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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940794
• Other study ID #: ArielU
• Status: Completed
• Phase: N/A
• Start date: July 17, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: June 2020
• Source: Ariel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2020
• Est. primary completion date: January 23, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

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.

Locations

Country	Name	City	State
Israel	Noa Ben Ami	Ariel

Sponsors (1)

Lead Sponsor	Collaborator
Ariel University

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View Citation

Bø K, Sherburn M. Evaluation of female pelvic-floor muscle function and strength. Phys Ther. 2005 Mar;85(3):269-82. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary bladder displacement in millimeters during verbal instructions	bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool	baseline
Secondary	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	Baseline
Secondary	Pelvic floor muscles endurance of contraction in seconds	time of muscle contraction will be measured during the last contraction in each instruction	Baseline