Clinical trial NCT05087810: Stress and Anxiety Effects on Overactive Bladder
Official title: Stress and Anxiety Effects on Overactive Bladder
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Overactive Bladder
Stress, Psychological
Anxiety
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective observational cohort study will recruit individuals with overactive bladder and age/sex matched healthy controls.

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. 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.

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

Primary outcomes:
measure: Bladder stress reactivity
timeFrame: 30 minutes
Secondary outcomes:
measure: Systolic blood pressure responses
timeFrame: 30 minutes
measure: Diastolic blood pressure response
timeFrame: 30 minutes
measure: Heart rate response
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: William S Reynolds, MD
role: PRINCIPAL_INVESTIGATOR
References: