Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000171415
Ethics application status
Approved
Date submitted
27/01/2016
Date registered
10/02/2016
Date last updated
3/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Postural control in women with urinary incontinence
Scientific title
The degree of urinary bladder filling and posture control in women with urinary incontinence
Secondary ID [1] 288408 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stability in postmenopausal women with urinary incontinence 297420 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297606 297606 0 0
Physiotherapy
Renal and Urogenital 297607 297607 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
1. The main aim of the project is an objective evaluation of posturography recordings in dynamic (gait) and static conditions. The target population in this study will be postmenopausal women suffering from stress urinary incontinence (group A) and continent women (group B). We will assess possible differences in postural stability between the groups and whether bladder filling has any effect on posturography recordings.
The measurements will be performed under standard testing conditions, the same for all subjects. The subjects will be requested not to engage in intense physical activity 24 hours before the measurement. They will also be asked to prepare comfortable clothes that would not restrict movement and remain barefoot. They will first pass urine and will perform trials with the empty bladder; afterwards they will drink 3 glasses of water (750 ml) in less than or equal to 15 minutes. After declaring the need to void, bladder volume will be measured with real-time ultrasonography. Patients will rest comfortably in a supine position. The examiner will place the US probe at two fingers over the pubic symphysis (abdominal midline). Measurements will be taken with Toshiba Famio 8 ultrasound. Volumes will be calculated as the product of 3 internal bladder diameters (height x width x depth x 0.52). Three measurements will be taken and the arithmetic mean calculated. The measuring methodology has been verified in the study of Poston et al. [Poston G. J., Joseph A. E. A., Riddle P. R.: The accuracy of ultrasound in the measure¬ment of changes in bladder volume. Brit. J. Urol., 1983, 55, 361]
When the urine volume will greater than or equal to 250 ml, the woman will again undertake trials on a force platform. The portable AMTI platform (AccuGait) allows the measurement of objective parameters of balance while the synchronous use of two platforms helps gait assessment. Data acquisition and export will be carried out using the AMTI's NetForce software. The results will be then processed with Matlab software (Mathworks, Natic, MA United States) The platform sampling frequency will be set at 100 Hz .
The study participants will be instructed to stand barefoot in a comfortable position with their arms along their sides and to look forward.
Before each session, the subjects will have enough time to practice walking on the force platforms.
One-platform test will consist of:
a/ Two 60-second trials in a quiet standing position were recorded for each of the four testing conditions: eyes open/full bladder, eyes open/empty bladder, eyes closed/full bladder, eyes closed/empty bladder. Slomka et al. have demonstrated high reliability of two trials of rambling and trembling measurements (Slomka K, Juras G, Sobota G, Bacik B. The reliability of a rambling-trembling analysis of centre of pressure measures. Gait Posture 2013;37(2):210-213).

b/ Two lean-forward trials to the limits of stability (LOS) with movement at the ankles only. The protocol of LOS will consist of three phases: 1st phase – 10s of quiet standing, 2nd phase – the maximal forward-lean in a self-paced manner, and 3rd phase – maintenance of the maximal forward-lean.
Two-platform test (Platforms A and B) will comprise 4 trials (12 repetitions):
a/ Three repetitions: quiet standing on platform A for 15 seconds, then changing to Platform B (1 step) followed by quiet standing for another 15 seconds. The distance between platforms: 10cm.
b/ Three repetitions–quiet standing on Platform A for 15 seconds, then changing to Platform B (1 step) followed by quiet standing for another 15 seconds. A 15-cm obstacle over the edge of the platforms; the distance between platforms: 10 cm.
c/ Three repetitions – quiet standing on Platform A for 15 seconds, then changing to Platform B (1 step up) followed by quiet standing for another 15 seconds. Platform B is placed on a 17-cm base directly at the edge of Platform A.
d/ Three repetitions – quiet standing on Platform B for 15 seconds, then changing to Platform A (1 step down) followed by quiet standing for another 15 seconds. Platform B is placed on a 17-cm base directly at the edge of Platform A.
Participants will need to attend the examination once only including participation in an empty bladder and full bladder trials. The duration of the examination will be approximately one hour.
Platform changing will start at a light signal displayed in the following sequence: red, orange, green. The participants will change platforms after the green light comes on.
Intervention code [1] 293722 0
Diagnosis / Prognosis
Intervention code [2] 293849 0
Diagnosis / Prognosis
Comparator / control treatment
Control participants (control group) will be performed the same trials to those that will use in the study group. The control participants will be continent women.
Control group
Active

