Use of the LEVA® Pelvic Health System for Fecal Incontinence

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-17

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fecal Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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8 week use of Leva

Group Type EXPERIMENTAL

The Leva Pelvic Health System

Intervention Type DEVICE

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.

16 week use of Leva

Group Type ACTIVE_COMPARATOR

The Leva Pelvic Health System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No