Efficacy of Prompted Voiding Therapy in Elderly Hospitalized.

A study testing Prompted voiding in people with Urinary Incontinence, run by Guadarrama Hospital at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Urinary Incontinence
What is being tested?: Prompted voiding
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 158 participants
Where: 1 siteSpain
Study dates: 15 Oct 2019to 15 Jul 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Laura Martín Losada
Guadarrama, Madrid, 28440

Other trials in Spain

About this study

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

Read the 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.

Conditions: Urinary Incontinence
Being tested: Prompted voiding
Keywords: aged, Therapeutics, hospitalization, nursing care, rehabilitation, prompted voiding
Medical subject headings: Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prompted voidingBehavioural
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.

Study groups in NCT04117126
Study group	Role	What they receive
urinary incontinence	Experimental	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. Receives: Behavioral: Prompted voiding

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
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.
Measured: at admission, each 15 days along admission, at discharge (about 30 to 60 days).

Secondary outcomes (18)

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.
Measured: at admission, at discharge.(about 30 to 60 days)
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.
Measured: at admission, at discharge.(about 30 to 60 days)
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.
Measured: at admission, at discharge.(about 30 to 60 days)
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.
Measured: at admission, at discharge.(about 30 to 60 days)
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.
Measured: at admission, at discharge.(about 30 to 60 days)
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.
Measured: at admission, at discharge.(about 30 to 60 days)
Urinary Incontinence (UI) status reached related with aged.
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.
Measured: at admission, at discharge (about 30 to 60 days)
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.
Measured: at admission, at discharge (about 30 to 60 days)
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.
Measured: at admission, at discharge (about 30 to 60 days)
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.
Measured: at admission, at discharge (about 30 to 60 days)
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.
Measured: at admission, at discharge (about 30 to 60 days)
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
Measured: at admission, at discharge (about 30 to 60 days)
Urinary Incontinence (UI) status reached related with caregiver presence.
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.
Measured: at admission, at discharge (about 30 to 60 days)
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.
Measured: at admission, at discharge (about 30 to 60 days)
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.
Measured: at admission, at discharge (about 30 to 60 days)
Urinary Incontinence (UI) status reached related to fall risk.
Data will be collected from clinical history records. It will be valuated with Sytratify Scale.
Measured: at admission, at discharge (about 30 to 60 days)
Urinary Incontinence (UI) status reached related to days of hospitalization.
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.
Measured: at admission, at discharge (about 30 to 60 days)
Urinary Incontinence (UI) status reached related with time of UI.
To Identify promoting/difficulty continence factors. Data will be collected from clinical history records.
Measured: at admission, at discharge (about 30 to 60 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 201915 Jul 2023

First posted7 Oct 2019
Study start15 Oct 2019
Primary completion11 Jan 2023
Study completion15 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04117126
Sponsor's protocol ID: 7.0
Status last verified: Sep 2023
First submitted: 17 Aug 2019
Last updated: 13 Sep 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 28239296
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.
PubMed 21600674
Promoting Continence Using Prompted Voiding Guideline. [Internet] RNAO, 2011. Available in https://rnao.ca/bpg/guidelines/promoting-continence-using-prompted-voiding
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.
PubMed 22670322
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.
PubMed 15713862
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.
PubMed 28335792
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.
PubMed 26426124
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.
PubMed 28236604
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.
PubMed 29517816
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.
PubMed 27399836
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.
PubMed 24656435
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.
PubMed 14982915
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.
PubMed 29454331
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.
PubMed 10796861
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)

All Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Prompted Voiding Therapy for Reverse the Urinary Incontinence Status in Elderly Patients Hospitalized in a Functional Recovery Ward.
ClinicalTrials.gov ID: NCT04117126
Acronym / sponsor ID: 7.0
Conditions: Urinary Incontinence
Keywords: aged, Therapeutics, hospitalization, nursing care, rehabilitation, prompted voiding
Study type: Interventional
Recruitment status: Completed
Enrolment: 158 participants (actual)
Lead sponsor: Guadarrama HospitalUniversity, hospital or other
Study start: 15 Oct 2019 (actual)
Primary completion: 11 Jan 2023 (actual)
Study completion: 15 Jul 2023 (actual)
First posted: 7 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
urinary incontinence	Experimental	Behavioral: Prompted voidingRecruitment, 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.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prompted voidingMonitoring: 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.	Behavioural	urinary incontinence

Primary outcome

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.
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.

18 secondary outcomes

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)
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)
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)
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)
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)
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)
Urinary Incontinence (UI) status reached related with aged.
Time frame: 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)
Urinary Incontinence (UI) status reached related with Functional ability.
Time frame: 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)
Urinary Incontinence (UI) status reached related with risk drugs.
Time frame: 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)
Urinary Incontinence (UI) status reached related with caregiver presence.
Time frame: 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)
Urinary Incontinence (UI) status reached related to risk of Skin Ulcer
Time frame: 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)
Urinary Incontinence (UI) status reached related to days of hospitalization.
Time frame: 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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
Background: PubMed 28239296Jansen 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.
Background: PubMed 21600674Thuroff 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.
BackgroundPromoting Continence Using Prompted Voiding Guideline. [Internet] RNAO, 2011. Available in https://rnao.ca/bpg/guidelines/promoting-continence-using-prompted-voiding
Background: PubMed 22670322Terzoni 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.
Background: PubMed 15713862Baztan 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.
Background: PubMed 28335792Riemsma 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.
Background: PubMed 26426124Holtzer-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.
Background: PubMed 28236604Lai 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.
Background: PubMed 29517816Gibson 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.
Background: PubMed 27399836Suzuki 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.
Background: PubMed 24656435Thomas 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.
Background: PubMed 14982915Holroyd-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.
Nursing Care Plan tool. NNNConsult. Elsevier; 2015.Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Urinary Incontinence

Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura Martin Losada principal investigator

Hospital Guadarrama

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Prompted voiding in people with Urinary Incontinence, run by Guadarrama Hospital at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04117126, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.