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

Urinary Incontinence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02731339
• Other study ID #: 2015-31/12
• Status: Completed
• Phase: N/A
• First received: March 30, 2016
• Last updated: April 7, 2016
• Start date: March 2015
• Est. completion date: June 2015

Study information

• Verified date: April 2016
• Source: Ataturk Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

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
• Urogenital symptoms measurement
The presence and severity of various urogenital symptoms was assessed with the Urogenital Distress Inventory-6
• Disability caused by low back pain
Disability caused by low back pain was assessed with the Oswestry Disability Index

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Low back pain, as measured by Visual Analog Scale		Low back pain will be followed through study completion, an average of 3 months	Yes
Secondary	Disability caused by low back pain, as measured by Oswestry Disability Index		Disability will be followed through study completion, an average of 3 months	Yes
Secondary	Urogenital symptoms, as measured by Urogenital Distress Inventory-6		Urogenital symptoms will be followed through study completion, an average of 3 months	Yes