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Trial registered on ANZCTR


Registration number
ACTRN12622000563763
Ethics application status
Approved
Date submitted
23/11/2021
Date registered
12/04/2022
Date last updated
9/05/2024
Date data sharing statement initially provided
12/04/2022
Date results information initially provided
9/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title

The impact of electromyographic (EMG)-biofeedback assisted training on the function of the pelvic floor muscles in women after vaginal and cesarean delivery
Scientific title
The impact of training according to the Bebo® concept and EMG-biofeedback-assisted training on the function of the pelvic floor muscles in women after vaginal and cesarean delivery.
Secondary ID [1] 305785 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Caesarean section 324292 0
Urinary incontinence 324293 0
Pelvic floor dysfunction 324294 0
Condition category
Condition code
Reproductive Health and Childbirth 321783 321783 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Before starting the research, all participants will be assessed: strength and endurance of the pelvic floor muscles with the help of palpation, EMG and perineometer, bladder diary, UDI-6 and IIQ-7 questionnaire, SES Self-assessment scale, changes in KHQ quality of life indicators and Questionnaire of the Quality of Women's Sexual Life.

Randomized controlled trials will be carried out on a group of not less than 100 patients aged 25-35 years, after the first vaginal delivery or after the first caesarean section, which will be randomly divided into groups:

Arm 1: Vaginal delivery Bebo® group

A group of women after vaginal delivery underwent a 6-week, each session according to the Bebo® concept runs for one hour . The training is conducted individually, by a qualified therapist, twice a week. We will monitor attendance using the attendance list.

The Bebo® concept - is based on five exercise groups, which are: awareness exercises, mobilization exercises, strengthening exercises, relaxation exercises, and the integration of pelvic floor muscles in everyday activities. Each group of exercises will last approximately 10 minutes.

Arm 2: Vaginal delivery Bebo®+ EMG group

A group of women after vaginal delivery underwent a 6-week, each session according to the Bebo® concept runs for one hour , supported by a 10-minute EMG-biofeedback training. The training is conducted individually, by a qualified therapist, twice a week.

The group, apart from exercises according to the Bebo® concept, will perform a 10-minute EMG-biofeedback training. Its aim will be to obtain conscious tension of the pelvic floor muscles with a strength corresponding to 20, 50, 80% of the previously measured maximum contraction and to maintain the tension at the previously indicated level for a preset time: e.g. 3, 5, 10 seconds, as well as muscle relaxation. The contraction time will be determined for each patient individually by the therapist. The biofeedback device will be inserted into the vagina so that participants may modify the tension of the pelvic floor muscles based on feedback from the device.

Arm 3: Cesarean delivery Bebo® group

A group of women after cesarean delivery underwent a 6-week, each session according to the Bebo® concept runs for one hour. The training is conducted individually, by a qualified therapist, twice a week.
Arm 4: Cesarean delivery Bebo® + EMG group

A group of women after cesarean delivery underwent a 6-week, each session according to the Bebo® concept runs for one hour , supported by a 10-minute EMG-biofeedback training. The training is conducted individually, by a qualified therapist, twice a week.



Intervention code [1] 322188 0
Treatment: Devices
Comparator / control treatment
The active, control group (n = 50), composed of women after the first vaginal delivery or the first caesarean delivery, will be examined twice, 6 weeks apart. Bebo® training and EMG-biofeedback training will not be delivered to participants in the comparator/control group.
Control group
Active

