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Uso do Sistema de Saúde Pélvica LEVA® para Incontinência Fecal

2 de setembro de 2026 atualizado por: University of Wisconsin, Madison

Comparação da duração do uso do sistema de saúde pélvica Leva® em mulheres com incontinência fecal

The goal of this clinical trial is to learn about how the duration of use of The Leva Pelvic Health System® affects treatment of fecal incontinence in women. The main question it aims to answer is to test whether use of the The Leva Pelvic Health System® for 8 weeks is as good as using it for 16 weeks.

Participants will complete surveys, and use the Leva device.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

This study will assess whether 8 weeks of use of the Leva Pelvic Health System (Leva) is non-inferior to 16 weeks of use for the treatment of chronic fecal incontinence (symptoms >/= 3 months) in adults with a vagina. Participants will be instructed to complete pelvic floor muscle training using the Leva for 8 or 16 weeks.

The hypothesis is that 8 weeks of use of Leva is non-inferior to 16 weeks of use, assessed by a validated FI symptom severity survey. Surveys will be completed at 0 weeks, 16 weeks, and 24 weeks. Long-term surveys will be completed at 1 year and 2 years from enrollment.

Tipo de estudo

Intervencional

Inscrição (Real)

38

Estágio

  • Fase 4

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

  • Estados Unidos
    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53705
        • University of Wisconsin

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:

  • Adult, age ≥ 18years, assigned female at birth
  • Fecal incontinence, defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment
  • Able to stand to perform daily training for at least 3 minutes
  • Able to speak and read English due to Leva smartphone application availability in only English at this time
  • Have an email address, owns a smartphone, and can download an app

Exclusion Criteria:

  • Inability to tolerate insertion of vaginal device (e.g., vaginal agenesis, vaginal stenosis, unremitting pelvic pain, within 12 weeks postpartum)
  • Current diagnosis of colorectal or anal malignancy
  • Diagnosis of uncontrolled inflammatory bowel disease
  • Current rectovaginal fistula or cloacal defect
  • Rectal prolapse (mucosal or full thickness)
  • Inability to utilize smart phone technology ("app" use)
  • Chronic Stool Types 6 or 7
  • Fecal impaction by exam
  • Stage 4 pelvic organ prolapse
  • Concurrent supervised anal sphincter exercise/pelvic floor muscle training with or without biofeedback
  • Presence of sacral neuromodulator
  • Pelvic floor surgery (including anal sphincteroplasty) within the past 3 months
  • Currently pregnant

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: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 8 semanas de uso de Leva
Dispositivo: The Leva Pelvic Health System

The Leva Pelvic Health System includes an intra-vaginal device that pairs with a smartphone application to provide real-time visual feedback about pelvic floor muscle performance during usage.
Comparador Ativo: 16 semanas de uso de Leva
Dispositivo: The Leva Pelvic Health System

The Leva Pelvic Health System includes an intra-vaginal device that pairs with a smartphone application to provide real-time visual feedback about pelvic floor muscle performance during usage.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Vaizey Score to Compare Effectiveness of Improving Fecal Incontinence Between 8 Weeks and 16 Weeks of Use
Prazo: Baseline to 16 weeks

Treatment response as length of use on symptom improvement at 16 weeks (comparing 8 weeks vs 16 weeks of use of Leva) as assessed by Vaizey Score, score ranges from 0-24, higher scores indicate more severe symptoms. A difference of -4.3 ± 3 is expected at 8 weeks and 16 weeks (compared to baseline), with an allowable difference of 1.
Baseline to 16 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Fecal Incontinence Severity
Prazo: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

Using St. Mark's Incontinence score, score ranges from 0-24, higher scores indicate more severe symptoms.
Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Cumulative Adherence Correlation With Change in St. Mark's Score
Prazo: Baseline to 24 weeks, long term follow up at 1 and 2 years

Adherence as a percentage of all expected exercise sessions correlated with change in St Mark's Incontinence Score (1-24)
Baseline to 24 weeks, long term follow up at 1 and 2 years
Patient Satisfaction and Usability of the Smartphone Application Component of the Leva Pelvic Health System
Prazo: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

Measured through the mHealth App Usability Questionnaire. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree. To determine the usability of an app, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the app.
Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Change in Fecal Incontinence From Baseline to 24 Weeks After 8 or 16 Weeks of Treatment
Prazo: Baseline to 24 weeks, long term follow up at 1 and 2 years

