38 Participants Needed

LEVA® Device for Bowel Incontinence

SB
UP
Overseen ByUshma Patel, MD
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Research Team

DG

Dobie Giles, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for adult women over 18 with fecal incontinence, occurring at least monthly and seeking treatment. Participants must be able to stand for daily training, speak/read English (as the app is English-only), have an email, own a smartphone, and can use apps. Exclusions include intolerance to vaginal devices, certain medical conditions like colorectal malignancy or inflammatory bowel disease, recent pelvic surgeries or pregnancy.

Inclusion Criteria

I have had uncontrollable bowel movements at least once a month for the last 3 months and want treatment.
I am an adult woman aged 18 or older.
I can stand and train for at least 3 minutes daily.
See 2 more

Exclusion Criteria

I have been diagnosed with colorectal or anal cancer.
Inability to tolerate insertion of vaginal device (e.g., vaginal agenesis, vaginal stenosis, unremitting pelvic pain, within 12 weeks postpartum)
My inflammatory bowel disease is not under control.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Leva Pelvic Health System for either 8 or 16 weeks to treat fecal incontinence

8-16 weeks
Surveys at 0, 16, and 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with surveys conducted at 1 and 2 years

Long-term
Surveys at 1 and 2 years

Treatment Details

Interventions

  • The Leva Pelvic Health System
Trial Overview The study tests the Leva Pelvic Health System's effectiveness on treating fecal incontinence over different durations: comparing results from using it for 8 weeks versus 16 weeks. Women will use the device alongside completing surveys about their condition.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: 8 week use of LevaExperimental Treatment1 Intervention
Group II: 16 week use of LevaActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+
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