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

Treatment of Overactive Bladder, Lower Urinary Tract Symptoms and Pelvic Pain With Medium Frequency Electrotherapy (Interferential Currents)

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

Study Overview

• Status: Completed
• Conditions: Urinary Bladder, Overactive; Lower Urinary Tract Symptoms; Pelvic Pain
• Intervention / Treatment: Other: No treatment; Other: Medium frequency electrotherapy (interferential currents)

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Group-A; No treatment	Other: No treatment; No treatment
EXPERIMENTAL: Group-B; Medium frequency electrotherapy (interferential currents)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urgency	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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urge urinary incontinence	is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Measured with 24 hour voiding diary.	24 hours
increased daytime frequency	is the complaint by the patient who considers that he/she voids too often by day. Measured with 24 hour voiding diary.	24 hours
nocturia	is the complaint that the individual has to wake at night one or more times to void. Measured with 24 hour voiding diary.	24 hours
increased bladder sensation	the individual feels an early and persistent desire to void. Measured with 24 hour voiding diary.	24 hours
feeling of incomplete emptying	is a self-explanatory term for a feeling experienced by the individual after passing urine. Measured with 24 hour voiding diary.	24 hours
nocturnal enuresis	is the complaint of loss of urine occurring during sleep. Measured with 24 hour voiding diary.	24 hours
incontinence	is the complaint of any involuntary leakage of urine. Measured with 24 hour voiding diary.	24 hours
pelvic pain	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.	24 hours

Collaborators and Investigators

• Sponsor: Fisioterapia Pélvica Avanzada Madrid, SRL
• Investigators: Principal Investigator: Cristina Naranjo-Ortiz, Ph.D, Fisioterapia Pelvica Avanzada Madrid, SRL

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2014
• Primary Completion (ACTUAL): June 15, 2017
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: April 26, 2018
• First Posted (ACTUAL): May 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: overactive bladder; LUTS; urgency; pelvic pain; frequency; electrostimulation
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Urological Manifestations; Pain; Neurologic Manifestations; Urinary Bladder, Overactive; Lower Urinary Tract Symptoms; Pelvic Pain
• Other Study ID Numbers: FPA01/2014; 1.010.817 (OTHER_GRANT: FUNDACION ALFONSO X)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No