Use of Medium Frequency Electrotherapy in the Treatment of OAB, LUTS and Pelvic Pain

Overview

The aim of this study is to assess the effectiveness of medium frequency electrotherapy (interferential currents) treatment for overactive bladder (OAB), lower urinary tract symptoms (LUTS) and pelvic pain

Full Title of Study: “Treatment of Overactive Bladder, Lower Urinary Tract Symptoms and Pelvic Pain With Medium Frequency Electrotherapy (Interferential Currents)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 15, 2017

Detailed Description

This study consists of 100 women, complaining of increased bladder sensation and urgency with or without incontinence as principal symptomatology and who had not received previous pharmacological treatment. Group-A was used as a control group (n = 50). Group-B patients received 18 sessions of medium frequency electrotherapy during 9 weeks, 2 weekly sessions

Interventions

  • Other: Medium frequency electrotherapy (interferential currents)
    • Treatment with medium frequency electrotherapy, interferential currents between 5500 Hz and 8500 Hz (Combi-200®, Gymna®), was performed using transvaginal application. The frequency was increased progressively over the first six sessions (twice a week), starting with a frequency of 5500 Hz until reaching a frequency of 8500 Hz, which remained until the end of treatment.
  • Other: No treatment
    • No treatment

Arms, Groups and Cohorts

  • Placebo Comparator: Group-A
    • No treatment
  • Experimental: Group-B
    • Medium frequency electrotherapy (interferential currents)

Clinical Trial Outcome Measures

Primary Measures

  • urgency
    • Time Frame: 24 hours
    • with or without urge incontinence, usually with frequency and nocturia, can be described as the overactive bladder syndrome, urge syndrome or urgency-frequency syndrome. Measured with 24 hour voiding diary.

Secondary Measures

  • urge urinary incontinence
    • Time Frame: 24 hours
    • is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Measured with 24 hour voiding diary.
  • increased daytime frequency
    • Time Frame: 24 hours
    • is the complaint by the patient who considers that he/she voids too often by day. Measured with 24 hour voiding diary.
  • nocturia
    • Time Frame: 24 hours
    • is the complaint that the individual has to wake at night one or more times to void. Measured with 24 hour voiding diary.
  • increased bladder sensation
    • Time Frame: 24 hours
    • the individual feels an early and persistent desire to void. Measured with 24 hour voiding diary.
  • feeling of incomplete emptying
    • Time Frame: 24 hours
    • is a self-explanatory term for a feeling experienced by the individual after passing urine. Measured with 24 hour voiding diary.
  • nocturnal enuresis
    • Time Frame: 24 hours
    • is the complaint of loss of urine occurring during sleep. Measured with 24 hour voiding diary.
  • incontinence
    • Time Frame: 24 hours
    • is the complaint of any involuntary leakage of urine. Measured with 24 hour voiding diary.
  • pelvic pain
    • Time Frame: 24 hours
    • is less well defined than, for example, bladder, urethral or perineal pain and is less clearly related to the micturition cycle or to bowel function and is not localised to any single pelvic organ. Measured with pain visual analogic pain scale single-item scale.

Participating in This Clinical Trial

Inclusion Criteria

Increased bladder sensation Urgency Overactive bladder Lower urinary tract symptoms Pelvic pain Exclusion Criteria:

Neurogenic bladder Acute urinary infection Pelvic floor surgery Congenital urological malformations Age less than 18 years Bladder organic pathology Pelvic radiotherapy

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fisioterapia Pélvica Avanzada Madrid, SRL
  • Provider of Information About this Clinical Study
    • Principal Investigator: Cristina Naranjo Ortiz, Principal Investigator – Fisioterapia Pélvica Avanzada Madrid, SRL
  • Overall Official(s)
    • Cristina Naranjo-Ortiz, Ph.D, Principal Investigator, Fisioterapia Pelvica Avanzada Madrid, SRL

References

Almeida CC, Silva VZMD, Junior GC, Liebano RE, Durigan JLQ. Transcutaneous electrical nerve stimulation and interferential current demonstrate similar effects in relieving acute and chronic pain: a systematic review with meta-analysis. Braz J Phys Ther. 2018 Sep-Oct;22(5):347-354. doi: 10.1016/j.bjpt.2017.12.005. Epub 2018 Feb 2.

Citations Reporting on Results

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.

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