Incorporation of Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing: a Randomized Controlled Trial
Phase: NA
Conditions: Stress Incontinence, Female, Overactive Bladder, Lower Urinary Tract Symptoms
Sponsor: San Antonio Uniformed Services Health Education Consortium

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1.  PROTOCOL TITLE:  Incorporation of Mindfulness Exercises to Reduce Anxiety and Pain during Urodynamic Testing: A 
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Randomized Controlled Trial 
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2.  ABSTRACT  Urodynamic study (UDS) is a series of tests that evaluate bladder and urethral function. UDS is associated 
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with pain and anxiety due to the invasive nature of the testing. Several interventions have been attempted to reduce the 
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unpleasantness associated with UDS without success.  A novel technique that has been shown to reduce chronic bladder 
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pain is mindfulness.  We want to study the changes in patient’s perceptions of UDS after a mindfulness intervention.  
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3.  OBJECTIVES/SPECIFIC AIMS/RESEARCH QUESTIONS.  
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The objective of the study is to investigate whether mindfulness techniques improve patient’s perceptions of UDS testing. 
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1. Objective #1-To evaluate changes in anxiety symptoms during UDS testing. 
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Hypothesis: anxiety will improve during UDS testing with prior mindfulness intervention. 
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2. Objective#2- To evaluate changes in pain intensity during UDS testing. 
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Hypothesis: pain will improve during UDS testing with prior mindfulness intervention  
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4.  MILITARY RELEVANCE   
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Pain and anxiety that may be present in UDS impacts the emotional and physical distress experienced by active duty 
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service members and beneficiaries who need testing.  The emotional and physical distress can interfere with the accuracy 
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of their diagnosis so that the proper treatment is not administered for their bothersome urinary issues. This may lead the 
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patient to suffer and this may restrict them from vital training, military readiness, or important life events. 
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5. BACKGROUND AND SIGNIFICANCE 
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Urodynamic study (UDS) is a series of tests that evaluate the bladder and urethral function.  UDS involves placing 
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catheters that are into the bladder and rectum that can be uncomfortable.  UDS is conducted by several people during 
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testing and UDS may require an extended amount of time that can further add to the emotional and physical demands.  
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Not surprisingly, UDS has been reported to be associated with anxiety, embarrassment, and pain1,2.   
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Several previous techniques to improve patient’s perceptions during UDS have been unsuccessful3-5.  These interventions 
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include lavender oil, music, and an educational video, and have not improved patients’ experiences during UDS.  Written 
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patient educational material given before UDS testing has mixed results in the literature3-4.   
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Mindfulness based stress reduction is a technique that improves coping during stress events.  Mindfulness has been 
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shown to reduce anxiety and pain in the chronic pain disorders of the bladder6.  Mindfulness can enhance, “detached 
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observation" which can aid in reducing subjective negative evaluation of nociceptive stimuli7. It has been suggested that 
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mindful meditation enhances self-regulation which is beneficial during physically and emotionally taxing experiences7 
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6.  RESEARCH DESIGN   
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A prospective randomized controlled pilot trial will be conducted from patients that undergo UDS testing. Eligible study 
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subjects that are willing to participate will be accrued from the Urology clinic.  Subjects will be consented by the PI.  Subjects 
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will be randomized between standard clinic UDS or UDS with mindfulness exercises.  Subjects will not be blinded to the 
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intervention or control group, although the physician performing the UDS will be blinded to the allocation of treatment. A power 
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calculation was performed and 30 subjects are required for this study. Assessment or methodology will be from 
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questionnaires after UDS testing.  All subjects will be evaluated with an anxiety questionnaire, urodynamic discomfort 
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questionnaire, and pain visual analog scale. 
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Brooke Army Medical Center 
Institutional Review Board 
 
HUMAN SUBJECTS RESEARCH  
 PROTOCOL APPLICATION – Part B 

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7.  RESEARCH PLAN 
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7.1 Selection of Subjects 
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7.1.1. Subject Population. The target population includes all adult (DoD beneficiaries) and active duty patients over the age 
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of 18 that are scheduled to have UDS testing.  Pregnant women, children, basic trainees or other special populations will not 
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be included.   
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7.1.2. Source of Research Material.  
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Source of Research Material 
  
Clinical Purposes(Y/N) 
Research Purposes (Y/N) 
 
