The Efficacy of Transcutaneous Tibial Nerve Stimulation in Women With Idiopathic Overactive Bladder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous Tibial Nerve Stimulation, sham Transcutaneous Tibial Nerve Stimulation.
- Who it may be relevant to
- Registry conditions: Overactive Bladder. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Investigation of the Efficacy of Transcutaneous Tibial Nerve Stimulation in the Treatment of Women Diagnosed With Idiopathic Overactive Bladder
Overview
This study will be conducted on women of reproductive age diagnosed with idiopathic overactive bladder who either do not want to use drug treatment or cannot tolerate it due to side effects. Our aim is to examine the effects of a treatment method called transcutaneous tibial nerve stimulation on overactive bladder symptoms, urine flow measurements (uroflowmetry), post-voiding residue, pelvic floor muscle activity, heart rate variability, and quality of life in these individuals.
Interventions
- Other Transcutaneous Tibial Nerve Stimulation
The treatment will be conducted twice a week for 30 minutes each time, for a total of 12 sessions over 6 weeks. - Other sham Transcutaneous Tibial Nerve Stimulation
Sham Transcutaneous Tibial Nerve Stimulation will be performed for 6 weeks, 2 days a week, for 30 minutes each day, for a total of 12 sessions.
Primary outcome measures
- Incontinence Impact Questionnaire scale [Time frame: From enrollment to the end of treatment at 6 weeks]
- Overactive bladder validation score 8 [Time frame: From enrollment to the end of treatment at 6 weeks]
- Voiding volume [Time frame: From enrollment to the end of treatment at 6 weeks]
- Voiding time [Time frame: From enrollment to the end of treatment at 6 weeks]
- Maximum flow rate [Time frame: From enrollment to the end of treatment at 6 weeks]
- Time to reach maximum flow [Time frame: From enrollment to the end of treatment at 6 weeks]
- Average flow rate [Time frame: From enrollment to the end of treatment at 6 weeks]
- Post-voiding residual urine [Time frame: From enrollment to the end of treatment at 6 weeks]
- SDNN (msn) [Time frame: From enrollment to the end of treatment at 6 weeks]
- RMSSD (msn) [Time frame: From enrollment to the end of treatment at 6 weeks]
Eligibility criteria
Inclusion criteria
- Eligibility criteria include being between 18 and 50 years of age, having an overactive bladder validation score of 8 (AAM-V8) above 7, refusing or being unable to tolerate antimuscarinic or mirabegron treatment, and being able to understand and follow verbal stimuli.
Exclusion criteria
- The following criteria were defined as contraindications: pelvic organ prolapse or other anatomical abnormality, being in the postmenopausal period, having used anticholinergic and/or mirabegron treatment within the last 4 weeks, being pregnant or planning to become pregnant during treatment, having an active genitourinary infection, having a mechanical obstruction in the bladder, having a neurological/congenital disorder, having undergone urogynecological surgery within the last 2 months, having concomitant stress incontinence, having previously received transcutaneous tibial nerve stimulation (TTNS) treatment, and having sensory loss in the area where the treatment will be applied.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Inonu University — Malatya
Identifiers
NCT: NCT07463326 · 2025/7708 · TTU-2025-4064