Dysfunctional Voiding, Urinary Dysfunction
Conditions
Keywords
dysfunctional voiding, diaphragmatic breathing, telehealth, incomplete bladder emptying
Brief summary
The goal of the DIVA trial is to test the effectiveness of at-home diaphragmatic breathing exercises with bladder hygiene education in female patients with symptoms of difficulty urinating (dysfunctional voiding). It aims to answer how effective are at-home diaphragmatic breathing exercises for dysfunctional voiding. Researchers will compare two groups of participants (a group using diaphragmatic breathing exercises with bladder hygiene education versus a group using just bladder hygiene education alone) for a total of 4 weeks. Participants will complete weekly surveys on their symptoms.
Detailed description
BACKGROUND: Dysfunctional voiding causes lower urinary tract symptoms of incomplete bladder emptying, weak urinary stream, and urinary hesitancy or delay. Often, patients search the internet for at-home methods of improving bladder emptying. However, diaphragmatic breathing, with and without pelvic floor physical therapy, is not well-studied in adults. The goal is to analyze the effect of low-cost, at-home diaphragmatic breathing training coupled with bladder hygiene education on dysfunctional voiding in adult patients. TYPE OF STUDY: Prospective trial HYPOTHESIS: There will be an improvement in voiding symptoms after 4 weeks of at-home diaphragmatic breathing exercises with an educational handout on bladder health versus an educational handout on bladder health in participants with bothersome dysfunctional voiding symptoms. PRIMARY STUDY AIM: Evaluate the impact of short interval at-home diaphragmatic breathing exercises with an educational handout on bladder health versus an educational handout on bladder health on patient-reported outcomes in participants with dysfunctional voiding using 10-item Lower Urinary Tract Research Network Symptom Index (LURN SI-10). SECONDARY STUDY AIMS: Evaluate the impact of short interval at-home diaphragmatic breathing exercises with an educational handout on bladder health versus an educational handout on bladder health on patient-reported outcomes in participants with dysfunctional voiding using other patient reported outcomes (LURN SI-10 Item 6 & 7, Urinary Distress Inventory Short Form -6 (UDI-6), UDI-6 Item, Force of Stream (FOS) subjective questioning). STUDY DESIGN: Prospective Bayesian adaptive randomized trial comparing at-home diaphragmatic breathing exercises in participants seeking care for dysfunctional voiding. After an initial standard-of-care clinic evaluation and after providing informed consent, participants will be enrolled and randomized into two arms (at-home diaphragmatic breathing exercises with an educational hand-out on bladder hygiene versus an educational hand-out on bladder hygiene alone - control). All participants will be asked to complete validated symptom questionnaires of LURN SI-10, UDI-6, GAD-2, and FOS. Responses will be collected at baseline and weekly for a total of 4 weeks with daily exercise logs for those in the exercise group. Statistical analysis plan will be predecided prior to analysis to facilitate interim and final analysis plan and associated stop triggers. EXPOSURES: Daily diaphragmatic breathing exercises plus educational hand-out on bladder health versus educational hand-out on bladder health OUTCOMES: * Change in scoring in patient-reported outcomes (above) after 4 weeks * Participant compliance with daily at-home diaphragmatic breathing exercises after 4 weeks
Interventions
BEHAVIORALDiaphragmatic Breathing Exercises
Mindful deep breathing cycle comprised of a 3-second inhale causing abdominal wall movement followed by a 5-second exhale, which will be completed for a total of 10 minutes of daily exercise
BEHAVIORALBladder Hygiene Education
Educational handout on bladder health and hygiene with recommendations endorsed by the International Urogynecologic Association
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants are new or established English-speaking patients \>= 18 years of age with symptomatic dysfunctional voiding defined as an affirmative answer of yes, bothers me somewhat or more to LURN SI-10 Item 6 and/or Item 7. * Participants must have a valid email address and telephone number.
Exclusion criteria
* Participant with: * neurological disorders, such as cognitive impairment, multiple sclerosis, upper or lower motor neuron disorders, cauda equina syndrome * history of pelvic irradiation * history of bladder cancer * known fistulation to the bladder, urethra, or any component of lower urinary tract * apical or anterior wall prolapse past the hymen. * plan for/history of pelvic surgery within 8 weeks. * pregnancy \>28 weeks gestation * desire to continue tamsulosin * a pessary fitted within the last one month * post void residual volume \>200 cc * ongoing supervised pelvic floor physical therapy in the last three months for any indication. * desire to modify overactive bladder medications and interstitial cystitis medications during trial period * Mybetriq * Ditropan * Santura * Vesicare * Tropsium * Detrol * Urispas * Toviaz * Gemtasa * Elmiron
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Baseline in the Lower Urinary Tract Network Symptom Index-10 (LURN SI-10) at 4 weeks | Baseline and Week 4 | The LURN SI-10 is a patient-reported survey with an ordinal scale that ranges from 0-4 with a total scale of 0-38. The patient responses (0-4) x 10/ # of questions answered is used to achieve the total score. Change = Week 4 Score - Baseline Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Baseline in the Urinary Distress Inventory Short Form (UDI-6) at 4 weeks | Baseline and Week 4 | The UDI-6 is a patient-reported survey with ordinal scale that ranges from 0-4 with a total scale of 0-100. The patient responses (0-4) X 25 to achieve the total score of the UDI-6. Change = Week 4 Score - Baseline Score |
| Change in Baseline in the patient-reported score of force of stream (FOS) at 4 weeks | Baseline and Week 4 | The force of stream (FOS) question is one question that is used to ask patients how they would rate their force of urinary stream from 0 to 120. For this scale, 0 would be a very weak stream and 120 would be a normal, strong stream based on the patient's perception. Change = Weak 4 Score - Baseline Score |
| Change in Baseline in Generalized Anxiety Disorder - 2 Item (GAD-2) at 4 weeks | Baseline and Week 4 | -The GAD-2 is a two-item validated survey on anxiety disorders with an ordinal scale of 0-3 and the total score is achieved by adding the total number of points per item. Change= Week 4 Score - Baseline |
| Change in Baseline in Composite Score of 2 or more of the following outcomes (FOS, LURN SI-10 Item 6 and 7) | Baseline and Week 4 | The force of stream (FOS) question is one question that is used to ask patients how they would rate their force of urinary stream from 0 to 120. For this scale, 0 would be a very weak stream and 120 would be a normal, strong stream based on the patient's perception. LURN SI-10 Item 6 is a patient reported item from the LURN SI-10 survey (in the past 7 days, how often did you have a delay before you started to urinate? and LURN SI-10 Item 7 from the LURN SI-10 survey (in the past 7 days, how often was your urine flow slow or weak?) Change = Week 4 score - Baseline |
Countries
United States
Outcome results
None listed