Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06576947

Virtual Reality in the Treatment of Pelvic Floor Dysfunction in Women With Multiple Sclerosis

The purpose of the current randomized clinical trial was to compare the effectiveness of virtual reality versus posterior tibial nerve stimulation on the improvement of pelvic floor dysfunctions in women with multiple sclerosis.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

  • Design: Randomized Clinical Trial. Objective: to determine the effects of virtual reality versus posterior tibial nerve stimulation and muscle activation exercises on the improvement of pelvic floor dysfunctions in women with multiple sclerosis.
  • Methods and Measures: forty five women will be randomly assigned to one of three groups.
  • Intervention: For 8-week, the group 1 will undergo treatment with virtual reality (2/week), the group 2 will receive posterior tibial nerve stimulation (2/week) and the group 3 will receive muscle activation exercises of the pelvic floor.
  • Main Outcome Measures: assessment of pelvic floor muscles function (strength and muscle tone), urodynamic studies, and validated questionnaires data will be collected at baseline, and 1 week after the last therapy application. Mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome measure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of multiple sclerosis
  • Presence of pelvic floor dysfunction
  • Acceptance participation
  • Not undergoing another physical therapy treatment

Exclusion criteria

  • Non-acceptance of participation
  • Mental illness
  • Interruption of adherence to protocolized treatment sessions
  • Indication of surgical treatment in the pelvic floor

Treatment and study plan

Virtual Reality

Other

Participants receive virtual reality treatment, 8 weeks of treatment/ 2 times a week

Neuromodulation of the tibialis posterior nerve

Other

Participants receive neuromodulation of the tibialis posterior nerve8 weeks of treatment/ 2 times a week/ 30 minutes

Pelvic Floor Muscle training

Other

Participants receive pelvic floor muscle training 5 times a day for 9 weeks

Primary outcomes

  1. Pelvic floor strength

    Time frame: At baseline, immediately after the intervention, and 4 weeks] [Safety Issue: No] It is a device for measuring the strength of the pelvic floor, to which a speculum is adapted. measure force in newtons

    Pelvic floor strength using a perineometer, a device for measuring the strength of the pelvic floor, to which a speculum is adapted. measure force in newtons

Secondary outcomes

  1. Australian pelvic floor questionnaire:

    Time frame: At baseline, immediately after the intervention, and 4 weeks

    The APFQ is an instrument consisting of 42 questions in 4 domains (bladder, bowel, and sexual function and pelvic organ prolapse). relevant questions and multiplied by 10; thus, the scores range from 0 to 10 for each domain, giving a maximum total score of 40

  2. Multiple Sclerosis Quality of Life-54 (MSQOL-54):

    Time frame: At baseline, immediately after the intervention, and 4 weeks

    The instrument has Likert scales and multiple-choice items. There is no single overall score for MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). The instrument has Likert scales and multiple-choice items. There is no single overall score for MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life).

  3. Euroqol

    Time frame: At baseline, immediately after the intervention, and 4 weeks

    It is a generic and standardized instrument developed to describe and assess health-related quality of life. The descriptive system contains five dimensions of health (mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression) and each of them has three levels of severity (no problems, some problems or moderate problems, and severe problems). In this part of the questionnaire, the individual must mark the level of severity corresponding to their health status in each of the dimensions, referring to the same day they completed the questionnaire. In each dimension of the EQ-5D, severity levels are coded as 1 if the response option is "I have no problems"; with a 2 if the response option is "some or moderate problems"; and with a 3 if the answer option is "many problems." The higher score meaning a worse result.

  4. SF12

    Time frame: At baseline, immediately after the intervention, and 4 weeks

    This questionnaire contains 12 items that assess 8 aspects of HRQoL: physical dimension, mental dimension, physical function, physical role, bodily pain, general health, vitality, emotional role, social function, and mental health. The SF-12 v2 response options form Likert-type scales that evaluate intensity or frequency. The number of response options ranges between three and six, depending on the item, and each question receives a value that is subsequently transformed into a scale from 0 to 100.

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study title

Effects of Virtual Reality in the Treatment of Pelvic Floor Dysfunction in Women With Multiple Sclerosis: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.