Urge Urinary IncontinenceNCT07536139
COMPARATIVE EFFICACY OF ELECTROMAGNETIC FIELD THERAPY AND TIBIAL NERVE STIMULATION IN URGE URINARY INCONTINENCE
A study testing Magnetic Field Therapy (PEMF), Posterior Tibial Nerve Stimulation (PTNS) and Pelvic Floor Muscle Exercise Program in people with Urge Urinary Incontinence, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Urge urinary incontinence is a prevalent condition characterized by involuntary leakage of urine accompanied by a sudden, compelling urge to void. It significantly impairs quality of life and is associated with substantial physical, psychological, and social burden. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Urge Urinary Incontinence
- What is being tested?
- Magnetic Field Therapy (PEMF), Posterior Tibial Nerve Stimulation (PTNS) and Pelvic Floor Muscle Exercise Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2026to Apr 2027
- Phase
- Interventional
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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged 18-65 years Diagnosis of urge urinary incontinence based on clinical evaluation Presence of urinary urgency with or without urge incontinence episodes Ability to understand and complete questionnaires Willingness to participate and provide written informed consent
Who cannot join
- Predominant stress urinary incontinence or mixed incontinence with stress predominance Neurological diseases affecting bladder function (e.g., multiple sclerosis, spinal cord injury, Parkinson's disease) Active urinary tract infection History of pelvic surgery affecting urinary function Pregnancy or breastfeeding Use of medications affecting bladder function (unless stable for at least 4 weeks) Presence of implanted electronic devices (e.g., pacemaker) Severe cognitive impairment preventing participation Participation in another clinical trial within the last 3 months
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey
Istanbul, Istanbul, 34307
Dilek Ün Oğuzhanasiltürk, MD, +905056367184, dilekunoguzhan@gmail.com
About this study
Official title: COMPARISON OF MAGNETIC FIELD THERAPY AND TIBIAL NERVE STIMULATION IN WOMEN WITH URGE URINARY INCONTINENCE: A PROSPECTIVE, RANDOMIZED, ASSESSOR-BLINDED CLINICAL TRIAL
Urge urinary incontinence is a prevalent condition characterized by involuntary leakage of urine accompanied by a sudden, compelling urge to void. It significantly impairs quality of life and is associated with substantial physical, psychological, and social burden. Noninvasive treatment modalities, including pulsed electromagnetic field (PEMF) therapy and posterior tibial nerve stimulation (PTNS), have gained attention due to their safety and ease of application.
This study is designed as a prospective, randomized, assessor-blinded clinical trial conducted in women diagnosed with urge urinary incontinence. Eligible participants will be randomly assigned to one of two intervention groups: PEMF therapy or tibial nerve stimulation. Both interventions will be applied over a predefined treatment period under standardized conditions.
Read more
Outcome measures will include symptom severity, frequency of incontinence episodes, and quality of life, assessed using validated instruments such as the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), bladder diaries, and quality-of-life scales. Assessments will be performed at baseline and after completion of the treatment period.
The primary aim of the study is to compare the efficacy of PEMF therapy and tibial nerve stimulation in reducing urinary symptoms. Secondary objectives include evaluating improvements in quality of life and functional outcomes. The findings of this study are expected to contribute to the optimization of noninvasive treatment strategies for urge urinary incontinence.
Read the detailed description
This study is designed as a two-arm, parallel-group, prospective, randomized, assessor-blinded clinical trial. Participants will be randomly assigned in a 1:1 ratio to either the pulsed electromagnetic field (PEMF) therapy group or the tibial nerve stimulation group. Randomization will be performed using a computer-generated simple randomization method.
The outcome assessor will be blinded to group allocation to minimize assessment bias. Both treatment modalities are noninvasive and commonly used in the management of urge urinary incontinence. Treatment allocation will be determined solely by randomization rather than clinical indication, as the primary aim of the study is to compare the efficacy of these two interventions. Therefore, no participant will be deprived of standard care.
A total of 40 female patients will be included in the study, with 20 participants in each group. Only women aged between 18 and 65 years will be recruited to ensure a homogeneous sample and to account for anatomical and physiological differences in the pelvic floor.
Both groups will receive a standardized pelvic floor exercise program in addition to their assigned treatment. The treatment duration will be 6 weeks, consisting of 18 sessions in total. During the first 2 weeks, treatments will be administered 5 days per week, followed by 2 sessions per week for the remaining 4 weeks.
The primary outcome measure will be the change in the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) total score. Assessments will be performed at baseline (pre-treatment), at the end of treatment (6th week), and at the 10th-week follow-up. A validated Turkish version of the questionnaire will be used, and all assessments will be conducted by an independent blinded evaluator.
Secondary outcome measures will include changes in the King's Health Questionnaire (KHQ) total and subscale scores, assessed at the same time points (baseline, post-treatment, and 10th-week follow-up) using the validated Turkish version.
Additionally, participants will complete a 3-day bladder diary at each assessment point. The following parameters will be recorded:
Daily voiding frequency Number of urgency episodes Number of urinary incontinence episodes Nocturia frequency Daily pad usage
Treatment adherence will be evaluated based on the completion rate of the planned 18 sessions and the number of missed sessions.
Safety will be assessed by recording any adverse events occurring during the treatment period.
- Conditions
- Urge Urinary Incontinence
- Being tested
- Magnetic Field Therapy (PEMF), Posterior Tibial Nerve Stimulation (PTNS), Pelvic Floor Muscle Exercise Program
- Keywords
- Urge Urinary Incontinence, Pulsed Electromagnetic Field Therapy, Posterior Tibial Nerve Stimulation, ICIQ-UI SF, Women's Health
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Field Therapy (PEMF)Device
Also called Pulsed Electromagnetic Field Therapy (PEMF)
Non-invasive pulsed electromagnetic field (PEMF) therapy will be applied for the treatment of urge urinary incontinence. The intervention will be administered over a 6-week period, consisting of 5 sessions per week during the first 2 weeks and 2 sessions per week during the following 4 weeks. Each session will be performed using a clinical magnetic stimulation device targeting pelvic floor muscles and associated neural pathways. The aim of the intervention is to improve bladder control by enhancing pelvic floor muscle activation and modulating neural reflex mechanisms involved in continence.
Posterior Tibial Nerve Stimulation (PTNS)Device
Also called Transcutaneous Tibial Nerve Stimulation (TTNS)
Non-invasive tibial nerve stimulation applied for the treatment of urge urinary incontinence. The intervention is administered over a 6-week period, consisting of 5 sessions per week during the first 2 weeks and 2 sessions per week during the following 4 weeks. The therapy aims to modulate sacral nerve pathways through stimulation of the tibial nerve.
Pelvic Floor Muscle Exercise ProgramBehavioural
Also called Pelvic Floor Training, Kegel Exercises, Pelvic Floor Muscle Training (PFMT)
A standardized pelvic floor muscle training (PFMT) program will be provided to all participants. The exercise program will be taught and supervised by a trained physiotherapist. Participants will be instructed to perform regular pelvic floor muscle contractions, including both slow and fast contractions, in accordance with current clinical guidelines. The exercises will be continued throughout the 6-week treatment period, and adherence will be monitored. The aim of the intervention is to improve pelvic floor muscle strength, endurance, and coordination, thereby enhancing bladder control.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Electromagnetic Field Therapy (PEMF) Group | Experimental | PEMF Group - Arm Description
Participants in this group will receive pulsed electromagnetic field (PEMF) therapy in addition to a standardized pelvic floor exercise program. The treatment will be administered over a 6-week period, with a total of 18 sessions (5 sessions per week for the first 2 weeks, followed by 2 sessions per week for the remaining 4 weeks). PEMF therapy will be applied using a clinical device under standardized conditions. Receives: Device: Magnetic Field Therapy (PEMF); Behavioral: Pelvic Floor Muscle Exercise Program |
| PTNS Group | Active comparator | PTNS Group - Arm Description
Participants in this group will receive posterior tibial nerve stimulation (PTNS) in addition to a standardized pelvic floor exercise program. The treatment will be administered over a 6-week period, with a total of 18 sessions (5 sessions per week for the first 2 weeks, followed by 2 sessions per week for the remaining 4 weeks). PTNS will be applied according to standard clinical protocols. Receives: Device: Posterior Tibial Nerve Stimulation (PTNS); Behavioral: Pelvic Floor Muscle Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ICIQ-UI Short Form Total Score
The primary outcome is the change in the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) total score. This validated questionnaire assesses the severity and impact of urinary incontinence on quality of life. A greater reduction in score indicates clinical improvement.
Time Frame: Baseline, 6 weeks (end of treatment), and 10-week follow-up
Measured: Baseline, 6 weeks (end of treatment), and 10-week follow-up
Secondary outcomes (1)
King's Health Questionnaire
Change in total and subscale scores of the King's Health Questionnaire (KHQ), used to assess quality of life related to urinary incontinence.
Measured: Baseline, Week 6, and Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urge 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
- Model description
- Participants will be randomized in a 1:1 ratio to one of two parallel groups: pulsed electromagnetic field (PEMF) therapy or posterior tibial nerve stimulation (PTNS). Both groups will receive their assigned intervention in addition to a standardized pelvic floor exercise program. The interventions will be applied over a 6-week treatment period. Outcomes will be assessed at baseline, at the end of treatment (6 weeks), and at the 10-week follow-up by a blinded assessor.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek ün oguzhanasilturk, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Dilek Ün oguzhanasiltürk, MD, Principal investigator, Kanuni Sultan Süleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536139
- Sponsor's protocol ID
- UI-PEMF-TNS-2026
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in this study will be made available upon reasonable request to the corresponding author. Data will be shared after publication of the study results, with no end date. Access to the data will be granted to researchers who provide a methodologically sound proposal, and data will be used only for scientific research purposes. All shared data will be anonymized to protect participant confidentiality.