Urinary IncontinenceNCT02731339
Spinal Curvature, Mobility, and Low Back Pain Relationship in Women With and Without Urinary Incontinence
A study testing Spinal Mouse® measurement, Low back pain intensity measurement and Urogenital symptoms measurement in people with Urinary Incontinence, run by Ataturk Training and Research Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Spinal Mouse® measurement, Low back pain intensity measurement and Urogenital symptoms measurement
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged between 20 and 65 years,
- diagnosed with stress and mixed urinary incontinence
- healthy women
Who cannot join
- 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
About this study
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
- Being tested
- Spinal Mouse® measurement, Low back pain intensity measurement, Urogenital symptoms measurement, Disability caused by low back pain
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Mouse® measurementDevice
The sagittal thoracic spinal curvature and mobility of all participants were assessed with Spinal Mouse® (Idiag, Fehraltorf, Switzerland) in standing position.
Low back pain intensity measurementBehavioural
Low back pain intensity of the patients was questioned by Visual Analogue Scale
Urogenital symptoms measurementBehavioural
The presence and severity of various urogenital symptoms was assessed with the Urogenital Distress Inventory-6
Disability caused by low back painBehavioural
Disability caused by low back pain was assessed with the Oswestry Disability Index
| Study group | Role | What they receive |
|---|---|---|
| Women with Urinary incontinence | Experimental | Not described Receives: Device: Spinal Mouse® measurement; Behavioral: Low back pain intensity measurement; Behavioral: Urogenital symptoms measurement; Behavioral: Disability caused by low back pain |
| Women without Urinary incontinence | Experimental | Not described Receives: Device: Spinal Mouse® measurement; Behavioral: Low back pain intensity measurement; Behavioral: Disability caused by low back pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal curve and mobility, as measured by Spinal Mouse® device
Measured: 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
Measured: 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
Measured: Disability will be followed through study completion, an average of 3 months
Urogenital symptoms, as measured by Urogenital Distress Inventory-6
Measured: Urogenital symptoms will be followed through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731339
- Sponsor's protocol ID
- 2015-31/12
- Status last verified
- Apr 2016
- First submitted
- 30 Mar 2016
- Last updated
- 8 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Curvature, Mobility, and Low Back Pain Relationship in Women With and Without Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02731339
- Acronym / sponsor ID
- 2015-31/12
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with Urinary incontinence | Experimental | Device: Spinal Mouse® measurement, Behavioral: Low back pain intensity measurement, Behavioral: Urogenital symptoms measurement, Behavioral: Disability caused by low back pain |
| Women without Urinary incontinence | Experimental | Device: Spinal Mouse® measurement, Behavioral: Low back pain intensity measurement, Behavioral: Disability caused by low back pain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged between 20 and 65 years,
- diagnosed with stress and mixed urinary incontinence
- healthy women
Key exclusion criteria (8 listed)
- Women with prior history of injury or surgery related to spine,
- spinal deformity,
- systemic pathology,
- any rheumatologic disease,
- neurologic condition,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Mouse® measurementThe sagittal thoracic spinal curvature and mobility of all participants were assessed with Spinal Mouse® (Idiag, Fehraltorf, Switzerland) in standing position. | Device | Women with Urinary incontinence, Women without Urinary incontinence |
| Low back pain intensity measurementLow back pain intensity of the patients was questioned by Visual Analogue Scale | Behavioural | Women with Urinary incontinence, Women without Urinary incontinence |
| Urogenital symptoms measurementThe presence and severity of various urogenital symptoms was assessed with the Urogenital Distress Inventory-6 | Behavioural | Women with Urinary incontinence |
| Disability caused by low back painDisability caused by low back pain was assessed with the Oswestry Disability Index | Behavioural | Women with Urinary incontinence, Women without Urinary incontinence |
Primary outcome
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
3 secondary outcomes
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
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
Urogenital symptoms, as measured by Urogenital Distress Inventory-6
Time frame: Urogenital symptoms will be followed through study completion, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Mouse® measurement, Low back pain intensity measurement and Urogenital symptoms measurement in people with Urinary Incontinence, run by Ataturk Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2016.