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

NCT ID: NCT05399901

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-10-01

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.

Conditions

Pelvic Floor Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Electromyographic biofeedback

Intervention Type: OTHER

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

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).

Group Type: EXPERIMENTAL

M-mode US biofeedback

Intervention Type: OTHER

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

Interventions

Electromyographic biofeedback

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

Intervention Type: OTHER

M-mode US biofeedback

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Murcia

OTHER

Sponsor Role: lead

Responsible Party

María Elena del Baño-Aledo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MARIA ELENA DEL BAÑO ALEDO, PhD

Role: PRINCIPAL_INVESTIGATOR

Murcia University

Central Contacts

MARIA ELENA DEL BAÑO ALEDO, PhD

Role: CONTACT

mbano@um.es

647193115

Other Identifiers

PerineUM2022

Identifier Type: -

Identifier Source: org_study_id