At-Home Diaphragmatic Interventions for Voiding Abnormalities (DIVA)
United States59 participantsStarted 2024-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Baseline in the Lower Urinary Tract Network Symptom Index-10 (LURN SI-10) at 4 weeks