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CompletedNCT02731339Updated Apr 8, 2016

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

An interventional study of Spinal Mouse® measurement and Low back pain intensity measurement in Urinary Incontinence, sponsored by Ataturk Training and Research Hospital. Completed. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-08.

Sponsored by Ataturk Training and Research Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Urinary Incontinence
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 73 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Ataturk Training and Research Hospital is the lead sponsor of 23 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
73 participants (actual)

Study arms

  • Experimental
    Women with Urinary incontinence

    Device: Spinal Mouse® measurement · Behavioral: Low back pain intensity measurement · Behavioral: Urogenital symptoms measurement · Behavioral: Disability caused by low back pain

  • Experimental
    Women without Urinary incontinence

    Device: Spinal Mouse® measurement · Behavioral: Low back pain intensity measurement · Behavioral: Disability caused by low back pain

Interventions

  • DeviceSpinal Mouse® measurement

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

  • BehavioralLow back pain intensity measurement

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

  • BehavioralUrogenital symptoms measurement

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

  • BehavioralDisability caused by low back pain

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

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02731339
Lead sponsor
Ataturk Training and Research Hospital
Responsible party
Seyda TOPRAK CELENAY (Assistant Professor, PT, PhD, Ataturk Training and Research Hospital) — Principal investigator
First posted
Apr 7, 2016
Start date
Mar 2015
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Apr 8, 2016
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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