Urinary IncontinenceNCT06450795
Effectiveness of High Intensity Electromagnetic Therapy and Pelvic Floor Exercises in Women With Urinary Incontinence
A study testing Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists. in people with Urinary Incontinence, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of pelvic floor exercises and high intensity electromagnetic therapy on pelvic floor muscle function, quality of life and urinary parameters in women with stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 17 Aug 2025
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as stress urinary incontinence by a physician,
- Between the ages of 20-65,
- Has not had recurrent vaginitis infection,
- Women with no active urinary tract infection or more than 3 urinary tract infections in the last 1 year will be included in the study.
Who cannot join
- History of cardiac implant or untreated cardiac arrhythmia,
- The presence of a metal implant,
- Vaginal and pelvic surgery within the last 6 months,
- Gave birth within the last 12 weeks and had a history of miscarriage within 6 weeks,
- A recent surgical procedure,
- Any concurrent UI treatment,
Show all 9Show fewer
- With renal and hepatic insufficiency,
- Neurological or neuromuscular disease
- It will be excluded in case of any contraindication listed in the investigational device manual.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the effect of pelvic floor exercises and high intensity electromagnetic therapy on pelvic floor muscle function, quality of life and urinary parameters in women with stress urinary incontinence. The individuals to be included in the study will be selected from women with stress urinary incontinence who receive follow-up from Medipol Acıbadem Hospital. Women who meet the inclusion criteria will be explained the details of the study by the responsible researcher and an informed consent form will be presented. The study is planned as two groups:
Group 1: Pelvic floor muscle training (PBST) group. Group 2: Pelvic floor muscle training and high intensity functional electromagnetic stimulation (HIFEM) treatment group.
Read more
Envelope opening method will be used for randomisation of the participants into two groups. They will be included in the first or second group according to the number in the envelope they choose.
Each participant will be given a baseline assessment. Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists. Participants in 2 groups will also receive HIFEM treatment for 6 weeks, 2 days a week for 28 minutes. The evaluations will be repeated at the end of the treatment.
Research Outcome Measures:
Demographic and Clinical Characteristics International Incontinence Consultation Questionnaire-Short Form Urogenital Distress Inventory (UDI-6) Quality of Life King Health Survey Muscle function Emg-Biofeedback
- Conditions
- Urinary Incontinence
- Being tested
- Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists.
- Keywords
- electromagnetic stimulation, urinary incontinence, pelvic floor muscle training
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists.Behavioural
Also called high intensity functional electromagnetic stimulation
HIFEM treatment for 6 weeks, 2 days a week for 28 minutes. The evaluations will be repeated at the end of the treatment.
| Study group | Role | What they receive |
|---|---|---|
| High intensity functional electromagnetic stimulation (HIFEM) treatment group | Experimental | Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists. Additionally, Participants will also receive HIFEM treatment for 6 weeks, 2 days a week for 28 minutes. The evaluations will be repeated at the end of the treatment. Receives: Behavioral: Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists. |
| Pelvic floor muscle training group | Experimental | Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists. Receives: Behavioral: Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists. |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Incontinence Consultation Questionnaire-Short Form
Urinary incontinence symptom severity and its effect on quality of life will be evaluated with the ICIQ-SF, the reliability and validity of the Turkish version of which was performed by Çetinel et al. The scale consists of a total of 6 items questioning the type, frequency and amount of urinary incontinence and the effects of incontinence on the individual's life. The scores that can be obtained from the scale vary between 0-21 and a higher score indicates an increase in the severity of incontinence.
Measured: 5 minute
Urogenital Distress Inventory (UDE-6)
The UDI-6 consists of 6 questions and is graded with a 4-point Likert-type score. A minimum score of 0 is obtained from the UDE-6 and this means that 'the patient is not disturbed at all', while the maximum score of 18 means that 'the patient is extremely disturbed by the symptoms'. The scores are converted to a percentage and the score is determined. The higher the score, the greater the severity of the symptoms.
Measured: 5 minute
King's Health Questionnaire
The reliability and validity of the Turkish version of the quality of life related to urinary symptoms will be evaluated with the KSA, which was studied by Kaya et al. The KSA consists of two parts and includes 32 items. The best score that can be obtained from the complaint severity scale is '0' and the worst score is '30', while the best score that can be obtained from the answers given to all KSA sub-section problems is '0' and the worst score is '100'.
Measured: 5 minute
EMG-Biofeedback
Used to evaluate pelvic floor muscle activation
Measured: 5 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Jun 2024
- Primary completion12 May 2025
- Study completion17 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mehtap kilicoz, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450795
- Sponsor's protocol ID
- E-10840098-202.3.02-2981
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kilicoz Bakar M, Ozkocak G, Algun ZC. Comparison of High-Intensity Electromagnetic Therapy and Pelvic Floor Muscle Exercises in Women with Urinary Incontinence: A Randomized Controlled Trial. Int J Womens Health. 2026 Jul 8;18:612726. doi: 10.2147/IJWH.S612726. eCollection 2026.