Anxiety Questionnaire 
N 
Y 
UDS Questionnaire 
N 
Y 
Pain VAS 
N 
Y 
 
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7.1.3. Inclusion and Exclusion Criteria. Inclusion criterion includes adults (DoD beneficiaries and active duty patients 
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over the age of 18-80) scheduled for UDS testing. Diagnosis to include urinary symptoms requiring urodynamic testing are 
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stress urinary incontinence, Mixed urinary incontinence, Urgency urinary incontinence, overactive bladder, urinary 
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retention, and lower urinary tract symptoms. 
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Exclusion criteria include age less than 18 years, pregnant-as verified by urine or blood sample, have an alteration in 
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neurologic bladder function, or inability to provide informed consent. Condition that will be excluded include neurogenic 
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bladder, Interstitial cystitis, chronic bladder pain, and inability to have urodynamics performed. 
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7.1.4. Description of the Recruitment and Prescreening Process.  The PI will be present at UDS testing and, in the same 
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setting, will identify potential study participants by reviewing their medical record.   The PI will recruit potential study 
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participants for enrollment into this study by discussing it with them and reviewing the attached consent. After completion of 
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informed consent, subjects will be enrolled in the study.  Subjects will register into the study and entered into randomization as 
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described previously. 
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7.1.5. Subject Screening Procedures. Pregnancy testing for subjects will the possibility of becoming pregnant which is 
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already routine testing before UDS testing.  Patients who, based on medical record or clinic visit, lack capacity to provide 
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informed consent will not be included in the study.  
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7.1.6. Consent Process. The PI will obtain the informed consent in a private clinic room on the day of the UDS testing.  For 
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subjects who wish to participate in the study, informed consent will be obtained at the time of counselling by the PI.  Subjects 
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who do not demonstrate the ability to understand or the willingness to sign the written consent document will be excluded from 
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study entry.  
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7.1.7. Compensation for participation.  No compensation or payment to subjects will be made for participation in this 
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study.  
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7.2 Drugs, Dietary Supplements, Biologics, or Devices.   
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7.2.1  N/A  
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7.2.2  N/A  
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7.3. Study Procedures/Research Interventions. Potential subjects will be invited to participate in this study by the PI, when 
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it is determined that a UDS evaluation is appropriate for their standard treatment. All subjects who agree to participate will be 
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randomized into either the control group or the intervention (mindfulness exercise) group.  Randomization assignment will be 
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computer generated at a 1:1 ratio. On the day of their scheduled appointment subjects will present to the Urology Clinic at 
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SAMMC. All subjects will be escorted to an exam room within the Urology Clinic, as per usual protocol, where they will be 
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consented to participate in the study. After consenting to participate, subjects will be asked to complete an initial self-report 
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assessment of state anxiety (see attached). Following completion of the initial state-anxiety assessment, subjects in the 
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control group will be asked to sit alone quietly in the exam room with the lights on, uninterrupted, for 10 minutes. They will be 
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given no other instructions other than to wait in the exam room. Subjects in the intervention group will be lead through a 
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mindfulness exercise in which they will be asked to focus their attention on their breath (see attached script). This exercise will 
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take approximately 10 minutes and will be led by a Clinical Psychologist. Mindfulness exercises facilitate a state of detached 
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observation of the subject’s situation and reduce negative physical and emotional stimuli7. At the end of the 10 minutes 
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(control) or the completion of the mindfulness exercise (intervention), all subjects will complete a second state-anxiety 
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assessment. Routine UDS evaluation (one catheter in the rectum and one catheter in the bladder) will commence for all 
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subjects. Following completion of the UDS evaluation, subjects will complete a third and final assessment of state-anxiety in 
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which they will be asked to assess their level of anxiety when it was at its highest while undergoing the UDS evaluation. 
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Assessment 
Visit / Follow Up (F/U) Interval 
Study Day / 
period 
1 week 
before 
Procedure 
 
Informed  
Consent, discuss  
Plan, etc. 
 
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Randomization 
 
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Demographics, 
History & 
Physical 
 
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Anxiety Questionnaire  
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UDS Questionnaire 
 
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Pain VAS 
 
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Self-evaluation 
Questionnaire 
 
x 
 
 
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7.3.1 Collection of Human Biological Specimens. N/A  
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7.3.1.1 Laboratory evaluations and special precautions. N/A  
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7.3.1.2 Specimen storage. N/A  
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7.3.2  Data Collection.  A de-identified electronic database will be maintained by the PI and associate PIs on a CAC 
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protected computer.  Access to the database will be only by study investigators.  Database will be password and firewall 
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protected.  There will be no transmission of data or external databases.   
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7.3.3. Human Biological Specimens/Tissue/Data Banking. N/A  
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 Statistical Consideration  
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7.4 7.4.1 Sample Size Estimation.  Based on a sample size calculation, to achieve an alpha of 0.05 with power of 80% 
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sample size should incorporate 25 subjects. After accounting for 15-20% drop out/withdrawal, a total of 30 patients should 
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be enrolled.   
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Estimate Required Sample Size 
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Estimate Participant Drop Out / Withdrawal 
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Total Enrollment Requirement 
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Enrollment at Each Site 
 
