Tibial Nerve and Extracorporeal Magnetic Stimulation for Overactive Bladder
NCT ID: NCT05387824
Last Updated: 2022-11-01
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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UNKNOWN
NA
66 participants
INTERVENTIONAL
2022-06-02
2022-11-15
Brief Summary
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Non-pharmacologic treatment methods are evaluated in two groups as active and passive methods. Active methods which active participation of the patient is required during treatment are Pelvic floor muscle exercise (PFME), biofeedback assisted PFME, vaginal cones, while passive methods are Electrical Stimulation, extracorporeal Magnetic Stimulation (MStim) and Transcutaneous Tibial Nerve Stimulation (TTNS) techniques.
In this study, investigators aim to evaluate the effectiveness of TTNS and extracorporeal MStim, which are noninvasive methods, added to bladder training (BT) in women with OAB, with a prospective randomized controlled research method.
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Detailed Description
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Participants will be informed about the purpose and contents of the study and all women give written consent to participate. By using a random number generator, all participants who include the study will be randomized into three groups as follows: The Group 1 will receive BT program alone, the Group 2 will be applied to BT plus TTNS, The Group 3 was applied to BT plus MStim.
Group 1: BT - Control group:
All women will be informed about BT for 30 minutes. Then it will be given as a written brochure to be implemented as a home program.
BT, consisting of four stages, will not contain any PFMT programs in anyone of three groups.
Group 2: BT plus TTNS:
Two self-adhesive surface electrodes will be positioned according to the protocol previously used with the negative electrode 2 cm behind the medial malleolus and positive electrode 10 cm proximal. Correct positioning will be determined by noting a hallux reaction (plantar flexion of great toe or fanning of all toes). The stimulation protocol will be delivered at fixed 20 Hz and pulse width 200 ms in continous mode in accordance with the PTNS stimulation protocol. The intensity of the stimulation current (range 0-50 mA) will be determined once correct positioning was established, according to the comfort level of the person. TTNS sessions will be performed twice a week for 6 weeks. Every session will be lasted 30 min. Treatment will consist of 12 sessions of stimulation.
Group 3: BT plus MStim:
Pariticipants will be told to sit on the chair with a magnetic coil below the chair. When a volume conductor is in serted by this magnetic field, an eddy current flow is generated. This eddy current stimulates nerve or muscle of the pelvic floor. To apply MStim, the device will be set to generate its maximum stimuli, with a stimulation pulse width of 200 μs and a stimulation repetition cycle of 10 Hz in accordance with the literature (10,13-15). When setting the device at each treatment session, participants will be interviewed so that they'll receive stimuli at the maximum stimulation intensity (maximum tolerable stimulation intensity). MStim will be applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks. MStim sessions will be performed by other physician.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1: Bladder Training - Control group
BT, consisting of four stages, won't contain any PFMT programs in all groups. In these stages, including urgency supression strategies, it was aimed to delay urination, to inhibit detrusor contraction and to prevent urgency; by squeezing the PFM several times in a row (women will be encouraged to pause/ stop their work, sit down if possible, relax the entire body and squeeze PFM repeatedly), breathing deeply, giving their attention to another job for a while and self-motivating (I can do it, I can check the urination, etc.).
Bladder Training
Control group All women were informed about BT for 30 minutes. Then it was given as a written brochure to be implemented as a home program.
BT, consisting of four stages, did not contain any PFMT programs in two groups.
Group 2: Bladder Training + TTNS
Two self-adhesive surface electrodes will be positioned according to the protocol which previously explained, with the negative electrode 2 cm behind the medial malleolus and positive electrode 10 cm proximal. Correct positioning wil be determined by noting a hallux reaction (plantar flexion of great toe or fanning of all toes). The stimulation protocol will be delivered at fixed 20 Hz and pulse width 200 ms in continous mode in accordance with the PTNS stimulation protocol. The intensity of the stimulation current (range 0-50 mA) will be determined once correct positioning are established, according to the comfort level of the person. TTNS sessions will be performed twice a week for 6 weeks. Every session will be lasted 30 min. Treatment will consist of 12 sessions of stimulation.
Electrical Stimulation- TTNS
TTNS were performed 2 days a week, for 30 min a day, for a total of 12 sessions for 6 weeks.
Bladder Training
Control group All women were informed about BT for 30 minutes. Then it was given as a written brochure to be implemented as a home program.
BT, consisting of four stages, did not contain any PFMT programs in two groups.
Group 3: Bladder Training + MStim
Patients are told to sit on the chair with a magnetic coil below the chair. When a volume conductor is in serted by this magnetic field, an eddy current flow is generated. This eddy current stimulates nerve or muscle of the pelvic floor. To apply MS, the device will be set to generate its maximum stimuli, with a stimulation pulse width of 200 μs and a stimulation repetition cycle of 10 Hz in accordance with the literature. When setting the device at each treatment session, patients will be interviewed so that they receive the stimuli at the maximum stimulation intensity (maximum tolerable stimulation intensity) .
Magnetic stimulation -Armchair type MS • NovaMag NT-60
MS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks.
Bladder Training
Control group All women were informed about BT for 30 minutes. Then it was given as a written brochure to be implemented as a home program.
BT, consisting of four stages, did not contain any PFMT programs in two groups.
Interventions
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Magnetic stimulation -Armchair type MS • NovaMag NT-60
MS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks.
Electrical Stimulation- TTNS
TTNS were performed 2 days a week, for 30 min a day, for a total of 12 sessions for 6 weeks.
Bladder Training
Control group All women were informed about BT for 30 minutes. Then it was given as a written brochure to be implemented as a home program.
BT, consisting of four stages, did not contain any PFMT programs in two groups.
Eligibility Criteria
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Inclusion Criteria
* Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks Able to give written, informed consent Able to understand the precedures, advantages and possible side effects Willing and able to complate the voiding diary and QoL questionnaire The strength of PFM 3/5 and more
Exclusion Criteria
* Pregnancy or intention to become pregnant during the study Current vulvovaginitis or urinary tract infections or malignancy
* More than stage 2 according to the pelvic organ prolapse quantification (POP-Q)
* Cardiac pacemaker, implanted defibrillator, coronary artery stent
* Ongoing treatment for arrhythmia
* Lower abdominal pain or dysmenorrhea
* yet to be diagnosed Electronic device or metallic implant applied to areas between the lumbar region and lower extremities
* Previous urogyneceological surgery within 3 months
* Ongoing surgical treatment or treatment with implantable devices for urinary incontinence or use of intrauterin copper devices
* Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
* Ultrasonographic evidence of PVR volume more than 100 ml
18 Years
90 Years
FEMALE
Yes
Sponsors
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Pamukkale University
OTHER
Responsible Party
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Necmettin Yildiz
Professor Medical Doctor
Locations
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Pamukkale University
Denizli, Kınıklı, Turkey (Türkiye)
Countries
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Facility Contacts
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References
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Yildiz N, Oztekin SNS, Akkoc Y. Comparison of Magnetic and Transcutaenous Tibial Nerve Stimulation Added to Bladder Training for Overactive Bladder: A Randomized Controlled Trial. Int Urogynecol J. 2025 Jul 7. doi: 10.1007/s00192-025-06215-w. Online ahead of print.
Other Identifiers
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sn 60116787-020/59365
Identifier Type: -
Identifier Source: org_study_id
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