Stress and Anxiety Effects on Overactive Bladder
Primary Purpose
Overactive Bladder, Stress, Psychological, Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychological stress induction
Accelerated oral hydration
Sponsored by
About this trial
This is an interventional basic science trial for Overactive Bladder
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- Prior pelvic irradiation
- Current or prior bladder malignancy
- Confirmed diagnosis of Interstitial Cystitis
- Hematuria without a clinically appropriate evaluation
Sites / Locations
- Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Systolic blood pressure responses
Changes to non-invasive systolic blood pressure prompted by psychological stress tasks.
Diastolic blood pressure response
Changes to non-invasive diastolic blood pressure prompted by psychological stress tasks.
Heart rate response
Changes to non-invasive heart rate prompted by psychological stress tasks.
Full Information
NCT ID
NCT05087810
First Posted
September 8, 2021
Last Updated
June 5, 2023
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05087810
Brief Title
Stress and Anxiety Effects on Overactive Bladder
Official Title
Stress and Anxiety Effects on Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Stress, Psychological, Anxiety
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a case-control study in which all participants undergo the same procedures
Masking
None (Open Label)
Allocation
N/A
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Subjects
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychological stress induction
Intervention Description
Subjects will undergo acute psychological stress induction by performing mental arithmetic tasks.
Intervention Type
Other
Intervention Name(s)
Accelerated oral hydration
Intervention Description
Participants will drink 2L of fluid in a short period of time to force diuresis and urine production.
Primary Outcome Measure Information:
Title
Bladder stress reactivity
Description
Changes to bladder sensation prompted by acute psychological stress tasks as measured by degree of perception of bladder fullness (100 point scale)
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Systolic blood pressure responses
Description
Changes to non-invasive systolic blood pressure prompted by psychological stress tasks.
Time Frame
30 minutes
Title
Diastolic blood pressure response
Description
Changes to non-invasive diastolic blood pressure prompted by psychological stress tasks.
Time Frame
30 minutes
Title
Heart rate response
Description
Changes to non-invasive heart rate prompted by psychological stress tasks.
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Prior pelvic irradiation
Current or prior bladder malignancy
Confirmed diagnosis of Interstitial Cystitis
Hematuria without a clinically appropriate evaluation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William S Reynolds, MD
Phone
6153431317
Email
w.stuart.reynolds@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William S Reynolds, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William S Reynolds, MD
Phone
615-343-1317
Email
w.stuart.reynolds@vumc.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Stress and Anxiety Effects on Overactive Bladder
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