Outcomes
Primary outcome [1] 297147 0
This is a composite outcome.
Measurement parameters of limits of stability (LOS):
-mean value of Center of Pressure (COP) anteripr -posterior (AP) position with appropriate index denoting the phase of trial (1, 2 or 3); Min – minimal value of COP trajectory in anterior -posterior (AP) plane in each phase; Max – maximal value of COP AP trajectory with an appropriate index according to the phase;
-range (R) – position of COP between the maximal and minimal positions in AP plane in each specific phase 1 (R1), 2 (R2), 3 (R3)
This outcome will assessed using AMTI platform and Matlab software..
Timepoint [1] 297147 0
the day of examination –immediately after the examinations; completed for each patient
Primary outcome [2] 297148 0
This is a composite outcome. Gait initiation / making steps under different conditions (with and without an obstacle, stepping up onto a platform situated at a higher level, stepping down onto a platform situated on a lower level).
The following will be determined:
:-Center of Pressure (COP) displacement, ie., mean COP, path and velocity of COP signal;
-Time of gait initiation (from mean COP +/-3 SD to removing from platform), time of gait termination (from contact time to mean COP +/-3 SD) and time of stepping (time from one stable position to a new stable position).
This outcome will assessed using AMTI platform and Matlab software.
Timepoint [2] 297148 0
the day of examination –immediately after the examinations; completed for each patient
Secondary outcome [1] 320167 0
This is a composite outcome in a quiet standing position:.
- range of Center of Pressure (COP) displacement in the anterio -posterior (AP) and medial-lateral (ML) directions [mm],
-mean velocity of (COP) displacement in the AP and ML directions [mm/s],
-standard deviation of COP trajectory in the AP and ML directions [mm]
-COP path lengthin the AP and ML directions [mm]
-area - ellipse area (95%) [mm2]
This outcome will assessed using AMTI platform and Matlab software.
Timepoint [1] 320167 0
The day of examination –immediately after the examinations; completed for each patient
Secondary outcome [2] 320168 0
This is a composite outcome in a quiet standing position..
The measurements of rambling (RM) trajectory :
-Range, path length, root mean square, standard deviation , velocity,

The measurements of trembling (TR) trajectory
-range, path length, root mean square, standard deviation, and velocity.
All calculations will be made for anterior- posterior (AP) and medial-lateral (ML) directions.
This outcome will assessed using AMTI platform and Matlab software.
Timepoint [2] 320168 0
The day of examination – immediately after the examinations; completed for each patient
Secondary outcome [3] 320169 0
Quality of life as assessed using the King's Health Questionnaire
Timepoint [3] 320169 0
At baseline (before examinations); completed for each patient
Secondary outcome [4] 320619 0
Severity of urinary incontinence as assessed using the ICIQ-Urinary Incontinence Short Form.
Timepoint [4] 320619 0
At baseline (before examinations), completed for each patient

Eligibility
Key inclusion criteria
Experimental group- women with urinary incontinence
1. Stress urinary incontinence diagnosed on urodynamic tests.
2. Consent for participation in the study
3. Good general condition of the participants on the day of examination.

