Postpartum pelvic floor recovery with Leva
Feasibility of Pelvic Floor Muscle Training With a Digital Therapeutic Motion-based Device (Leva Device) in a Postpartum Population
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of South Florida Academic / other |
| Locations | 2 sites (Tampa, Florida and 1 other locations) |
| Trial ID | NCT06609317 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tampa, Florida and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.