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

Pelvic Floor Disorders Clinical Trial

— PerineUM  

Official title:

Use of Transabdominal M-mode Ultrasonography in the Assessment and Treatment of Pelviperineal Dysfunctions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05399901
• Other study ID #: PerineUM2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2022
• Source: Universidad de Murcia
• Contact: MARIA ELENA DEL BAÑO ALEDO, PhD
• Phone: 647193115
• Email: mbano[@]um.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Floor Disorders

Intervention

Other:
• Electromyographic biofeedback
Active exercises of the pelvic floor muscles and verbal instructions and EMG Biofeedback
• M-mode US biofeedback
Active exercises of the pelvic floor muscles and verbal instructions and M-mode Ultrasound Biofeedback

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline and after the intervention (1 week from baseline)
Primary	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.	At baseline and after the intervention (1 week from baseline)
Secondary	Change in the displacement of the base of the bladder during voluntary contraction of the pelvic floor.	It will be measured by Ultrasonography.	At baseline and after the intervention (1 hour from baseline)