Overactive BladderNCT05087810
Stress and Anxiety Effects on Overactive Bladder
An observational study of Overactive Bladder and Stress, Psychological, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess how psychological stress and anxiety relate to bladder sensitivity and to psychological burdens in people with overactive bladder and how this can be measured effectively. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder, Stress, Psychological, Anxiety
- What is being tested?
- Psychological stress induction and Accelerated oral hydration
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2023to 5 Jun 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This prospective observational cohort study will recruit individuals with overactive bladder and age/sex matched healthy controls.
Who may be able to join
- Male or Female, at least 18 years of age
- Cognitive status and English language skills sufficient to complete all study related assessment materials
- Presence of OAB (score of ≥4 on the OAB-V3 awareness tool)
- Urgency predominant urinary incontinence, if incontinence present
- Specific entry criteria for control subjects
- Subject to the same inclusion/exclusion criteria, plus:
- Absence of OAB (score of ≤3 on the OAB-V3)
- No urgency-related urinary incontinence
Who cannot join
- Post void residual urine >150ml
- Need for catheterization, indwelling or intermittent
- Men: uroflow < 10 ml per sec
- Current symptomatic urinary tract infection that has not resolved
- Comorbid neurological conditions, including spinal cord injury, systemic neurologic illnesses (i.e. multiple sclerosis, Parkinson's disease) or central nervous system disease (i.e. brain tumor, stroke) thought to impact bladder function
- Iatrogenic (i.e. post-surgical) or non-iatrogenic obstructive conditions (i.e. pelvic organ prolapse greater than stage 2, urethral stricture, benign prostatic enlargement)
Show all 10Show fewer
- Prior pelvic irradiation
- Current or prior bladder malignancy
- Confirmed diagnosis of Interstitial Cystitis
- Hematuria without a clinically appropriate evaluation
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The purpose of this study is to assess how psychological stress and anxiety relate to bladder sensitivity and to psychological burdens in people with overactive bladder and how this can be measured effectively. UPDATE: June 2024 - Upon guidance from the NIDDK, this record was updated to an observational study as it was determined not to be an interventional clinical trial.
Read the detailed description
Overactive bladder (OAB) (i.e. urinary urgency, with or without urgency urinary incontinence, frequency, and nocturia) affects 1 in 7 U.S. men and women and results in substantial impairment to quality of life (QOL). To help self-manage and cope with OAB, many people adopt compensatory bladder behaviors, such as restricting fluids, using containment products, strategic planning and mapping restroom access, and even curtailing activities or travel altogether, which further adversely impact QOL. These behaviors may be driven by anxiety and stress related to urinary urgency and incontinence episodes as well as ensuing distress and embarrassment. Prior research has linked anxiety and OAB: up to 40% of women and 30% of men with OAB also have generalized anxiety disorder. The link between stress and OAB is less studied. In animals, experimental stress can cause OAB-like symptoms and behaviors as well as bladder and somatic hypersensitivity. In limited human studies, women with OAB may have greater physiologic and psychologic stress reactivity, and acute stress may exacerbate urinary urgency. However, how stress impacts on the bladder in the context of OAB or what psychological factors drive compensatory behaviors that impair QOL in OAB remain unknown, as there are no highly-controlled studies of anxiety-OAB links. Understanding these relationships would be a critical advance to individualizing care of patients with OAB. The proposed project will comprehensively investigate for the first time how stress, anxiety and OAB interact, including the impacts on bladder sensitivity, urinary symptoms, and compensatory bladder behaviors. The investigators propose a feedforward loop, whereby increased OAB symptoms increase anxiety (via response to coping with stressful situations), which in turn increases OAB symptoms (via increased bladder sensitivity). The study further proposes that compensatory behaviors are driven by anxiety-related learning processes that help perpetuate this relationship. The team will test the hypotheses in a sample of men and women with OAB and healthy controls. Aim 1 will test the hypothesis that acute, experimentally induced psychological stress will be more strongly associated with increased bladder sensitivity in OAB patients than in controls, using a novel bladder sensation meter with oral hydration and stress induction procedures. Aim will test the hypothesis that psychological stress and anxiety will have concurrent and lagged effects on day-to-day urinary symptoms that are stronger in individuals with OAB than in controls, using an ecological momentary assessment approach (7-day electronic diary) to examine prospective associations between everyday perceived stress, anxiety and urinary symptoms. Aim 3 will test the hypothesis that compensatory behaviors (i.e. coping) used at the time of voiding will be associated with subsequent reductions in anxiety levels, using a 3-day sensation-related bladder diary that captures concurrent bladder behaviors and anxiety symptoms as well as lagged symptoms 30 minutes post-void. Delineating these relationships and patterns will allow for identification of potentially modifiable factors or areas for intervention.
