Urinary Incontinence, StressNCT05871281
Electrostimulation and PFMT for Stress Urinary Incontinence
A study testing Pelvic floor muscle exercises in people with Urinary Incontinence, Stress, run by Lithuanian Sports University at 1 site in Lithuania.
Trial summary
The goal of this randomized controlled trial is to evaluate and compare the effects of electrostimulation in addition to pelvic floor muscle training and pelvic floor muscle training alone on pelvic floor muscle (PFM) function, urinary incontinence and quality of life in women with stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- Pelvic floor muscle exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteLithuania
- Study dates
- 15 Jan 2022to 15 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Have given birth at least once
- Voluntary consent to participate in the study
- Do not have concomitant diseases
- Do not use hormonal drugs.
Who cannot join
- Less than three months have passed after childbirth
- Have heart implants or other metal implants
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pelvic Floor Muscle Training and Electrostimulation on Women's Quality of Life and Pelvic Floor Muscle Function in Stress Urinary Incontinence
The goal of this randomized controlled trial is to evaluate and compare the effects of electrostimulation in addition to pelvic floor muscle training and pelvic floor muscle training alone on pelvic floor muscle (PFM) function, urinary incontinence and quality of life in women with stress urinary incontinence. The main questions are:
What is the effect of electrostimulation combined with pelvic floor muscle training on pelvic floor muscle function, symptoms of urinary incontinence and quality of life in women with stress urinary incontinence? What is the effect of pelvic floor muscle training program on pelvic floor muscle function, symptoms of urinary incontinence and quality of life in women with stress urinary incontinence? Which intervention is more effective - electrostimulation with pelvic floor muscle training or pelvic floor muscle training alone?
Read more
Participants will be evaluated before and after the interventions with the following methods:
International Incontinence Counseling Questionnaire - Short Form (ICIQ-SF) Pelvic floor muscle strength and endurance will be assessed with a "Pelvexiser" perineometer.
Read the detailed description
The study involved 24 women 20-49 years old who have complained of stress urinary incontinence for at least 4 weeks, who gave at least one birth vaginally and signed the consent form. Subjects were excluded if they were pregnant, were diagnosed with vaginismus, urinary tract infections, cancer, epilepsy, pelvic organ prolapse greater than stage I, skin diseases, had undergone previous pelvic floor surgeries, had heart stimulator, or metal implant and were unable to contract the PFM. Study participants were randomly divided into two groups: the I group (n=12), in which participants underwent pelvic floor muscle training (PFMT) and the II group (n=12) in which subjects received pelvic floor muscle exercises combined with electrostimulation (PFMES).Participants were evaluated before the interventions and repeated after 4 weeks. Before and after the interventions, women's quality of life (QoL) was assessed according to the International Incontinence Counseling Questionnaire - Short Form. Perineometry with Pelvexiser perineometer was used to measure pelvic floor muscle strength and endurance and vaginal resting pressure. Statistical analysis was performed by IBM SPSS Statistics 26.0 and Microsoft Excel software 365.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- Pelvic floor muscle exercises
- Keywords
- stress incontinence, pelvic floor, electrostimulation, muscle training
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle exercisesProcedure or surgery
Pelvic floor muscle exercises were performed from different body positions. Duration of interventions - 4 weeks. Frequency - 2 times per week, number of individual contact sessions - 8 .
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor muscle training group | Active comparator | All subjects attended individual physiotherapy procedures, the duration of one of which was 60 minutes. One woman was assigned a total of 8 contact procedures over four weeks. During the individual procedures, exercises were selected and modified according to the women's ability to perform them. All women were taught correct abdominal breathing while lying down, to activate the abdominal muscles. Also, all were trained to perform Kegel exercises, explaining their benefits. In order to diversify and modify the exercises, they were performed with auxiliary means, i.e. using balls, gymnastic sticks, a bench, elastic bands, a physiotherapy wall, yoga blocks, rollers, weights and an aerial yoga band. Receives: Procedure: Pelvic floor muscle exercises |
| Pelvic floor muscle electrostimulation group | Experimental | Electrostimulation was performed with a Kegel 8 home elektrostymulator. The subjects were prescribed two electrostimulation programs: PO3 in the morning and PO10 in the evening. The duration of the PO3 program was 45 minutes, and was intended for general strengthening of the pelvic floor muscles. The duration of the PO10 program is 40 minutes. and it is prescribed for stress incontinence. Duration of interventions 4 week. Receives: Procedure: Pelvic floor muscle exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life by International Incontinence Counseling Questionnaire - Short Form (ICIQ - SF)
The questionnaire consists of four items and the overall score ranges from 0 to 21, with greater values indicating increased symptom severity: 0 - no symptoms of UI, 1-5 scores - mild symptoms of UI, 6-12 scores - moderate symptoms of UI, 13-18 scores - severe symptoms of UI, 19 - 21 scores - and very severe symptoms of UI.
Measured: Change from Baseline Quality of Life at 4 weeks
Pelvic floor muscle strength and endurance
Perineometry with Pelvexiser perineometer (mm Hg). The higher the results- the better function of pelvic floor muscle strength and endurance.
Measured: Change from Baseline Pelvic floor Muscle Strength and Endurance at 4 weeks
Resting vaginal pressure
Perineometry with Pelvexiser perineometer (mm Hg).
