Status:
COMPLETED
Pelvic Floor Magnetic Stimulation in Women With Idiopathic Overactive Bladder
Lead Sponsor:
Pamukkale University
Conditions:
Urge Incontinence Episodes After the Magnetic Stimulation Added to Bladder Training in Women With Idiopathic Overactive Bladder
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
In clinical practice, Bladder Training (BT) and Magnetic stimulation (MS) are frequently used together in the treatment of women with idiopathic overactive bladder (OAB). Up to our knowledge, there is...
Detailed Description
This study is a prospectively randomized, controlled trial. The trial is held at Urogynecological Rehabilitation Unit of University Hospital, Physical Medicine and Rehabilitation Department between Se...
Eligibility Criteria
Inclusion
- 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 procedures, advantages and possible side effects
- Willing and able to complete the voiding diary and QoL questionnaire
- The strength of PFM 3/5 and more
Exclusion
- 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
- 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 urogynecological surgery within 3 months
- Ongoing surgical treatment or treatment with implantable devices for urinary incontinence or use of intrauterine copper devices
- Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
- Ultrasonographic evidence of post voiding residual volume more than 100 ml
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2021
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04450511
Start Date
September 1 2020
End Date
November 29 2021
Last Update
November 1 2022
Active Locations (1)
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1
Pamukkale University
Denizli, Kınıklı, Turkey (Türkiye), 20100