- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00177541
Further Enhancing Non-pharmacologic Therapy for Incontinence
4. august 2017 opdateret af: Neil Resnick, University of Pittsburgh
To determine the mechanisms mediating the therapeutic efficacy of pelvic floor muscle exercises and biofeedback for urge urinary incontinence, as well as the characteristics of patients most likely to respond.
By identifying the key components of this treatment, we hope to simplify it and make it more easily applicable, more effective, less expensive, and thus more useful for people with urge incontinence in the future.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Urinary incontinence (UI) is prevalent and morbid in the elderly, and its associated costs exceed $26 billion annually.
Although effective therapy exists, it is underutilized.
This is particularly true for non-pharmacologic therapies, which are at least as effective as drugs but safer, and recommended as the initial approach by every national panel.
If therapies such as biofeedback (which targets pelvic muscles and detrusor suppression) are to become more widely used, they will require simplification, fewer and briefer sessions, less expensive equipment, and less sophisticated therapists.
Unfortunately, such protocols cannot yet be devised because it is unknown which components are essential.
We postulate that the mechanisms mediating effectiveness can be identified and that such knowledge will make it possible to enhance efficacy and to formulate more feasible and cost-effective protocols.
Since reduction in UI correlates weakly with improved quality of life, however, it is important that biofeedback's impact on life quality be assessed concomitantly to ensure that formulation of such streamlined methods does not eliminate components essential for improved quality of life, even if they have no physiological correlates.
We will address these issues by treating at least 150 elderly subjects with urge UI in an 8-week course of biofeedback.
We will collect clinical and quality of life data and perform extensive physiologic testing on each subject at baseline and 8 weeks later.
Improvement will be correlated with change in physiologic and quality of life parameters to identify the parameters that likely mediated it.
Knowledge from this study should identify predictors and mechanisms mediating success of biofeedback; suggest ways that it could be further improved; facilitate development of less expensive, quicker, and more feasible protocols to deliver it (potentially permitting application to less motivated or cognitively impaired patients); and shed insight into mechanisms that may even improve efficacy of other interventions.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
123
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Geriatric Continence Research Unit, NE547 Montefiore UPMC
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
60 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- ambulatory women over age 60, who are incontinent at least twice weekly for 3 months despite correction of potentially reversible causes.
- urinary incontinence (urge or predominantly urge) by clinical criteria.
- able to accurately complete a voiding diary, to perform a 24-hour pad test under direction, and to undergo instruction in biofeedback.
Exclusion Criteria:
- significant mental impairment [mini mental status exam (MMSE) ≤ 20)
- urethral obstruction
- history of bladder cancer
- spinal cord lesions
- multiple sclerosis
- pelvic radiation
- interstitial cystitis
- artificial sphincter implant
- expected to have changes in medications/doses during the trial
- medically unstable
- Patients with factors that could cause transient UI [e.g., current urinary tract infection (UTI), acute confusion] will be treated in concert with the subject's primary care provider and considered for enrollment if their UI persists.
- conditions that require endocarditis prophylaxis (such as heart valve problems or bacterial endocarditis)
- being unable to undergo fMRI because of claustrophobia or any metallic objects in the body, such pacemakers, metallic prostheses, aneurism clips or others.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Biofeedback
Biofeedback assisted pelvic floor muscle therapy (3 visits)
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Biofeedback, pelvic floor muscle training, fMRI
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Percentage reduction in urge incontinence episodes at 12 weeks
Tidsramme: 12 weeks
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Various urodynamic parameters such as, e.g.:
Tidsramme: 12 weeks
|
12 weeks
|
Increase in functional bladder capacity at 12 weeks
Tidsramme: 12 weeks
|
12 weeks
|
Volume at first detrusor overactivity at 12 weeks
Tidsramme: 12 weeks
|
12 weeks
|
Improvement in QoL at 12 weeks
Tidsramme: 12 weeks
|
12 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Neil M Resnick, MD, University of Pittsburgh
- Studieleder: Becky Clarkson, PhD, University of Pittsburgh
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Burgio KL, Locher JL, Goode PS, Hardin JM, McDowell BJ, Dombrowski M, Candib D. Behavioral vs drug treatment for urge urinary incontinence in older women: a randomized controlled trial. JAMA. 1998 Dec 16;280(23):1995-2000. doi: 10.1001/jama.280.23.1995.
- Resnick NM. Improving treatment of urinary incontinence. JAMA. 1998 Dec 16;280(23):2034-5. doi: 10.1001/jama.280.23.2034. No abstract available.
- Resnick NM, Perera S, Tadic S, Organist L, Riley MA, Schaefer W, Griffiths D. What predicts and what mediates the response of urge urinary incontinence to biofeedback? Neurourol Urodyn. 2013 Jun;32(5):408-15. doi: 10.1002/nau.22347. Epub 2012 Nov 20.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2004
Primær færdiggørelse (Faktiske)
1. september 2016
Studieafslutning (Faktiske)
1. september 2016
Datoer for studieregistrering
Først indsendt
13. september 2005
Først indsendt, der opfyldte QC-kriterier
13. september 2005
Først opslået (Skøn)
15. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 5R01AG020629-02 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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