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

Primary Purpose

Urinary Bladder, Overactive, Lower Urinary Tract Symptoms, Pelvic Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Medium frequency electrotherapy (interferential currents)
No treatment
Sponsored by
Fisioterapia Pélvica Avanzada Madrid, SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring urgency, frequency, overactive bladder, LUTS, pelvic pain, electrostimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Group-A

    Group-B

    Arm Description

    No treatment

    Medium frequency electrotherapy (interferential currents)

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    urge urinary incontinence
    is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Measured with 24 hour voiding diary.
    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.
    nocturia
    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
    the individual feels an early and persistent desire to void. Measured with 24 hour voiding diary.
    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.
    nocturnal enuresis
    is the complaint of loss of urine occurring during sleep. Measured with 24 hour voiding diary.
    incontinence
    is the complaint of any involuntary leakage of urine. Measured with 24 hour voiding diary.
    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.

    Full Information

    First Posted
    April 16, 2018
    Last Updated
    April 26, 2018
    Sponsor
    Fisioterapia Pélvica Avanzada Madrid, SRL
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03520166
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 10, 2014 (Actual)
    Primary Completion Date
    June 15, 2017 (Actual)
    Study Completion Date
    June 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fisioterapia Pélvica Avanzada Madrid, SRL

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Bladder, Overactive, Lower Urinary Tract Symptoms, Pelvic Pain
    Keywords
    urgency, frequency, overactive bladder, LUTS, pelvic pain, electrostimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Quasi-experimental, longitudinal, pre-/post-. Level of evidence II/III.
    Masking
    None (Open Label)
    Masking Description
    Type inclusion was consecutively type
    Allocation
    Non-Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group-A
    Arm Type
    Placebo Comparator
    Arm Description
    No treatment
    Arm Title
    Group-B
    Arm Type
    Experimental
    Arm Description
    Medium frequency electrotherapy (interferential currents)
    Intervention Type
    Other
    Intervention Name(s)
    Medium frequency electrotherapy (interferential currents)
    Intervention Description
    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
    Intervention Name(s)
    No treatment
    Intervention Description
    No treatment
    Primary Outcome Measure Information:
    Title
    urgency
    Description
    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.
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    urge urinary incontinence
    Description
    is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Measured with 24 hour voiding diary.
    Time Frame
    24 hours
    Title
    increased daytime frequency
    Description
    is the complaint by the patient who considers that he/she voids too often by day. Measured with 24 hour voiding diary.
    Time Frame
    24 hours
    Title
    nocturia
    Description
    is the complaint that the individual has to wake at night one or more times to void. Measured with 24 hour voiding diary.
    Time Frame
    24 hours
    Title
    increased bladder sensation
    Description
    the individual feels an early and persistent desire to void. Measured with 24 hour voiding diary.
    Time Frame
    24 hours
    Title
    feeling of incomplete emptying
    Description
    is a self-explanatory term for a feeling experienced by the individual after passing urine. Measured with 24 hour voiding diary.
    Time Frame
    24 hours
    Title
    nocturnal enuresis
    Description
    is the complaint of loss of urine occurring during sleep. Measured with 24 hour voiding diary.
    Time Frame
    24 hours
    Title
    incontinence
    Description
    is the complaint of any involuntary leakage of urine. Measured with 24 hour voiding diary.
    Time Frame
    24 hours
    Title
    pelvic pain
    Description
    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.
    Time Frame
    24 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cristina Naranjo-Ortiz, Ph.D
    Organizational Affiliation
    Fisioterapia Pelvica Avanzada Madrid, SRL
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Individual participant data will not be shared with other researchers
    Citations:
    PubMed Identifier
    29426587
    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.
    Results Reference
    background
    PubMed Identifier
    12559262
    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.
    Results Reference
    result

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

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