Extraction of Muscle Synergies to Investigate Changes in Biomechanical Parameters after the Addition of Abdominal Hypopressive Technique to Pelvic Floor Muscle Training in Women with Urinary Incontinence

Determining the synergy of the pelvic floor and abdominal muscles due to the addition of hypopressive abdominal training to the routine pelvic floor muscle training in women with stress urinary incontinence

A randomized controlled clinical trial with two parallel intervention groups and one control group, triple-blind study on 78 individuals, randomized by Matlab code 'randi'

Patients will be randomly entered into the intervention groups. Initial assessment will be done. After a total of 10 training sessions, the final assessment will be performed. The healthy control group has only an initial assessment. Patients, researchers, and analyzers will be blinded to the intervention groups.

Inclusion criteria: women with stress urinary incontinence, Age between 25 and 50 years, married, leak at least three times a week, ICIQ-UI-SF questionnaire score equal to or greater than 5. Exclusion criteria: pregnancy, menopause, POP > 2, Oxf < 3, Res > 50 ml, history of cancer, pelvic surgery, overactive bladder, hormone therapy, urinary tract infection, low back pain in the last 3 months, or other diagnosed neurologic diseases.

Group 1: Women with stress incontinence receiving routine pelvic floor training. Group 2: Women with stress incontinence receiving pelvic floor training + low abdominal training. Control group: Women without complaints of urinary incontinence.

Time and frequency-domain parameters of the pelvic floor and abdominal muscles' electromyography; muscular synergy matrices; intra-abdominal and vaginal pressures; scores of ICIQ-UI SF, ICIQ-LUTS QOL, and BROOME questionnaires.

Random numbers will be generated between 1 and 52 by using a computer algorithm (matlab code: randi) to specify two intervention groups (1 and 2, each group owns 26 participants). The numbers will be kept in concealed envelopes. Patients, researchers, and analyzers will not be aware of what intervention has been applied to the participants.

The patient is explained that there are two types of intervention, but the person is not informed of her assigned group. The patient is initially evaluated by a researcher (blind) before assigning the group. At the end of the initial evaluation, the patient chooses a concealed envelope and delivers it to the research assistant. In this way, the patient identifies the group itself but is not aware of the results of randomization. The clinical assistant teach the home exercises and explains the training sessions based on the intervention group that she is in. At the end of the intervention, the researcher performs the final evaluation of the patient without knowing the treatment the patient has received. The analyzer which is blind to the intervention group using coded results performs the output analyses. The healthy control group does not need to be blind, as they are not patient and do not receive any intervention, and, only have an initial evaluation. The blindness of the participants means blindness of the patients who all receive interventions.

All processed and analyzed data will be released. These data include the questionnaire scores and linear and nonlinear outcomes of the stability, before and after the interventions.

from 6 months after the official publication of results

All academic and clinical researchers

Only for therapeutical applications and use in neuro-musculoskeletal simulations

By contacting the corresponding author of the published papers by email, phone or postal address

Process: 1. Determining the data of interest by the applicant 2. contacting the corresponding author to submit the queries by the applicant 3. Reviewing the queries by the research team 4. Responding to the queries till 10 working days by the research team