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

Study Overview
=================
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.

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Device: Spinal Mouse® measurement
* Behavioral: Low back pain intensity measurement
* Behavioral: Urogenital symptoms measurement
* Behavioral: Disability caused by low back pain


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women with Urinary incontinence<br> | Device: Spinal Mouse® measurement<br>* The sagittal thoracic spinal curvature and mobility of all participants were assessed with Spinal Mouse® (Idiag, Fehraltorf, Switzerland) in standing position.<br>Behavioral: Low back pain intensity measurement<br>* Low back pain intensity of the patients was questioned by Visual Analogue Scale<br>Behavioral: Urogenital symptoms measurement<br>* The presence and severity of various urogenital symptoms was assessed with the Urogenital Distress Inventory-6<br>Behavioral: Disability caused by low back pain<br>* Disability caused by low back pain was assessed with the Oswestry Disability Index<br>|
| Experimental: Women without Urinary incontinence<br> | Device: Spinal Mouse® measurement<br>* The sagittal thoracic spinal curvature and mobility of all participants were assessed with Spinal Mouse® (Idiag, Fehraltorf, Switzerland) in standing position.<br>Behavioral: Low back pain intensity measurement<br>* Low back pain intensity of the patients was questioned by Visual Analogue Scale<br>Behavioral: Disability caused by low back pain<br>* Disability caused by low back pain was assessed with the Oswestry Disability Index<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal curve and mobility, as measured by Spinal Mouse® device |  | spinal curve and mobility will be followed through study completion, an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low back pain, as measured by Visual Analog Scale |  | Low back pain will be followed through study completion, an average of 3 months | 
| Disability caused by low back pain, as measured by Oswestry Disability Index |  | Disability will be followed through study completion, an average of 3 months | 
| Urogenital symptoms, as measured by Urogenital Distress Inventory-6 |  | Urogenital symptoms will be followed through study completion, an average of 3 months |