Clinical trial NCT03940794: Pelvic Floor Muscle Contraction in Response to Different Verbal Instructions in Women With Urinary Incontinence
Official title: Pelvic Floor Muscle Contraction in Response to Different Verbal Instructions in Women With Urinary Incontinence - A Self-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Urinary incontinence
Pelvic floor muscle contraction
Transabdominal ultrasound
Verbal instructions
Lead sponsor: Ariel University
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment all participants will receive the same verbal instruction
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: urinary bladder displacement in millimeters during verbal instructions
timeFrame: baseline
Secondary outcomes:
measure: International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
timeFrame: Baseline
measure: Pelvic floor muscles endurance of contraction in seconds
timeFrame: Baseline
Other outcomes:
Locations:
city: Ariel
country: Israel
facility: Noa Ben Ami
Study officials:
affiliation: Ariel University
name: Noa Ben Ami, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bo K, Sherburn M. Evaluation of female pelvic-floor muscle function and strength. Phys Ther. 2005 Mar;85(3):269-82.
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.