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

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ClinicalTrials.gov Identifier: NCT02731339
Recruitment Status : Completed
First Posted : April 7, 2016
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Device: Spinal Mouse® measurement Behavioral: Low back pain intensity measurement Behavioral: Urogenital symptoms measurement Behavioral: Disability caused by low back pain Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Study Start Date : March 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Women with Urinary incontinence Device: Spinal Mouse® measurement
The sagittal thoracic spinal curvature and mobility of all participants were assessed with Spinal Mouse® (Idiag, Fehraltorf, Switzerland) in standing position.

Behavioral: Low back pain intensity measurement
Low back pain intensity of the patients was questioned by Visual Analogue Scale

Behavioral: Urogenital symptoms measurement
The presence and severity of various urogenital symptoms was assessed with the Urogenital Distress Inventory-6

Behavioral: Disability caused by low back pain
Disability caused by low back pain was assessed with the Oswestry Disability Index

Experimental: Women without Urinary incontinence Device: Spinal Mouse® measurement
The sagittal thoracic spinal curvature and mobility of all participants were assessed with Spinal Mouse® (Idiag, Fehraltorf, Switzerland) in standing position.

Behavioral: Low back pain intensity measurement
Low back pain intensity of the patients was questioned by Visual Analogue Scale

Behavioral: Disability caused by low back pain
Disability caused by low back pain was assessed with the Oswestry Disability Index




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. Urogenital symptoms, as measured by Urogenital Distress Inventory-6 [ Time Frame: Urogenital symptoms will be followed through study completion, an average of 3 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Seyda TOPRAK CELENAY, Assistant Professor, PT, PhD, Ataturk Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02731339     History of Changes
Other Study ID Numbers: 2015-31/12
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders