NCT04117126

Brief Summary

This study evaluates effectiveness to apply prompted voiding in urinary incontinence and dependence patients admitted at functional recovery ward in a mid-stay hospital. This behavioural therapy is recommended in Best Practice Guidelines, and it has good results in elderly living in the community or in nursing home but yet it has not shown his benefits in hospitalized elderly patients for a long time.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

3.2 years

First QC Date

August 17, 2019

Last Update Submit

September 12, 2023

Conditions

Keywords

agedTherapeuticshospitalizationnursing carerehabilitationprompted voiding

Outcome Measures

Primary Outcomes (2)

  • Change of Urinary Incontinence status after prompted voiding program (PVP)

    To value the efficacy of prompted voiding therapy to recovery urinary continence in elderly hospitalized at functional recovery ward. Data wil be collected from nursing assessment at admission, at discharge and telephone call.

    at admission, at discharge (about 30 to 60 days), 1 , 3 and 6 month post discharge

  • Improve urinary incontinence episodes/symptoms after prompted voiding program.

    To value the efficacy of prompted voiding therapy to improve urinary incontinence episodes/symptoms (episodes frequency, volume loss, type pad used) in elderly hospitalized at functional recovery ward. It Will be measure with assistance nurse record.

    at admission, each 15 days along admission, at discharge (about 30 to 60 days).

Secondary Outcomes (18)

  • Change of Urinary Incontinence status after PVP in admitted patients with Stress Urinary Incontinence

    at admission, at discharge.(about 30 to 60 days)

  • Change of Urinary Incontinence status after PVP in admitted patients with Emergency Urinary Incontinence

    at admission, at discharge.(about 30 to 60 days)

  • Change of Urinary Incontinence status after PVP in admitted patients with Mixed Urinary Incontinence

    at admission, at discharge.(about 30 to 60 days)

  • Change of Urinary Incontinence status after PVP in admitted patients with Functional Urinary Incontinence

    at admission, at discharge.(about 30 to 60 days)

  • Change from Urinary Incontinence status after PVP in admitted patients with Reflects Urinary Incontinence

    at admission, at discharge.(about 30 to 60 days)

  • +13 more secondary outcomes

Study Arms (1)

urinary incontinence

EXPERIMENTAL

Recruitment, 3-day voiding record, initiate a individualized prompted voiding schedule based on the client's toileting needs until discharge, 1, 3 and 6 month follow-up post-discharge.

Behavioral: Prompted voiding

Interventions

Monitoring: This involves asking the incontinent individual, at regular intervals, if he or she needs to use the toilet. The care provider may look for behaviours that the client needs to be toileted (e.g., restlessness, agitation, disrobing), and take the client to the toilet at regular intervals specific to their schedule, rather than routinely every two hours. Prompting: This process includes prompting the person to use the toilet at regular intervals, and encourages the maintenance of bladder control between prompted voiding sessions. Praising: This important step is the positive reinforcement of dryness and appropriate toileting, and is the response from the care provider to the individual's success with maintaining bladder control.

urinary incontinence

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • onset of Urinary Incontinence less than 1 year (information extracted from the Patient's Medical History, or provided by the patient or family caregiver)
  • sign the informed consent.

You may not qualify if:

  • patient with indwelling urinary catheters at admission
  • irreversible urinary incontinence by disease itself
  • moderate-severe cognitive impairment (Pfeiffer's questionnaire \> 4)
  • patients with indication of water restriction.
  • patients who do not collaborate in Prompted Voiding therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laura Martín Losada

Guadarrama, Madrid, 28440, Spain

Location

Related Publications (24)

  • Jansen APD, Muntinga ME, Bosmans JE, Berghmans B, Dekker J, Hugtenburgh J, Nijpels G, van Houten P, Laurant MGH, van der Vaart HCH. Cost-effectiveness of a nurse-led intervention to optimise implementation of guideline-concordant continence care: Study protocol of the COCON study. BMC Nurs. 2017 Feb 22;16:10. doi: 10.1186/s12912-017-0204-8. eCollection 2017.

