ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Renal and Urogenital

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]

Diagnosis / Prognosis

Intervention code [2]

Rehabilitation

Comparator / control treatment

Patients without urinary incontinence

Control group

Active

Outcomes

Primary outcome [1]

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]

the date of examination - immediately after all examinations are completed for each patient

Secondary outcome [1]

The synergistic muscle (maximus, medial femoral, rectus abdominis, and oblique abdominal muscles) of pelvic floor muscle are assessed using surface electromyography

Timepoint [1]

the date of examination - immediately after all examinations are completed for each patient

Secondary outcome [2]

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]

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?

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]

Poland

State/province [1]

Wroclaw

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Science Centre in Poland

Address [1]

ul. Krolewska 57,
30-081 Krakow, Poland

Country [1]

Poland

Primary sponsor type

University

Name

Wroclaw Medical University

Address

Wybrzeze L. Pasteura 1,
50-367 Wroclaw
Poland

Country

Poland

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bioethics Committee of the Wroclaw Medical University

Ethics committee address [1]

ul. Pasteura 1,
50-367 Wroclaw
Poland

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

Approval date [1]

05/07/2012

Ethics approval number [1]

KB-611/2012

Summary

Brief summary

The main 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) 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 (SUI) and urinary continent women.

Trial website

Trial related presentations / publications

1.	Ptaszkowski, K., Paprocka-Borowicz, M., Slupska, L., Bartnicki, J., Dymarek, R., Rosinczuk, J., … Zdrojowy, R. (2015). Assessment of bioelectrical activity of synergistic muscles during pelvic floor muscles activation in postmenopausal women with and without stress urinary incontinence: a preliminary observational study. Clinical Interventions in Aging, 10, 1521–1528. http://doi.org/10.2147/CIA.S89852
Journal from the JCR list
5-Year Impact Factor: 2.179
Times Cited: 0 (from Web of Science Core Collection) 
2.	Halski, T., Slupska, L., Dymarek, R., Bartnicki, J., Halska, U., Król, A., … Ptaszkowski, K. (2014). Evaluation of bioelectrical activity of pelvic floor muscles and synergistic muscles depending on orientation of pelvis in menopausal women with symptoms of stress urinary incontinence: a preliminary observational study. BioMed Research International, 2014, 274938. http://doi.org/10.1155/2014/274938
Journal from the JCR list
5-Year Impact Factor: 1.593
Times Cited: 2 (from Web of Science Core Collection) 
3.	K[uba] Ptaszkowski, L[ucyna] Slupska, R[obert] Dymarek, T. Halski, J. Taradaj, J[anusz] Bartnicki, M[algorzata] Paprocka-Borowicz, J[anusz] Dembowski, R[omuald] Zdrojowy.: The bioelectrical activity of pelvic floor muscles depending on orientation of pelvis in menopausal women with symptoms of urinary incontinence: a preliminary study. In: Contemporary rehabilitation directions; Malgorzaty Paprockiej-Borowicz, Slawomira Jarzaba, Jadwigi Kuciel-Lewandowskiej; Wroclaw Medical University, 2014; s.48-54
ISBN 978-83-7055-431-6
MNiSW/KBN points: 4.000
5-Year Impact Factor: -
4.	K[uba] Ptaszkowski, L[ucyna] Slupska, J[anusz] Bartnicki, T. Halski, R[obert] Dymarek, M[algorzata] Paprocka-Borowicz, J. Taradaj, J[anusz] Dembowski, R[omuald] Zdrojowy.: Changes of bioelectrical activity of pelvic floor muscles during pelvis movement in menopausal women with symptoms of stress urinary incontinence: a preliminary observational study.
J.Rehabil.Med. 2015 suppl.54; s.270
5-Year Impact Factor: -
5.	K[uba] Ptaszkowski, L[ucyna] Slupska, T. Halski, R[obert] Dymarek, M[algorzata] Paprocka-Borowicz, J. Taradaj, J[anusz] Dembowski, R[omuald] Zdrojowy: Comparison of bioelectrical activity of pelvic floor muscles between women in menopausal period with stress urinary incontinence and without: a preliminary observational study. J.Rehabil.Med. 2015 suppl.54; s.270-271
5-Year Impact Factor: -
6.	Kuba Ptaszkowski; promoter: dr hab. n. med. Janusz Bartnicki; Wroclaw Medical University. Department of Gynecology and Obstetrics. Faculty of Health Sciences: The dependence of bioelectrical activity of the pelvic floor muscles of the setting of the pelvis in women during menopause [PhD thesis]; Wroclaw, 2015; 106 k.
5-Year Impact Factor: -
7.	Kuba Ptaszkowski, Lucyna Slupska, Tomasz Halski, Robert Dymarek, Janusz Dembowski, Romuald Zdrojowy, Joanna Rosinczuk, Malgorzata Paprocka-Borowicz.: Comparison of electromyographic activity of pelvic floor muscles depending on the orientation of pelvis in menopausal women during menopause with symptoms of stress urinary incontinence: a prospective observational study. Ortop.Traumatol.Rehabil. 2016 Vol.18 supl.1; s.56 poz.4
5-Year Impact Factor: -

Public notes

Contacts

Principal investigator

Name

Mr Kuba Ptaszkowski

Address

Department of Gynaecology and Obstetrics,
Medical University in Wroclaw,
ul. K. Bartla 5,
51-618 Wroclaw
Poland

Country

Poland

Phone

+48 606 81 61 61

Fax

kptaszkowski@gmail.com

Contact person for public queries

Name

Kuba Ptaszkowski

Address

Department of Gynaecology and Obstetrics, Medical University in Wroclaw,
ul. K. Bartla 5,
51-618 Wroclaw
Poland

Country

Poland

Phone

+48 606 81 61 61

Fax

kptaszkowski@gmail.com

Contact person for scientific queries

Name

Kuba Ptaszkowski

Address

Department of Gynaecology and Obstetrics, Medical University in Wroclaw,
ul. K. Bartla 5,
51-618 Wroclaw
Poland

Country

Poland

Phone

+48 71 784 18 56

Fax

kptaszkowski@gmail.com

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

Source	Title	Year of Publication	DOI
Dimensions AI	Assessment of bioelectrical activity of synergistic muscles during pelvic floor muscles activation in postmenopausal women with and without stress urinary incontinence: a preliminary observational study	2015	https://doi.org/10.2147/cia.s89852
Dimensions AI	The Prognostic Value of the Surface Electromyographic Assessment of Pelvic Floor Muscles in Women with Stress Urinary Incontinence	2020	https://doi.org/10.3390/jcm9061967

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically