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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Field Therapy (PEMF) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 6 weeks (end of treatment), and 10-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 6, and Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 3-Day Bladder Diary Parameters | Change in bladder diary parameters recorded over 3 consecutive days, including daily voiding frequency, urgency episodes, urinary incontinence episodes, nocturia episodes, and pad usage. This measure provides a comprehensive assessment of bladder habits and symptom severity. | Baseline, Week 6, and Week 10 |
Inclusion Criteria:
Exclusion Criteria:
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dilek Ün Oğuzhanasiltürk, MD | Contact | +90 5056367184 | dilekunoguzhan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dilek Ün oguzhanasiltürk, MD | Kanuni Sultan Süleyman Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey | Istanbul | Istanbul | 34307 | Turkey (Türkiye) |
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.
After publication of the study results, with no end date.
Access to the data will be granted upon reasonable request to the corresponding author. Researchers must provide a methodologically sound proposal. Data will be shared for scientific research purposes only, and all shared data will be de-identified to ensure participant confidentiality.
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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.
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he outcome assessor will be blinded to group allocation to minimize assessment bias. Due to the nature of the interventions, participants and treating therapists cannot be blinded. Data will be analyzed using coded group allocation to maintain objectivity during statistical evaluation.
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| Posterior Tibial Nerve Stimulation (PTNS) | Device | 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. |
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| Pelvic Floor Muscle Exercise Program | Behavioral | 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. |
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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