M-mode Ultrasonography in the Assessment and Treatment of Pelviperineal Dysfunctions (PerineUM)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EMG BFB An educational program will be implemented, and active exercises of the PFM will be performed using verbal instructions together with electromyographic biofeedback (BFB). |
Other: Electromyographic biofeedback
Active exercises of the pelvic floor muscles and verbal instructions and EMG Biofeedback
|
| Experimental: M-mode US 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). |
Other: M-mode US biofeedback
Active exercises of the pelvic floor muscles and verbal instructions and M-mode Ultrasound Biofeedback
|
Outcome Measures
Primary Outcome Measures
- Changes in the self efficacy expectations in performing pelvic floor exercises. [At baseline and after the intervention (1 week from baseline)]
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. [At baseline and after the intervention (1 week from baseline)]
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. [At baseline and after the intervention (1 hour from baseline)]
It will be measured by Ultrasonography.
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Universidad de Murcia
Investigators
- Principal Investigator: MARIA ELENA DEL BAÑO ALEDO, PhD, Murcia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PerineUM2022