Overactive BladderSURFACENCT04910555
Strong Desire to Void and Balance in Older Women With Overactive Bladder
An observational study of Overactive Bladder and Urinary Incontinence, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Falls have multifactorial etiologies in older people. Lower urinary tract symptoms (LUTS) are one of those, with an increase prevalence over years (30% of people over 75 years old have overactive bladder [OAB]). Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Overactive Bladder, Urinary Incontinence
- What is being tested?
- strong desire to void - cognitive task
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 26 May 2021to 21 Jul 2022
- Phase
- Observational
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Study population: Community-dweeling women over 65 years old, with non-neurogenic OAB, with or without UI
Who may be able to join
- women;
- over 65 years old;
- with OAB with or without UI;
- able to walk without mobility aid; consent to participate in the study
Who cannot join
- neurologic pathology; history of spine surgery;
- cognitive impairment defined as a MMSE < 24;
- legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Strong Desire to Void an Equivalent of Cognitive Task Affecting Balance in Older Women With Overactive Bladder?
Falls have multifactorial etiologies in older people. Lower urinary tract symptoms (LUTS) are one of those, with an increase prevalence over years (30% of people over 75 years old have overactive bladder [OAB]). Previous studies showed that older women with OAB with or without urinary incontinence (UI) are prone to have gait disorders (decrease of gait speed and step width and increase of number of step). Besides UI, it is more likely the strong desire to void (SDV) that seems to impact gait and balance control. In older women with UI, balance on stabilometric parameters have been affected with an increase of the center of pression (COP) sway range, COP area and rambling trajectory. SDV seems to act like an additional cognitive task. A similar and increased reaction time has been observed in comparing with a distracting task in healthy volunteers. In older people who are susceptible to distracting task, SDV may alters balance and gait.
The primary objective of this prospective study is to assess the impact of SDV on stabilometric parameters (center of foot pressure (COP) area, the distance travelled made by COP, the mean X-axis displacement and the mean Y-axis displacement) compared to the "empty bladder" condition.
The secondary objectives are to assess the impact of a cognitive task (verbal fluency) on stabilometric parameters in comparison with the "no cognitive task condition" and the "SDV condition"; to assess the impact of "SDV condition" on balance and gait clinical evaluation (Timed up and go test, unipedal stance test, Berg scale, 10m walking speed, 5 chair stand) Thus, showing that SDV may impact balance in geriatric population will lead to the importance to identify and LUTS as potential fall risk factor in order to decrease falls incidence in this population.
Read the detailed description
Falls have multifactorial etiologies in older people. Lower urinary tract symptoms (LUTS) are one of those, with an increase prevalence over years (30% of people over 75 years old have overactive bladder [OAB]). Previous studies showed that older women with oAB with or without urinary incontinence (UI) are prone to have gait disorders (decrease of gait speed and step width and increase of number of step). Besides UI, it is more likely the strong desire to void (SDV) that seems to impact gait and balance control. In older women with UI, balance on stabilometric parameters has been affected with an increase of the center of pression (COP) sway range, COP area and rambling trajectory. SDV seems to act like an additional cognitive task.
A similar and increased reaction time has been observed in comparing with a distracting task in healthy volunteers. In older people who are susceptible to distracting task, SDV may alters balance and gait.
The primary objective of this prospective study is to assess the impact of SDV on stabilometric parameters (center of foot pressure (COP) area, the distance travelled made by COP, the mean X-axis displacement and the mean Y-axis displacement) compared to the "empty bladder" condition.
The secondary objectives are assessing the impact of a cognitive task (verbal fluency) on stabilometric parameters in comparison with the "no cognitive task condition" and the "SDV condition"; and assessing the impact of "SDV condition" on balance and gait clinical evaluation (Timed up and go test, unipedal stance test, Berg scale, 10m walking speed, 5 chair stand) This prospective study will take place in a rehabilitation department during a 2hours-consultation. The eligible criteria are: women over 65 years old, with OAB with or without UI, able to walk without mobility equipment without neurologic pathology or spine surgery, without severe cognitive impairment (MMSE > 24) or legal protection, and who agree to be involved in the study. OAB was defined by urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence.
The included women will first have a standard urinary consultation in which comorbidities, treatments and urinary symptoms will be recorded. Participants will also have questionnaires on urinary symptoms (Urinary Symptom Profile and Incontinence Consultation Incontinence Questionnaires) and the Mini Mental Status Examination (assessing cognitive functions).
