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

April 7, 2016 updated by: Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
spinal curve and mobility will be followed through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: Disability will be followed through study completion, an average of 3 months
Disability will be followed through study completion, an average of 3 months
Urogenital symptoms, as measured by Urogenital Distress Inventory-6
Time Frame: Urogenital symptoms will be followed through study completion, an average of 3 months
Urogenital symptoms will be followed through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

April 2, 2016

First Posted (Estimate)

April 7, 2016

Study Record Updates

Last Update Posted (Estimate)

April 8, 2016

Last Update Submitted That Met QC Criteria

April 7, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-31/12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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