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CompletedNCT03940794Updated Jun 24, 2020

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

An interventional study of Verbal instruction in Urinary Incontinence, sponsored by Ariel University. Completed at 1 site in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-24.

Sponsored by Ariel University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Urinary Incontinence

Keywords

  • Urinary incontinence
  • Pelvic floor muscle contraction
  • Transabdominal ultrasound
  • Verbal instructions
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 60 is close to the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Ariel University is the lead sponsor of 29 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Has been treated before for pelvic floor rehabilitation by a physiotherapist
  • Received medication or surgery for the problem
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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

Interventions

  • OtherVerbal 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.

    Also known as: Trans abdominal Ultrasound examination for pelvic floor contraction

06

What researchers measure

Primary outcomes

  1. urinary bladder displacement in millimeters during verbal instructions

    bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool

    Time frame: baseline

Secondary outcomes

  1. 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

    Time frame: Baseline

  2. Pelvic floor muscles endurance of contraction in seconds

    time of muscle contraction will be measured during the last contraction in each instruction

    Time frame: Baseline

07

Study locations

1 site
  • Noa Ben Ami
    Ariel, 40700, Israel
08

References and documents

Publications

  • 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. PubMed 30152550 ↗
  • Bo K, Sherburn M. Evaluation of female pelvic-floor muscle function and strength. Phys Ther. 2005 Mar;85(3):269-82. PubMed 15733051 ↗
  • 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. PubMed 28977091 ↗

Individual participant data

Plan to share: No — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03940794
Lead sponsor
Ariel University
Responsible party
Sponsor
First posted
May 7, 2019
Start date
Jul 17, 2019
Primary completion
Jan 23, 2020
Completion
Mar 1, 2020
Last update
Jun 24, 2020

Study contacts

Noa Ben Ami, PhD
principal investigator · Ariel University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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