At-Home Diaphragmatic Interventions for Voiding Abnormalities (DIVA): A Randomized Trial

Study Overview
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Brief Summary
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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
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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 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. 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

Official Title
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At-Home Diaphragmatic Interventions for Voiding Abnormalities (DIVA): A Randomized Trial

Conditions
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Dysfunctional Voiding, Urinary Dysfunction

Intervention / Treatment
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* Behavioral: Diaphragmatic Breathing Exercises
* Behavioral: Bladder Hygiene Education


Participation Criteria
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Eligibility Criteria
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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 pelvic surgery within 8 weeks. pregnancy desire to continue tamsulosin a pessary fitted within the last one month 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diaphragmatic Breathing Exercise (DB)<br>Participants will undergo a total of 10 minutes of at-home diaphragmatic breathing exercises (5 minutes in the morning and 5 minutes in the evening) with the practice of standard bladder hygiene recommendations. Participants will exercise daily for a total of 4 weeks and complete daily exercise logs. | Behavioral: Diaphragmatic Breathing Exercises<br>* 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<br>* Other names: Belly Breathing;Behavioral: Bladder Hygiene Education<br>* Educational handout on bladder health and hygiene with recommendations endorsed by the International Urogynecologic Association<br>* Other names: Bladder Health Handout;|
| Active Comparator: Educational Handout (EH)<br>Participants assigned to this group will participate in the usual standard care of bladder hygiene, which will include common practices of timed voiding, reduction in constipation, avoidance of bladder irritants, daily recommended aerobic exercise, adequate hydration, and appropriate perineal hygiene. Participants will practice standard bladder hygiene recommendations daily for a total of 4 weeks. | Behavioral: Bladder Hygiene Education<br>* Educational handout on bladder health and hygiene with recommendations endorsed by the International Urogynecologic Association<br>* Other names: Bladder Health Handout;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline in the Lower Urinary Tract Network Symptom Index-10 (LURN SI-10) at 4 weeks | 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 | Baseline and Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline in the Urinary Distress Inventory Short Form (UDI-6) at 4 weeks | 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 | Baseline and Week 4 | 
| Change in Baseline in the patient-reported score of force of stream (FOS) at 4 weeks | 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 | Baseline and Week 4 | 
| Change in Baseline in Generalized Anxiety Disorder - 2 Item (GAD-2) at 4 weeks | -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 | Baseline and Week 4 | 
| Change in Baseline in Composite Score of 2 or more of the following outcomes (FOS, LURN SI-10 Item 6 and 7) | 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 | Baseline and Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dysfunctional voiding, diaphragmatic breathing, telehealth, incomplete bladder emptying