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Stress and Anxiety Effects on Overactive Bladder
N/A
Recruiting
Led By William S Reynolds, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Presence of OAB (score of ≥4 on the OAB-V3 awareness tool)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
Study Summary
This trial is measuring psychological stress and anxiety's relation to bladder sensitivity and psychological burdens in people with overactive bladder to see if there is an effective way to measure it.
Who is the study for?
This trial is for adults with overactive bladder (OAB) who score ≥4 on the OAB-V3 tool. It includes those with urgency-predominant urinary incontinence but excludes individuals with post-void residual urine >150ml, need for catheterization, certain obstructive conditions, prior pelvic radiation, bladder cancer history, interstitial cystitis diagnosis or significant neurological conditions.Check my eligibility
What is being tested?
The study aims to understand how stress and anxiety affect bladder sensitivity and psychological well-being in people with OAB. Participants will undergo psychological stress induction and accelerated oral hydration to measure their impact on OAB symptoms.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include increased discomfort due to induced stress or anxiety during the trial procedures and possible exacerbation of overactive bladder symptoms due to accelerated hydration.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have overactive bladder symptoms and no urgency-related urinary incontinence.
Select...
I have been diagnosed with overactive bladder (OAB).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bladder stress reactivity
Secondary outcome measures
Diastolic blood pressure response
Heart rate response
Systolic blood pressure responses
Trial Design
1Treatment groups
Experimental Treatment
Group I: SubjectsExperimental Treatment2 Interventions
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.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
866 Previous Clinical Trials
672,459 Total Patients Enrolled
William S Reynolds, MDPrincipal InvestigatorVanderbilt University Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My urine flow rate is less than 10 ml per second.I currently have symptoms of a urinary tract infection that hasn't gone away.I have had radiation therapy to my pelvic area before.I have a blockage due to surgery or conditions like severe pelvic organ prolapse.I have been diagnosed with Interstitial Cystitis.I am 18 years old or older.I experience sudden urges to urinate that I cannot control.I do not have overactive bladder symptoms and no urgency-related urinary incontinence.I have or had bladder cancer.You have blood in your urine without getting it checked by a doctor.You do not have a condition where you cannot control your urine when you need to go to the bathroom.I have been diagnosed with overactive bladder (OAB).You have more than 150ml of urine left in your bladder after you pee.I use a catheter regularly.I have a neurological condition that affects my bladder.
Research Study Groups:
This trial has the following groups:- Group 1: Subjects
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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