Postpartum pelvic floor recovery with Leva
Official title: Feasibility of Pelvic Floor Muscle Training With a Digital Therapeutic Motion-based Device (Leva Device) in a Postpartum Population
Run by University of South Florida · NCT06609317 · Data updated 2026-11-12
This study tests whether a motion-based Leva device can help people 4–8 weeks after a vaginal birth rebuild pelvic floor strength and reduce bladder, bowel, and pelvic symptoms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 25 (estimated) |
| Sponsor | University of South Florida Academic / other |
| Locations | 2 sites (Tampa, Florida and 1 other locations) |
| Status | Recruiting |
| Started | April 4, 2025 |
| Main results expected | November 2025 |
| Study ends | February 2026 |
| Registry record updated | July 29, 2025 |
| Trial ID | NCT06609317 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are ambulatory adults (≥18 years) who had a spontaneous vaginal delivery 4–8 weeks earlier, speak English, own a smartphone, and do not have operative delivery, severe perineal tears, episiotomy, or multiples.
✕Probably not a fit
People who had a cesarean or operative delivery, third- or fourth-degree perineal lacerations, an episiotomy, multiple births, delivery before 20 weeks, who are non-ambulatory, or who lack a smartphone are unlikely to qualify or benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective cohort study enrolls people 4–8 weeks after a spontaneous vaginal delivery to use an FDA-cleared, motion-based digital therapeutic (Leva) for pelvic floor muscle training. Participants will use the device at home and complete electronic questionnaires about bladder and bowel function, pelvic organ prolapse symptoms, and vaginal/perineal pain. Sexual function will also be measured at 3 and 6 months postpartum. The primary focus is feasibility of device use in the immediate postpartum period, with clinical symptom tracking at 3 and 6 months.
Why it matters
Potential benefit: If successful, the device could speed pelvic floor recovery and reduce postpartum urinary and bowel symptoms, pain, and sexual dysfunction.
How similar studies have gone: Digital pelvic floor training and biofeedback devices have shown promise for urinary incontinence and pelvic function in non-postpartum populations, but evidence specific to the immediate postpartum period is still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Spontaneous vaginal delivery within the last 4-8 weeks * Age ≥ 18 years * Ambulatory * Willing and able to consent to participate. * English speaking * Owns a smartphone Exclusion Criteria: * Operative or cesarean delivery * Obstetric delivery at less than 20 weeks gestation * Third- or fourth-degree perineal laceration * Episiotomy * Multiples
Where it's running
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University of South Florida
Tampa, Florida, United States Recruiting -
Ohio State University Wexner Medical Center
Columbus, Ohio, United States Recruiting
Study contacts
- Study coordinator: Katie Propst, MD
- Email: katiepropst@usf.edu
- Phone: 813-259-0655
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.