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
About this trial
This is an interventional treatment trial for Pelvic Floor Disorders
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.
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
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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