At-Home Diaphragmatic Interventions for Voiding Abnormalities (DIVA)
NCT ID: NCT06165731
Last Updated: 2024-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
59 participants
INTERVENTIONAL
2024-05-01
2024-08-23
Brief Summary
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Participants will complete weekly surveys on their symptoms.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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
Bladder Hygiene Education
Educational handout on bladder health and hygiene with recommendations endorsed by the International Urogynecologic Association
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.
Bladder Hygiene Education
Educational handout on bladder health and hygiene with recommendations endorsed by the International Urogynecologic Association
Interventions
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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
Bladder Hygiene Education
Educational handout on bladder health and hygiene with recommendations endorsed by the International Urogynecologic Association
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have a valid email address and telephone number.
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Cindy Amundsen
Role: PRINCIPAL_INVESTIGATOR
Duke University
Annika Sinha
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke Urogynecology - Patterson Place
Durham, North Carolina, United States
Duke Urogynecology - Navaho
Raleigh, North Carolina, United States
Countries
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References
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Carlson KV, Rome S, Nitti VW. Dysfunctional voiding in women. J Urol. 2001 Jan;165(1):143-7; discussion 147-8. doi: 10.1097/00005392-200101000-00035.
Yagci S, Kibar Y, Akay O, Kilic S, Erdemir F, Gok F, Dayanc M. The effect of biofeedback treatment on voiding and urodynamic parameters in children with voiding dysfunction. J Urol. 2005 Nov;174(5):1994-7; discussion 1997-8. doi: 10.1097/01.ju.0000176487.64283.36.
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Ross JH, Sinha A, Propst K, Ferrando CA. Adherence to Pelvic Floor Physical Therapy Referrals in Women With Fecal Incontinence. Female Pelvic Med Reconstr Surg. 2022 Mar 1;28(3):e29-e33. doi: 10.1097/SPV.0000000000001140.
Bharucha AE, Dunivan G, Goode PS, Lukacz ES, Markland AD, Matthews CA, Mott L, Rogers RG, Zinsmeister AR, Whitehead WE, Rao SS, Hamilton FA. Epidemiology, pathophysiology, and classification of fecal incontinence: state of the science summary for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) workshop. Am J Gastroenterol. 2015 Jan;110(1):127-36. doi: 10.1038/ajg.2014.396. Epub 2014 Dec 23.
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da Mata KRU, Costa RCM, Carbone EDSM, Gimenez MM, Bortolini MAT, Castro RA, Fitz FF. Telehealth in the rehabilitation of female pelvic floor dysfunction: a systematic literature review. Int Urogynecol J. 2021 Feb;32(2):249-259. doi: 10.1007/s00192-020-04588-8. Epub 2020 Nov 11.
Zoorob D, Yunghans S, Methenitis A, Garcia E, ElShariaha R, Wahl H. Patient Receptivity to Integration of Telehealth in Pelvic Floor Physical Therapy Regimens. Urogynecology (Phila). 2023 Feb 1;29(2):281-286. doi: 10.1097/SPV.0000000000001294.
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Barber MD, Spino C, Janz NK, Brubaker L, Nygaard I, Nager CW, Wheeler TL; Pelvic Floor Disorders Network. The minimum important differences for the urinary scales of the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire. Am J Obstet Gynecol. 2009 May;200(5):580.e1-7. doi: 10.1016/j.ajog.2009.02.007.
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Related Links
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Diaphragmatic breathing - stop and smell the roses - Urology Austin Blog.
Other Identifiers
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Pro00114721
Identifier Type: -
Identifier Source: org_study_id
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