Status:
COMPLETED
Intravaginal Electrical Stimulation With Different Treatment Frequency in Women With Idiopathic Overactive Bladder
Lead Sponsor:
Pamukkale University
Conditions:
Overactive Bladder
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Electrical stimulation (ES) is one of the techniques used in urogynecological physiotherapy, which uses implanted or non-implanted electrodes. Intravaginal ES (IVES) is a conservative treatment option...
Detailed Description
This study is a prospective, randomized controlled trial. The trial is held at Urogynecological Rehabilitation Unit of Physical Medicine and Rehabilitation Department between February 2021 and July 20...
Eligibility Criteria
Inclusion
- Women ≥ 18 years old with clinical diagnosis of idiopathic overactive bladder
- 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 quality of life questionnaire
- The strength of pelvic floor muscle score 3/5 and more
Exclusion
- Women with stress urinary incontinence
- History of conservative therapy for idiopathic overactive bladder within 6 months
- 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
- More than stage 2 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 post-void residual urine volume \> 100 ml
- Allergy to condom or lubricant gel that is used with perineometer/vaginal probe
Key Trial Info
Start Date :
February 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04734301
Start Date
February 5 2021
End Date
July 15 2021
Last Update
November 1 2022
Active Locations (1)
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1
Pamukkale University
Denizli, Kınıklı, Turkey (Türkiye), 20100