At-Home Diaphragmatic Interventions for Voiding Abnormalities (DIVA)
- Conditions
- Urinary DysfunctionDysfunctional Voiding
- Interventions
- Behavioral: Diaphragmatic Breathing ExercisesBehavioral: Bladder Hygiene Education
- Registration Number
- NCT06165731
- Lead Sponsor
- Duke University
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 59
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Diaphragmatic Breathing Exercise (DB) Diaphragmatic Breathing Exercises 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. Diaphragmatic Breathing Exercise (DB) Bladder Hygiene Education 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. Educational Handout (EH) Bladder Hygiene Education 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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
Trial Locations
- Locations (2)
Duke Urogynecology - Patterson Place
🇺🇸Durham, North Carolina, United States
Duke Urogynecology - Navaho
🇺🇸Raleigh, North Carolina, United States