At-Home Diaphragmatic Interventions for Voiding Abnormalities (DIVA)

Completed · Not applicable

Conditions studied: Dysfunctional Voiding, Urinary Dysfunction

In brief

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.

Key facts

Study ID

NCT06165731

Run by

Duke University

People needed

59

Starts

2024-05-01

Expected to finish

2024-08-23

Last updated by the study team

2024-10-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Duke Urogynecology - Patterson Place — Durham, North Carolina, United States
• Duke Urogynecology - Navaho — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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