Pelvic floor muscle training with surface electromyography

• Register: ISRCTN
• Last refreshed on: 21 February 2022
• Main ID: ISRCTN92265528
• Date of registration: 25/07/2016
• Prospective Registration: No
• Primary sponsor: Gdansk University of Physical Education and Sport
• Public title: Pelvic floor muscle training with surface electromyography
• Scientific title: The influence of Pelvic Floor Muscle Training with surface Electromyography on selected EMG parameters among women in reproductive age undergoing different modes of exercise instructions and supervision
• Date of first enrolment: 01/02/2014
• Target sample size: 500
• Recruitment status: Ongoing
• URL: https://www.isrctn.com/ISRCTN92265528
• Study type: Interventional
• Study design: Single-centre assessor-blind randomised controlled trial (Other)
• Phase: Not Applicable

Countries of recruitment

Poland

Contacts

• Name: Anna Szumilewicz

Key inclusion & exclusion criteria

Inclusion criteria:
1. Women at the age of 18-45 years old (including pregnant women; nulliparous, primiparous or multiparous)
2. Health condition allows for physical activity
3. Availability to implement 6-week training program

Exclusion criteria:
1. History of pelvic-floor disorders
2. History of urogenital tract dysfunctions
3. Complicated pregnancy during the study
4. Any contraindications to physical activity


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Pelvic floor muscle function
Musculoskeletal Diseases
Pelvic floor muscle function

Intervention(s)

Women are randomly allocated to one of four groups.

Group 1: Participants receive usual advice and unsupervised training. This involves verbal and written instructions for the pelvic-floor muscle activation after the initial test (described below). They also receive a written program of pelvic-floor exercises (described below) and a training diary to record the completed sessions. They execute these exercises for six weeks without any supervision.
Group 2: Participants receive biofeedback and unsupervised training. This involves verbal and written instructions for the pelvic-floor muscle activation after the initial test (described below) and one session of instructions about muscle activation while viewing the EMG (EMG biofeedback session).They also receive a written program of pelvic-floor exercises (described below) and a training diary to record the completed sessions. They execute these exercises for six weeks without any supervision.
Group 3: Participants receive biofeedback and supervised training ( incorporated into general health-enhancing exercise programme -added 16/04/2018). This involves verbal and written instructions for the pelvic-floor muscle activation after the initial test (described below) and one session of instructions about muscle activation while viewing the EMG (EMG biofeedback session).They also receive a written program of pelvic-floor exercises (described below) and a training diary to record the completed sessions. They meet an exercise professional to implement the training program.
Group 4: Participants don’t receive get any feedback on the EMG test or any advice how to exercise pelvic-floor muscles.

The instructions given to participants h

Primary Outcome(s)

1. Pelvic-floor muscle function is measured using the TeleMyo™ 2400T Direct Transmission System (DTS), NORAXON EMG and Sensors System (Scottsdale, AZ, USA) at baseline and 6 weeks.

Added 16/04/2018:
2. The lif eimpact of urinary incontinence symptoms is assessed using the Incontinence Impact Questionnaire at baseline and 6 weeks.

Secondary Outcome(s)

Technique of the pelvic-floor muscle contraction is determined using a electromyography (EMG) data at baseline and 6 weeks.

Secondary ID(s)

KB - 8/13; KB - 22/15

Source(s) of Monetary Support

Gdansk University of Physical Education and Sport

Ethics review

Status:
Approval date:
Contact:

Komisja Bioetyczna przy Okregowej Izbie lekarskiej w Gdansku (Bioethical Commission of the Regional Medical Chamber in Gdansk), ref: B - 8/13 (pilot) and KB - 8/14 (main study)

Results

• Results available: Yes
• Date Completed: 31/12/2022