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

NCT04734301 | Completed

• 1 other identifier: E-60116787-020-4274
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overactive Bladder

Keywords

idiopathic overactive bladder; intravaginal electrical stimulation; bladder training

Outcome Measures

Primary Outcomes (1)

• Incontinence episodes-Incontinence related outcome measure

  Women with a 50% or greater reduction in incontinence episodes were considered positive responders

  20 minutes

Secondary Outcomes (9)

• Severity of incontinence-Incontinence related outcome measure

  20 sessions (each sessions is 20 minutes )

• Nocturia-Incontinence related outcome measure

  20 sessions (each sessions is 20 minutes )

• Frequency-Incontinence related outcome measure

  20 sessions (each sessions is 20 minutes )

• Number of Pads-Incontinence related outcome measure

  20 sessions (each sessions is 20 minutes )

• Symptom severity-Incontinence related outcome measure

  20 sessions (each sessions is 20 minutes )

Study Arms (2)

Group 1: IVES (2 times in a week)

ACTIVE COMPARATOR

This group included the IVES in addition to all components of the BT. IVES was performed in lithotomy position via electrical stimulation device with a vaginal probe.

Device: Intravaginal Electrical Stimulation (2 times/week)

Group 2: IVES (5 times in a week)

EXPERIMENTAL

This group also included the IVES in addition to all components of the BT as in Group 1. IVES performed in the same way as Group 1, except for frequency of treatment.

Device: Intravaginal Electrical Stimulation (5 times/week)

Interventions

Intravaginal Electrical Stimulation (2 times/week) DEVICE

IVES sessions were performed two times in a week, for 10 weeks. Every session lasted 20 minutes. The intervention comprised a 20-sessions treatment program of ES. The stimulation parameters were frequency at 10 Hz, a 5-10s work-rest cycle and 100 ms pulse width. The symmetric biphasic pulse wave could be delivered over a range of 0-100 mA. The intensity was controlled according to patients' discomfort level feedback.

Group 1: IVES (2 times in a week)

Intravaginal Electrical Stimulation (5 times/week) DEVICE

IVES performed in the same way as Group 1, except for frequency of treatment. IVES sessions were performed five times in a week, for 4 weeks. Every session lasted 20 minutes. The intervention comprised a 20-sessions treatment program of ES. Stimulation parameters were the same as Group 1.

Group 2: IVES (5 times in a week)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women ≥ 18 years old with clinical diagnosis of idiopathic overactive bladder
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ≥ 18 years old with clinical diagnosis of idiopathic overactive bladder
• Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks
• Able to give written, informed consent
• Able to understand the procedures, advantages and possible side effects
• Willing and able to complete the voiding diary and quality of life questionnaire
• The strength of pelvic floor muscle score 3/5 and more

You may not qualify if:

• Women with stress urinary incontinence
• History of conservative therapy for idiopathic overactive bladder within 6 months
• Pregnancy or intention to become pregnant during the study
• Current vulvovaginitis or urinary tract infections or malignancy
• History of urogynecological surgery within 3 months
• Anatomic structural disorders of genital region that could not allow to apply the vaginal probe
• More than stage 2 according to the pelvic organ prolapse quantification
• Cardiac pacemaker or implanted defibrillator
• Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
• Ultrasonographic evidence of post-void residual urine volume \> 100 ml
• Allergy to condom or lubricant gel that is used with perineometer/vaginal probe

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Kınıklı, 20100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 2, 2021
• Study Start: February 5, 2021
• Primary Completion: June 30, 2021
• Study Completion: July 15, 2021
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)