NCT04734301

Intravaginal Electrical Stimulation With Different Treatment Frequency in Women With Idiopathic Overactive Bladder

Completed NA Last updated 1 November 2022

What this trial tests

NA trial testing Intravaginal Electrical Stimulation (2 times/week) in Overactive Bladder in 52 participants. Completed in 15 July 2021.

Timeline

5 February 2021

Primary endpoint
30 June 2021

15 July 2021

Quick facts

Lead sponsor	Pamukkale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	52
Start date	5 February 2021
Primary completion	30 June 2021
Estimated completion	15 July 2021
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Intravaginal Electrical Stimulation (2 times/week)
• Intravaginal Electrical Stimulation (5 times/week)

Conditions studied

• Overactive Bladder — all drugs for Overactive Bladder →

Sponsor

Pamukkale University

Who can join

18 and older, female only, with Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Electrical stimulation (ES) is one of the techniques used in urogynecological physiotherapy, which uses implanted or non-implanted electrodes. Intravaginal ES (IVES) is a conservative treatment option, described more than 40 years ago. IVES is used in patients with OAB and urge urinary incontinence (UUI), for detrusor inhibition. It has been suggested that IVES probably targets the detrusor muscle or pelvic floor muscle (PFM) or afferent innervation in UUI. According to the European Association Urology (EAU) Guidelines; in adults with urinary incontinence, ES may improve urinary incontinence compared to sham treatment. The IVES programs lasted between 4 weeks and 6 months in women with idiopathic OAB, although generally IVES was applied for 4-12 weeks. In most studies, IVES was applied 2-3 times a week, whereas in fewer studies it was applied more frequently. Despite that, no randomised studies compared different treatment frequencies in women with idiopathic OAB and thus, there is no evidence of which frequencies of treatment are the most effective ones. It should be kept in mind that different stimulation frequency may lead to different results. In addition, in the light of scientific evidence and our clinical experience, we think that this issue is still open for research. Better methodological quality studies are needed to obtain a higher level of scientific evidence and to know the optimal treatment frequency for OAB.

Our study is the first prospective randomized controlled trial that compares the efficacy of IVES with different treatment frequency in women with idiopathic OAB. In this study, we aimed to assess the efficacy of 2 times and 5 times in a week IVES added to BT on quality of life (QoL) and clinical parameters asssociated with idiopathic OAB. The results of the our study will be of great benefit in deciding or preferring the treatment frequency and total treatment duration of IVES for the women with idiopathic OAB and their physicians.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy of intravaginal electrical stimulation with different treatment frequency in women with refractory idiopathic overactive bladder.
   Yildiz N, Alkan H, Findikoglu G. · · 2022 · cited 1× · PMID 35363455 · DOI 10.1590/s1677-5538.ibju.2021.0837