Comparison of the Efficacy of Perineal and Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder

Обзор

The investigators conducted a prospective, randomized double-blind, placebo-controlled study based on a placebo technique to evaluate the efficacy of IVES vs perineal ES in women with idiopathic OAB. The main questions aimed to be answered are: Is Intravaginal Electrical Stimulation (IVES) or perineal ES more effective on clinical parameters related to incontinence and quality of life in women with idiopathic overactive bladder (OAB)? Participants (n:63) with idiopathic OAB who meet the exclusion and inclusion criteria will be divided into 3 groups using a randomization table. The first group will receive IVES and bladder training (n:21), second group will receive perineal ES and bladder training (n:21) and third group will receive bladder training (n=21) . Measurements will be performed twice in total, before and at the end of treatment (8th week).

Вмешательства

• Другое Intravaginal ES
  IVES will be performed in the lithotomy position using a vaginal probe and a stimulation device . IVES will be performed three days a week for 20 minutes per day for 8 weeks, totaling 24 sessions. Stimulation parameters will be a frequency of 10 Hz, a 5-10 second work-rest cycle, and a 100 ms pulse width. A symmetrical biphasic pulse wave can be delivered in the range of 1-100 mA (based on the patient's discomfort level feedback).
• Другое BT
  A written brochure will then be provided as a program that can be implemented at home. In the first stage, women will be informed about the location of the BT, pelvic anatomy, and pathophysiology. Following this informational session, they will be demonstrated how to squeeze the BT at least once using digital palpation techniques to suppress urgency. In the second stage, which includes urgency suppression strategies, the aim is to delay urination, inhibit detrusor contraction, and prevent urgenc
• Другое Perineal ES
  Perineal ES will be administered in the lithotomy position using a combined electrotherapy stimulation device with surface electrodes. Perineal ES will be administered 20 minutes per day, 3 days per week, for 8 weeks, for a total of 24 sessions. Stimulation parameters will be 10 Hz frequency, 5-10 s work-rest cycle, and 100 µs pulse width. A symmetrical biphasic current wave can be delivered in the 1-100 mA range (depending on the patient's discomfort level feedback). In this application, five 2

Первичные конечные точки

• Improvement in rate incontinence episodes [Срок оценки: Change from baseline Improvement in incontinence episodes at the 8th week after the treatment]

Вторичные конечные точки (10)

• The 24-hour pad test [Срок оценки: Change from baseline the severity of incontinence at the 8th week after the treatment]
• Symptom severity [Срок оценки: Change from baseline symptom severity at the 8th week after the treatment]
• Frequency of voiding, nocturia, number of pads [Срок оценки: Change from baseline Frequency of voiding, nocturia, number of pads at the 8th week after the treatment]
• The Quality of Life [Срок оценки: Change from baseline the Quality of Life at the 8th week after the treatment]
• Anxiety and Depression level [Срок оценки: Change from baseline anxiety and Depression level at the 8th week after the treatment]
• Assessment of sexual functions Assessment of sexual functions [Срок оценки: Change from baseline assessment of sexual functions at the 8th week after the treatment]
• Cure and improvement rates [Срок оценки: Change from baseline cure and improvement rates at the 8th week after the treatment]
• Treatment Satisfaction Level [Срок оценки: Change from baseline Treatment Satisfaction Level at the 8th week after the treatment]
• Pelvic Floor Muscle (PFM) Strength [Срок оценки: Change from baseline Pelvic Floor Muscle (PFM) Strength at the 8th week after the treatment]
• Side Effects [Срок оценки: 8th week]

Критерии участия

Критерии включения

• Women over the age of 18 with a clinical diagnosis of idiopathic OAB
• Intolerant or unresponsive to antimuscarinic or oral β3 adrenoceptor agonist (mirabegron) medications and not using them for at least 4 weeks
• Ability to understand the procedures, advantages, and potential side effects
• Ability to provide written, informed consent
• Pelvic floor muscle (PFM) strength of 3/5 or higher (modified Oxford scale, minimum: 0 - maximum: 5)

Критерии исключения

• Women with pure stress urinary incontinence
• History of conservative treatment for OAB within the last 6 months (MI, IVES, perineal ES, etc.)
• Pregnant or planning to become pregnant at the time of the study
• Diagnosis of vaginal infection, urinary tract infection, or cancer
• Women with urinary incontinence within the last 3 months Those who have undergone urogynecological surgery
• Those with genital area disorders that may preclude the use of a vaginal probe or perineal electrode
• Those diagnosed with stage 2 or higher according to the Pelvic Organ Prolapse Assessment (POP-Q)
• Those with a pacemaker or implanted defibrillator
• Those with neurogenic bladder or a history of neurological disease
• Those with a urine residual of more than 100 ml detected by ultrasound (using an ultrasound device)
• Those with allergies to condoms or lubricating gels used with a vaginal probe or perineometer

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Pamukkale University — Denizli

Идентификаторы

NCT: NCT07366918 · E-60116787-020-728459

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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