a Face to Face Versus a Remote Physiotherapy Instruction Session About Pelvic Floor in Women With Urinary Incontinence
- Conditions
- Urinary Incontinence
- Interventions
- Other: Face to face intervention groupOther: Remote intervention groupOther: Control group
- Registration Number
- NCT05443074
- Lead Sponsor
- University of Sao Paulo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 90
- 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.
- Who have intolerance to physical examination, or latex allergy;
- Who withdraws from participating in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Face to face intervention group Face to face intervention group This group will be composed of participants who will receive face to face physiotherapy instruction session. Remote intervention group Remote intervention group This group will be composed of participants who will receive real time remote physiotherapy instruction session. Control group 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.
- Primary Outcome Measures
Name Time Method Change in self-perception of the PFM 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 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 Outcome Measures
Name Time Method System usability assessment Immediately after intervention The usability of the system used to carry out the remote intervention group session will be evaluated through the systems usability scale. The system usability assessment score can range from 0 (the lower the score, the greater the usability problems of the system used) to 100 (the higher the score, the lower the usability problems of the system used).
Satisfaction with the orientations Immediately after intervention Satisfaction with the instructions received during the session will be evaluated by the numerical visual scale. In the post-intervention evaluation, face to face intervention group and remote intervention group will be asked to evaluate and mark on the line the point corresponding to the degree of satisfaction with the guidelines given in the session. Scores closer to 0 correspond to no satisfaction with the instruction received during session about pelvic floor and scores closer to 10 correspond to satisfaction with the instruction received during session about pelvic floor.
Self-report of UI symptoms At baseline and 20 days after the intervention. Reports of UI symptoms will be evaluated through the International Consultation on Incontinence Questionnaire - Short Form. Participants who report having had no urinary leakage in the last four weeks will be considered continents. The International Consultation on Incontinence Questionnaire score can range from 0 (when there is no report of urinary leakage, with no impact on quality of life) to 21 (highest in UI severity and maximum impact on quality of life).
Assessment of the usefulness of teaching resources Immediately after intervention The usefulness of teaching resources will be evaluated by the numerical visual scale and by a questionnaire developed by the researchers. In the post-intervention evaluation of face to face intervention group and remote intervention group, the numerical visual scale and the questionnaire will be presented to the participants and then they will be asked to evaluate and mark on the line the point corresponding to the degree of satisfaction/usefulness of the resources. Scores closer to 0 correspond to no satisfaction with the resources used in the instruction session about pelvic floor and scores closer to 10 correspond to satisfaction with the resources used.
Trial Locations
- Locations (1)
University of São Paulo
🇧🇷Ribeirão Preto, São Paulo, Brazil