Actively Recruiting
Comparison of the Efficacy of Perineal and Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder
Led by Pamukkale University · Updated on 2026-01-26
63
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of intravaginal electrical stimulation (IVES) versus perineal electrical stimulation (ES) in women with idiopathic overactive bladder (OAB). This study aims to determine which method better improves symptoms related to incontinence and quality of life. The trial is a prospective, randomized, double-blind, placebo-controlled study involving 63 women with idiopathic OAB, divided into three groups to compare these treatments alongside bladder training. Participants are assigned to one of three groups: one receiving IVES plus bladder training, another receiving perineal ES plus bladder training, and a third group receiving bladder training alone. IVES is applied using a vaginal probe with specific electrical stimulation parameters three times a week for 20 minutes over 8 weeks. Perineal ES uses surface electrodes placed around the perianal region under similar timing and stimulation settings. Bladder training involves education and exercises designed to help manage urgency and improve bladder control, supported by a written program for home use. During the 8-week treatment period, assessments occur before and after therapy to measure changes in incontinence episodes, severity of symptoms, frequency of voiding, quality of life, anxiety, depression, sexual function, pelvic floor muscle strength, and treatment satisfaction. Researchers will also monitor side effects. The study is conducted under medical supervision with all sessions performed by trained physicians, ensuring careful adherence and safety monitoring throughout the trial.
CONDITIONS
Brief Title
Comparison of the Efficacy of Perineal and Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 strength of 3/5 or higher on the modified Oxford scale
You will not qualify if you...
- Women with pure stress urinary incontinence
- History of conservative treatment for OAB within the last 6 months (including MI, IVES, perineal ES)
- 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
- Genital area disorders that may prevent use of vaginal probe or perineal electrode
- Pelvic Organ Prolapse stage 2 or higher
- Presence of pacemaker or implanted defibrillator
- Neurogenic bladder or history of neurological disease
- Urine residual volume over 100 ml detected by ultrasound
- Allergies to condoms or lubricating gels used with vaginal probe or perineometer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive one of three interventions: Bladder Training combined with Intravaginal Electrical Stimulation, Bladder Training combined with Perineal Electrical Stimulation, or Bladder Training alone. Electrical stimulation sessions occur three days a week for 20 minutes each over 8 weeks, totaling 24 sessions. Bladder Training includes educational sessions and home-based exercises.
Three visits per week for 8 weeks for electrical stimulation sessions; initial educational session for bladder training
Duration - 1 visit at 8 weeks post-treatment
Participants are monitored for improvements in symptoms, quality of life, and side effects at 8 weeks after completing treatment.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Pamukkale University
Denizli, Turkey (Türkiye)
Actively Recruiting
Research Team
R
Rabia Melis Gundogan M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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