Efficacy of Prompted Voiding Therapy in Elderly Hospitalized.

September 12, 2023 updated by: Laura Martín Losada, Guadarrama Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Guadarrama, Madrid, Spain, 28440
        • Laura Martín Losada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: urinary incontinence
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Urinary Incontinence status after prompted voiding program (PVP)
Time Frame: at admission, at discharge (about 30 to 60 days), 1 , 3 and 6 month post discharge
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.
Time Frame: at admission, each 15 days along admission, at discharge (about 30 to 60 days).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Urinary Incontinence status after PVP in admitted patients with Stress Urinary Incontinence
Time Frame: at admission, at discharge.(about 30 to 60 days)
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)
Change of Urinary Incontinence status after PVP in admitted patients with Emergency Urinary Incontinence
Time Frame: at admission, at discharge.(about 30 to 60 days)
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)
Change of Urinary Incontinence status after PVP in admitted patients with Mixed Urinary Incontinence
Time Frame: at admission, at discharge.(about 30 to 60 days)
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)
Change of Urinary Incontinence status after PVP in admitted patients with Functional Urinary Incontinence
Time Frame: at admission, at discharge.(about 30 to 60 days)
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)
Change from Urinary Incontinence status after PVP in admitted patients with Reflects Urinary Incontinence
Time Frame: at admission, at discharge.(about 30 to 60 days)
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)
Change of Urinary Incontinence status after PVP in admitted patients with Total Urinary Incontinence
Time Frame: at admission, at discharge.(about 30 to 60 days)
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)
Urinary Incontinence (UI) status reached related with aged.
Time Frame: at admission, at discharge (about 30 to 60 days)
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.
at admission, at discharge (about 30 to 60 days)
Urinary Incontinence (UI) status reached related with cognitive ability.
Time Frame: at admission, at discharge (about 30 to 60 days)
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)
Urinary Incontinence (UI) status reached related with Functional ability.
Time Frame: at admission, at discharge (about 30 to 60 days)
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)
Urinary Incontinence (UI) status reached related with risk diseases presence.
Time Frame: at admission, at discharge (about 30 to 60 days)
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)
Urinary Incontinence (UI) status reached related with risk drugs.
Time Frame: at admission, at discharge (about 30 to 60 days)
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)
Urinary Incontinence (UI) status reached related with overweigth.
Time Frame: at admission, at discharge (about 30 to 60 days)
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)
Urinary Incontinence (UI) status reached related with caregiver presence.
Time Frame: at admission, at discharge (about 30 to 60 days)
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.
at admission, at discharge (about 30 to 60 days)
Urinary Incontinence (UI) status reached related to diagnosis of admission
Time Frame: at admission, at discharge (about 30 to 60 days)
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)
Urinary Incontinence (UI) status reached related to risk of Skin Ulcer
Time Frame: at admission, at discharge (about 30 to 60 days)
Data will be collected from clinical history records. It will be valuated with Norton Scale.
at admission, at discharge (about 30 to 60 days)
Urinary Incontinence (UI) status reached related to fall risk.
Time Frame: at admission, at discharge (about 30 to 60 days)
Data will be collected from clinical history records. It will be valuated with Sytratify Scale.
at admission, at discharge (about 30 to 60 days)
Urinary Incontinence (UI) status reached related to days of hospitalization.
Time Frame: at admission, at discharge (about 30 to 60 days)
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.
at admission, at discharge (about 30 to 60 days)
Urinary Incontinence (UI) status reached related with time of UI.
Time Frame: at admission, at discharge (about 30 to 60 days)
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.
at admission, at discharge (about 30 to 60 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guadarrama Hospital

Investigators

  • Principal Investigator: Laura Martin Losada, Hospital Guadarrama

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2019

Primary Completion (Actual)

January 11, 2023

Study Completion (Actual)

July 15, 2023

Study Registration Dates

First Submitted

August 17, 2019

First Submitted That Met QC Criteria

October 3, 2019

First Posted (Actual)

October 7, 2019

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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