Stress Incontinence, Female, Overactive Bladder, Lower Urinary Tract Symptoms
Conditions
Keywords
urodynamics
Brief summary
In this pilot study the investigators attempt to answer the question, does mindfulness exercises before urodynamic testing reduce patient's perception of anxiety or pain?
Detailed description
The subjects are being asked to consider participation in this research study. The purpose of this study is to see if incorporating mindfulness exercises prior to urodynamic studies (UDS) results in less pain, anxiety and discomfort. The participants will be guided through a mindfulness meditation exercise by a licensed professional. During this exercise participants will be asked to focus attention on breathing, physical sensations, and thoughts. This exercise will last for approximately 10 minutes in which participants will not be asked to engage in any physical activity other than sitting and breathing. The participants will be randomly assigned to one of 2 treatment plans. Randomization is a process like flipping a coin and means the chance of being assigned to either of the plans. One treatment plan includes undergoing mindfulness exercises prior to your UDS evaluation. The other treatment plan includes simply undergoing the UDS evaluation. After the participants UDS evaluation, questions will be asked about the urodynamic procedure. The participants will be asked to answer questions on a UDS and anxiety questionnaire which pertain to emotional and physical experiences during the procedure.
Interventions
BEHAVIORALMindfulness exercises
Sponsors
San Antonio Uniformed Services Health Education Consortium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of urinary symptoms requiring urodynamic testing * Stress incontinence * Mixed incontinence * Urge incontinence * Overactive bladder * Urinary retention * Lower urinary tract symptoms * Are Department of Defense (DoD) beneficiaries
Exclusion criteria
* Neurogenic bladder * Interstitial cystitis * Chronic bladder pain * Inability to have urodynamics performed * Are Not DoD beneficiaries * Pregnant * Lack capacity to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety during urodynamics as measured the STAI-6. | Day 1 | The STAI-6, State Trait Anxiety Inventory, is a validated questionnaire that measures anxiety. The total score from the STAI-6 will be used with a range of score from 4-24. Higher scores indicate higher level of anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive and negative emotions as measured by the urodynamic questionnaire | Day 1 | The urodynamic questionnaire is clinically validated with participants self-reporting emotions fear, discomfort, embarrassment, and if the test was better or worse than expected. The questions are analyzed individually with score ranked on a likert scale of 1-4. Higher score indicate higher levels of that particular emotion. |
| Pain as measured by the VAS | Day 1 | The visual analog scale (VAS) for pain total score will be recorded. The minimum and Maximum scores range from 1-10. Higher scores indicate more pain. |
Outcome results
None listed