Analysis of the influence of electrostimulation and exercises on pelvic floor muscles tension in young, healthy women
| ISRCTN | ISRCTN81464370 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81464370 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | KB-254/2022 |
| Sponsor | Opole University |
| Funder | Uniwersytet Opolski |
- Submission date
- 17/07/2022
- Registration date
- 25/07/2022
- Last edited
- 25/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The pelvic floor is an extremely important place in a woman's body. Like any other area of the organism, this one can also undergo various types of related dysfunctions with disturbed muscle tone present there. There are many factors that can contribute to the development of pelvic floor dysfunction, such as: physiological childbirth, menstrual cycle, previous lower urinary tract infections, comorbidities, medications taken, profession and many others. Therefore, it is necessary to look for therapeutic methods that will prove effective in strengthening the pelvic floor muscles in young, healthy women, and thus in the prevention of the occurrence of dysfunctions in the genitourinary system in the next stages of their lives.
The aim of the study is the electromyographic analysis of the effect of endovaginal electrostimulation and exercises on the pelvic floor muscle tone in young women, showing no dysfunction in the genitourinary system. The study will assess whether the applied physioprophylactic procedures will be effective in increasing PFM tension, and thus in the prevention of dysfunction of this muscle group.
Who can participate?
Women who have not previously given birth, aged 19-29 years, without pelvic floor dysfunction.
What does the study involve?
Women will be randomly assigned to one of three groups: two test groups with pelvic floor electrostimulation and exercise, and a control group with exercise only. Bioelectrical activity of pelvic floor muscles are measured before and after treatment and during follow-up visits 1 and 3 months after the end of the study.
What are the possible benefits and risks of participating?
Participants will receive a complete physioprophylaxis program that can improve pelvic floor muscle tone. There is no risk involved in participating.
Where is the study run from?
University of Opole (Poland)
When is the study starting and how long is it expected to run for?
March 2022 to December 2023
Who is the main contact?
Julia Duda
julia.konrad@uni.opole.pl
Prof. Jakub Taradaj
j.taradaj@awf.katowice.pl
Contact information
Public
68 Katowicka Street
Opole
45-060
Poland
 ORCID ID |
0000-0001-8094-5685 |
|---|---|
| Phone | +48 (0)788257367 |
| julia.duda@uni.opole.pl |
Scientific
Academy of Physical Education
72 Mikolowska Street
Katowice
40-065
Poland
| ORCID ID |
0000-0002-1796-5832 |
|---|---|
| Phone | +48 (0)668613945 |
| j.taradaj@awf.katowice.pl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomized clinical study with follow-up analysis |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Electromagnetic electrostimulation and exercises in the physioprophylaxis of pelvic floor dysfunction |
| Study objectives | 1. Pelvic floor muscles exercises improve the bioelectrical activity of the pelvic floor muscles. 2. Endovaginal electrostimulation improve the bioelectrical activity of the pelvic floor muscles. 3. The frequency used in endovaginal electrostimulation affects the bioelectric activity of the pelvic floor muscles |
| Ethics approval(s) | Approved 31/03/2022, Research Ethics Committee from Wroclaw Medical University (1 Pasteur Street, 50-367, Wroclaw, Poland; +48 (0)717841014; bioetyka@umed.wroc.pl), ref: KB-254/2022 |
| Health condition(s) or problem(s) studied | Bioelectric activity of pelvic floor muscles |
| Intervention | After baseline assessments, the participants will be randomly assigned (using an online tool) to: 1. Endovaginal electrostimulation using the 50 Hz frequency and pelvc floor muscles exercises 2. Endovaginal electrostimulation using the 10 Hz frequency and pelvc floor muscles exercises 3. Pelvic floor muscles exercises The individuals receiving the treatment will be blinded. A computer-generated list of random numbers will be used and concealed from the researchers enrolling and assessing the participants. The outcome assessors and data analysts will be kept blinded to the allocation. The therapy programme lasts 8 weeks during which all the participants will perform pelvic floor exercises at home 3 times a week. Women will exercise according to the schedule (3 series, 9 contractions in series, contraction time 6s, rest time 12s, 3 quick contractions at the end of each series (1,2,3s), a 2-minute recovery between sets). Additionally, in two groups, women will undergo endovaginal electrostimulation 3 times a week. A single treatment will take 20 minutes. In group 1, it is planned to use a frequency of 50 Hz and in the second group, a frequency of 10 Hz. The remaining treatment parameters for both groups will be identical (pulse time 200 μs, contraction time 5s, rest time 10s, intensity to the patient's feelings). All participants will undergo assessment of the bioelectrical activity of pelvic floor muscles before the start of treatment, after intervention and 1 and 3 months after the therapy programme. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Bioelectrical activity of pelvic floor muscle measured using an endovaginal electrode, an EMG apparatus and integrated computer software. An assessment of the bioelectrical activity of pelvic floor muscle using the Glazer protocol. The measurements will be performed before the therapy, after the therapy, i.e. 8 weeks later and 4 and 12 weeks after the end of intervention |
| Key secondary outcome measure(s) |
Assessment of the bioelectric activity of the pelvic floor muscles using the glazer protocol: |
| Completion date | 30/12/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 19 Years |
| Upper age limit | 29 Years |
| Sex | Female |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Women aged 19 - 29 years 2. Nulliparous 3. Women who have already had intercourse 4. Women without pelvic floor dysfunction |
| Key exclusion criteria | 1. Women before 19 and after 29 years of age 2. Women who gave birth 3. Virgins 4. Pelvic floor dysfunction 5. Sensory deficits 6. Pacemakers and other electronic implants 7. Metal implants 8. Psychiatric disorders 9. Cancer 10. Infections 11. Fever 12. Acute inflammation 13. Hypersensitivity to electricity |
| Date of first enrolment | 08/08/2022 |
| Date of final enrolment | 30/12/2023 |
Locations
Countries of recruitment
- Poland
Study participating centre
Opole
45-060
Poland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request (j.taradaj@awf.katowice.pl) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/07/2022: Trial's existence confirmed by Research Ethics Committee from Wrocław Medical University
