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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPamukkale University

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Bladder Training + Intravaginal ES
  • BT
  • Bladder Training + Perineal ES

Treatment groups

63 Participants
are divided into 3 treatment groups

Sponsors and collaborators