Clinical trial NCT03400540: What is the Best Verbal Instruction for Contraction the Pelvic Floor Muscles?
Official title: What is the Best Verbal Instruction for Contraction the Pelvic Floor Muscles?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Muscle Weakness
Keywords: verbal instruction, pelvic diaphragm, muscle contraction
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Ariel University
First posted: 2018-01-17
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups randomly divided. Both groups will be given three different verbal instructions to contract pelvic floor muscles.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to T to compare the effectiveness of producing a pelvic floor muscle contraction by different verbal instruction. Pelvic floor muscle contraction will be measured displacement of the pelvic floor when imaged on ultrasound.

Detailed description: This study will examine pelvic floor muscle contraction following different verbal instructions. This is a cross-sectional exploratory study. Physical-therapy students will be recruited to complete a survey and non-invasive transabdominal ultrasound assessment.

A bladder filling protocol will be implemented to ensure subjects will have sufficient fluid in their bladders to allow clear ultrasound imaging. This protocol involved subjects consuming 600-750 ml of water in a 1 hr. period. The participants will be tested in a crook-lying supine position with a pillow under their heads for comfort.

The participants will be divided into 2 groups randomly. Both groups will be given three different verbal instructions to contract pelvic floor muscles. Each contraction will be performed 3 time with rests of 10 sec between contractions. While the first 2 contractions for each verbal instruction will be held for 3 sec. the last contraction will be held as long as the participant can conduct and the time of contraction will be measured as well. The pelvic floor contraction will be measured by assessing bladder displacement via diagnostic ultrasound.

To image the pelvic floor a 5 MHz curved linear array transducer (Mindray M5) 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:

* willing to participate in the study

Exclusion Criteria:

* pregnancy
* previous abdominal surgeries

Primary outcomes:
measure: urinary bladder displacement in millimeters during first verbal instruction
timeFrame: up to 6 months
measure: urinary bladder displacement in millimeters during second verbal instruction
timeFrame: up to 6 months
measure: urinary bladder displacement in millimeters during third verbal instruction
timeFrame: up to 6 months
Secondary outcomes:
measure: pelvic floor muscles endurance of contraction in seconds
timeFrame: up to 6 months
measure: demographic self reported questionnaire regarding height
timeFrame: baseline
measure: demographic self reported questionnaire regarding weight
timeFrame: baseline
measure: self reported questionnaire regarding physical activity
timeFrame: baseline
measure: questionnaire regarding symptoms of urinary incontinence = International Consultation on Incontinence Questionnaire - Short Form
timeFrame: baseline
measure: BMI
timeFrame: baseline
Other outcomes:
Locations:
city: Ariel
country: Israel
facility: Ariel University, Department of Physical Therapy
Study officials:
affiliation: University of Haifa
name: Gali Dar, PHd
role: STUDY_DIRECTOR
affiliation: Ariel University
name: Noa Ben-Ami, PhD
role: STUDY_DIRECTOR
References:
citation: Bo K, Sherburn M, Allen T. Transabdominal ultrasound measurement of pelvic floor muscle activity when activated directly or via a transversus abdominis muscle contraction. Neurourol Urodyn. 2003;22(6):582-8. doi: 10.1002/nau.10139.
citation: Barton A, Serrao C, Thompson J, Briffa K. Transabdominal ultrasound to assess pelvic floor muscle performance during abdominal curl in exercising women. Int Urogynecol J. 2015 Dec;26(12):1789-95. doi: 10.1007/s00192-015-2791-9. Epub 2015 Jul 28.