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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

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Caesarean section

Urinary incontinence

Pelvic floor dysfunction

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

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]