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

Overview

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).

Interventions

• Other 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).
• Other 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
• Other 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

Primary outcome measures

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

Secondary outcome measures (10)

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Other

Study locations

Turkey (Türkiye) · 1 center

• Pamukkale University — Denizli

Identifiers

NCT: NCT07366918 · E-60116787-020-728459

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