Strong Desire to Void and Balance in Older Women With Overactive Bladder

NCT04910555 | Completed

• 2 other identifiers: APHP2100722021-A00406-35
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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 \[OAB\]). 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.

Conditions

Overactive Bladder; Urinary Incontinence

Keywords

balance; strong desire to void; older women; overactive bladder; cognitive task

Outcome Measures

Primary Outcomes (1)

• 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).

  1 day

Secondary Outcomes (3)

• Clinical balance

  1 day

• Gait assesment

  1 day

• cognitive task assesment

  1 day

Study Arms (1)

women over 65 years old with OAB

Community-dwelling women over 65 years old, with non-neurogenic OAB, with or without UI

Other: strong desire to void - cognitive task

Interventions

strong desire to void - cognitive task OTHER

Strong desire to void - cognitive task (verbal fluency)

women over 65 years old with OAB

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community-dweeling women over 65 years old, with non-neurogenic OAB, with or without UI

You may qualify if:

• women;
• over 65 years old;
• with OAB with or without UI;
• able to walk without mobility aid; consent to participate in the study

You may not qualify if:

• neurologic pathology; history of spine surgery;
• cognitive impairment defined as a MMSE \< 24;
• legal protection

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Rothschild

Paris, 75012, France

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: June 2, 2021
• Study Start: May 26, 2021
• Primary Completion: July 21, 2022
• Study Completion: July 21, 2022
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)