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Utilisation du système de santé pelvienne LEVA® pour l'incontinence fécale

2 septembre 2026 mis à jour par: University of Wisconsin, Madison

Comparaison de la durée d'utilisation du système de santé pelvienne Leva® chez les femmes souffrant d'incontinence fécale

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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

38

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Wisconsin
      • Madison, Wisconsin, États-Unis, 53705
        • University of Wisconsin

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 8 semaines d'utilisation de Leva
Dispositif: 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.
Comparateur actif: 16 semaines d'utilisation de Leva
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Vaizey Score to Compare Effectiveness of Improving Fecal Incontinence Between 8 Weeks and 16 Weeks of Use
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Fecal Incontinence Severity
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Wisconsin, Madison

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

17 janvier 2024

Achèvement primaire (Réel)

17 décembre 2024

Achèvement de l'étude (Estimé)

1 décembre 2026

Dates d'inscription aux études

Première soumission

21 novembre 2023

Première soumission répondant aux critères de contrôle qualité

21 novembre 2023

Première publication (Réel)

30 novembre 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Non

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