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Completed

NCT Number: NCT02731339

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

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal Mouse® measurement

Device

The sagittal thoracic spinal curvature and mobility of all participants were assessed with Spinal Mouse® (Idiag, Fehraltorf, Switzerland) in standing position.

Low back pain intensity measurement

Behavioral

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

Urogenital symptoms measurement

Behavioral

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

Disability caused by low back pain

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ataturk Training and Research Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 7, 2016
Registry last updated
Apr 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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