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

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Verbal instruction
Sponsored by
Ariel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary incontinence, Pelvic floor muscle contraction, Transabdominal ultrasound, Verbal instructions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Noa Ben Ami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Verbal instruction

Arm Description

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.

Outcomes

Primary Outcome Measures

urinary bladder displacement in millimeters during verbal instructions
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool

Secondary Outcome Measures

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
Pelvic floor muscles endurance of contraction in seconds
time of muscle contraction will be measured during the last contraction in each instruction

Full Information

First Posted
May 5, 2019
Last Updated
June 23, 2020
Sponsor
Ariel University
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1. Study Identification

Unique Protocol Identification Number
NCT03940794
Brief Title
Pelvic Floor Muscle Contraction in Response to Different Verbal Instructions in Women With Urinary Incontinence
Official Title
Pelvic Floor Muscle Contraction in Response to Different Verbal Instructions in Women With Urinary Incontinence - A Self-controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 17, 2019 (Actual)
Primary Completion Date
January 23, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ariel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Urinary incontinence, Pelvic floor muscle contraction, Transabdominal ultrasound, Verbal instructions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment all participants will receive the same verbal instruction
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verbal instruction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Verbal instruction
Other Intervention Name(s)
Trans abdominal Ultrasound examination for pelvic floor contraction
Intervention Description
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.
Primary Outcome Measure Information:
Title
urinary bladder displacement in millimeters during verbal instructions
Description
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
Time Frame
baseline
Secondary Outcome Measure Information:
Title
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Description
Questionnaire regarding symptoms of urinary incontinence,scale range 0-21 points. higher values represent worse outcome
Time Frame
Baseline
Title
Pelvic floor muscles endurance of contraction in seconds
Description
time of muscle contraction will be measured during the last contraction in each instruction
Time Frame
Baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noa Ben Ami, PhD
Organizational Affiliation
Ariel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Noa Ben Ami
City
Ariel
ZIP/Postal Code
40700
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
30152550
Citation
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.
Results Reference
result
PubMed Identifier
15733051
Citation
Bo K, Sherburn M. Evaluation of female pelvic-floor muscle function and strength. Phys Ther. 2005 Mar;85(3):269-82.
Results Reference
result
PubMed Identifier
28977091
Citation
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.
Results Reference
result

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

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