NCT07536139

COMPARATIVE EFFICACY OF ELECTROMAGNETIC FIELD THERAPY AND TIBIAL NERVE STIMULATION IN URGE URINARY INCONTINENCE

COMPARISON OF MAGNETIC FIELD THERAPY AND TIBIAL NERVE STIMULATION IN WOMEN WITH URGE URINARY INCONTINENCE: A PROSPECTIVE, RANDOMIZED, ASSESSOR-BLINDED CLINICAL TRIAL

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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. 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.

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

Interventions

Type	Name	Description
DEVICE	Magnetic 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.
DEVICE	Posterior Tibial Nerve Stimulation (PTNS)	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.
BEHAVIORAL	Pelvic Floor Muscle Exercise Program	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-03-01
• Completion: 2027-04-01
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: Turkey (Türkiye)