Comparison of the Efficacy of Perineal and Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Pamukkale University
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Improvement in rate incontinence episodes
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
BT + Intravaginal ES
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.
Intervention: Intravaginal ES (Other)
BT + Perineal ES
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
Intervention: Perineal ES (Other)
Bladder Training (BT)
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
Intervention: BT (Other)
Outcomes
Primary Outcomes
Improvement in rate incontinence episodes
Time Frame: Change from baseline Improvement in incontinence episodes at the 8th week after the treatment
Reduction in incontinence episodes will be collected. Women with ≥50% reduction in incontinence episodes will be considered positive responders
Improvement in incontinence episodes
Time Frame: Change from baseline Improvement in incontinence episodes at the 8th week after the treatment
Reduction in incontinence episodes will be collected. Women with ≥50% reduction in incontinence episodes will be considered positive responders
Secondary Outcomes
- The 24-hour pad test(Change from baseline the severity of incontinence at the 8th week after the treatment)
- The severity of incontinence(Change from baseline the severity of incontinence at the 8th week after the treatment)
- Symptom severity(Change from baseline symptom severity at the 8th week after the treatment)
- The Quality of Life(Change from baseline the Quality of Life at the 8th week after the treatment)
- Frequency of voiding, nocturia, number of pads(Change from baseline Frequency of voiding, nocturia, number of pads at the 8th week after the treatment)
- Anxiety and Depression level(Change from baseline anxiety and Depression level at the 8th week after the treatment)
- Cure and improvement rates(Change from baseline cure and improvement rates at the 8th week after the treatment)
- Assessment of sexual functions Assessment of sexual functions(Change from baseline assessment of sexual functions at the 8th week after the treatment)
- Treatment Satisfaction Level(Change from baseline Treatment Satisfaction Level at the 8th week after the treatment)
- Pelvic Floor Muscle (PFM) Strength(Change from baseline Pelvic Floor Muscle (PFM) Strength at the 8th week after the treatment)
- Side Effects(8th week)
Investigators
Necmettin Yildiz
Professor Doctor
Pamukkale University