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M-mode Ultrasonography in the Assessment and Treatment of Pelviperineal Dysfunctions (PerineUM)

NCT05399901 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-06-01

No results posted yet for this study

Summary

Objectives: To analyze the Mode M ultrasound use in the assessment of pelvic floor musculature (PFM) and in the rehabilitation of motor control in pelviperineal dysfunctions that affect the support of pelvic organs, urinary and fecal continence and reproductive and sexual functions.

Methodology: A cross-sectional descriptive study will be followed by a randomized clinical trial. There will be two samples: a sample of volunteers without PFM dysfunction; and a sample of patients with pelviperineal dysfunction derived from health centers in the Region of Murcia. An intra- and interobserver reliability study of transabdominal M-mode ultrasound of PFM will be performed. Then, a cross-sectional descriptive study of the functional behavior of PFM will be used in different functional situations such as: voluntary contraction at maximum force, fast contraction, Valsalva maneuver and forced cough. The following ultrasound variables will be measured: direction and amount of displacement, speed of displacement and time of contraction. Correlations between ultrasound variables and sociodemographic and clinical variables will be analyzed. The randomized clinical trial will compare a PFM contraction awareness treatment based on endocavitary digital contact with a motor learning program based on transabdominal mode M ultrasound biofeedback.

Conditions

  • Pelvic Floor Disorders

Interventions

OTHER

Electromyographic biofeedback

Active exercises of the pelvic floor muscles and verbal instructions and EMG Biofeedback

OTHER

M-mode US biofeedback

Active exercises of the pelvic floor muscles and verbal instructions and M-mode Ultrasound Biofeedback

Sponsors & Collaborators

  • Universidad de Murcia

    lead OTHER

Principal Investigators

  • MARIA ELENA DEL BAÑO ALEDO, PhD · Murcia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-10-01
Completion
2024-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05399901 on ClinicalTrials.gov