Clinical trial NCT03520166: Use of Medium Frequency Electrotherapy in the Treatment of OAB, LUTS and Pelvic Pain
Official title: Treatment of Overactive Bladder, Lower Urinary Tract Symptoms and Pelvic Pain With Medium Frequency Electrotherapy (Interferential Currents)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Pelvic Pain
Keywords: urgency
frequency
overactive bladder
LUTS
pelvic pain
electrostimulation
Lead sponsor: Fisioterapia Pélvica Avanzada Madrid, SRL
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental, longitudinal, pre-/post-. Level of evidence II/III.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: urgency
timeFrame: 24 hours
Secondary outcomes:
measure: urge urinary incontinence
timeFrame: 24 hours
measure: increased daytime frequency
timeFrame: 24 hours
measure: nocturia
timeFrame: 24 hours
measure: increased bladder sensation
timeFrame: 24 hours
measure: feeling of incomplete emptying
timeFrame: 24 hours
measure: nocturnal enuresis
timeFrame: 24 hours
measure: incontinence
timeFrame: 24 hours
measure: pelvic pain
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Fisioterapia Pelvica Avanzada Madrid, SRL
name: Cristina Naranjo-Ortiz, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.