Treatment response as length of use on symptom improvement at 24 weeks (comparing 8 weeks vs 16 weeks of use of Leva) as assessed by St Mark's (Vaizey) scores.
Baseline to 24 weeks, long term follow up at 1 and 2 years
Change in Pelvic Organ Prolapse Quantification System (POP-Q)
Prazo: Baseline to 16 weeks

The POP-Q system is an objective, site-specific system used to describe, quantify, and stage pelvic support. Measurements are rated as Stage 0-Stage 4, with Stage 4 being complete prolapse.
Baseline to 16 weeks
Change in Brink Scale Score: Pressure
Prazo: Baseline to 16 weeks

The Brink scale evaluates 3 PFM contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner's fingers, and duration of contraction. Each muscle contraction variable is rated on a 4-point ordinal scale (1-4). Higher scores indicating greater strength.
Baseline to 16 weeks
Change in Brink Scale Score: Vertical Displacement
Prazo: Baseline to 16 weeks

The Brink scale evaluates 3 PFM contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner's fingers, and duration of contraction. Each muscle contraction variable is rated on a 4-point ordinal scale (1-4). Higher scores indicating greater strength.
Baseline to 16 weeks
Change in Brink Scale Score: Duration Contraction
Prazo: Baseline to 16 weeks

The Brink scale evaluates 3 PFM contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner's fingers, and duration of contraction. Each muscle contraction variable is rated on a 4-point ordinal scale (1-4). Higher scores indicating greater strength.
Baseline to 16 weeks
Change in Stool Consistency
Prazo: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

Use the Bristol Stool Scale to evaluate stool consistency. Ranges from Type 1 to Type 7, where Type 1 is hardest consistency and Type 7 is entirely liquid.
Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Change in Fecal Incontinence Quality of Life (FIQoL)
Prazo: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

Use FIQoL scale, in which participants rate questions about how often an issue is a concern, and how much they agree with statements on a scale of 1-5. Higher scores indicate lower quality of life.
Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Change in Sexual Function (PISQ-IR)
Prazo: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

PISQ-IR is a 20 item survey, where higher scores indicate lower sexual function.
Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Patient Global Impression of Improvement (PGI-I)
Prazo: 16 and 24 weeks, long term follow up at 1 and 2 years

PGI-I is a 2 question qualitative survey in which participants state their satisfaction and perception of improvement.
16 and 24 weeks, long term follow up at 1 and 2 years
Patient Satisfaction (PGI-I)
Prazo: 16 and 24 weeks, long term follow up at 1 and 2 years

PGI-I is a 2 question qualitative survey in which participants state their satisfaction and perception of improvement.
16 and 24 weeks, long term follow up at 1 and 2 years
Estimated Percentage of Change
Prazo: 16 and 24 weeks, long term follow up at 1 and 2 years

Qualitative question in which participants state their estimate of how much better they are, on a scale from 0% (no better) to 100% (completely better).
16 and 24 weeks, long term follow up at 1 and 2 years
Change in Global Pelvic Floor Symptoms
Prazo: Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years

Use the Pelvic Floor Distress Inventory (PFDI-20) to evaluate change in pelvic floor symptoms. It is a 20 item survey with a range from 0-100 where higher scores indicate greater symptoms.
Baseline to 16 and 24 weeks, long term follow up at 1 and 2 years
Evaluate Self-continuation of Pelvic Floor Muscle Exercises
Prazo: Baseline and 24 weeks, long term follow up at 1 and 2 years

Participant self-report on whether and how often they continued the pelvic floor muscle exercises.
Baseline and 24 weeks, long term follow up at 1 and 2 years
Number of Cumulative Adverse Events
Prazo: Baseline and 24 weeks, long term follow up at 1 and 2 years

Systematic assessment of all adverse events over the course of the study, reported as a number of total AEs.
Baseline and 24 weeks, long term follow up at 1 and 2 years
mHealth App Usability Questionnaire (MAUQ)
Prazo: 16 weeks

MAUQ is an 18-item survey scored on a 7 point likert scale from 1 (disagree) to 7 (agree) with higher scores indicative of higher usability.
16 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Wisconsin, Madison

Investigadores

  • Investigador principal: Dobie Giles, MD, University of Wisconsin, Madison

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 (Real)

17 de janeiro de 2024

Conclusão Primária (Real)

17 de dezembro de 2024

Conclusão do estudo (Estimado)

1 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

21 de novembro de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de novembro de 2023

Primeira postagem (Real)

30 de novembro de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2023-1304
  • A532810 (Outro identificador: UW- Madison)
  • SMPH/OBGYN BENIGN GYN (Outro identificador: UW - Madison)
  • Protocol Version 10/1/2024 (Outro identificador: UW - Madison)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Não

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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