BAMC 
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7.4.2 Primary (i.e., primary outcome variables) and secondary endpoints. The primary outcome is a reduction in anxiety 
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as measured by the anxiety survey.  Secondary outcome is a reduction in physical distress as measured by the pain VAS and 
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UDS survey. Secondary endpoints will include self-evaluation questionnaires to assess differences between both groups.  
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7.4.3 Data analysis. ANOVA will be used to compare the visual analog scale scores between groups. Paired t-test will be 
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used to evaluate the anxiety difference.  Chi-squared test will be used to compare self-evaluation categories between both 
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groups.  
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7.7 Confidentiality.  Questionnaires will be de-identified of PII. Data will be entered into the database within 24 hours of 
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collection.  Questionnaires will then be stored in a locked cabinet in the Urology Clinic, only accessible by Dr Jellison.  
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Electronic database will be stored on a CAC protected computer within a password protected folder.  Only investigators in this 
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study will have access to the electronic database. Upon completion of the study, hard copy data will be archived and secured 
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in a locked cabinet within a locked office.  The signed informed consent documents will be retained for 3 years and the signed 
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HIPAA Authorizations will be maintained for 6 years after the date of completion, after which, the files will be destroyed in 
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HIPAA approved disposal container and electronic data will be destroyed through the Information Management Division (IMD) 
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as per SAMMC protocol.  
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7.7.1 Certificate of Confidentiality.  Particularly sensitive information will not be collected.  
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8.0  RISKS/BENEFITS ASSESSMENT 
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8.1  Risks.  Risks associated with participating in this study are minimal. There is a very slight risk for loss of 
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confidentiality. This risk will be minimized by maintaining data on secure computers.  There may be minimal risks to 
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subjects of emotional unease by participating in mindfulness exercises. 
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8.2 Potential Benefits.  Subjects may experience lower levels of anxiety, pain and/or discomfort after undergoing 
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mindfulness exercises.  
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9.0  ADVERSE EVENTS, UNANTICIPATED PROBLEMS, AND DEVIATIONS 
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9.1  No adverse events are anticipated. If subjects are not comfortable with the UDS testing, we will stop testing as per 
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standard clinic protocol.  
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9.2  Reporting Unanticipated Problems Involving Risks to Subjects or Others, Serious Adverse Events and Deaths to 
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the Office of the IRB, BAMC.   
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All unanticipated problems involving risk to subjects or others, serious adverse events, and all subject 
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deaths related to the study will be reported within 48 hours of the research team’s knowledge of the 
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event by phone (210-916-0606), by e-mail (BAMC_IRB_AE@amedd.army.mil), by facsimile (210-
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916-1650) or via letter addressed to Human Protections Administrator, Office of the Institutional 
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Review Board, Brooke Army Medical Center, Attn: MCHE-CI,3698 Chambers Pass, Fort Sam 
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Houston, TX 78234-6315. A complete written report will follow the initial notification within 10 working 
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days. 
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9.3  Research Monitor.  N/A 
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10.0 WITHDRAWAL FROM STUDY PARTICIPATION.  In the event a subject decides to withdraw from the study, the 
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mindfulness exercises will end and the patient will proceed with routine UDS evaluation. There are no consequences to 
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the subject from withdrawing from the study.   
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11.0 USAMRMC Volunteer Registry Database. N/A 
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12.0  REFERENCES.   
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1. 
Suskind AM, Clemens JQ, Kaufman SR, Stoffel JT, Oldendorf A, Malaeb BS, Jandron T, Cameron AP. Patient perceptions of 
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physical and emotional discomfort related to urodynamic testing: a questionnaire-based study in men and women with and 
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without neurologic conditions. Urology. 2015;85(3):547-51. 
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2. 
Yeung JY, Eschenbacher MA, Pauls RN. Pain and embarrassment associated with urodynamic testing in women. Int 
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Urogynecol J. 2014 May;25(5):645-50. 
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3. 
Hougardy V, Vandeweerd JM, Reda AA, Foidart JM. The impact of detailed explanatory leaflets on patient satisfaction with 
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urodynamic consultation: a double-blind randomized controlled trial. Neurourol Urodyn. 2009; 2009;28(5):374-9.  
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4. 
Stav K, Siegel YI, Beberashvili I, Sella HZ, Zisman A. Provision of information leaflet before urodynamic study reduces the pre-
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examination anxiety level. Neurourol Urodyn. 2015 Jul 21. [Epub ahead of print] 
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5. 
Solomon ER, Ridgeway B. Interventions to decrease pain and anxiety in patients undergoing urodynamic testing: A 
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randomized controlled trial. Neurourol Urodyn. 2015 Jul 30. doi: 10.1002/nau.22840. [Epub ahead of print] 
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6. 
Kanter G, Komesu YM, Qaedan F, Jeppson PC, Dunivan GC, Cichowski SB, Rogers RG. Mindfulness-based stress reduction 
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as a novel treatment for interstitial cystitis/bladder pain syndrome: a randomized controlled trial. Int Urogynecol J. 2016 Apr 26. 
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[Epub ahead of print] 
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7.  
Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness 
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meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry.1982; 4(1):33-47.  
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13.0  TIME REQUIRED TO COMPLETE THE RESEARCH (including data analysis).  
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With an estimated accrual of 6 patients per month, participant accrual is estimated at 10 months. Another 2 months would be 
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spent processing data. This results in an estimated study duration of 12 months.  
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14.0  STUDY CLOSURE PROCEDURES  
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A Protocol Closure Report will be completed and submitted to the Brooke Army Medical Center IRB upon 
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completion of all data collection, analysis and publications/presentations. The informed consent document will 
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be kept for a minimum of 3 years, and the HIPAA Authorization form will be kept for a minimum of 6 years, 
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following completion of the study at the urology clinic in locked cabinet that is accessible by the PI  
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