At-Home Diaphragmatic Interventions for Voiding Abnormalities (DIVA)

Last updated: October 7, 2024
Sponsor: Duke University
Overall Status: Completed

Phase

N/A

Condition

Enuresis

Birth Defects

Holoprosencephaly

Treatment

Bladder Hygiene Education

Diaphragmatic Breathing Exercises

Clinical Study ID

NCT06165731
Pro00114721
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants are new or established English-speaking patients >= 18 years of agewith 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

Exclusion Criteria:

  • Participant with:

  • neurological disorders, such as cognitive impairment, multiple sclerosis, upper orlower 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 anyindication.

  • desire to modify overactive bladder medications and interstitial cystitismedications during trial period

  • Mybetriq

  • Ditropan

  • Santura

  • Vesicare

  • Tropsium

  • Detrol

  • Urispas

  • Toviaz

  • Gemtasa

  • Elmiron

Study Design

Total Participants: 59
Treatment Group(s): 2
Primary Treatment: Bladder Hygiene Education
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
August 23, 2024

Study 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

Connect with a study center

  • Duke Urogynecology - Patterson Place

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Duke Urogynecology - Navaho

    Raleigh, North Carolina 27609
    United States

    Site Not Available

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