At-Home Diaphragmatic Interventions for Voiding Abnormalities (DIVA) (DIVA)

October 7, 2024 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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-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 Bayesian adaptive 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. Statistical analysis plan will be predecided prior to analysis to facilitate interim and final analysis plan and associated stop triggers.

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Urogynecology - Patterson Place
      • Raleigh, North Carolina, United States, 27609
        • Duke Urogynecology - Navaho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diaphragmatic Breathing Exercise (DB)
Participants will undergo a total of 10 minutes of at-home diaphragmatic breathing exercises (5 minutes in the morning and 5 minutes in the evening) with the practice of standard bladder hygiene recommendations. Participants will exercise daily for a total of 4 weeks and complete daily exercise logs.
Behavioral: Diaphragmatic Breathing Exercises
Mindful deep breathing cycle comprised of a 3-second inhale causing abdominal wall movement followed by a 5-second exhale, which will be completed for a total of 10 minutes of daily exercise
Other Names:
  • Belly Breathing
Behavioral: Bladder Hygiene Education
Educational handout on bladder health and hygiene with recommendations endorsed by the International Urogynecologic Association
Other Names:
  • Bladder Health Handout
Active Comparator: Educational Handout (EH)
Participants assigned to this group will participate in the usual standard care of bladder hygiene, which will include common practices of timed voiding, reduction in constipation, avoidance of bladder irritants, daily recommended aerobic exercise, adequate hydration, and appropriate perineal hygiene. Participants will practice standard bladder hygiene recommendations daily for a total of 4 weeks.
Behavioral: Bladder Hygiene Education
Educational handout on bladder health and hygiene with recommendations endorsed by the International Urogynecologic Association
Other Names:
  • Bladder Health Handout

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Baseline in the Lower Urinary Tract Network Symptom Index-10 (LURN SI-10) at 4 weeks
Time Frame: Baseline and Week 4
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Baseline in the Urinary Distress Inventory Short Form (UDI-6) at 4 weeks
Time Frame: Baseline and Week 4
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
Change in Baseline in the patient-reported score of force of stream (FOS) at 4 weeks
Time Frame: Baseline and Week 4
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
Change in Baseline in Generalized Anxiety Disorder - 2 Item (GAD-2) at 4 weeks
Time Frame: Baseline and Week 4
-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
Change in Baseline in Composite Score of 2 or more of the following outcomes (FOS, LURN SI-10 Item 6 and 7)
Time Frame: Baseline and Week 4
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Cindy Amundsen, Duke University
  • Principal Investigator: Annika Sinha, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

August 23, 2024

Study Completion (Actual)

August 23, 2024

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00114721

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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