COMPARISON OF MAGNETIC FIELD THERAPY AND TIBIAL NERVE STIMULATION IN WOMEN WITH URGE URINARY INCONTINENCE: A PROSPECTIVE, RANDOMIZED, ASSESSOR-BLINDED CLINICAL TRIAL
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in ICIQ-UI Short Form Total Score
Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Magnetic Field Therapy (PEMF) (Device)
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.
Intervention: Pelvic Floor Muscle Exercise Program (Behavioral)
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.
Intervention: Posterior Tibial Nerve Stimulation (PTNS) (Device)
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.
Intervention: Pelvic Floor Muscle Exercise Program (Behavioral)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- King's Health Questionnaire(Baseline, Week 6, and Week 10)
Investigators
Dilek ün oguzhanasilturk
Specialist in Physical Medicine and Rehabilitation
Kanuni Sultan Suleyman Training and Research Hospital