Control group – continent women
1. Consent to participate in the study,
2. Good general condition of the participants on the day of examination.
Minimum age
50 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
.1. Lack of consent,
2. Previous therapy or surgery for UI,
3. Diabetes mellitus
4. Hypertension> grade 1 according to ESH/ESC,
5. Neurological abnormalities,
6. Urinary tract infection,
7. Body Mass Index over 33 kg/m2
8. History of myocardial infarction within 6 months prior to the study
9. History of cerebral stroke (ischaemic, haemorrhagic)
10. Autoimmunedisease
11. Advanced neoplasticdisease
12. Acuteinflammatoryconditions and infections
13. Elevated temperature
14. Positive Romberg’s and Unterberger’s tests
15. Past or present injuries within the pelvis, hip joint or spine,

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
The stabilographic parameters is analyzed statistically using the ANOVAs with repeated measures, depending on meeting the specific criteria. The repeated factors are the eyes open/eyes closed condition (2 repetitions) and the full/empty bladder condition (two repetitions). The grouping factor is the presence or absence of urinary incontinence (2 groups). The post-hoc comparisons are performed using the Bonferroni test.
Sample size
We assumed the probability of a type I error alfa rate of 0.05, target power 1-beta 0.80 and a 25% minimum significant difference between the means of the parameters studied. The resultant minimum sample size was 20 patients in group. Forty study participants were assigned to 2 groups (Group A – 20; Group B – 20). Two additional participants were recruited to account for dropouts.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/02/2016
Actual
24/02/2016
Date of last participant enrolment
Anticipated
Actual
30/06/2016
Date of last data collection
Anticipated
Actual
30/06/2016
Sample size
Target
45
Accrual to date
Final
42
Recruitment outside Australia
Country [1] 7550 0
Poland
State/province [1] 7550 0
Silesia

Funding & Sponsors
Funding source category [1] 292758 0
University
Name [1] 292758 0
The Jerzy Kukuczka Academy of Physical Education,
Country [1] 292758 0
Poland
Primary sponsor type
University
Name
The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland
Address
Mikolowska 72, 40-065 Katowice
Country
Poland
Secondary sponsor category [1] 291488 0
None
Name [1] 291488 0
none
Address [1] 291488 0
none
Country [1] 291488 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294257 0
The Research Ethics Committee from The Jerzy Kukuczka Academy of Physical Education in Katowice
Ethics committee address [1] 294257 0
Mikolowska 72, 40-065 Katowice
Ethics committee country [1] 294257 0
Poland
Date submitted for ethics approval [1] 294257 0
23/11/2012
Approval date [1] 294257 0
13/12/2012
Ethics approval number [1] 294257 0
4/2012

Summary
Brief summary
Stress urinary incontinence frequently occurs during physical activity including walking up or down the stairs. On history taking women often declare that, in order to prevent urine leakage, they walk more slowly or avoid the activities that cause unintentional urine loss. Stress incontinence aggravates with age which is associated with a decrease in balance control.
The main aim of the project is an to objectively determine whether bladder filling assessed on ultrasound and the related urinary urgency will result in more considerable center of pressure displacement during dynamic and static balance tasks. Also, whether differences will be observed between continent and incontinent study participants.
The target population in this study will be postmenopausal women suffering from stress urinary incontinence (SUI). The control group will include continent women of the same age.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63030 0
Dr Daria Chmielewska
Address 63030 0
Department of Physical Therapy, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72, 40-065 Katowice, Poland
Country 63030 0
Poland
Phone 63030 0
+48 691 951 906
Fax 63030 0
Email 63030 0
[email protected]
Contact person for public queries
Name 63031 0
Dr Daria Chmielewska
Address 63031 0
Department of Physical Therapy, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72, 40-065 Katowice, Poland
Country 63031 0
Poland
Phone 63031 0
+48 691 951 906
Fax 63031 0
Email 63031 0
[email protected]
Contact person for scientific queries
Name 63032 0
Dr Daria Chmielewska
Address 63032 0
Department of Physical Therapy, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72, 40-065 Katowice, Poland
Country 63032 0
Poland
Phone 63032 0
+48 691 951 906
Fax 63032 0
Email 63032 0
[email protected]

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