    PMID: 28239296BACKGROUND
  • Thuroff JW, Abrams P, Andersson KE, Artibani W, Chapple CR, Drake MJ, Hampel C, Neisius A, Schroder A, Tubaro A; European Association of Urology. [EAU Guidelines on Urinary Incontinence]. Actas Urol Esp. 2011 Jul-Aug;35(7):373-88. doi: 10.1016/j.acuro.2011.03.012. Epub 2011 May 19. Spanish.

    PMID: 21600674BACKGROUND
  • Promoting Continence Using Prompted Voiding Guideline. [Internet] RNAO, 2011. Available in https://rnao.ca/bpg/guidelines/promoting-continence-using-prompted-voiding

    BACKGROUND
  • Terzoni S, Montanari E, Mora C, Destrebecq A. Urinary incontinence in adults: nurses' beliefs, education and role in continence promotion. A narrative review. Arch Ital Urol Androl. 2011 Dec;83(4):213-6.

    PMID: 22670322BACKGROUND
  • Baztan JJ, Arias E, Gonzalez N, Rodriguez de Prada MI. New-onset urinary incontinence and rehabilitation outcomes in frail older patients. Age Ageing. 2005 Mar;34(2):172-5. doi: 10.1093/ageing/afi001. No abstract available.

    PMID: 15713862BACKGROUND
  • Riemsma R, Hagen S, Kirschner-Hermanns R, Norton C, Wijk H, Andersson KE, Chapple C, Spinks J, Wagg A, Hutt E, Misso K, Deshpande S, Kleijnen J, Milsom I. Can incontinence be cured? A systematic review of cure rates. BMC Med. 2017 Mar 24;15(1):63. doi: 10.1186/s12916-017-0828-2.

    PMID: 28335792BACKGROUND
  • Holtzer-Goor KM, Gaultney JG, van Houten P, Wagg AS, Huygens SA, Nielen MM, Albers-Heitner CP, Redekop WK, Rutten-van Molken MP, Al MJ. Cost-Effectiveness of Including a Nurse Specialist in the Treatment of Urinary Incontinence in Primary Care in the Netherlands. PLoS One. 2015 Oct 1;10(10):e0138225. doi: 10.1371/journal.pone.0138225. eCollection 2015.

    PMID: 26426124BACKGROUND
  • Lai CKY, Wan X. Using Prompted Voiding to Manage Urinary Incontinence in Nursing Homes: Can It Be Sustained? J Am Med Dir Assoc. 2017 Jun 1;18(6):509-514. doi: 10.1016/j.jamda.2016.12.084. Epub 2017 Feb 22.

    PMID: 28236604BACKGROUND
  • Gibson JM, Thomas LH, Harrison JJ, Watkins CL; ICONS Project Team and the ICONS Patient, Public and Carer Involvement Groups. Stroke survivors' and carers' experiences of a systematic voiding programme to treat urinary incontinence after stroke. J Clin Nurs. 2018 May;27(9-10):2041-2051. doi: 10.1111/jocn.14346.

    PMID: 29517816BACKGROUND
  • Suzuki M, Iguchi Y, Igawa Y, Yoshida M, Sanada H, Miyazaki H, Homma Y. Ultrasound-assisted prompted voiding for management of urinary incontinence of nursing home residents: Efficacy and feasibility. Int J Urol. 2016 Sep;23(9):786-90. doi: 10.1111/iju.13156. Epub 2016 Jul 11.

    PMID: 27399836BACKGROUND
  • Thomas LH, French B, Burton CR, Sutton C, Forshaw D, Dickinson H, Leathley MJ, Britt D, Roe B, Cheater FM, Booth J, Watkins CL; ICONS Project Team; ICONS Patient, Public and Carer Involvement Groups. Evaluating a systematic voiding programme for patients with urinary incontinence after stroke in secondary care using soft systems analysis and Normalisation Process Theory: findings from the ICONS case study phase. Int J Nurs Stud. 2014 Oct;51(10):1308-20. doi: 10.1016/j.ijnurstu.2014.02.009. Epub 2014 Feb 20.

