Efficacy of a Face to Face Versus a Remote Physiotherapy Instruction Session About Pelvic Floor in Women With Urinary Incontinence

U

University of Sao Paulo

Status

Enrolling

Conditions

Urinary Incontinence

Treatments

Other: Remote intervention group
Other: Control group
Other: Face to face intervention group

Study type

Interventional

Funder types

Other

Identifiers

NCT05443074
52672521.0.0000.5440

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

Female

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 3 patient groups

Face to face intervention group
Active Comparator group
Description:
This group will be composed of participants who will receive face to face physiotherapy instruction session.
Treatment:
Other: Face to face intervention group
Remote intervention group
Experimental group
Description:
This group will be composed of participants who will receive real time remote physiotherapy instruction session.
Treatment:
Other: Remote intervention group
Control group
Active Comparator group
Description:
This group will be composed of participants who will not receive any type of physiotherapy instruction session during the period of the study.
Treatment:
Other: Control group

Trial contacts and locations

1

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Central trial contact

Caroline C Pena

Data sourced from clinicaltrials.gov

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