- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01599715
Translating Unique Learning for Incontinence Prevention (TULIP)
Translating Unique Learning for Incontinence Prevention for Women Over the Age of 55
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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:
- Female, aged 55 years or older
- An additive sum of the frequency (question 1) and volume (question 2) items from the International Consultation on Incontinence Questionnaire-Short Form is ≤5
- Negative for demonstrable UI on the standardized Paper Towel Test
- Willing to undergo vaginal/pelvic examination
- Willing and able to be compliant with visit schedule and study procedures for the study duration
- Provide written informed consent form
- Able to understand and read English
Exclusion:
- Non-ambulatory (patient confined to bed or wheelchair)
- Persistent pelvic pain (defined as daily pelvic pain)
- 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)
- Actively taking UI, OAB, or any other bladder control medication.
- 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)
- Participation in another research project that may influence the results of this trial
- Pelvic organ prolapse protruding past the introitus upon straining
- Absolute absence of pelvic floor muscle strength manifested by zero Brink test (Brink et al., 1994 for pressure and displacement 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.
- History of > 2 recurrent UTI's in the past year and no more than one UTI within 6 months
- Post void residual > 150 cc
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan School of Nursing
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania Department of Urology
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Female, aged 55 years or older
- An additive sum of the frequency (question 1) and volume (question 2) items from the International Consultation on Incontinence Questionnaire-Short Form is ≤5
- Negative for demonstrable UI on the standardized Paper Towel Test
- Willing to undergo vaginal/pelvic examination
- Willing and able to be compliant with visit schedule and study procedures for the study duration
- Provide written informed consent form
- Able to understand and read English
Exclusion Criteria:
- Non-ambulatory (patient confined to bed or wheelchair)
- Persistent pelvic pain (defined as daily pelvic pain)
- 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)
- Actively taking UI, OAB, or any other bladder control medication.
- 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)
- Participation in another research project that may influence the results of this trial
- Pelvic organ prolapse protruding past the introitus upon straining
- Absolute absence of pelvic floor muscle strength manifested by zero Brink test (Brink et al., 1994 for pressure and displacement 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.
- History of > 2 recurrent UTI's in the past year and no more than one UTI within 6 months
- Post void residual > 150 cc
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: 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
|
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.
|
|
Otro: 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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Translating Unique Learning for Incontinence Prevention (TULIP)
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Carolyn Sampselle, PHD, RN, University of Michigan
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- The TULIP Project
- R01NR012011-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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