Tibial Nerve and Extracorporeal Magnetic Stimulation for Overactive Bladder
Idiopathic Overactive Bladder, Bladder Training, Transcutaneous Tibial Nerve Stimulation
About this trial
This is an interventional treatment trial for Idiopathic Overactive Bladder
Eligibility Criteria
Inclusion Criteria:
- Women over the age of 18 with clinical diagnosis of idiopathic OAB Urodynamically confirmed detrusor overactivity (the presence of detrusor contractions in the filling phase of saline cystometry)
- 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:
- History of BT, MS therapy
- 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
Sites / Locations
- Pamukkale UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Group 1: Bladder Training - Control group
Group 2: Bladder Training + TTNS
Group 3: Bladder Training + MStim
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.).
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.
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) .