Efficacy of Prompted Voiding Therapy in Elderly Hospitalized.

Urinary Incontinence Clinical Trial

Official title:

Efficacy of Prompted Voiding Therapy for Reverse the Urinary Incontinence Status in Elderly Patients Hospitalized in a Functional Recovery Ward.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04117126
• Other study ID #: 7.0
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: July 15, 2023

Study information

• Verified date: September 2023
• Source: Guadarrama Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The increased level of chronic diseases, greater chances of survival and older people hospitalized, place the Urinary Incontinence (UI) problem in a priority position both in hospital and community care. Guadarrama (Public Madrid Health Service) is a medium-stay Hospital. It makes treatment to recover from acute disease and UI has 80% prevalence at admitted patients.

Main objective:To assess the efficacy of Prompted Voiding (PV) therapy for reverse of UI status in elderly patients hospitalized in a Functional Recovery Ward. (FRW) Methods: Experimental research pre/post-Intervention, with 5 repeated measures data: baseline (preintervention); at discharge, at one, three and six months after discharge (post-intervention). Sample size is 212 admitted patients in the FRW with UI. Prompted voiding intervention will be applied by nursing team following the procedure hospital approved and it will be individualized to each patient.

Main Outcome: urinary continence (YES/NO), others outcomes: amount and frequency of urine loss, type of incontinence pads; follow-up: urinary continence at one, three, and six months after discharge.

Applicability: Incorporating Prompted Voiding Therapy in UI patients care, encouraging global care, relevant implications for reduce the morbidity, improvement the quality of life, decrease health costs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: July 15, 2023
• Est. primary completion date: January 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Behavioral:
• Prompted voiding
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.

Locations

Country	Name	City	State
Spain	Laura Martín Losada	Guadarrama	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Guadarrama Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (24)

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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.

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change of Urinary Incontinence status after PVP in admitted patients with Stress Urinary Incontinence	Assessment will be with IU4 questionnaire and NANDA diagnosis. Data will be collected from nursing assessment at admission and nursing assesment at discharge records.	at admission, at discharge.(about 30 to 60 days)
Secondary	Change of Urinary Incontinence status after PVP in admitted patients with Emergency Urinary Incontinence	Assessment will be with IU4 questionnaire and NANDA diagnosis. Data will be collected from nursing assessment at admission and nursing assesment at discharge records.	at admission, at discharge.(about 30 to 60 days)
Secondary	Change of Urinary Incontinence status after PVP in admitted patients with Mixed Urinary Incontinence	Assessment will be with IU4 questionnaire and NANDA diagnosis. Data will be collected from nursing assessment at admission and nursing assesment at discharge records.	at admission, at discharge.(about 30 to 60 days)
Secondary	Change of Urinary Incontinence status after PVP in admitted patients with Functional Urinary Incontinence	Assessment will be with IU4 questionnaire and NANDA diagnosis. Data will be collected from nursing assessment at admission and nursing assesment at discharge records.	at admission, at discharge.(about 30 to 60 days)
Secondary	Change from Urinary Incontinence status after PVP in admitted patients with Reflects Urinary Incontinence	Assessment will be with IU4 questionnaire and NANDA diagnosis. Data will be collected from nursing assessment at admission and nursing assesment at discharge records.	at admission, at discharge.(about 30 to 60 days)
Secondary	Change of Urinary Incontinence status after PVP in admitted patients with Total Urinary Incontinence	Assessment will be with IU4 questionnaire and NANDA diagnosis. Data will be collected from nursing assessment at admission and nursing assesment at discharge records.	at admission, at discharge.(about 30 to 60 days)
Secondary	Urinary Incontinence (UI) status reached related with aged.	To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.	at admission, at discharge (about 30 to 60 days)
Secondary	Urinary Incontinence (UI) status reached related with cognitive ability.	To Identify promoting/difficulty continence factors. Data will be collected from clinical history records. Cognitive impairments will be measure with Pfeiffer test.	at admission, at discharge (about 30 to 60 days)
Secondary	Urinary Incontinence (UI) status reached related with Functional ability.	To Identify promoting/difficulty continence factors. Data will be collected from clinical history records. Functional ability will be measure with Barthel Scale.	at admission, at discharge (about 30 to 60 days)
Secondary	Urinary Incontinence (UI) status reached related with risk diseases presence.	To Identify promoting/difficulty continence factors. Data will be collected from clinical history records. Risk diseases: Diabetes Mellitus, Parkinson Disease, Heart Failure, Obesity, Urinary Tract infection, Nervous System Diseases, Stroke, Abdomen and pelvis surgery.	at admission, at discharge (about 30 to 60 days)
Secondary	Urinary Incontinence (UI) status reached related with risk drugs.	To Identify promoting/difficulty continence factors. Data will be collected from clinical history records and drug prescriptions. Risk drugs: Diuretics; sedatives; hypnotics; anticholinergics; amitriptyline; opioid analgesics, cholinesterase inhibitors.	at admission, at discharge (about 30 to 60 days)
Secondary	Urinary Incontinence (UI) status reached related with overweigth.	To Identify promoting/difficulty continence factors. Data will be collected from clinical history records. Body Mass Index greater than or equal to 25	at admission, at discharge (about 30 to 60 days)
Secondary	Urinary Incontinence (UI) status reached related with caregiver presence.	To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.	at admission, at discharge (about 30 to 60 days)
Secondary	Urinary Incontinence (UI) status reached related to diagnosis of admission	To Identify promoting/difficulty continence factors. Data will be collected from clinical history records. 3 groups will be assigned: Femoral Fractures, stroke, functional disability.	at admission, at discharge (about 30 to 60 days)
Secondary	Urinary Incontinence (UI) status reached related to risk of Skin Ulcer	Data will be collected from clinical history records. It will be valuated with Norton Scale.	at admission, at discharge (about 30 to 60 days)
Secondary	Urinary Incontinence (UI) status reached related to fall risk.	Data will be collected from clinical history records. It will be valuated with Sytratify Scale.	at admission, at discharge (about 30 to 60 days)
Secondary	Urinary Incontinence (UI) status reached related to days of hospitalization.	To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.	at admission, at discharge (about 30 to 60 days)
Secondary	Urinary Incontinence (UI) status reached related with time of UI.	To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.	at admission, at discharge (about 30 to 60 days)

External Links

•   Nursing Care Plan tool. NNNConsult. Elsevier; 2015.