Status:
COMPLETED
At-Home Diaphragmatic Interventions for Voiding Abnormalities (DIVA)
Lead Sponsor:
Duke University
Conditions:
Dysfunctional Voiding
Urinary Dysfunction
Eligibility:
FEMALE
18+ years
Phase:
NA
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 (dysfunctio...
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-ho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2024
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT06165731
Start Date
May 1 2024
End Date
August 23 2024
Last Update
October 8 2024
Active Locations (2)
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1
Duke Urogynecology - Patterson Place
Durham, North Carolina, United States, 27705
2
Duke Urogynecology - Navaho
Raleigh, North Carolina, United States, 27609