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Completed

NCT Number: NCT04117126

Efficacy of Prompted Voiding Therapy in Elderly Hospitalized.

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laura Martín Losada

Guadarrama, Madrid, 28440, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prompted voiding

Behavioral

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

Sponsors and collaborators

Lead sponsor

Guadarrama Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 7, 2019
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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