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OpenTrials
Completed

NCT Number: NCT03940794

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

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Noa Ben Ami

Ariel, 40700, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

verbal instruction

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.

Other names: Trans abdominal Ultrasound examination for pelvic floor contraction

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ariel University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 7, 2019
Registry last updated
Jun 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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