Then, participants will be evaluated on balance and gait clinical and instrumental parameters under "SDV" and "empty bladder" conditions. The order of these evaluations (SDV/empty bladder) is randomized by computer. The clinical evaluations are the Timed up and go test, the unipedal stance test, the Berg scale, the 10m walking speed test and the 5-chair-stand test. The stabilometry evaluation (recording the center of foot pressure (COP) area, the distance travelled made by COP, the mean X-axis displacement and the mean Y-axis displacement) will be on a force platform under 4 conditions: SDV with and without verbal fluency and empty bladder with and without verbal fluency.
The stabilographic parameters will be analyzed using a two-way repeated measures ANOVAs. The repeated factors are the SDV and empty bladder condition and with or without verbal fluency. Four testing combinations of these factors will be used: SDV/with verbal fluency, SDV/without verbal fluency, empty bladder/with verbal fluency and empty bladder/without verbal fluency. The ANOVA results will be used to calculate the F statistics for each main effect and interaction. The post-hoc comparisons will be performed using the Bonferroni test. The level of statistical significance was set in all tests at P≤0.05.
Thus, if we show that SDV may impact balance in geriatric population it will lead to the importance to identify and treat LUTS as potential fall risk factor in order to decrease falls incidence in this population.
- Conditions
- Overactive Bladder, Urinary Incontinence
- Being tested
- strong desire to void - cognitive task
- Keywords
- balance, strong desire to void, older women, overactive bladder, cognitive task
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strong desire to void - cognitive taskOther
Strong desire to void - cognitive task (verbal fluency)
| Study group | Role | What they receive |
|---|---|---|
| women over 65 years old with OAB | Community-dwelling women over 65 years old, with non-neurogenic OAB, with or without UI Receives: Other: strong desire to void - cognitive task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stabilometry platform assesment
The primary outcome is a composite criterion of 4 parameters, assessing changes in stabilometry platform between "strong desire to void" and "empty bladder" conditions. These 4 parameters are the center of foot pressure (COP) area, the distance travelled made by COP, the mean X-axis displacement and the mean Y-axis displacement. need for bladder emptiness).
Measured: 1 day
Secondary outcomes (3)
Clinical balance
Comparison of the Timed up and go test results between the 2 conditions: "strong desire to void" and "empty bladder".
Measured: 1 day
Gait assesment
Gait assesment: 10m walking speed
Measured: 1 day
cognitive task assesment
cognitive task evaluation ( words per minute) during B3 compared to B0 ( absence of need for bladder emptiness).bladder" conditions.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start26 May 2021
- Primary completion21 Jul 2022
- Study completion21 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910555
- Sponsor's protocol ID
- APHP210072
- Other IDs
- 2021-A00406-35
- Acronym
- SURFACE
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2021
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Strong Desire to Void an Equivalent of Cognitive Task Affecting Balance in Older Women With Overactive Bladder?
- ClinicalTrials.gov ID
- NCT04910555
- Acronym / sponsor ID
- SURFACE / APHP210072
- Conditions
- Overactive Bladder, Urinary Incontinence
- Keywords
- balance, strong desire to void, older women, overactive bladder, cognitive task
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 2 Jun 2021 (actual)
- 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.
Falls have multifactorial etiologies in older people. Lower urinary tract symptoms (LUTS) are one of those, with an increase prevalence over years (30% of people over 75 years old have overactive bladder [OAB]). Previous studies showed that older women with OAB with or without urinary incontinence (UI) are prone to have gait disorders (decrease of gait speed and step width and increase of number of step). Besides UI, it is more likely the strong desire to void (SDV) that seems to impact gait and balance control. In older women with UI, balance on stabilometric parameters have been affected with an increase of the center of pression (COP) sway range, COP area and rambling trajectory. SDV seems to act like an additional cognitive task. A similar and increased reaction time has been observed in comparing with a distracting task in healthy volunteers. In older people who are susceptible to distracting task, SDV may alters balance and gait.
The primary objective of this prospective study is to assess the impact of SDV on stabilometric parameters (center of foot pressure (COP) area, the distance travelled made by COP, the mean X-axis displacement and the mean Y-axis displacement) compared to the "empty bladder" condition.
The secondary objectives are to assess the impact of a cognitive task (verbal fluency) on stabilometric parameters in comparison with the "no cognitive task condition" and the "SDV condition"; to assess the impact of "SDV condition" on balance and gait clinical evaluation (Timed up and go test, unipedal stance test, Berg scale, 10m walking speed, 5 chair stand) Thus, showing that SDV may impact balance in geriatric population will lead to the importance to identify and LUTS as potential fall risk factor in order to decrease falls incidence in this population.