PubMed 42438479
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High Intensity Electromagnetic Therapy and Pelvic Floor Exercises in Women With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06450795
- Acronym / sponsor ID
- E-10840098-202.3.02-2981
- Conditions
- Urinary Incontinence
- Keywords
- electromagnetic stimulation, urinary incontinence, pelvic floor muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 17 Aug 2025 (actual)
- First posted
- 10 Jun 2024 (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 aim of this study is to evaluate the effect of pelvic floor exercises and high intensity electromagnetic therapy on pelvic floor muscle function, quality of life and urinary parameters in women with stress urinary incontinence. The individuals to be included in the study will be selected from women with stress urinary incontinence who receive follow-up from Medipol Acıbadem Hospital. Women who meet the inclusion criteria will be explained the details of the study by the responsible researcher and an informed consent form will be presented. The study is planned as two groups:
Group 1: Pelvic floor muscle training (PBST) group. Group 2: Pelvic floor muscle training and high intensity functional electromagnetic stimulation (HIFEM) treatment group.
Envelope opening method will be used for randomisation of the participants into two groups. They will be included in the first or second group according to the number in the envelope they choose.
Each participant will be given a baseline assessment. Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists. Participants in 2 groups will also receive HIFEM treatment for 6 weeks, 2 days a week for 28 minutes. The evaluations will be repeated at the end of the treatment.
Research Outcome Measures:
Demographic and Clinical Characteristics International Incontinence Consultation Questionnaire-Short Form Urogenital Distress Inventory (UDI-6) Quality of Life King Health Survey Muscle function Emg-Biofeedback
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity functional electromagnetic stimulation (HIFEM) treatment group | Experimental | Behavioral: Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists.Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists. Additionally, Participants will also receive HIFEM treatment for 6 weeks, 2 days a week for 28 minutes. The evaluations will be repeated at the end of the treatment. |
| Pelvic floor muscle training group | Experimental | Behavioral: Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists.Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed as stress urinary incontinence by a physician,
- Between the ages of 20-65,
- Has not had recurrent vaginitis infection,
- Women with no active urinary tract infection or more than 3 urinary tract infections in the last 1 year will be included in the study.
Key exclusion criteria (9 listed)
- History of cardiac implant or untreated cardiac arrhythmia,
- The presence of a metal implant,
- Vaginal and pelvic surgery within the last 6 months,
- Gave birth within the last 12 weeks and had a history of miscarriage within 6 weeks,
- A recent surgical procedure,
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 |
|---|---|---|
| Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists.Also: high intensity functional electromagnetic stimulationHIFEM treatment for 6 weeks, 2 days a week for 28 minutes. The evaluations will be repeated at the end of the treatment. | Behavioural | High intensity functional electromagnetic stimulation (HIFEM) treatment group, Pelvic floor muscle training group |
Primary outcome
International Incontinence Consultation Questionnaire-Short Form
Time frame: 5 minute
Urinary incontinence symptom severity and its effect on quality of life will be evaluated with the ICIQ-SF, the reliability and validity of the Turkish version of which was performed by Çetinel et al. The scale consists of a total of 6 items questioning the type, frequency and amount of urinary incontinence and the effects of incontinence on the individual's life. The scores that can be obtained from the scale vary between 0-21 and a higher score indicates an increase in the severity of incontinence.
Urogenital Distress Inventory (UDE-6)
Time frame: 5 minute
The UDI-6 consists of 6 questions and is graded with a 4-point Likert-type score. A minimum score of 0 is obtained from the UDE-6 and this means that 'the patient is not disturbed at all', while the maximum score of 18 means that 'the patient is extremely disturbed by the symptoms'. The scores are converted to a percentage and the score is determined. The higher the score, the greater the severity of the symptoms.
King's Health Questionnaire
Time frame: 5 minute
The reliability and validity of the Turkish version of the quality of life related to urinary symptoms will be evaluated with the KSA, which was studied by Kaya et al. The KSA consists of two parts and includes 32 items. The best score that can be obtained from the complaint severity scale is '0' and the worst score is '30', while the best score that can be obtained from the answers given to all KSA sub-section problems is '0' and the worst score is '100'.
EMG-Biofeedback
Time frame: 5 minute
Used to evaluate pelvic floor muscle activation
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 22 Sep 2026.
- Derived from this study: PubMed 42438479Kilicoz Bakar M, Ozkocak G, Algun ZC. Comparison of High-Intensity Electromagnetic Therapy and Pelvic Floor Muscle Exercises in Women with Urinary Incontinence: A Randomized Controlled Trial. Int J Womens Health. 2026 Jul 8;18:612726. doi: 10.2147/IJWH.S612726. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists. in people with Urinary Incontinence, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 9 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 22 Sep 2026. 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 Turkey (Türkiye). 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?
International Incontinence Consultation Questionnaire-Short Form (time frame: 5 minute). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06450795, which also lists 1 linked publication.
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 22 Sep 2026.