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

Primary Purpose

Pelvic Floor Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Electromyographic biofeedback
M-mode US biofeedback
Sponsored by
Universidad de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with pelvic floor dysfunction derived from the pelvic floor unit of HLA La Vega in the city of Murcia diagnosed by the doctor and without previous training in pelvic floor muscles contraction.

Exclusion Criteria:

  • Pregnancy, a history of pelvic floor surgery in the previous year, neurological injury with affectation of the sacral reflex from S2 to S4, previous delivery in a period of less than 6 weeks or known or suspected urinary tract infection.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    EMG BFB

    M-mode US

    Arm Description

    An educational program will be implemented, and active exercises of the PFM will be performed using verbal instructions together with electromyographic biofeedback (BFB).

    An educational program will be implemented, and active exercises of the PFM will be performed using verbal instructions together with transabdominal M-mode ultrasound biofeedback (US).

    Outcomes

    Primary Outcome Measures

    Changes in the self efficacy expectations in performing pelvic floor exercises.
    It will be assessed by the Broome Pelvic Muscle Self-Efficacy Scale (PMSES) Spanish version. Self-efficacy expectations, specifically for performing pelvic floor exercises, are measured with 14 items with responses between 0 and 100. One hundred represents high level of confidence.
    Changes in the outcome expectations for pelvic-floor exercise treatment.
    It will be assessed by the Broome Pelvic Muscle Self-Efficacy Scale (PMSES) Spanish version. Outcome expectations are measured with 9 items with responses between 0 and 100. One hundred represents high level of confidence.

    Secondary Outcome Measures

    Change in the displacement of the base of the bladder during voluntary contraction of the pelvic floor.
    It will be measured by Ultrasonography.

    Full Information

    First Posted
    May 23, 2022
    Last Updated
    May 26, 2022
    Sponsor
    Universidad de Murcia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05399901
    Brief Title
    M-mode Ultrasonography in the Assessment and Treatment of Pelviperineal Dysfunctions (PerineUM)
    Acronym
    PerineUM
    Official Title
    Use of Transabdominal M-mode Ultrasonography in the Assessment and Treatment of Pelviperineal Dysfunctions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    October 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad de Murcia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvic Floor Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EMG BFB
    Arm Type
    Experimental
    Arm Description
    An educational program will be implemented, and active exercises of the PFM will be performed using verbal instructions together with electromyographic biofeedback (BFB).
    Arm Title
    M-mode US
    Arm Type
    Experimental
    Arm Description
    An educational program will be implemented, and active exercises of the PFM will be performed using verbal instructions together with transabdominal M-mode ultrasound biofeedback (US).
    Intervention Type
    Other
    Intervention Name(s)
    Electromyographic biofeedback
    Intervention Description
    Active exercises of the pelvic floor muscles and verbal instructions and EMG Biofeedback
    Intervention Type
    Other
    Intervention Name(s)
    M-mode US biofeedback
    Intervention Description
    Active exercises of the pelvic floor muscles and verbal instructions and M-mode Ultrasound Biofeedback
    Primary Outcome Measure Information:
    Title
    Changes in the self efficacy expectations in performing pelvic floor exercises.
    Description
    It will be assessed by the Broome Pelvic Muscle Self-Efficacy Scale (PMSES) Spanish version. Self-efficacy expectations, specifically for performing pelvic floor exercises, are measured with 14 items with responses between 0 and 100. One hundred represents high level of confidence.
    Time Frame
    At baseline and after the intervention (1 week from baseline)
    Title
    Changes in the outcome expectations for pelvic-floor exercise treatment.
    Description
    It will be assessed by the Broome Pelvic Muscle Self-Efficacy Scale (PMSES) Spanish version. Outcome expectations are measured with 9 items with responses between 0 and 100. One hundred represents high level of confidence.
    Time Frame
    At baseline and after the intervention (1 week from baseline)
    Secondary Outcome Measure Information:
    Title
    Change in the displacement of the base of the bladder during voluntary contraction of the pelvic floor.
    Description
    It will be measured by Ultrasonography.
    Time Frame
    At baseline and after the intervention (1 hour from baseline)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with pelvic floor dysfunction derived from the pelvic floor unit of HLA La Vega in the city of Murcia diagnosed by the doctor and without previous training in pelvic floor muscles contraction. Exclusion Criteria: Pregnancy, a history of pelvic floor surgery in the previous year, neurological injury with affectation of the sacral reflex from S2 to S4, previous delivery in a period of less than 6 weeks or known or suspected urinary tract infection.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    MARIA ELENA DEL BAÑO ALEDO, PhD
    Phone
    647193115
    Email
    mbano@um.es
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MARIA ELENA DEL BAÑO ALEDO, PhD
    Organizational Affiliation
    Murcia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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