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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03940794

Recruitment Status Completed

First Posted May 7, 2019

Last update posted June 24, 2020

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.

  • Condition or Disease:Urinary Incontinence
  • Intervention/Treatment: Other: Verbal instruction
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Actual Enrollment: 60 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: Single Group Assignment all participants will receive the same verbal instruction
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Pelvic Floor Muscle Contraction in Response to Different Verbal Instructions in Women With Urinary Incontinence - A Self-controlled Clinical Trial
  • Actual Study Start Date: July 2019
  • Actual Primary Completion Date: January 2020
  • Actual Study Completion Date: March 2020
Arms and interventions
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.
Outcome Measures
  • Primary Outcome Measures: 1. urinary bladder displacement in millimeters during verbal instructions [ Time Frame: baseline ]
    bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
  • Secondary Outcome Measures: 1. International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) [ Time Frame: Baseline ]
    Questionnaire regarding symptoms of urinary incontinence,scale range 0-21 points. higher values represent worse outcome
  • 2. Pelvic floor muscles endurance of contraction in seconds [ Time Frame: Baseline ]
    time of muscle contraction will be measured during the last contraction in each instruction
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts
Locations

Israel
Noa Ben Ami
Ariel

Sponsors and Collaborators

Ariel University

Investigators

Principal Investigator: Noa Ben Ami, PhD Ariel University

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