NCT06165731

At-Home Diaphragmatic Interventions for Voiding Abnormalities (DIVA)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Dysfunctional Voiding
• Urinary Dysfunction

Interventions

Type	Name	Description
BEHAVIORAL	Diaphragmatic 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
BEHAVIORAL	Bladder Hygiene Education	Educational handout on bladder health and hygiene with recommendations endorsed by the International Urogynecologic Association

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-08-23
• Completion: 2024-08-23
• First posted: 2023-12-11
• Last updated: 2024-10-08

Locations

2 sites across 1 country: United States