Outcomes
Primary outcome [1] 329553 0
EMG-test. The EMG is used to assess the function of the pelvic floor muscles. The test will be carried out using surface and vaginal electrodes. The first electrode will be placed on the lower abdomen and the second will be mounted on the vaginal probe. The test will be performed according to a protocol consisting of 5 activities:
1.60-second rest (before starting the test - divided into 3 intervals: I-5s, II-5s, III-50s).
2. Five 2-second phase contractions (fast movements), with a 10-second interval in between.
3. Five 10-second tonic contractions, with a 10-second rest in between.
4. One 60-second strength contraction.
5.60-second rest (after exercise).
Timepoint [1] 329553 0
The procedure will be performed at the start of the tests and after 6 weeks.
Primary outcome [2] 329554 0
A perineometer is a device used to measure the resting tension [cmH2O], the maximum voluntary force of contraction [cmH2O] and the strength of the pelvic floor muscles [s]. The examined person places the probe into the vagina to a depth of 3.5 cm. The subject is asked to perform 3 contractions and hold them for 5 seconds, the pause between each contraction was 30 seconds.
Timepoint [2] 329554 0
The procedure will be performed at the start of the tests and after 6 weeks.
Primary outcome [3] 329555 0
Muscle strength assessed by palpation. The examination consists in inserting the index finger into the vagina, after disinfecting the hands, wearing disposable gloves and applying the gel, as well as observing the perineum area. The strength of the pelvic floor muscles during vaginal palpation will be assessed according to the PERFECT scheme.
Timepoint [3] 329555 0
The procedure will be performed at the start of the tests and after 6 weeks.
Secondary outcome [1] 402944 0
Self-assessment of the respondents on the basis of the SES Self-Evaluation Scale by M. Rosenberg. This tool evaluates your self-esteem.
Timepoint [1] 402944 0
The procedure will be performed at the start of the tests and after 6 weeks.
Secondary outcome [2] 402945 0
Quality of life using the King's Health Questionnaire (KHQ questionnaire)
Timepoint [2] 402945 0
The procedure will be performed at the start of the tests and after 6 weeks.
Secondary outcome [3] 402946 0
The quality of sexual life based on the Sexual Quality of Life Questionnaire Female- (SQoL-F)
Timepoint [3] 402946 0
The procedure will be performed at the start of the tests and after 6 weeks.
Secondary outcome [4] 402947 0
Symptoms of urinary incontinence using the Urinary Distress Inventory, Short Form (UDI-6)
Timepoint [4] 402947 0
The procedure will be performed at the start of the tests and after 6 weeks.
Secondary outcome [5] 402948 0
Assessment of the impact of urinary incontinence on daily activity using the Incontinence Impact Questionnaire, Short Form (IIQ-7)
Timepoint [5] 402948 0
The procedure will be performed at the start of the tests and after 6 weeks.
Secondary outcome [6] 402949 0
Assessment of toilet habits and fluid intake using the bladder diary. The bladder diary was designed specifically for this study.
Timepoint [6] 402949 0
The procedure will be performed at the start of the tests and after 6 weeks.
Each patient will be asked to complete the diary for 3 days at the start of the study and after 6 weeks.

Eligibility
Key inclusion criteria
primipara
single pregnancy
proper course of pregnancy
6-8 weeks after vaginal delivery or cesarean delivery
correct body weight
consent to participate in free research
a medical certificate confirming that there are no contraindications to participate in the research
Minimum age
25 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
lack of a medical certificate allowing participation in the research
no written consent to participate in the study
multiple pregnancy
more than one birth
postpartum complications in the form of: separation of the pubic symphysis and sacroiliac joints, thrombophlebitis, 3rd and 4th degree perineal tears
operations on the abdominal cavity and in the area of the reproductive system
orthopedic diseases (spine surgery, broken in the pelvis and spine)
3rd or 4th degree pelvic organ prolapse, lower urinary tract or vaginal infections, endometriosis
other health problems (thyroid diseases, diabetes, overweight, obesity, cancer, rheumatic diseases, respiratory diseases, neurological diseases, cognitive disorders that prevent cooperation, mental diseases, depression, neurological diseases)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/11/2021
Date of last participant enrolment
Anticipated
1/11/2023
Actual
18/09/2023
Date of last data collection
Anticipated
13/12/2023
Actual
18/12/2023
Sample size
Target
150
Accrual to date
Final
150
Recruitment outside Australia
Country [1] 24323 0
Poland
State/province [1] 24323 0
malopolska