Measured: Change from Baseline Resting Vaginal Prressure at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start15 Jan 2022
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a four week, single blinded randomized controlled trial with pre-post design comparing PFM training group with PFM electrostimulation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vilma Dudoniene, PhD, Study chair, Lithuanian Sports University, Lithuania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871281
- Sponsor's protocol ID
- LithuanianSportsU 14
- Status last verified
- May 2023
- First submitted
- 12 Apr 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can not be shared according to signed by participants consent form.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pelvic Floor Muscle Training and Electrostimulation on Women's Quality of Life and Pelvic Floor Muscle Function in Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05871281
- Acronym / sponsor ID
- LithuanianSportsU 14
- Conditions
- Urinary Incontinence, Stress
- Keywords
- stress incontinence, pelvic floor, electrostimulation, muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled trial is to evaluate and compare the effects of electrostimulation in addition to pelvic floor muscle training and pelvic floor muscle training alone on pelvic floor muscle (PFM) function, urinary incontinence and quality of life in women with stress urinary incontinence. The main questions are:
What is the effect of electrostimulation combined with pelvic floor muscle training on pelvic floor muscle function, symptoms of urinary incontinence and quality of life in women with stress urinary incontinence? What is the effect of pelvic floor muscle training program on pelvic floor muscle function, symptoms of urinary incontinence and quality of life in women with stress urinary incontinence? Which intervention is more effective - electrostimulation with pelvic floor muscle training or pelvic floor muscle training alone?
Participants will be evaluated before and after the interventions with the following methods:
International Incontinence Counseling Questionnaire - Short Form (ICIQ-SF) Pelvic floor muscle strength and endurance will be assessed with a "Pelvexiser" perineometer.
Detailed description
The study involved 24 women 20-49 years old who have complained of stress urinary incontinence for at least 4 weeks, who gave at least one birth vaginally and signed the consent form. Subjects were excluded if they were pregnant, were diagnosed with vaginismus, urinary tract infections, cancer, epilepsy, pelvic organ prolapse greater than stage I, skin diseases, had undergone previous pelvic floor surgeries, had heart stimulator, or metal implant and were unable to contract the PFM. Study participants were randomly divided into two groups: the I group (n=12), in which participants underwent pelvic floor muscle training (PFMT) and the II group (n=12) in which subjects received pelvic floor muscle exercises combined with electrostimulation (PFMES).Participants were evaluated before the interventions and repeated after 4 weeks. Before and after the interventions, women's quality of life (QoL) was assessed according to the International Incontinence Counseling Questionnaire - Short Form. Perineometry with Pelvexiser perineometer was used to measure pelvic floor muscle strength and endurance and vaginal resting pressure. Statistical analysis was performed by IBM SPSS Statistics 26.0 and Microsoft Excel software 365.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a four week, single blinded randomized controlled trial with pre-post design comparing PFM training group with PFM electrostimulation
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor muscle training group | Active comparator | Procedure: Pelvic floor muscle exercisesAll subjects attended individual physiotherapy procedures, the duration of one of which was 60 minutes. One woman was assigned a total of 8 contact procedures over four weeks. During the individual procedures, exercises were selected and modified according to the women's ability to perform them. All women were taught correct abdominal breathing while lying down, to activate the abdominal muscles. Also, all were trained to perform Kegel exercises, explaining their benefits. In order to diversify and modify the exercises, they were performed with auxiliary means, i.e. using balls, gymnastic sticks, a bench, elastic bands, a physiotherapy wall, yoga blocks, rollers, weights and an aerial yoga band. |
| Pelvic floor muscle electrostimulation group | Experimental | Procedure: Pelvic floor muscle exercisesElectrostimulation was performed with a Kegel 8 home elektrostymulator. The subjects were prescribed two electrostimulation programs: PO3 in the morning and PO10 in the evening. The duration of the PO3 program was 45 minutes, and was intended for general strengthening of the pelvic floor muscles. The duration of the PO10 program is 40 minutes. and it is prescribed for stress incontinence. Duration of interventions 4 week. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Have given birth at least once
- Voluntary consent to participate in the study
- Do not have concomitant diseases
- Do not use hormonal drugs.
Key exclusion criteria (3 listed)
- Less than three months have passed after childbirth
- Have heart implants or other metal implants
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor muscle exercisesPelvic floor muscle exercises were performed from different body positions. Duration of interventions - 4 weeks. Frequency - 2 times per week, number of individual contact sessions - 8 . | Procedure or surgery | Pelvic floor muscle electrostimulation group, Pelvic floor muscle training group |
Primary outcome
Quality of life by International Incontinence Counseling Questionnaire - Short Form (ICIQ - SF)
Time frame: Change from Baseline Quality of Life at 4 weeks
The questionnaire consists of four items and the overall score ranges from 0 to 21, with greater values indicating increased symptom severity: 0 - no symptoms of UI, 1-5 scores - mild symptoms of UI, 6-12 scores - moderate symptoms of UI, 13-18 scores - severe symptoms of UI, 19 - 21 scores - and very severe symptoms of UI.
Pelvic floor muscle strength and endurance
Time frame: Change from Baseline Pelvic floor Muscle Strength and Endurance at 4 weeks
Perineometry with Pelvexiser perineometer (mm Hg). The higher the results- the better function of pelvic floor muscle strength and endurance.
Resting vaginal pressure
Time frame: Change from Baseline Resting Vaginal Prressure at 4 weeks
Perineometry with Pelvexiser perineometer (mm Hg).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: No. IPD can not be shared according to signed by participants consent form.
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Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
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Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
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Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vilma Dudoniene, PhD study chair
Lithuanian Sports University, Lithuania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle exercises in people with Urinary Incontinence, Stress, run by Lithuanian Sports University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life by International Incontinence Counseling Questionnaire - Short Form (ICIQ - SF) (time frame: Change from Baseline Quality of Life at 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.