Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07366918

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

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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 (PFM) strength of 3/5 or higher (modified Oxford scale, minimum: 0 - maximum: 5)
Not Eligible

You will not qualify if you...

  • 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
  • Those with allergies to condoms or lubricating gels used with a vaginal probe or perineometer

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Pamukkale University

Denizli, Turkey (Türkiye)

Actively Recruiting

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Research Team

R

Rabia Melis Gundogan M.D.

CONTACT

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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