Funding & Sponsors
Funding source category [1] 310140 0
University
Name [1] 310140 0
University of Physical Education in Krakow
Country [1] 310140 0
Poland
Primary sponsor type
Individual
Name
Prof. Agnieszka Suder
Address
University of Physical Education in Krakow al. Jana Pawla II 78, 31-571 Kraków, Kraków, Poland
Country
Poland
Secondary sponsor category [1] 311216 0
Individual
Name [1] 311216 0
M.Sc.Paulina Handzlik-Waszkiewicz
Address [1] 311216 0
University of Physical Education in Krakow al. Jana Pawla II 78, 31-571 Kraków, Kraków, Poland
Country [1] 311216 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309830 0
The Ethical Committee of Regional Medical Chamber in Krakow, Poland
Ethics committee address [1] 309830 0
ul. Krupnicza 11a
31-123 Kraków, Poland
Ethics committee country [1] 309830 0
Poland
Date submitted for ethics approval [1] 309830 0
Approval date [1] 309830 0
19/03/2021
Ethics approval number [1] 309830 0

Summary
Brief summary
The aim of the study will be to evaluate and compare the effects achieved during the 6-week training according to the Bebo® concept and training according to the Bebo® concept supported by EMG-biofeedback in women after vaginal delivery and after cesarean section.
The following hypotheses are posed:

1. The training programs used significantly improve the strength and endurance of the perineum
and mm of transverse abdomen.
2. There are differences in the strength and endurance of the perineum and mm of the transverse abdomen
depending on the training program used.
3. The training programs used have a positive effect on urinary incontinence.

100 women aged 25-35 will be included in the study after their first vaginal delivery or after their first caesarean section. Additionally, a group of 50 women will be selected after the first vaginal or cesarean delivery, in the same age group. They will constitute the control group. Qualification for therapy will be carried out during a medical examination, based on strictly defined qualification criteria. Then, two groups will be randomly selected from vaginal delivery patients: the first group will participate in a 6-week pelvic floor muscle training based on the Bebo® concept. The second group will undergo a 6-week pelvic floor muscle training according to the Bebo® concept, supported by a 10-minute EMG biofeedback training. The third and fourth groups will consist of women giving birth by caesarean section. One of the randomly selected group will implement a 6-week training program according to the Bebo® concept, while the other group will have a training according to the Bebo® concept supported by a 10-minute EMG-biofeedback training. Patients from all groups will participate in exercises twice a week for one hour for 6 weeks. In order to test the effectiveness of treatment, variables are planned to be assessed before the study, after its completion and after the next 3 months. The variables assessed over time will be: muscle strength The EMG will be used to assess: tension, endurance, ability to relax the pelvic floor muscles, micturition diary, UDI-6 and IIQ-7 questionnaire, SES Self-Evaluation scale, changes in KHQ quality of life indicators and the Quality of Life Questionnaire Sexual Women.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115530 0
Prof Agnieszka Suder
Address 115530 0
University School of Physical Education in Kraków
al. Jana Pawla II 78, 31-571 Kraków, Kraków, Poland
Country 115530 0
Poland
Phone 115530 0
+48126831104
Fax 115530 0
Email 115530 0
agnieszka.suder@awf.krakow.pl
Contact person for public queries
Name 115531 0
Ms Paulina Handzlik-Waszkiewicz
Address 115531 0
University School of Physical Education in Kraków
al. Jana Pawla II 78, 31-571 Kraków, Kraków, Poland
Country 115531 0
Poland
Phone 115531 0
+48512803119
Fax 115531 0
Email 115531 0
paulina.handzlik@interia.pl
Contact person for scientific queries
Name 115532 0
Prof Agnieszka Suder
Address 115532 0
University School of Physical Education in Kraków
al. Jana Pawla II 78, 31-571 Kraków, Kraków, Poland
Country 115532 0
Poland
Phone 115532 0
+48126831104
Fax 115532 0
Email 115532 0
agnieszka.suder@awf.krakow.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is forbidden due to country law


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
No additional documents have been identified.