- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87106
- University of New Mexico Cancer Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
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.
|
Estudos auxiliares
Undergo PFMT
Outros nomes:
|
Comparador Ativo: Arm II (usual care)
Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study.
|
Estudos auxiliares
Receive usual care
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Improvement in the Patient Global Impression of Improvement (PGI-I) rating
Prazo: 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).
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12 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Changes in the Incontinence Severity Index (ISI) score
Prazo: 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)
Prazo: 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
Prazo: 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
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Neoplasias por Tipo Histológico
- Neoplasias
- Neoplasias urogenitais
- Neoplasias por local
- Doenças Urológicas
- Carcinoma
- Neoplasias Glandulares e Epiteliais
- Sintomas do Trato Urinário Inferior
- Manifestações Urológicas
- Neoplasias uterinas
- Neoplasias Genitais Femininas
- Doenças uterinas
- Doenças do Sistema Endócrino
- Doenças ovarianas
- Doenças anexiais
- Distúrbios Gonadais
- Neoplasias das Glândulas Endócrinas
- Distúrbios da micção
- Doenças vulvares
- Neoplasias ovarianas
- Incontinencia urinaria
- Neoplasias endometriais
- Carcinoma Epitelial Ovariano
- Neoplasias vulvares
Outros números de identificação do estudo
- INST 0912
- NCI-2012-01319 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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