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

April 11, 2026 updated by: Dilek ün oguzhanasilturk, Kanuni Sultan Suleyman Training and Research Hospital

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34307
        • Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulsed Electromagnetic Field Therapy (PEMF) Group

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.
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.
Other Names:
  • Pulsed Electromagnetic Field Therapy (PEMF)
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.
Other Names:
  • Pelvic Floor Muscle Training (PFMT)
  • Pelvic Floor Training
  • Kegel Exercises
Active Comparator: PTNS Group

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.
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.
Other Names:
  • Pelvic Floor Muscle Training (PFMT)
  • Pelvic Floor Training
  • Kegel Exercises
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.
Other Names:
  • Transcutaneous Tibial Nerve Stimulation (TTNS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ICIQ-UI Short Form Total Score
Time Frame: Baseline, 6 weeks (end of treatment), and 10-week follow-up

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
King's Health Questionnaire
Time Frame: Baseline, Week 6, and Week 10
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 3-Day Bladder Diary Parameters
Time Frame: Baseline, Week 6, and Week 10
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

  • Principal Investigator: Dilek Ün oguzhanasiltürk, MD, Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

April 11, 2026

First Submitted That Met QC Criteria

April 11, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UI-PEMF-TNS-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After publication of the study results, with no end date.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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