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

Not Applicable

Completed

• Conditions: Urinary Bladder, Overactive; Pelvic Pain; Lower Urinary Tract Symptoms
• Interventions: Other: No treatment; Other: Medium frequency electrotherapy (interferential currents)

• Registration Number: NCT03520166
• Lead Sponsor: Fisioterapia Pélvica Avanzada Madrid, SRL

Brief Summary

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

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 Timeline

• Study Start: 2014-01-10
• Primary Completion: 2017-06-15
• Study Completion: 2017-06-30
• Status Verified: 2018-04
• Study First Submitted: 2018-04-16
• Study First Submitted QC: 2018-04-26
• Last Update Submitted: 2018-04-26
• Study First Posted: 2018-05-09
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-A	No treatment	No treatment
Group-B	Medium frequency electrotherapy (interferential currents)	Medium frequency electrotherapy (interferential currents)

Primary Outcome Measures

Name	Time	Method
urgency	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 Outcome Measures

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