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

NCT05399901 | Unknown

• 1 other identifier: PerineUM2022
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (1)

• 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)

Study Arms (2)

EMG BFB

EXPERIMENTAL

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

M-mode US

EXPERIMENTAL

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

Interventions

Electromyographic biofeedback OTHER

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

EMG BFB

M-mode US biofeedback OTHER

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

M-mode US

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Murcia: lead

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• MARIA ELENA DEL BAÑO ALEDO, PhD

  Murcia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MARIA ELENA DEL BAÑO ALEDO, PhD

CONTACT

647193115; mbano@um.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 1, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2024
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share