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- Ensaio Clínico NCT00740428
Pelvic Floor Exercises During Gestation in the Prevention of Urinary Incontinence and Pelvic Floor Muscle Dysfunction
4 de dezembro de 2009 atualizado por: UPECLIN HC FM Botucatu Unesp
The Effectiveness of Pelvic Floor Exercises During Gestation in the Prevention of Urinary Incontinence and Pelvic Floor Muscle Dysfunction.
Urinary incontinence is any involuntary loss of urine.
During gestation, hormonal and mechanical factors favor the incidence of urinary loss that may persist after delivery in up to 50% of women.
Gestational urine loss can be prevented or treated during pregnancy with physical therapy.
Pregnancy and delivery have been widely deemed important risk factors that should be assessed while developing preventive and curative treatments for both female urinary incontinence and pelvic floor muscle dysfunction.
Pelvic floor muscle exercises, led by skilled physical therapists, can prevent, reduce, or even cure involuntary urine loss as well as pelvic floor muscle dysfunction.
Within this framework, developing a low-cost, easy-to-perform method for the treatment of urinary incontinence and pelvic floor muscle dysfunction, with a preventive or curative approach, is considered necessary.
The overall objective of this study is to assess the effects of pelvic floor exercises during pregnancy on pelvic floor muscles and urinary continence.
Secondary aims include determining whether exercises change pelvic floor muscle function; if changing pelvic floor muscle function reduces the occurrence of urinary incontinence; developing and applying a manual guide; and determining whether the physical therapy guide is well accepted, easily understandable and reproducible.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Urinary incontinence is any involuntary loss of urine.
During gestation, hormonal and mechanical factors favor the incidence of urinary loss that may persist after delivery in up to 50% of women.
Gestational urine loss can be prevented or treated during pregnancy with physical therapy.
Pregnancy and delivery have been widely deemed important risk factors that should be assessed while developing preventive and curative treatments for both female urinary incontinence and pelvic floor muscle dysfunction.
Pelvic floor muscle exercises, led by skilled physical therapists, can prevent, reduce, or even cure involuntary urine loss as well as pelvic floor muscle dysfunction.
Within this framework, developing a low-cost, easy-to-perform method for the treatment of urinary incontinence and pelvic floor muscle dysfunction, with a preventive or curative approach, is considered necessary.
The overall objective of this study is to assess the effects of pelvic floor exercises during pregnancy on pelvic floor muscles and urinary continence.
Secondary aims include determining whether exercises change pelvic floor muscle function; if changing pelvic floor muscle function reduces the occurrence of urinary incontinence; developing and applying a manual guide; and determining whether the physical therapy guide is well accepted, easily understandable and reproducible.
Thus, 58 consenting primipregnants aged between 20 and 35 years, with no experience of urinary loss episodes before gestation will be assessed.
They will be allocated into 2 groups: G-I: pregnants for the first time who will receive the physical therapy guide, perform the exercises under the supervision of a physical therapist, and complete an exercise compliance form and a log with information on urinary losses; and G-II: pregnants for the first time who will just complete the urinary loss log without receiving the physical therapy guide and performing the exercises.
Meetings with each participant will take place at 6 occasions throughout pregnancy: at 18, 22, 26, 30, 34 and 38 weeks of gestation.
At 18 weeks, all participants will be asked to respond to a baseline questionnaire with overall and specific gestational data.
They will also be questioned about urine loss episodes over the past 30 days, and whether urine loss started during pregnancy.
In addition, they will undergo pelvic floor evaluation by Pelvic Floor Functional Assessment (PFFA), and perineometry with a Portable PerinaStim perineometer.
G-I women will be taught perineal contraction and receive an exercise guide for perineal contraction in 4 different positions.
These women will be instructed to write down exercise frequency on a compliance form as well as the occurrence of urinary incontinence on a urinary loss log.
In all 6 meetings, G-I and G-II participants will be reassessed by PFFA and perineometry, and asked to provide their completed urinary loss logs.
G-I participants will also be requested to provide their completed exercise compliance form and once again perform the sequence of exercises included in the guide under the supervision of a physical therapist.
During all meetings, the notes made on the exercise compliance form will be checked and later added to the baseline form of each participant.
The performance of pelvic floor exercises during gestation is expected to have a positive effect on pelvic floor muscles and urinary continence.
Pelvic floor muscle function is expected to improve reducing the occurrence of gestational urinary incontinence.
In addition, the physical therapy guide is expected to be well accepted, understandable and reproducible.
The results obtained in this study are intended to help clinical practice and open new research lines that may significantly contribute to women's health.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
48
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
São Paulo
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Assis, São Paulo, Brasil, 19810-000
- Assis Regional Hospital
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
20 anos a 35 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- 58 consenting pregnant for the first time aged between 20 and 35 years, with no experience of urinary loss episodes before gestation will be assessed.
Exclusion Criteria:
- Women who had more than one previous pregnancy
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: G1
pregnants for the first time who will receive the physical therapy guide
|
pregnants for the first time who will receive the physical therapy guide, perform the exercises under the supervision of a physical therapist, and complete an exercise compliance form and a log with information on urinary losses.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
UI reduction
Prazo: 12 months
|
12 months
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Pelvic floor muscle dysfunction reduction
Prazo: 12 monhs
|
12 monhs
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Adriano Dias, Dr., Botucatu Medical School
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
- de Assis LC, Bernardes JM, Barbosa AM, Santini AC, Vianna LS, Dias A. [Effectiveness of an illustrated home exercise guide on promoting urinary continence during pregnancy: a pragmatic randomized clinical trial]. Rev Bras Ginecol Obstet. 2015 Oct;37(10):460-6. doi: 10.1590/SO100-720320150005361. Portuguese.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de março de 2008
Conclusão Primária (Real)
1 de dezembro de 2008
Conclusão do estudo (Real)
1 de julho de 2009
Datas de inscrição no estudo
Enviado pela primeira vez
22 de agosto de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de agosto de 2008
Primeira postagem (Estimativa)
25 de agosto de 2008
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
7 de dezembro de 2009
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de dezembro de 2009
Última verificação
1 de dezembro de 2009
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- upeclin/HC/FMB-Unesp-10
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