- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01806350
Pelvic Floor Muscle Training in Treating Urinary Incontinence in Gynecologic Cancer Survivors
A Pilot Randomized Control Trial to Evaluate Pelvic Floor Muscle Training for Urinary Incontinence Among Gynecologic Cancer Survivors
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVES:
I. To assess whether pelvic floor muscle training and behavioral therapy in gynecologic cancer survivors results in improvement in incontinence symptoms as measured by a validated questionnaire (Patient Global Impression of Improvement) at three month follow-up when compared to women who do not undergo pelvic floor muscle training.
II. To evaluate whether women who undergo pelvic floor muscle training and behavioral therapy report greater improvement in validated urinary incontinence symptom severity, pelvic floor distress and quality of life measures than women who do not undergo pelvic floor muscle training.
III. To evaluate the acceptability of pelvic floor muscle training (PFMT) among gynecological cancer survivors and to provide preliminary data to inform a power analysis for a larger randomized trial.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive a handout describing behavioral management tips for urinary incontinence, including information and suggestions about optimal volume fluid intake, constipation management, measures to reduce urgency by spreading fluid intake, and avoiding caffeine and other bladder irritants that have proved effective in other intervention trials. Patients undergo PFMT over 20-30 minutes teaching them to contract the pelvic floor muscles correctly and receive feedback to avoid the contraction of abdominal, gluteal or adductor muscles. Patients are asked to perform 3 sets of 10 pelvic muscle contractions with a goal of holding the contraction for 5 seconds daily for 12 weeks and also receive a reminder phone call to address concerns and review the instructions at 4 weeks.
ARM II: Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study.
After completion of study treatment, patients are followed up at 3 months.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87106
- University of New Mexico Cancer Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- History of uterine, cervical, ovarian or vulvar malignancy
- Treatment free interval of >= one year and currently have no evidence of cancer
- Reports urinary incontinence based on screening questionnaire
- Must have a stable address for the three month period
Exclusion Criteria:
- Current clinical evidence of urinary tract infection
- Within three months of failed surgery for urinary incontinence
- Planned surgery for urinary incontinence in the next three months
- Presence of neurologic condition that may impact bladder symptoms such as multiple sclerosis, stroke
- Pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Arm I (PFMT)
Patients receive a handout describing behavioral management tips for urinary incontinence, including information and suggestions about optimal volume fluid intake, constipation management, measures to reduce urgency by spreading fluid intake, and avoiding caffeine and other bladder irritants that have proved effective in other intervention trials.
Patients undergo PFMT over 20-30 minutes teaching them to contract the pelvic floor muscles correctly and receive feedback to avoid the contraction of abdominal, gluteal or adductor muscles.
Patients are asked to perform 3 sets of 10 pelvic muscle contractions with a goal of holding the contraction for 5 seconds daily for 12 weeks and also receive a reminder phone call to address concerns and review the instructions at 4 weeks.
|
Estudios complementarios
Undergo PFMT
Otros nombres:
|
Comparador activo: Arm II (usual care)
Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study.
|
Estudios complementarios
Receive usual care
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Improvement in the Patient Global Impression of Improvement (PGI-I) rating
Periodo de tiempo: 12 weeks
|
Fisher's exact test will be used to test whether the chance of success is identical for the two groups (intervention vs. control).
|
12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in the Incontinence Severity Index (ISI) score
Periodo de tiempo: Baseline to 3 months
|
The Brinks scale will be used by the trainers for the treatment group follow-up to evaluate the adequacy of the contractions in a qualitative manner.
A two sample t-test on the within individual differences will be used.
A non-parametric Mann-Whitney test will be used if the sample differences are non-normally distributed.
|
Baseline to 3 months
|
Changes in Urinary Distress Inventory (UDI)
Periodo de tiempo: Baseline to 3 months
|
The Brinks scale will be used by the trainers for the treatment group follow-up to evaluate the adequacy of the contractions in a qualitative manner.
A two sample t-test on the within individual differences will be used.
A non-parametric Mann-Whitney test will be used if the sample differences are non-normally distributed.
|
Baseline to 3 months
|
Changes in Incontinence Impact Questionnaire (IIQ), which measures the impact of urinary incontinence on quality of life
Periodo de tiempo: Baseline to 3 months
|
The Brinks scale will be used by the trainers for the treatment group follow-up to evaluate the adequacy of the contractions in a qualitative manner.
A two sample t-test on the within individual differences will be used.
A non-parametric Mann-Whitney test will be used if the sample differences are non-normally distributed.
|
Baseline to 3 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Teresa Rutledge, MD, University of New Mexico Cancer Center
Publicaciones y enlaces útiles
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
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias urogenitales
- Neoplasias por sitio
- Enfermedades urológicas
- Carcinoma
- Neoplasias Glandulares y Epiteliales
- Síntomas del tracto urinario inferior
- Manifestaciones Urológicas
- Neoplasias Uterinas
- Neoplasias Genitales Femeninas
- Enfermedades uterinas
- Enfermedades del sistema endocrino
- Enfermedades Ováricas
- Enfermedades anexiales
- Trastornos gonadales
- Neoplasias de glándulas endocrinas
- Trastornos de la micción
- Enfermedades Vulvares
- Neoplasias Ováricas
- Incontinencia urinaria
- Neoplasias Endometriales
- Carcinoma Epitelial De Ovario
- Neoplasias Vulvares
Otros números de identificación del estudio
- INST 0912
- NCI-2012-01319 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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