- Conditions
- Overactive Bladder, Stress, Psychological, Anxiety
- Being tested
- Psychological stress induction, Accelerated oral hydration
- Medical subject headings
- Urinary Bladder, Overactive, Stress, Psychological, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological stress inductionBehavioural
Subjects will undergo acute psychological stress induction by performing mental arithmetic tasks.
Accelerated oral hydrationOther
Participants will drink 2L of fluid in a short period of time to force diuresis and urine production.
| Study group | Role | What they receive |
|---|---|---|
| Subjects | All subjects will undergo accelerated oral hydration to induce diuresis and then acute psychological stress tasks to induce acute stress. Outcomes will measure changes to perceived bladder sensation in response to acute stress provocation. Receives: Behavioral: Psychological stress induction; Other: Accelerated oral hydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder stress reactivity
Changes to bladder sensation prompted by acute psychological stress tasks as measured by degree of perception of bladder fullness (100 point scale)
Measured: 30 minutes
Secondary outcomes (3)
Systolic blood pressure responses
Changes to non-invasive systolic blood pressure prompted by psychological stress tasks.
Measured: 30 minutes
Diastolic blood pressure response
Changes to non-invasive diastolic blood pressure prompted by psychological stress tasks.
Measured: 30 minutes
Heart rate response
Changes to non-invasive heart rate prompted by psychological stress tasks.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start16 Feb 2023
- Primary completion5 Jun 2024
- Study completion5 Jun 2024
Why it stopped: Change in status - Update June 2024: Upon guidance from the funding source (NIDDK), this record was pdated to an observational study as it was determined not to be an interventional clinical trial.
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 Vanderbilt University Medical CenterThe 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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabeth Sebesta, Vanderbilt University Medical Center
- Investigators
- William S Reynolds, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087810
- Sponsor's protocol ID
- 211147
- Status last verified
- Aug 2024
- First submitted
- 8 Sep 2021
- Last updated
- 13 Aug 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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress and Anxiety Effects on Overactive Bladder
- ClinicalTrials.gov ID
- NCT05087810
- Acronym / sponsor ID
- 211147
- Conditions
- Overactive Bladder, Stress, Psychological, Anxiety
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Change in status - Update June 2024: Upon guidance from the funding source (NIDDK), this record was pdated to an observational study as it was determined not to be an interventional clinical trial.
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 21 Oct 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.
The purpose of this study is to assess how psychological stress and anxiety relate to bladder sensitivity and to psychological burdens in people with overactive bladder and how this can be measured effectively. UPDATE: June 2024 - Upon guidance from the NIDDK, this record was updated to an observational study as it was determined not to be an interventional clinical trial.