Detailed description
Falls have multifactorial etiologies in older people. Lower urinary tract symptoms (LUTS) are one of those, with an increase prevalence over years (30% of people over 75 years old have overactive bladder [OAB]). Previous studies showed that older women with oAB with or without urinary incontinence (UI) are prone to have gait disorders (decrease of gait speed and step width and increase of number of step). Besides UI, it is more likely the strong desire to void (SDV) that seems to impact gait and balance control. In older women with UI, balance on stabilometric parameters has been affected with an increase of the center of pression (COP) sway range, COP area and rambling trajectory. SDV seems to act like an additional cognitive task.
A similar and increased reaction time has been observed in comparing with a distracting task in healthy volunteers. In older people who are susceptible to distracting task, SDV may alters balance and gait.
The primary objective of this prospective study is to assess the impact of SDV on stabilometric parameters (center of foot pressure (COP) area, the distance travelled made by COP, the mean X-axis displacement and the mean Y-axis displacement) compared to the "empty bladder" condition.
The secondary objectives are assessing the impact of a cognitive task (verbal fluency) on stabilometric parameters in comparison with the "no cognitive task condition" and the "SDV condition"; and assessing the impact of "SDV condition" on balance and gait clinical evaluation (Timed up and go test, unipedal stance test, Berg scale, 10m walking speed, 5 chair stand) This prospective study will take place in a rehabilitation department during a 2hours-consultation. The eligible criteria are: women over 65 years old, with OAB with or without UI, able to walk without mobility equipment without neurologic pathology or spine surgery, without severe cognitive impairment (MMSE > 24) or legal protection, and who agree to be involved in the study. OAB was defined by urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence.
The included women will first have a standard urinary consultation in which comorbidities, treatments and urinary symptoms will be recorded. Participants will also have questionnaires on urinary symptoms (Urinary Symptom Profile and Incontinence Consultation Incontinence Questionnaires) and the Mini Mental Status Examination (assessing cognitive functions).
Then, participants will be evaluated on balance and gait clinical and instrumental parameters under "SDV" and "empty bladder" conditions. The order of these evaluations (SDV/empty bladder) is randomized by computer. The clinical evaluations are the Timed up and go test, the unipedal stance test, the Berg scale, the 10m walking speed test and the 5-chair-stand test. The stabilometry evaluation (recording the center of foot pressure (COP) area, the distance travelled made by COP, the mean X-axis displacement and the mean Y-axis displacement) will be on a force platform under 4 conditions: SDV with and without verbal fluency and empty bladder with and without verbal fluency.
The stabilographic parameters will be analyzed using a two-way repeated measures ANOVAs. The repeated factors are the SDV and empty bladder condition and with or without verbal fluency. Four testing combinations of these factors will be used: SDV/with verbal fluency, SDV/without verbal fluency, empty bladder/with verbal fluency and empty bladder/without verbal fluency. The ANOVA results will be used to calculate the F statistics for each main effect and interaction. The post-hoc comparisons will be performed using the Bonferroni test. The level of statistical significance was set in all tests at P≤0.05.
Thus, if we show that SDV may impact balance in geriatric population it will lead to the importance to identify and treat LUTS as potential fall risk factor in order to decrease falls incidence in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women over 65 years old with OAB | – | Other: strong desire to void - cognitive taskCommunity-dwelling women over 65 years old, with non-neurogenic OAB, with or without UI |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Community-dweeling women over 65 years old, with non-neurogenic OAB, with or without UI
Key inclusion criteria (4 listed)
- women;
- over 65 years old;
- with OAB with or without UI;
- able to walk without mobility aid; consent to participate in the study
Key exclusion criteria (3 listed)
- neurologic pathology; history of spine surgery;
- cognitive impairment defined as a MMSE < 24;
- legal protection
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 |
|---|---|---|
| strong desire to void - cognitive taskStrong desire to void - cognitive task (verbal fluency) | Other | women over 65 years old with OAB |
Primary outcome
Stabilometry platform assesment
Time frame: 1 day
The primary outcome is a composite criterion of 4 parameters, assessing changes in stabilometry platform between "strong desire to void" and "empty bladder" conditions. These 4 parameters are the center of foot pressure (COP) area, the distance travelled made by COP, the mean X-axis displacement and the mean Y-axis displacement. need for bladder emptiness).
3 secondary outcomes
Clinical balance
Time frame: 1 day
Gait assesment
Time frame: 1 day
cognitive task assesment
Time frame: 1 day
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 12 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Overactive Bladder
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder and Urinary Incontinence, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 3 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 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Stabilometry platform assesment (time frame: 1 day). 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 12 Apr 2024.