    PMID: 24656435BACKGROUND
  • Holroyd-Leduc JM, Straus SE. Management of urinary incontinence in women: scientific review. JAMA. 2004 Feb 25;291(8):986-95. doi: 10.1001/jama.291.8.986.

    PMID: 14982915BACKGROUND
  • Franken MG, Corro Ramos I, Los J, Al MJ. The increasing importance of a continence nurse specialist to improve outcomes and save costs of urinary incontinence care: an analysis of future policy scenarios. BMC Fam Pract. 2018 Feb 17;19(1):31. doi: 10.1186/s12875-018-0714-9.

    PMID: 29454331BACKGROUND
  • Eustice S, Roe B, Paterson J. Prompted voiding for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2000;2000(2):CD002113. doi: 10.1002/14651858.CD002113.

    PMID: 10796861BACKGROUND
  • Morilla JC, Iglesias J, Izquierdo JM, Martín MJ, Martín MC, Rodríguez C. et al. Guía de atención enfermera a pacientes con incontinencia urinaria. Asociación Andaluza de Enfermería Comunitaria, 2007.

    BACKGROUND
  • Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.

    PMID: 12559262BACKGROUND
  • Barentsen JA, Visser E, Hofstetter H, Maris AM, Dekker JH, de Bock GH. Severity, not type, is the main predictor of decreased quality of life in elderly women with urinary incontinence: a population-based study as part of a randomized controlled trial in primary care. Health Qual Life Outcomes. 2012 Dec 18;10:153. doi: 10.1186/1477-7525-10-153.

    PMID: 23249635BACKGROUND
  • García M. Análisis descriptivo del gasto sanitario español: evolución, desglose, comparativa internacional y relación con la renta. [Internet] Instituto de Estudios Fiscales. I.S.S.N.: 1578-0252 Available in http://www.ief.es/documentos/recursos/publicaciones/papeles_trabajo/2006_24.pdf

    BACKGROUND
  • Miner PB Jr. Economic and personal impact of fecal and urinary incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S8-13. doi: 10.1053/j.gastro.2003.10.056.

    PMID: 14978633BACKGROUND
  • Baena V, Blasco P, Cozar-Olmo JM, Díez-Itza I, Espuña M, Hidalgo A. Libro Blanco de la Carga Socioeconómica de la Incontinencia Urinaria en España, 2017.

    BACKGROUND
  • Martinez Agullo E, Ruiz Cerda JL, Gomez Perez L, Ramirez Backhaus M, Delgado Oliva F, Rebollo P, Gonzalez-Segura Alsina D, Arumi D; Grupo de Estudio Cooperativo EPICC. [Prevalence of urinary incontinence and hyperactive bladder in the Spanish population: results of the EPICC study]. Actas Urol Esp. 2009 Feb;33(2):159-66. doi: 10.1016/s0210-4806(09)74117-8. Spanish.

    PMID: 19418840BACKGROUND
  • Rexach Cano, L., Verdejo Bravo, C. Incontinencia urinaria. Inf Ter Sist Nac Salud 1999; 23:149-159.

    BACKGROUND
  • Fantl JA, Newman DK, Colling J, DeLancey JO, Keeys C, Loughery R. Urinary Incontinence in Adults: Acute and Chronic Management Clinical Practice Guideline, N. 2, 1996 Update. AHCPR.

    BACKGROUND
  • Lyons SS, Specht JKP. Research-based protocol: prompted voiding for persons with urinary incontinence. The University of Iowa Gerontological Nursing Interventions Research Center, Research Development and Dissemination Core, 1999

    BACKGROUND

Related Links

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Laura Martin Losada

    Hospital Guadarrama

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Nurse, Doctoral student.

Study Record Dates

First Submitted

August 17, 2019

First Posted

October 7, 2019

Study Start

October 15, 2019

Primary Completion

January 11, 2023

Study Completion

July 15, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations