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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

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
      • Assis, São Paulo, Brasil, 19810-000
        • Assis Regional Hospital

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:
  • Physical therapy guide

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.

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.

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

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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