Dysfunctional Voiding Clinical Trial
— DIVAOfficial title:
At-Home Diaphragmatic Interventions for Voiding Abnormalities (DIVA)
NCT number | NCT06165731 |
Other study ID # | Pro00114721 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2024 |
Est. completion date | June 2026 |
Verified date | May 2024 |
Source | Duke University |
Contact | Annika Sinha |
Phone | 9194011000 |
annika.sinha[@]duke.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 156 |
Est. completion date | June 2026 |
Est. primary completion date | June 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 pelvic surgery within 8 weeks. - pregnancy - desire to continue tamsulosin - a pessary fitted within the last one month - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke Urogynecology - Patterson Place | Durham | North Carolina |
United States | Duke Urogynecology - Navaho | Raleigh | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Baseline in the Lower Urinary Tract Network Symptom Index-10 (LURN SI-10) at 4 weeks | The LURN SI-10 is a patient-reported survey with an ordinal scale that ranges from 0-4 with a total scale of 0-38. The patient responses (0-4) x 10/ # of questions answered is used to achieve the total score. Change = Week 4 Score - Baseline Score | Baseline and Week 4 | |
Secondary | Change in Baseline in the Urinary Distress Inventory Short Form (UDI-6) at 4 weeks | The UDI-6 is a patient-reported survey with ordinal scale that ranges from 0-4 with a total scale of 0-100. The patient responses (0-4) X 25 to achieve the total score of the UDI-6. Change = Week 4 Score - Baseline Score | Baseline and Week 4 | |
Secondary | Change in Baseline in the patient-reported score of force of stream (FOS) at 4 weeks | The force of stream (FOS) question is one question that is used to ask patients how they would rate their force of urinary stream from 0 to 120. For this scale, 0 would be a very weak stream and 120 would be a normal, strong stream based on the patient's perception. Change = Weak 4 Score - Baseline Score | Baseline and Week 4 | |
Secondary | Change in Baseline in Generalized Anxiety Disorder - 2 Item (GAD-2) at 4 weeks | -The GAD-2 is a two-item validated survey on anxiety disorders with an ordinal scale of 0-3 and the total score is achieved by adding the total number of points per item. Change= Week 4 Score - Baseline | Baseline and Week 4 | |
Secondary | Change in Baseline in Composite Score of 2 or more of the following outcomes (FOS, LURN SI-10 Item 6 and 7) | The force of stream (FOS) question is one question that is used to ask patients how they would rate their force of urinary stream from 0 to 120. For this scale, 0 would be a very weak stream and 120 would be a normal, strong stream based on the patient's perception. LURN SI-10 Item 6 is a patient reported item from the LURN SI-10 survey ("in the past 7 days, how often did you have a delay before you started to urinate?" and LURN SI-10 Item 7 from the LURN SI-10 survey ("in the past 7 days, how often was your urine flow slow or weak?") Change = Week 4 score - Baseline | Baseline and Week 4 |
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