NCT03940794

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 17, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

6 months

First QC Date

May 5, 2019

Last Update Submit

June 23, 2020

Conditions

Urinary Incontinence

Keywords

Urinary incontinencePelvic floor muscle contractionTransabdominal ultrasoundVerbal instructions

Outcome Measures

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

    baseline

Secondary Outcomes (2)

  • International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)

    Baseline

  • Pelvic floor muscles endurance of contraction in seconds

    Baseline

Study Arms (1)

Verbal instruction

EXPERIMENTAL

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

Verbal instructionOTHER

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
Verbal instruction

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Noa Ben Ami

Ariel, 40700, Israel

Location

Related 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.

    PMID: 30152550RESULT

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

    PMID: 15733051RESULT

  • 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.

    PMID: 28977091RESULT

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Noa Ben Ami, PhD

    Ariel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment all participants will receive the same verbal instruction
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2019

First Posted

May 7, 2019

Study Start

July 17, 2019

Primary Completion

January 23, 2020

Study Completion

March 1, 2020

Last Updated

June 24, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

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.

Locations

IL(1)