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Efficacy of Prompted Voiding Therapy in Elderly Hospitalized.

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Prompted voiding
Sponsored by
Guadarrama Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring aged, Therapeutics, hospitalization, nursing care, rehabilitation, prompted voiding

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Laura Martín Losada

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

urinary incontinence

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Urinary Incontinence (UI) status reached related with aged.
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.
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.
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.
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.
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.
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
Urinary Incontinence (UI) status reached related with caregiver presence.
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.
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.
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.
Urinary Incontinence (UI) status reached related to fall risk.
Data will be collected from clinical history records. It will be valuated with Sytratify Scale.
Urinary Incontinence (UI) status reached related to days of hospitalization.
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.
Urinary Incontinence (UI) status reached related with time of UI.
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.

Full Information

First Posted
August 17, 2019
Last Updated
September 12, 2023
Sponsor
Guadarrama Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04117126
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
January 11, 2023 (Actual)
Study Completion Date
July 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guadarrama Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
aged, Therapeutics, hospitalization, nursing care, rehabilitation, prompted voiding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
urinary incontinence
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Prompted voiding
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Urinary Incontinence status after prompted voiding program (PVP)
Description
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.
Time Frame
at admission, at discharge (about 30 to 60 days), 1 , 3 and 6 month post discharge
Title
Improve urinary incontinence episodes/symptoms after prompted voiding program.
Description
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.
Time Frame
at admission, each 15 days along admission, at discharge (about 30 to 60 days).
Secondary Outcome Measure Information:
Title
Change of Urinary Incontinence status after PVP in admitted patients with Stress Urinary Incontinence
Description
Assessment will be with IU4 questionnaire and NANDA diagnosis. Data will be collected from nursing assessment at admission and nursing assesment at discharge records.
Time Frame
at admission, at discharge.(about 30 to 60 days)
Title
Change of Urinary Incontinence status after PVP in admitted patients with Emergency Urinary Incontinence
Description
Assessment will be with IU4 questionnaire and NANDA diagnosis. Data will be collected from nursing assessment at admission and nursing assesment at discharge records.
Time Frame
at admission, at discharge.(about 30 to 60 days)
Title
Change of Urinary Incontinence status after PVP in admitted patients with Mixed Urinary Incontinence
Description
Assessment will be with IU4 questionnaire and NANDA diagnosis. Data will be collected from nursing assessment at admission and nursing assesment at discharge records.
Time Frame
at admission, at discharge.(about 30 to 60 days)
Title
Change of Urinary Incontinence status after PVP in admitted patients with Functional Urinary Incontinence
Description
Assessment will be with IU4 questionnaire and NANDA diagnosis. Data will be collected from nursing assessment at admission and nursing assesment at discharge records.
Time Frame
at admission, at discharge.(about 30 to 60 days)
Title
Change from Urinary Incontinence status after PVP in admitted patients with Reflects Urinary Incontinence
Description
Assessment will be with IU4 questionnaire and NANDA diagnosis. Data will be collected from nursing assessment at admission and nursing assesment at discharge records.
Time Frame
at admission, at discharge.(about 30 to 60 days)
Title
Change of Urinary Incontinence status after PVP in admitted patients with Total Urinary Incontinence
Description
Assessment will be with IU4 questionnaire and NANDA diagnosis. Data will be collected from nursing assessment at admission and nursing assesment at discharge records.
Time Frame
at admission, at discharge.(about 30 to 60 days)
Title
Urinary Incontinence (UI) status reached related with aged.
Description
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.
Time Frame
at admission, at discharge (about 30 to 60 days)
Title
Urinary Incontinence (UI) status reached related with cognitive ability.
Description
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records. Cognitive impairments will be measure with Pfeiffer test.
Time Frame
at admission, at discharge (about 30 to 60 days)
Title
Urinary Incontinence (UI) status reached related with Functional ability.
Description
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records. Functional ability will be measure with Barthel Scale.
Time Frame
at admission, at discharge (about 30 to 60 days)
Title
Urinary Incontinence (UI) status reached related with risk diseases presence.
Description
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.
Time Frame
at admission, at discharge (about 30 to 60 days)
Title
Urinary Incontinence (UI) status reached related with risk drugs.
Description
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.
Time Frame
at admission, at discharge (about 30 to 60 days)
Title
Urinary Incontinence (UI) status reached related with overweigth.
Description
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records. Body Mass Index greater than or equal to 25
Time Frame
at admission, at discharge (about 30 to 60 days)
Title
Urinary Incontinence (UI) status reached related with caregiver presence.
Description
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.
Time Frame
at admission, at discharge (about 30 to 60 days)
Title
Urinary Incontinence (UI) status reached related to diagnosis of admission
Description
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records. 3 groups will be assigned: Femoral Fractures, stroke, functional disability.
Time Frame
at admission, at discharge (about 30 to 60 days)
Title
Urinary Incontinence (UI) status reached related to risk of Skin Ulcer
Description
Data will be collected from clinical history records. It will be valuated with Norton Scale.
Time Frame
at admission, at discharge (about 30 to 60 days)
Title
Urinary Incontinence (UI) status reached related to fall risk.
Description
Data will be collected from clinical history records. It will be valuated with Sytratify Scale.
Time Frame
at admission, at discharge (about 30 to 60 days)
Title
Urinary Incontinence (UI) status reached related to days of hospitalization.
Description
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.
Time Frame
at admission, at discharge (about 30 to 60 days)
Title
Urinary Incontinence (UI) status reached related with time of UI.
Description
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.
Time Frame
at admission, at discharge (about 30 to 60 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Martin Losada
Organizational Affiliation
Hospital Guadarrama
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laura Martín Losada
City
Guadarrama
State/Province
Madrid
ZIP/Postal Code
28440
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
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URL
http://www.nnnconsult.com/
Description
Nursing Care Plan tool. NNNConsult. Elsevier; 2015.

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Efficacy of Prompted Voiding Therapy in Elderly Hospitalized.

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