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

NCT ID: NCT03940794

Last Updated: 2020-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-17

Study Completion Date

2020-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment all participants will receive the same verbal instruction
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Verbal instruction

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Trans abdominal Ultrasound examination for pelvic floor contraction

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ariel University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Noa Ben Ami, PhD

Role: PRINCIPAL_INVESTIGATOR

Ariel University

Locations

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Noa Ben Ami

Ariel, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type RESULT
PMID: 30152550 (View on PubMed)

Bo K, Sherburn M. Evaluation of female pelvic-floor muscle function and strength. Phys Ther. 2005 Mar;85(3):269-82.

Reference Type RESULT
PMID: 15733051 (View on PubMed)

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.

Reference Type RESULT
PMID: 28977091 (View on PubMed)

Other Identifiers

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ArielU

Identifier Type: -

Identifier Source: org_study_id

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