Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06165731
Study type Interventional
Source Duke University
Contact Annika Sinha
Phone 9194011000
Email annika.sinha@duke.edu
Status Recruiting
Phase N/A
Start date May 1, 2024
Completion date June 2026

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04981340 - Diaphragmatic Breathing Exercises and Pelvic Floor Retraining in Children With Dysfunctional Voiding N/A
Completed NCT01733290 - Botulinum Toxin Urethral Sphincter Injection for Dysfunctional Voiding Phase 2
Completed NCT06040333 - Dynamic Neuromuscular Stabilization Training in Dysfunctional Voiding N/A
Not yet recruiting NCT04147793 - Case Control Study to Investigate the Use of Urethral Pressure Profile Measurement in Children
Completed NCT05313984 - OptiLUTS Part C: The Development of a Symptom Assessment Tool in Sacral Neuromodulation.
Active, not recruiting NCT04490642 - Linguistic Validation of the Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ) for 5-12 Years Old in Korean
Terminated NCT01465581 - Treatment of Neurogenic Incontinence by Surgery to Cut the Filum Terminale N/A
Completed NCT02806713 - The Effect of Oral PhenazopyrIdine on Perioperative Voiding After Mid-urethral sliNg (EPIPhANy Study) Phase 3