Clinical trial NCT04117126: Efficacy of Prompted Voiding Therapy in Elderly Hospitalized.
Official title: Efficacy of Prompted Voiding Therapy for Reverse the Urinary Incontinence Status in Elderly Patients Hospitalized in a Functional Recovery Ward.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: aged
Therapeutics
hospitalization
nursing care
rehabilitation
prompted voiding
Lead sponsor: Guadarrama Hospital
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 158
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of Urinary Incontinence status after prompted voiding program (PVP)
timeFrame: at admission, at discharge (about 30 to 60 days), 1 , 3 and 6 month post discharge
measure: Improve urinary incontinence episodes/symptoms after prompted voiding program.
timeFrame: at admission, each 15 days along admission, at discharge (about 30 to 60 days).
Secondary outcomes:
measure: Change of Urinary Incontinence status after PVP in admitted patients with Stress Urinary Incontinence
timeFrame: at admission, at discharge.(about 30 to 60 days)
measure: Change of Urinary Incontinence status after PVP in admitted patients with Emergency Urinary Incontinence
timeFrame: at admission, at discharge.(about 30 to 60 days)
measure: Change of Urinary Incontinence status after PVP in admitted patients with Mixed Urinary Incontinence
timeFrame: at admission, at discharge.(about 30 to 60 days)
measure: Change of Urinary Incontinence status after PVP in admitted patients with Functional Urinary Incontinence
timeFrame: at admission, at discharge.(about 30 to 60 days)
measure: Change from Urinary Incontinence status after PVP in admitted patients with Reflects Urinary Incontinence
timeFrame: at admission, at discharge.(about 30 to 60 days)
measure: Change of Urinary Incontinence status after PVP in admitted patients with Total Urinary Incontinence
timeFrame: at admission, at discharge.(about 30 to 60 days)
measure: Urinary Incontinence (UI) status reached related with aged.
timeFrame: at admission, at discharge (about 30 to 60 days)
measure: Urinary Incontinence (UI) status reached related with cognitive ability.
timeFrame: at admission, at discharge (about 30 to 60 days)
measure: Urinary Incontinence (UI) status reached related with Functional ability.
timeFrame: at admission, at discharge (about 30 to 60 days)
measure: Urinary Incontinence (UI) status reached related with risk diseases presence.
timeFrame: at admission, at discharge (about 30 to 60 days)
measure: Urinary Incontinence (UI) status reached related with risk drugs.
timeFrame: at admission, at discharge (about 30 to 60 days)
measure: Urinary Incontinence (UI) status reached related with overweigth.
timeFrame: at admission, at discharge (about 30 to 60 days)
measure: Urinary Incontinence (UI) status reached related with caregiver presence.
timeFrame: at admission, at discharge (about 30 to 60 days)
measure: Urinary Incontinence (UI) status reached related to diagnosis of admission
timeFrame: at admission, at discharge (about 30 to 60 days)
measure: Urinary Incontinence (UI) status reached related to risk of Skin Ulcer
timeFrame: at admission, at discharge (about 30 to 60 days)
measure: Urinary Incontinence (UI) status reached related to fall risk.
timeFrame: at admission, at discharge (about 30 to 60 days)
measure: Urinary Incontinence (UI) status reached related to days of hospitalization.
timeFrame: at admission, at discharge (about 30 to 60 days)
measure: Urinary Incontinence (UI) status reached related with time of UI.
timeFrame: at admission, at discharge (about 30 to 60 days)
Other outcomes:
Locations:
city: Guadarrama
country: Spain
facility: Laura Martín Losada
state: Madrid
Study officials:
affiliation: Hospital Guadarrama
name: Laura Martin Losada
role: PRINCIPAL_INVESTIGATOR
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