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

NCT07536139 | Not Yet Recruiting

• 1 other identifier: UI-PEMF-TNS-2026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urge Urinary Incontinence

Keywords

Urge Urinary Incontinence; Pulsed Electromagnetic Field Therapy; Posterior Tibial Nerve Stimulation; ICIQ-UI SF; Women's Health

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• King's Health Questionnaire

  Baseline, Week 6, and Week 10

Other Outcomes (1)

• Change in 3-Day Bladder Diary Parameters

  Baseline, Week 6, and Week 10

Study Arms (2)

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.

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.

Device: Posterior Tibial Nerve Stimulation (PTNS); Behavioral: Pelvic Floor Muscle Exercise Program

Interventions

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.

Also known as: Pulsed Electromagnetic Field Therapy (PEMF)

Pulsed Electromagnetic Field Therapy (PEMF) Group

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.

Also known as: Pelvic Floor Training, Kegel Exercises, Pelvic Floor Muscle Training (PFMT)

PTNS Group; Pulsed Electromagnetic Field Therapy (PEMF) Group

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.

Also known as: Transcutaneous Tibial Nerve Stimulation (TTNS)

PTNS Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey

Istanbul, Istanbul, 34307, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Interventions

Magnetic Field Therapy

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Dilek Ün oguzhanasiltürk, MD

  Kanuni Sultan Süleyman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek Ün Oğuzhanasiltürk, MD

CONTACT

+90 5056367184; dilekunoguzhan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Physical Medicine and Rehabilitation

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of the study results, with no end date.
• 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.

Locations

TU (1)