Status:
COMPLETED
Intravaginal Electrical Stimulation in Idiopathic Overactive Bladder
Lead Sponsor:
Pamukkale University
Conditions:
Idiopathic Overactive Bladder
Electrical Stimulation
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Overactive bladder (OAB) is a symptom complex defined as urgency, with or without urge urinary incontinence (UUI), usually with frequency and nocturia, in the absence of urinary tract infection. Curre...
Eligibility Criteria
Inclusion
- Women over the age of 18 with clinical diagnosis of idiopathic OAB
- Urodynamically diagnosed detrusor overactivity
- The strength of pelvic floor muscle 3/5 and more
- 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
Exclusion
- History of conservative therapy (BT, ES) for OAB within 3 months
- Previously treated with antimuscarinics (within 4 weeks)
- Pregnancy or intention to become pregnant during the study
- Current vulvovaginitis or urinary tract infections or malignancy
- History of urogynecological surgery within 3 months
- Anatomic structural disorders of genital region that could not allow to apply the vaginal probe
- Having stage 2 or more according to the pelvic organ prolapse quantification
- Cardiac pacemaker or implanted defibrillator
- Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
- Ultrasonographic evidence of residual urine volume more than 100 ml
- Allergy to condom or lubricant gel that is used with perineometer/vaginal probe
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04389307
Start Date
June 1 2020
End Date
December 31 2020
Last Update
May 25 2021
Active Locations (1)
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1
Hakan Alkan
Denizli, None Selected, Turkey (Türkiye), 20100