Detailed description
Overactive bladder (OAB) (i.e. urinary urgency, with or without urgency urinary incontinence, frequency, and nocturia) affects 1 in 7 U.S. men and women and results in substantial impairment to quality of life (QOL). To help self-manage and cope with OAB, many people adopt compensatory bladder behaviors, such as restricting fluids, using containment products, strategic planning and mapping restroom access, and even curtailing activities or travel altogether, which further adversely impact QOL. These behaviors may be driven by anxiety and stress related to urinary urgency and incontinence episodes as well as ensuing distress and embarrassment. Prior research has linked anxiety and OAB: up to 40% of women and 30% of men with OAB also have generalized anxiety disorder. The link between stress and OAB is less studied. In animals, experimental stress can cause OAB-like symptoms and behaviors as well as bladder and somatic hypersensitivity. In limited human studies, women with OAB may have greater physiologic and psychologic stress reactivity, and acute stress may exacerbate urinary urgency. However, how stress impacts on the bladder in the context of OAB or what psychological factors drive compensatory behaviors that impair QOL in OAB remain unknown, as there are no highly-controlled studies of anxiety-OAB links. Understanding these relationships would be a critical advance to individualizing care of patients with OAB. The proposed project will comprehensively investigate for the first time how stress, anxiety and OAB interact, including the impacts on bladder sensitivity, urinary symptoms, and compensatory bladder behaviors. The investigators propose a feedforward loop, whereby increased OAB symptoms increase anxiety (via response to coping with stressful situations), which in turn increases OAB symptoms (via increased bladder sensitivity). The study further proposes that compensatory behaviors are driven by anxiety-related learning processes that help perpetuate this relationship. The team will test the hypotheses in a sample of men and women with OAB and healthy controls. Aim 1 will test the hypothesis that acute, experimentally induced psychological stress will be more strongly associated with increased bladder sensitivity in OAB patients than in controls, using a novel bladder sensation meter with oral hydration and stress induction procedures. Aim will test the hypothesis that psychological stress and anxiety will have concurrent and lagged effects on day-to-day urinary symptoms that are stronger in individuals with OAB than in controls, using an ecological momentary assessment approach (7-day electronic diary) to examine prospective associations between everyday perceived stress, anxiety and urinary symptoms. Aim 3 will test the hypothesis that compensatory behaviors (i.e. coping) used at the time of voiding will be associated with subsequent reductions in anxiety levels, using a 3-day sensation-related bladder diary that captures concurrent bladder behaviors and anxiety symptoms as well as lagged symptoms 30 minutes post-void. Delineating these relationships and patterns will allow for identification of potentially modifiable factors or areas for intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | – | Behavioral: Psychological stress induction, Other: Accelerated oral hydrationAll subjects will undergo accelerated oral hydration to induce diuresis and then acute psychological stress tasks to induce acute stress. Outcomes will measure changes to perceived bladder sensation in response to acute stress provocation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective observational cohort study will recruit individuals with overactive bladder and age/sex matched healthy controls.
Key inclusion criteria (8 listed)
- Male or Female, at least 18 years of age
- Cognitive status and English language skills sufficient to complete all study related assessment materials
- Presence of OAB (score of ≥4 on the OAB-V3 awareness tool)
- Urgency predominant urinary incontinence, if incontinence present
- Specific entry criteria for control subjects
Key exclusion criteria (10 listed)
- Post void residual urine >150ml
- Need for catheterization, indwelling or intermittent
- Men: uroflow < 10 ml per sec
- Current symptomatic urinary tract infection that has not resolved
- Comorbid neurological conditions, including spinal cord injury, systemic neurologic illnesses (i.e. multiple sclerosis, Parkinson's disease) or central nervous system disease (i.e. brain tumor, stroke) thought to impact bladder function
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 |
|---|---|---|
| Psychological stress inductionSubjects will undergo acute psychological stress induction by performing mental arithmetic tasks. | Behavioural | Subjects |
| Accelerated oral hydrationParticipants will drink 2L of fluid in a short period of time to force diuresis and urine production. | Other | Subjects |
Primary outcome
Bladder stress reactivity
Time frame: 30 minutes
Changes to bladder sensation prompted by acute psychological stress tasks as measured by degree of perception of bladder fullness (100 point scale)
3 secondary outcomes
Systolic blood pressure responses
Time frame: 30 minutes
Diastolic blood pressure response
Time frame: 30 minutes
Heart rate response
Time frame: 30 minutes
Results and safety
The study was stopped early (reason given: Change in status - Update June 2024: Upon guidance from the funding source (NIDDK), this record was pdated to an observational study as it was determined not to be an interventional clinical trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
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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.
William S Reynolds, MD principal investigator
Vanderbilt University Medical Center
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 Stress, Psychological, run by Vanderbilt University Medical Center at 1 site in United States.
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 8 inclusion and 10 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: stopped early, as of the sponsor's last update on 13 Aug 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 United States. 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 was stopped early (reason given: Change in status - Update June 2024: Upon guidance from the funding source (NIDDK), this record was pdated to an observational study as it was determined not to be an interventional clinical trial.). Results are not available in the source record.
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?
Bladder stress reactivity (time frame: 30 minutes). 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 13 Aug 2024.