Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001144707
Ethics application status
Approved
Date submitted
9/10/2013
Date registered
14/10/2013
Date last updated
28/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of pelvic orientation and synergistic muscle tone on bioelectrical activity of pelvic floor muscles in menopausal and postmenopausal women with or without urinary incontinence
Scientific title
Influence of pelvic orientation and synergistic muscle tone on bioelectrical activity of pelvic floor muscles in menopausal and postmenopausal women with or without urinary incontinence
Secondary ID [1] 283384 0
None
Universal Trial Number (UTN)
U1111-1148-8157
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
urinary incontinence in menopause and postmenopausal women 290282 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290670 290670 0 0
Physiotherapy
Renal and Urogenital 290671 290671 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The superior scientific aim of the project is an objective evaluation of the influence of pelvic orientation and the tone of muscles indirectly acting on the pelvic floor (synergists PFM – SPFM) on electromyographic activity of the pelvic floor muscles (PFM). The target population in this study will be menopausal and postmenopausal women suffering from stress urinary incontinence (group A) and urinary continent women (group B). The first target action will be the evaluation of pelvic dimensions and orientation in sagittal and frontal planes in the examined population. Next, according to the assumptions of the main research hypothesis, it will be assessed whether various pelvic configurations influence the changes of the resting and functional PFM activity. Moreover, the project will include the analysis of SPFM tone influence on the pelvic orientation and bioelectrical PFM activity.
Participants will need to attend the examination once only. The duration of the examination will be approximately one hour.

The measurements:
1. Examination of pelvic orientation,
2. Electromyographic examination of:
- pelvic floor muscles by means of intravaginal electrode
- muscles indirectly acting on the pelvic floor
3. The position of patient during examination:
Standing position:
- Pelvic orientation in the maximum anterior tilt,
- Pelvic orientation in the maximum posterior tilt,
- Pelvic movements forward and backward.
Supine position:
- Supine of lower limbs - 90 degrees flexion in hip and knee joints; lower limbs placed freely on adequately profiled moulder - decreased anterior pelvic tilt;
- Position of lower limbs with a slight flexion of hip and knee joints – intermediate pelvic position;
- Position of lower limbs without a flexion in hip and knee joints; Lower limbs resting freely on the medical exam table – increased anterior pelvic tilt.
Intervention code [1] 288108 0
Diagnosis / Prognosis
Intervention code [2] 288110 0
Rehabilitation
Comparator / control treatment
Patients without urinary incontinence
Control group
Active

Outcomes
Primary outcome [1] 290692 0
The electromyographic examination of pelvic floor muscles by means of intravaginal electrode.
The examination of pelvic orientation by means of the digital inclinometer.
Timepoint [1] 290692 0
the date of examination - immediately after all examinations are completed for each patient
Secondary outcome [1] 305044 0
The synergistic muscle (maximus, medial femoral, rectus abdominis, and oblique abdominal muscles) of pelvic floor muscle are assessed using surface electromyography
Timepoint [1] 305044 0
the date of examination - immediately after all examinations are completed for each patient
Secondary outcome [2] 305045 0
Quality of life, menopausal symptoms and the degree of urinary incontinence as assessed using the ICIQ-Urinary Incontinence Short Form, the Menopause Rating Scale, the WHO Quality of Life-BREF, The King's Health Questionnaire.
Timepoint [2] 305045 0
the date of examination - immediately after all examinations are completed for each patient

Eligibility
Key inclusion criteria
1. Subject's consent to participate in the study,
2. Attending physician's consent,
3. Good general well-being of the participants in the day of examination.
Minimum age
55 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous therapy or surgery related to UI,
2. Lack of subject's consent,
3. Lack of attending physician's consent,
4. Malaise on the examination day,
5. Worsening of ailments during examination,
6. Contraindications to measurements (infection, menstruation),
7. Past or present injuries within the pelvis, hip joint or spine,
8. Type or urinary incontinence other than stress urinary incontinence,
9. UI before menopause.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Analysis and evaluation of the results will be based on the comparison of intra- and intergroup results. Statistical analysis of these results will be performed by means of the Statistica 10 software, manufactured by StatSoft (licence of Medical University in Wroclaw). All analysed intergroup variables will be checked with respect to their similarity (uniformity; chi2 NW). A critical significance level a (alpha) = 0.05 or less will be considered statistically significant. For measurable variables (quantitative), arithmetic mean, standard deviations, medians and range of variability (extreme values) will be calculated. For qualitative variables, the frequency of occurrence (percentage) will be calculated. Comparison of intergroup results in order to determine the significance of the achieved differences, will be performed by means of parametric (Student's t-test, Welch's t test) or non-parametric (Mann-Whitney`s test) tests, depending on meeting criteria for the specific test. Correlation of variables in the examined groups will also be checked.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/05/2013
Actual
9/05/2013
Date of last participant enrolment
Anticipated
Actual
31/12/2014
Date of last data collection
Anticipated
Actual
31/12/2014
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 5494 0
Poland
State/province [1] 5494 0
Wroclaw

Funding & Sponsors
Funding source category [1] 288108 0
Government body
Name [1] 288108 0
National Science Centre in Poland
Country [1] 288108 0
Poland
Primary sponsor type
University
Name
Wroclaw Medical University
Address
Wybrzeze L. Pasteura 1,
50-367 Wroclaw
Poland
Country
Poland
Secondary sponsor category [1] 286828 0
None
Name [1] 286828 0
Address [1] 286828 0
Country [1] 286828 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290030 0
Bioethics Committee of the Wroclaw Medical University
Ethics committee address [1] 290030 0
Ethics committee country [1] 290030 0
Poland
Date submitted for ethics approval [1] 290030 0
Approval date [1] 290030 0
05/07/2012
Ethics approval number [1] 290030 0
KB-611/2012

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43586 0
Mr Kuba Ptaszkowski
Address 43586 0
Department of Gynaecology and Obstetrics,
Medical University in Wroclaw,
ul. K. Bartla 5,
51-618 Wroclaw
Poland
Country 43586 0
Poland
Phone 43586 0
+48 606 81 61 61
Fax 43586 0
Email 43586 0
[email protected]
Contact person for public queries
Name 43587 0
Kuba Ptaszkowski
Address 43587 0
Department of Gynaecology and Obstetrics, Medical University in Wroclaw,
ul. K. Bartla 5,
51-618 Wroclaw
Poland
Country 43587 0
Poland
Phone 43587 0
+48 606 81 61 61
Fax 43587 0
Email 43587 0
[email protected]
Contact person for scientific queries
Name 43588 0
Kuba Ptaszkowski
Address 43588 0
Department of Gynaecology and Obstetrics, Medical University in Wroclaw,
ul. K. Bartla 5,
51-618 Wroclaw
Poland
Country 43588 0
Poland
Phone 43588 0
+48 71 784 18 56
Fax 43588 0
Email 43588 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIAssessment of bioelectrical activity of synergistic muscles during pelvic floor muscles activation in postmenopausal women with and without stress urinary incontinence: a preliminary observational study2015https://doi.org/10.2147/cia.s89852
Dimensions AIThe Prognostic Value of the Surface Electromyographic Assessment of Pelvic Floor Muscles in Women with Stress Urinary Incontinence2020https://doi.org/10.3390/jcm9061967
N.B. These documents automatically identified may not have been verified by the study sponsor.