Pelvic Floor Muscle Contraction in Response to Different Verbal Instructions in Women With Urinary Incontinence

Pelvic Floor Muscle Contraction in Response to Different Verbal Instructions in Women With Urinary Incontinence - A Self-controlled Clinical Trial

The aim of this study is to investigate which verbal instruction will lead to the most efficient contraction of pelvic floor muscles (PFM) in patients with urinary incontinence.

and to examine whether correct PFM contraction can be taught by transabdominal ultrasound, which is used as biofeedback.

Pelvic floor muscle contraction will be evaluated via transabdominal ultrasound.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Other: Verbal instruction

Detailed Description

A self-controlled clinical trial is planned for patients who receive physiotherapy for pelvic floor rehabilitation at one of the Meuhedet Institutes' physiotherapy clinics.

Each participant will be asked to contract the pelvic floor muscles using three different verbal instructions: (1) "contract your pelvic floor - all sphincters"; (2) "contract your anus"; (3) "contract your pelvic floor as if you're trying to stop urinating". Those who will not be able to contract will be taught by the ultrasound as biofeedback.

The assessment of pelvic floor contraction will be measured by measuring bladder displacement via abdominal ultrasound. A curved linear array transducer will be placed in the transverse plane immediately suprapubically over the lower abdomen angled at 15-30 degrees from the vertical. An on-screen caliper and measurement tool will be used to measure bladder displacement.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ariel, Israel, 40700
    • Noa Ben Ami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Diagnosis of urinary incontinence
• Understand the language and simple instruction
• Willing to participate in the study

Exclusion Criteria:

• Has been treated before for pelvic floor rehabilitation by a physiotherapist
• Received medication or surgery for the problem

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Verbal instruction; The participants will be instructed to contract the pelvic floor muscle with the following verbal instruction: (1) "contract your pelvic floor - all sphincters"; (2) "contract your anus"; (3) "contract your pelvic floor as if you're trying to stop urinating".Those who will not be able to contract will be taught by the ultrasound as biofeedback.	Other: Verbal instruction; Verbal instruction for pelvic floor contraction will be given to participants. A transabdominal Ultrasound examination will be conducted to asses urinary bladder displacement being a marker for pelvic floor muscle function.; Other Names: Trans abdominal Ultrasound examination for pelvic floor contraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urinary bladder displacement in millimeters during verbal instructions	bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)	Questionnaire regarding symptoms of urinary incontinence,scale range 0-21 points. higher values represent worse outcome	Baseline
Pelvic floor muscles endurance of contraction in seconds	time of muscle contraction will be measured during the last contraction in each instruction	Baseline

Collaborators and Investigators

• Sponsor: Ariel University
• Investigators: Principal Investigator: Noa Ben Ami, PhD, Ariel University

Publications and helpful links

General Publications

• Oliveira M, Ferreira M, Azevedo MJ, Firmino-Machado J, Santos PC. Pelvic floor muscle training protocol for stress urinary incontinence in women: A systematic review. Rev Assoc Med Bras (1992). 2017 Jul;63(7):642-650. doi: 10.1590/1806-9282.63.07.642.
• Ben Ami N, Dar G. What is the most effective verbal instruction for correctly contracting the pelvic floor muscles? Neurourol Urodyn. 2018 Nov;37(8):2904-2910. doi: 10.1002/nau.23810. Epub 2018 Aug 28.
• Bo K, Sherburn M. Evaluation of female pelvic-floor muscle function and strength. Phys Ther. 2005 Mar;85(3):269-82.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2019
• Primary Completion (Actual): January 23, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: May 5, 2019
• First Submitted That Met QC Criteria: May 5, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Urinary incontinence; Pelvic floor muscle contraction; Transabdominal ultrasound; Verbal instructions
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: ArielU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the result of the study will be analyzed. a paper will be submitted to an international journal with study description including methods, examination protocol results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No