Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder
NCT ID: NCT06390488
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-11-28
2025-02-28
Brief Summary
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The main questions aimed to be answered are:
What are the effects of Transcutaneous Medial Plantar Nerve Stimulation (T-MPSS) on clinical parameters related to incontinence and quality of life compared to the placebo group in women with idiopathic overactive bladder (OAB)? Participants (n:40) with idiopathic OAB who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive T-MPSS (n:20) and the second group will receive placebo T-MPSS (n:20). Measurements will be performed twice in total, before and at the end of treatment (6th week).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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T-MPNS
In this study, the stimulation device will be connected to the patient via channel 1, and active stimulation will be performed. Channel 2 will not be connected to the patient, thus no stimulation will be given through this channel. Both channels will utilize a stimulation protocol set to continuous mode with a frequency of 20 Hz and a pulse width of 200 ms. The intensity of the current for channel 1 (ranging from 0 to 50 mA) will be determined based on the comfort level of the patient after ensuring correct positioning. Correct positioning will be confirmed by observing a hallux reaction (plantar flexion of the big toe or, rarely, fanning of the fingers). T-MPNS sessions will be conducted twice a week for 6 weeks, with each session lasting 30 minutes. The intervention will consist of a 12-session T-MPNS treatment program.
Transcutaneous medial plantar nerve stimulation (T-MPNS)
T-MPNS will be conducted unilaterally in the supine position using the electrotherapy device with surface electrodes. Two round self-adhesive electrodes will be positioned, with the negative electrode near the metatarsal-phalangeal joint of the great toe on the medial aspect of the foot and the positive electrode approximately 2 cm inferior-posterior to the medial malleolus (in front of the Medio-Malleolar-Calcaneal axis). Channel 1 will provide active stimulation, while channel 2 will remain inactive.
Sham T-MPNS
In the Sham T-MPNS group, patients will receive stimulation with the same electrotherapy device, same patient and electrode positioning, and identical current characteristics as the T-MPNS group. Channel 2 of the device will be connected to the patient without delivering stimulation, while channel 1 will not be connected but will display current intensity and treatment duration on the device screen. The current intensity on channel 1 will only be able to be increased up to 2-3 mA to prevent patients from exceeding this level. Patients will be advised that higher stimulations might negatively affect treatment outcomes. All patients, including those in the placebo group, will be informed that the absence of motor or sensory responses during treatment does not imply ineffectiveness, alleviating concerns about lack of sensation. Sham T-MPNS sessions will be conducted twice weekly for 6 weeks, with each session lasting 30 minutes, totaling 12 sessions.
Sham Transcutaneous medial plantar nerve stimulation (T-MPNS)
Sham T-MPNS group will be stimulated using the same electrotherapy device, with patients positioned identically and electrodes placed in the same positions as in the T-MPNS group. The current characteristics (pulse frequency 20 Hz and pulse width 200 ms) will also remain consistent across both channels. The second channel of the stimulation device will be designated as the channel connected to the patient but without delivering stimulation.
Interventions
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Transcutaneous medial plantar nerve stimulation (T-MPNS)
T-MPNS will be conducted unilaterally in the supine position using the electrotherapy device with surface electrodes. Two round self-adhesive electrodes will be positioned, with the negative electrode near the metatarsal-phalangeal joint of the great toe on the medial aspect of the foot and the positive electrode approximately 2 cm inferior-posterior to the medial malleolus (in front of the Medio-Malleolar-Calcaneal axis). Channel 1 will provide active stimulation, while channel 2 will remain inactive.
Sham Transcutaneous medial plantar nerve stimulation (T-MPNS)
Sham T-MPNS group will be stimulated using the same electrotherapy device, with patients positioned identically and electrodes placed in the same positions as in the T-MPNS group. The current characteristics (pulse frequency 20 Hz and pulse width 200 ms) will also remain consistent across both channels. The second channel of the stimulation device will be designated as the channel connected to the patient but without delivering stimulation.
Eligibility Criteria
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Inclusion Criteria
* Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks
* Able to understand the procedures, advantages and possible side effects
* Willing and able to complete the voiding diary and QoL questionnaire
* The strength of pelvic floor muscles 3/5 and more
Exclusion Criteria
* History of conservative therapy (T-MPNS and Transcutaneous Tibial Nerve Stimulation/PTNS) within 6 months
* Pregnancy or intention to become pregnant during the study
* Current vulvovaginitis or urinary tract infections or malignancy
* Anatomic or posttraumatic malformations/skin disorders of medial plantar nerve region on inner foot that cannot allow to apply the electrodes
* More than stage 2 according to the pelvic organ prolapse quantification (POP-Q)
* Cardiac pacemaker, implanted defibrillator
* Previous urogynecological surgery within 3 months
* Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
* Ultrasonographic evidence of post-void residual volume more than 100 ml
18 Years
FEMALE
No
Sponsors
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Pamukkale University
OTHER
Responsible Party
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Necmettin Yildiz
Professor Doctor
Principal Investigators
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Necmettin Yıldız, Prof.
Role: STUDY_DIRECTOR
Pamukkale University
Locations
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Pamukkale University
Denizli, , Turkey (Türkiye)
Countries
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Central Contacts
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References
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Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Int Urogynecol J. 2017 Feb;28(2):191-213. doi: 10.1007/s00192-016-3123-4. Epub 2016 Dec 5.
C.K. Harding, M.C. Lapitan, S. Arlandis, K. Bø, H. Cobussen-Boekhorst, E. Costantini, et al. The European Association of Urology (EAU) Guidelines. EAU Guidelines on Management of Non-Neurogenic Female Lower Urinary Tract Symptoms. In: EAU Guidelines, 2023 (Internet). Available online at: https://uroweb.org/guidelines/non-neurogenic-female-luts
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Other Identifiers
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PamukkaleU.ftr-NYıldız-2
Identifier Type: -
Identifier Source: org_study_id