search
Back to results

Spinal Curvature, Mobility, and Low Back Pain Relationship in Women With and Without Urinary Incontinence

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Spinal Mouse® measurement
Low back pain intensity measurement
Urogenital symptoms measurement
Disability caused by low back pain
Sponsored by
Ataturk Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urinary Incontinence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • aged between 20 and 65 years,
  • diagnosed with stress and mixed urinary incontinence
  • healthy women

Exclusion Criteria:

  • Women with prior history of injury or surgery related to spine,
  • spinal deformity,
  • systemic pathology,
  • any rheumatologic disease,
  • neurologic condition,
  • symptomatic pelvic organ prolapse,
  • malignancy,
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Women with Urinary incontinence

    Women without Urinary incontinence

    Arm Description

    Outcomes

    Primary Outcome Measures

    Spinal curve and mobility, as measured by Spinal Mouse® device

    Secondary Outcome Measures

    Low back pain, as measured by Visual Analog Scale
    Disability caused by low back pain, as measured by Oswestry Disability Index
    Urogenital symptoms, as measured by Urogenital Distress Inventory-6

    Full Information

    First Posted
    March 30, 2016
    Last Updated
    April 7, 2016
    Sponsor
    Ataturk Training and Research Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02731339
    Brief Title
    Spinal Curvature, Mobility, and Low Back Pain Relationship in Women With and Without Urinary Incontinence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ataturk Training and Research Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    The aim of this study was to investigate the relationship among sagittal spinal curvatures, mobility, and low back pain in women with and without urinary incontinence.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Incontinence

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    73 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Women with Urinary incontinence
    Arm Type
    Experimental
    Arm Title
    Women without Urinary incontinence
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Spinal Mouse® measurement
    Intervention Description
    The sagittal thoracic spinal curvature and mobility of all participants were assessed with Spinal Mouse® (Idiag, Fehraltorf, Switzerland) in standing position.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Low back pain intensity measurement
    Intervention Description
    Low back pain intensity of the patients was questioned by Visual Analogue Scale
    Intervention Type
    Behavioral
    Intervention Name(s)
    Urogenital symptoms measurement
    Intervention Description
    The presence and severity of various urogenital symptoms was assessed with the Urogenital Distress Inventory-6
    Intervention Type
    Behavioral
    Intervention Name(s)
    Disability caused by low back pain
    Intervention Description
    Disability caused by low back pain was assessed with the Oswestry Disability Index
    Primary Outcome Measure Information:
    Title
    Spinal curve and mobility, as measured by Spinal Mouse® device
    Time Frame
    spinal curve and mobility will be followed through study completion, an average of 3 months
    Secondary Outcome Measure Information:
    Title
    Low back pain, as measured by Visual Analog Scale
    Time Frame
    Low back pain will be followed through study completion, an average of 3 months
    Title
    Disability caused by low back pain, as measured by Oswestry Disability Index
    Time Frame
    Disability will be followed through study completion, an average of 3 months
    Title
    Urogenital symptoms, as measured by Urogenital Distress Inventory-6
    Time Frame
    Urogenital symptoms will be followed through study completion, an average of 3 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: aged between 20 and 65 years, diagnosed with stress and mixed urinary incontinence healthy women Exclusion Criteria: Women with prior history of injury or surgery related to spine, spinal deformity, systemic pathology, any rheumatologic disease, neurologic condition, symptomatic pelvic organ prolapse, malignancy, pregnancy

    12. IPD Sharing Statement

    Learn more about this trial

    Spinal Curvature, Mobility, and Low Back Pain Relationship in Women With and Without Urinary Incontinence

    We'll reach out to this number within 24 hrs