At-Home Diaphragmatic Interventions for Voiding Abnormalities (DIVA)

NCT06165731 | Completed

• 1 other identifier: Pro00114721
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Dysfunctional Voiding; Urinary Dysfunction

Keywords

dysfunctional voiding; diaphragmatic breathing; telehealth; incomplete bladder emptying

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Baseline in the Urinary Distress Inventory Short Form (UDI-6) at 4 weeks

  Baseline and Week 4

• Change in Baseline in the patient-reported score of force of stream (FOS) at 4 weeks

  Baseline and Week 4

• Change in Baseline in Generalized Anxiety Disorder - 2 Item (GAD-2) at 4 weeks

  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)

  Baseline and Week 4

Study Arms (2)

Diaphragmatic Breathing Exercise (DB)

EXPERIMENTAL

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; Behavioral: Bladder Hygiene Education

Educational Handout (EH)

ACTIVE COMPARATOR

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

Interventions

Diaphragmatic Breathing Exercises BEHAVIORAL

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

Also known as: Belly Breathing

Diaphragmatic Breathing Exercise (DB)

Bladder Hygiene Education BEHAVIORAL

Educational handout on bladder health and hygiene with recommendations endorsed by the International Urogynecologic Association

Also known as: Bladder Health Handout

Diaphragmatic Breathing Exercise (DB); Educational Handout (EH)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

Duke Urogynecology - Patterson Place

Durham, North Carolina, 27705, United States

Location

Duke Urogynecology - Navaho

Raleigh, North Carolina, 27609, United States

Location

Related Publications (23)

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• Vasconcelos M, Lima E, Caiafa L, Noronha A, Cangussu R, Gomes S, Freire R, Filgueiras MT, Araujo J, Magnus G, Cunha C, Colozimo E. Voiding dysfunction in children. Pelvic-floor exercises or biofeedback therapy: a randomized study. Pediatr Nephrol. 2006 Dec;21(12):1858-64. doi: 10.1007/s00467-006-0277-1. Epub 2006 Sep 12.

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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.

  PMID: 35272329 BACKGROUND

• 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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• ACOG Practice Bulletin No. 155: Urinary Incontinence in Women. Obstet Gynecol. 2015 Nov;126(5):e66-e81. doi: 10.1097/AOG.0000000000001148. No abstract available.

  PMID: 26488524 BACKGROUND

• Brown HW, Barnes HC, Lim A, Giles DL, McAchran SE. Better together: multidisciplinary approach improves adherence to pelvic floor physical therapy. Int Urogynecol J. 2020 May;31(5):887-893. doi: 10.1007/s00192-019-04090-w. Epub 2019 Aug 28.

  PMID: 31463525 BACKGROUND

• Shannon MB, Genereux M, Brincat C, Adams W, Brubaker L, Mueller ER, Fitzgerald CM. Attendance at Prescribed Pelvic Floor Physical Therapy in a Diverse, Urban Urogynecology Population. PM R. 2018 Jun;10(6):601-606. doi: 10.1016/j.pmrj.2017.11.008. Epub 2017 Nov 11.

  PMID: 29138041 BACKGROUND

• Chiang CH, Jiang YH, Kuo HC. Therapeutic efficacy of biofeedback pelvic floor muscle exercise in women with dysfunctional voiding. Sci Rep. 2021 Jul 2;11(1):13757. doi: 10.1038/s41598-021-93283-9.

  PMID: 34215820 BACKGROUND

• 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.

  PMID: 33175229 BACKGROUND

• 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.

  PMID: 36735445 BACKGROUND

• Zivkovic V, Lazovic M, Vlajkovic M, Slavkovic A, Dimitrijevic L, Stankovic I, Vacic N. Diaphragmatic breathing exercises and pelvic floor retraining in children with dysfunctional voiding. Eur J Phys Rehabil Med. 2012 Sep;48(3):413-21. Epub 2012 Jun 5.

  PMID: 22669134 BACKGROUND

• Toprak N, Sen S, Varhan B. The role of diaphragmatic breathing exercise on urinary incontinence treatment: A pilot study. J Bodyw Mov Ther. 2022 Jan;29:146-153. doi: 10.1016/j.jbmt.2021.10.002. Epub 2021 Oct 20.

  PMID: 35248263 BACKGROUND

• Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9. doi: 10.1002/nau.1930140206.

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• Shumaker SA, Wyman JF, Uebersax JS, McClish D, Fantl JA. Health-related quality of life measures for women with urinary incontinence: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program in Women (CPW) Research Group. Qual Life Res. 1994 Oct;3(5):291-306. doi: 10.1007/BF00451721.

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• Tunitsky-Bitton E, Murphy A, Barber MD, Goldman HB, Vasavada S, Jelovsek JE. Assessment of voiding after sling: a randomized trial of 2 methods of postoperative catheter management after midurethral sling surgery for stress urinary incontinence in women. Am J Obstet Gynecol. 2015 May;212(5):597.e1-9. doi: 10.1016/j.ajog.2014.11.033. Epub 2014 Nov 27.

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• Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.

  PMID: 17339617 BACKGROUND

• Hughes AJ, Dunn KM, Chaffee T, Bhattarai JJ, Beier M. Diagnostic and Clinical Utility of the GAD-2 for Screening Anxiety Symptoms in Individuals With Multiple Sclerosis. Arch Phys Med Rehabil. 2018 Oct;99(10):2045-2049. doi: 10.1016/j.apmr.2018.05.029. Epub 2018 Jun 30.

  PMID: 29964000 BACKGROUND

• Cella D, Smith AR, Griffith JW, Kirkali Z, Flynn KE, Bradley CS, Jelovsek JE, Gillespie BW, Helfand BT, Talaty P, Weinfurt KP; LURN Study Group. A New Brief Clinical Assessment of Lower Urinary Tract Symptoms for Women and Men: LURN SI-10. J Urol. 2020 Jan;203(1):164-170. doi: 10.1097/JU.0000000000000465. Epub 2019 Jul 31.

  PMID: 31364922 BACKGROUND

• 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.

  PMID: 19375574 BACKGROUND

• Depaoli S, van de Schoot R. Improving transparency and replication in Bayesian statistics: The WAMBS-Checklist. Psychol Methods. 2017 Jun;22(2):240-261. doi: 10.1037/met0000065. Epub 2015 Dec 21.

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• Cameron AP, Lewicky-Gaupp C, Smith AR, Helfand BT, Gore JL, Clemens JQ, Yang CC, Siddiqui NY, Lai HH, Griffith JW, Andreev VP, Liu G, Weinfurt K, Amundsen CL, Bradley CS, Kusek JW, Kirkali Z; Symptoms of Lower Urinary Tract Dysfunction Research Network Study Group. Baseline Lower Urinary Tract Symptoms in Patients Enrolled in LURN: A Prospective, Observational Cohort Study. J Urol. 2018 Apr;199(4):1023-1031. doi: 10.1016/j.juro.2017.10.035. Epub 2017 Oct 28.

  PMID: 29111381 RESULT

Related Links

• Diaphragmatic breathing - stop and smell the roses - Urology Austin Blog.

Study Officials

• Cindy Amundsen

  Duke University

  PRINCIPAL INVESTIGATOR

• Annika Sinha

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 11, 2023
• Study Start: May 1, 2024
• Primary Completion: August 23, 2024
• Study Completion: August 23, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)