NCT02731339

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
Last Updated

April 8, 2016

Status Verified

April 1, 2016

Enrollment Period

3 months

First QC Date

March 30, 2016

Last Update Submit

April 7, 2016

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

Women with Urinary incontinence

EXPERIMENTAL
Device: Spinal Mouse® measurementBehavioral: Low back pain intensity measurementBehavioral: Urogenital symptoms measurementBehavioral: Disability caused by low back pain

Women without Urinary incontinence

EXPERIMENTAL
Device: Spinal Mouse® measurementBehavioral: Low back pain intensity measurementBehavioral: Disability caused by low back pain

Interventions

Spinal Mouse® measurementDEVICE

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

Women with Urinary incontinenceWomen without Urinary incontinence
Low back pain intensity measurementBEHAVIORAL

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

Women with Urinary incontinenceWomen without Urinary incontinence
Urogenital symptoms measurementBEHAVIORAL

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

Women with Urinary incontinence
Disability caused by low back painBEHAVIORAL

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

Women with Urinary incontinenceWomen without Urinary incontinence

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged between 20 and 65 years,
  • diagnosed with stress and mixed urinary incontinence
  • healthy women

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PT, PhD

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 7, 2016

Study Start

March 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 8, 2016

Record last verified: 2016-04