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

NCT ID: NCT03520166

Last Updated: 2018-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-10

Study Completion Date

2017-06-30

Brief Summary

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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

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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

Conditions

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Urinary Bladder, Overactive Lower Urinary Tract Symptoms Pelvic Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Quasi-experimental, longitudinal, pre-/post-. Level of evidence II/III.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Type inclusion was consecutively type

Study Groups

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Group-A

No treatment

Group Type PLACEBO_COMPARATOR

No treatment

Intervention Type OTHER

No treatment

Group-B

Medium frequency electrotherapy (interferential currents)

Group Type EXPERIMENTAL

Medium frequency electrotherapy (interferential currents)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

No treatment

No treatment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fisioterapia Pélvica Avanzada Madrid, SRL

OTHER

Sponsor Role lead

Responsible Party

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Cristina Naranjo Ortiz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cristina Naranjo-Ortiz, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Fisioterapia Pelvica Avanzada Madrid, SRL

References

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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.

Reference Type BACKGROUND
PMID: 29426587 (View on PubMed)

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.

Reference Type RESULT
PMID: 12559262 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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1.010.817

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FPA01/2014

Identifier Type: -

Identifier Source: org_study_id

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