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

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Other: Verbal instruction

• Registration Number: NCT03940794
• Lead Sponsor: Ariel University

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.

Study Timeline

• Study First Submitted: 2019-05-05
• Study First Submitted QC: 2019-05-05
• Study First Posted: 2019-05-07
• Study Start: 2019-07-17
• Primary Completion: 2020-01-23
• Study Completion: 2020-03-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-23
• Last Update Posted: 2020-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Verbal instruction	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)	Baseline	Questionnaire regarding symptoms of urinary incontinence,scale range 0-21 points.; higher values represent worse outcome
Pelvic floor muscles endurance of contraction in seconds	Baseline	time of muscle contraction will be measured during the last contraction in each instruction

Trial Locations

Locations (1)

Noa Ben Ami; 🇮🇱 Ariel, Israel