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

Pamukkale University

Status: Enrolling

Conditions: Urinary Bladder, Overactive

Treatments: Other: Bladder Training + Intravaginal ES; Other: BT; Other: Bladder Training + Perineal ES

Study type: Interventional

Funder types: Other

Identifiers

NCT07366918

E-60116787-020-728459

Details and patient eligibility

About

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).

Enrollment: 63 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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63 participants in 3 patient groups

BT + Intravaginal ES

Experimental group

Description:

In this group, IVES will be administered in addition to BT. IVES will be performed in the lithotomy position using a vaginal probe and a stimulation device (Enraf Nonius Myomed 632). 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) . IVES sessions will be performed by a physical medicine and rehabilitation physician.

Treatment:

Other: Bladder Training + Intravaginal ES

BT + Perineal ES

Experimental group

Description:

Perineal ES will be administered in the lithotomy position using a combined electrotherapy stimulation device with surface electrodes (Enraf Nonius Myomed 632). 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 cm diameter surface electrodes will be used: four electrodes symmetrically in the perianal region and one electrode (ground-neutral electrode) on the leg. Patients will not perform voluntary contractions during ES. Surface electrodes will be used individually for each patient. Perineal ES sessions will be performed by a physical medicine and rehabilitation physician

Treatment:

Other: Bladder Training + Perineal ES

Bladder Training (BT)

Active Comparator group

Description:

All women will be informed about BT, which consists of four stages lasting 30 minutes. 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 urgency by squeezing the BT several times in a row, taking deep breaths, focusing on another task for a while, and self-motivating themselves. In the third stage, a timed voiding program will be initiated. This will be carried out in two steps: timed voiding and increasing the time between voids by keeping a voiding diary. In the final stage, women will be encouraged to continue BT

Treatment:

Other: BT