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Translating Unique Learning for Incontinence Prevention (TULIP)

10 mai 2016 mis à jour par: Carolyn Sampselle, University of Michigan

Translating Unique Learning for Incontinence Prevention for Women Over the Age of 55

More than one in three US women suffers from the distressing, embarrassing, and often unreported problem of urinary incontinence (UI). UI severity increases with age and the financial cost exceeds $19 billion per year . The Adult Conservative Management Committee of the 2008 International Consultation on Incontinence concluded that pelvic floor muscle training (PFMT) should be offered as first line therapy to all women with stress, urge, or mixed UI; and that bladder training (BT) may be preferred to drug therapy. Conservative strategies are low risk and differ from other forms of UI management in that they do not prejudice future treatments. They also may decrease symptoms of urgency and frequency that do not entail UI, but greatly reduce the quality of life for nearly 1 in 11 US women.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

The study will attempt to accomplish 3 aims:

Aim 1: Compare outcomes of the two-hour BH Class with the condensed DVD version.

To accomplish this aim we will conduct a comparative effectiveness trial of 600 women 55 years and older randomized to BH Class or DVD. Women will be followed for 24 months post-intervention in order to assess long-term outcomes and sustainability.

Aim 2: Conduct an economic analysis comparing the two-hour BH Class with the DVD version. Describing the costs, quality of life, and analyzing the willingness to pay and employment/ productivity data will be the primary economic focus of this study.

Aim 3: Conduct a qualitative analysis to gain insight into elements of the intervention that contribute to sustainability.

Inclusion/Exclusion Criteria

Inclusion:

  1. Female, aged 55 years or older
  2. An additive sum of the frequency (question 1) and volume (question 2) items from the International Consultation on Incontinence Questionnaire-Short Form is ≤5
  3. Negative for demonstrable UI on the standardized Paper Towel Test
  4. Willing to undergo vaginal/pelvic examination
  5. Willing and able to be compliant with visit schedule and study procedures for the study duration
  6. Provide written informed consent form
  7. Able to understand and read English

Exclusion:

  1. Non-ambulatory (patient confined to bed or wheelchair)
  2. Persistent pelvic pain (defined as daily pelvic pain)
  3. History of neurologic diseases (e.g. Cerebral Vasular Accident, Parkinson's disease, Multiple sclerosis, Epilepsy, Spinal cord tumor or trauma, spina bifida, current symptomatic herniated disc)
  4. Actively taking UI, OAB, or any other bladder control medication.
  5. Other urinary conditions or procedures that may affect continence status (e.g. history of bladder cancer, urethral diverticula, previous augmentation cystoplasty or artificial sphincter; implanted nerve stimulators for urinary symptoms, history of sling surgery for UI or prolapse)
  6. Participation in another research project that may influence the results of this trial
  7. Pelvic organ prolapse protruding past the introitus upon straining
  8. Absolute absence of pelvic floor muscle strength manifested by zero Brink test (Brink et al., 1994 for pressure and displacement 9
  9. Evidence of UTI or hematuria - Urine dipstick positive for red blood cells will exclude the participant from enrollment in the study until a microscopic urinalysis is negative. Urine dipstick positive for leukocytes plus nitrates will exclude the participant from enrollment in the study and require further evaluation for UTI.
  10. History of > 2 recurrent UTI's in the past year and no more than one UTI within 6 months
  11. Post void residual > 150 cc

Type d'étude

Interventionnel

Inscription (Réel)

647

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48109
        • University of Michigan School of Nursing
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19104
        • University of Pennsylvania Department of Urology

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

55 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  1. Female, aged 55 years or older
  2. An additive sum of the frequency (question 1) and volume (question 2) items from the International Consultation on Incontinence Questionnaire-Short Form is ≤5
  3. Negative for demonstrable UI on the standardized Paper Towel Test
  4. Willing to undergo vaginal/pelvic examination
  5. Willing and able to be compliant with visit schedule and study procedures for the study duration
  6. Provide written informed consent form
  7. Able to understand and read English

Exclusion Criteria:

  1. Non-ambulatory (patient confined to bed or wheelchair)
  2. Persistent pelvic pain (defined as daily pelvic pain)
  3. History of neurologic diseases (e.g. Cerebral Vasular Accident, Parkinson's disease, Multiple sclerosis, Epilepsy, Spinal cord tumor or trauma, spina bifida, current symptomatic herniated disc)
  4. Actively taking UI, OAB, or any other bladder control medication.
  5. Other urinary conditions or procedures that may affect continence status (e.g. history of bladder cancer, urethral diverticula, previous augmentation cystoplasty or artificial sphincter; implanted nerve stimulators for urinary symptoms, history of sling surgery for UI or prolapse)
  6. Participation in another research project that may influence the results of this trial
  7. Pelvic organ prolapse protruding past the introitus upon straining
  8. Absolute absence of pelvic floor muscle strength manifested by zero Brink test (Brink et al., 1994 for pressure and displacement 9
  9. Evidence of UTI or hematuria - Urine dipstick positive for red blood cells will exclude the participant from enrollment in the study until a microscopic urinalysis is negative. Urine dipstick positive for leukocytes plus nitrates will exclude the participant from enrollment in the study and require further evaluation for UTI.
  10. History of > 2 recurrent UTI's in the past year and no more than one UTI within 6 months
  11. Post void residual > 150 cc

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: Instructional DVD Intervention
Participants randomized to this arm watched an eighteen minute bladder health instructional DVD at the conclusion of a successful baseline screening visit. This intervention occurred only once
Comportemental: Instructional DVD
Participants randomized to this arm watched an eighteen minute bladder health instructional DVD at the conclusion of a successful baseline screening visit. This intervention occurred only once.
Autre: Bladder Health Class Intervention
Participants randomized to this arm attended a two-hour bladder health instruction session that reviewed 3 primary self-care techniques that have been proven to prevent or lessen the severity of urinary incontinence. This session occurred only once 1-3 weeks subsequent to a successful baseline screening visit.
Comportemental: Bladder Health Class
Participants randomized to this arm attended a two-hour bladder health instruction session that reviewed 3 primary self-care techniques that have been proven to prevent or lessen the severity of urinary incontinence. This session occurred only once 1-3 weeks subsequent to a successful baseline screening visit.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Translating Unique Learning for Incontinence Prevention (TULIP)
Délai: 5 years
Prevention study for Urinary Incontinence in women over the age of 55 who are fully continent (do not leak urine at all) or mildly continent (leak small drops of urine on occasion). This study will measure the effectiveness of 2 interventions: a bladder health instruction session or Bladder Health DVD administration.
5 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Michigan

Collaborateurs

National Institute of Nursing Research (NINR)

Les enquêteurs

  • Chercheur principal: Carolyn Sampselle, PHD, RN, University of Michigan

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2010

Achèvement primaire (Réel)

1 janvier 2015

Achèvement de l'étude (Réel)

1 janvier 2015

Dates d'inscription aux études

Première soumission

14 mai 2012

Première soumission répondant aux critères de contrôle qualité

14 mai 2012

Première publication (Estimation)

16 mai 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

12 mai 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 mai 2016

Dernière vérification

1 mai 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • The TULIP Project
  • R01NR012011-01 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Manuscript preparation for data dissemination is currently in progress.

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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